Medical Licensure Program Targeted Series of Cme for License Renewal

CME FOR PHYSICIANS AND OTHER HEALTH CARE PROVIDERS

2021 TEXAS MEDICAL LICENSURE PROGRAM TARGETED SERIES OF CME FOR LICENSE RENEWAL

PROGRAM SATISFIES: 2 HOURS PAIN MANAGEMENT/OPIOIDS (NEW)* 1 HOUR v HHSC APPROVED *NEW MANDATORY CME REQUIREMENTS MUST HUMAN TRAFFICKING (NEW)* BE COMPLETED PRIOR TO NEXT RENEWAL

CME FOR: AMA PRA CATEGORY 1 CREDITS™ MIPS MOC STATE LICENSURE TX.CME.EDU InforMed is Accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 2021 TEXAS

01 OPIOID ANALGESICS IN THE MANAGEMENT OF ACUTE AND CHRONIC PAIN COURSE ONE | 3 CREDITS * *THIS COURSE SATISFIES THE NEW PAIN MANAGEMENT/OPIOIDS REQUIREMENT 43 A CLINICIAN’S GUIDE TO RECOGNIZING AND RESPONDING TO HUMAN TRAFFICKING IN TEXAS COURSE TWO | 1 CREDIT + +THIS HHSC APPROVED COURSE SATISFIES THE NEW HUMAN TRAFFICKING TRAINING REQUIREMENT 52 PREVENTING CLINICIAN BURNOUT COURSE THREE | 6 CREDITS 85 SUICIDE ASSESSMENT & PREVENTION COURSE FOUR | 6 CREDITS 128 LEARNER RECORDS: ANSWER SHEET & EVALUATION REQUIRED TO RECEIVE CREDIT

*+ In addition to satisfying the new Opioid and Human Trafficking requirements, these formal hours may be credited towards the requirement for Medical Ethics or Professional Responsibility for physicians.

method and answers to the evaluation questions

$50.00 $75.00 $95.00 courses 1 & 2 COURSES 1 & 2 PLUS COURSE 3 OR 4 entire program

ONLINE MAIL FAX 1015 Atlantic Blvd #301 TX.CME.EDU 1.800.647.1356 Jacksonville, FL 32233 INFORMED TRACKS WHAT YOU NEED, WHEN YOU NEED IT

Texas Professional License Requirements PHYSICIANS (MD/DO) AND PHYSICIAN ASSISTANTS (PA) CONTINUING MEDICAL EDUCATION REQUIREMENT Physicians need to complete at least 48 hours of continuing medical education every 24 months (24 month timeline is in relation to the biennial registration period, not the calendar year). At least 24 of these hours must be in formal courses (AMA Category 1 or equivalent). Physician Assistants need to complete at least 40 hours of CME every 24 months (in relation to the biennial registration period, not the calendar year). At least 24 of these hours must be formal courses (AAPA or AMA Category 1).

NEW PAIN MANAGEMENT AND THE PRESCRIPTION OF OPIOIDS REQUIREMENT Per Texas Administrative Code Title 22, Part 9, Chapter 166 for licensed physicians (MD/DO) and Chapter 185 for licensed physician assistants (PA), at least two (2) of the formal hours required must involve the study of the following topics: best practices, alternative treatment options, and multi-modal approaches to pain management that may include physical therapy, psychotherapy, and other treatments; safe and effective pain management related to the prescription of opioids and other controlled substances, including education regarding standards of care, identification of drug-seeking behavior in patients, and effectively communicating with patients regarding the prescription of an opioid or other controlled substances; and prescribing and monitoring of controlled substances. This requirement applies to the renewal of a license on or after September 1, 2020. These formal hours may be credited towards the requirements for Medical Ethics or Professional Responsibility for any physician.

NEW HUMAN TRAFFICKING TRAINING REQUIREMENT Per Texas Occupations Code, Title 3, Subtitle B, Sec. 156.060, licensed physicians (MD/DO) and physician assistants (PA) are now required to complete a human trafficking prevention course approved by the Texas Health and Human Services Commission (HHSC).This requirement applies to the renewal of a license on or after September 1, 2020. These formal hours may be credited towards the requirements for medical ethics or professional responsibility for physicians. What This Means For You:

During each biennial registration period as a prerequisite for registration renewal, licensed MD/DOs must complete at least 48 hours of CME, and licensed PAs must complete at least 40 hours. Additionally, you are now required to complete at least two (2) hours on Pain Management/Opioids and one (1) hour on HHSC Approved Human Trafficking Training. These hours may be credited towards the requirements for Medical Ethics or Professional Responsibility for physicians (MD/DO) and will count toward the total amount of formal hours required.

Texas Medical Board 333 Guadalupe LICENSE TYPES: Tower 3, Suite 610 COMPLETION DEADLINE: MD/DO Austin, TX 78701 PRIOR TO YOUR NEXT PA P : (512) 305-7010 LICENSE RENEWAL

Disclaimer: The above information is provided by InforMed and is intended to summarize state CE/CME license requirements for informational purposes only. This is not intended as a comprehensive statement of the law on this topic, nor to be relied upon as authoritative. All information should be verified independently.

i MOC/OCC/MIPS CREDIT INFORMATION In addition to awarding AMA PRA Category 1 CreditsTM, the successful completion of enclosed activities may award the following MOC points and credit types. To be awarded MOC points, you must obtain a passing score and complete the corresponding Activity Evaluation.

Table 1. MOC Recognition Statements Successful completion of certain enclosed CME activities, which includes participation in the evaluation component, enables the participant to earn up to the amounts and credit types shown in Table 2 below. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit. Board Programs ABA American Board of Anesthesiology’s redesigned Maintenance of Certification in AnesthesiologyTM (MOCA®) program, known as MOCA 2.0®

ABIM American Board of Internal Medicine’s Maintenance of Certification (MOC) program

ABO American Board of Ophthalmology’s Maintenance of Certification (MOC) program

ABOHNS American Board of Otolaryngology – Head and Neck Surgery’s Continuing Certification program (formerly known as MOC)

ABPath American Board of Pathology’s Continuing Certification Program

ABP American Board of Pediatrics’ Maintenance of Certification (MOC) program.

Table 2. Credits and Type Awarded Activity Title AMA PRA Category 1 ABA ABIM ABO ABOHNS ABPath ABP CreditsTM Opioid Analgesics in the 3 AMA PRA Category 1 3 Credits 3 Credits 3 Credits 3 Credits 3 Credits 3 Credits Management of Acute CreditsTM LL MK LL & SA SA LL & SAM LL+SA And Chronic Pain Preventing Clinician Burnout 6 AMA PRA Category 1 6 Credits 6 Credits 6 Credits 6 Credits 6 Credits 6 Credits CreditsTM LL & PS MK & PS LL, SA, & PS SA & PS LL & SAM LL+SA Suicide Assessment & 6 AMA PRA Category 1 6 Credits 6 Credits 6 Credits 6 Credits 6 Credits 6 Credits Prevention CreditsTM LL & PS MK & PS LL, SA, & PS SA & PS LL & SAM LL+SA Legend: LL = Lifelong Learning, MK = Medical Knowledge, SA = Self-Assessment, SAM = Self-Assessment Module, LL+SA = Lifelong Learning & Self- Assessment, PS = Patient Safety

Table 3. Osteopathic Continuous Certification (OCC) Credit Information Completion of each accredited CME activity awards AMA PRA Category 1 CreditsTM which may be reported as AOA Category 2-B Credit toward CME requirements for AOA Specialty Certifying Boards. Reporting of CME earned for AMA PRA Category 1 CreditTM to the AOA is the responsibility of the physician. Visit https://osteopathic.org/cme/cme-guide/ for more information on this topic.

Table 4. CME for MIPS Statement Completion of each accredited CME activity meets the expectations of an Accredited Safety or Quality Improvement Program (IA PSPA_28) for the Merit- based Incentive Payment Program (MIPS). Participation in this Clinical Practice Improvement Activity (CPIA) is optional for eligible providers.

DATA REPORTING: Federal, State, and Regulatory Agencies require disclosure of data reporting to all course participants. InforMed abides by each entity’s requirements for data reporting to attest compliance on your behalf. Reported data is governed by each entity’s confidentiality policy. To report compliance on your behalf, it’s mandatory that you must achieve a passing score and accurately fill out the learner information, activity and program evaluation, and the 90-day follow up survey. Failure to accurately provide this information may result in your data being non-reportable and subject to actions by these entities.

ii For more than 49 years InforMed has been providing high level education activities to physicians and other healthcare providers. Through our level of engagement with a wide variety of stakeholders, including our physician association, we have become the foremost public health policy continuing medical education organization in the United States. We are recognized as the leading provider of mandatory CME activities to physicians as a means of updating knowledge, improving competencies and fulfilling requirements for federal, state, regulatory and license renewal.

Dear Texas Medical Professional,

InforMed is pleased to offer this collection of CME activities for health care professionals in the state of Texas. The uniquely tailored curriculum is customized to the educational needs of the Texas medical professional. Participants earn AMA PRA Category 1 CreditTM, MOC credit, and MIPS points through these self-directed, on-demand courses.

The CME series is designed to streamline the continuing medical education requirements of the Texas Medical Board. Licensees who complete this program optimize their learning path while satisfying new professional credentialing requirements for two (2) hours on Pain Management/Opioids and one (1) hour on HHSC Approved Human Trafficking Training. All activities are independently sponsored by InforMed Continuing Medical Education without commercial support.

Thank you for choosing InforMed as your CME provider. Please do not hesitate to contact us with any questions, concerns or suggestions.

-InforMed CME Team

Visit TX.CME.EDU, select NETPASS to begin. TX.CME.EDU

1015 Atlantic Blvd #301 Jacksonville, FL 32233

Inquiries related to any part of the program or associated materials including, but not limited to, interpretation of any ACCME, AMA, ABMS Specialty Boards, FDA, federal, state, and/or regulatory agency standards and statues may be submitted in writing to: Legal Compliance and Rulings, 1015 Atlantic Boulevard #301, Jacksonville, FL 32233

iii OPIOID ANALGESICS IN THE Release Date: 09/2019 3 AMA PRA Enduring Material MANAGEMENT OF ACUTE & Exp. Date: 08/2022 Category 1 Credits™ (Self Study) CHRONIC PAIN

TARGET AUDIENCE

This course is designed for all physicians and health care providers involved in the treatment and monitoring of patients with pain. Read the course materials

Complete the self-assessment questions at the end. A score of 70% is required. COURSE OBJECTIVE Return your customer information/ This course is designed to increase physician knowledge and skills answer sheet, evaluation, and regarding guideline-recommended principles of pain management, the payment to InforMed by mail, phone, fax range of opioid and non-opioid analgesic treatment options, and specific or complete online at course strategies for minimizing opioid analgesic prescription, diversion, and website under NETPASS. abuse.

LEARNING OBJECTIVES

Completion of this course will better enable the course participant to: 1. Discuss the fundamental concepts of pain management, including pain types and mechanisms of action of major analgesics. 2. Identify the range of therapeutic options for managing acute and chronic pain, including non-pharmacologic approaches and pharmacologic (non-opioid and opioid analgesics) therapies. 3. Explain how to integrate opioid analgesics into a pain treatment plan individualized to the needs of the patient, including counseling patients and caregivers about the safe use of opioid analgesics. 4. Discuss recommendations for incorporating emergency opioid antagonists into prescribing practice, and for training patients and family members on the use of naloxone. 5. Recognize the risks of addiction inherent in the use of opioids for both acute and chronic pain and identify strategies to mitigate risks of diversion and misuse. 6. Identify medications currently approved for the treatment of opioid use disorder and the ways these medications differ in terms of mechanisms of action, regulatory requirements, and modes of administration.

ACCREDITATION STATEMENT InforMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

DESIGNATION STATEMENT InforMed designates this enduring material for a maximum of 3 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. 1 FACULTY

Paul J. Christo, MD, MBA Associate Professor, The Johns Hopkins University School of Medicine Director, Multidisciplinary Pain Fellowship Program (2003-2011) Director, Blaustein Pain Treatment Center (2003-2008) Division of Pain Medicine 3 Melissa B. Weimer, DO, MCR, FASAM PAIN MANAGEMENT/ Assistant Professor OPIOIDS Department of Internal Medicine Yale University School of Medicine

Stephen Braun SPECIAL DESIGNATION Medical Writer Braun Medical Communications This course satisfies the new two (2) hour requirement on Pain Management and the Prescription of Opioids. ACTIVITY PLANNER

Michael Brooks Per Texas Admin Code Title 22, Part 9, Chapter Director of CME, InforMed 166 for MD/DOs and Chapter 185 for PAs, at least two (2) of the total formal hours required must include Pain Management/Opioids every DISCLOSURE OF INTEREST biennial registration period. In accordance with the ACCME Standards for Commercial Support of CME, InforMed implemented mechanisms, prior to the planning and implementation of this CME activity, to identify and resolve conflicts of interest for all individuals in a position to control content of this CME activity.

FACULTY/PLANNING COMMITTEE DISCLOSURE

The following faculty and/or planning committee members The following faculty and/or planning committee members have indicated they have no relationship(s) with industry to have indicated that they have relationship(s) with industry to disclose relative to the content of this CME activity: disclose: • Stephen Braun • Paul J. Christo, MD, MBA has received honoraria from • Michael Brooks GlaxoSmithKline, Daiichi Sankyo, and BTG International. • Melissa B. Weimer, DO, MCR, FASAM has received honoraria from Alkermes.

STAFF AND CONTENT REVIEWERS

InforMed staff, input committee and all content validation reviewers involved with this activity have reported no relevant financial relationships with commercial interests.

3 Pain can be classified on the basis of its Figure 3: The biopsychosocial model of pain1 pathophysiology. Nociceptive pain is caused by the activation of nociceptors (pain receptors), and is generally, though not always, short-lived, and associated with the presence of an underlying medical condition. This is “normal” acute pain: a physiological response to an injurious stimulus. Neuropathic pain, on the other hand, results from an injury to the peripheral or central nervous system. It is an abnormal response to a stimulus caused by dysfunctional neuronal firing in the absence of active tissue damage. It may be continuous or episodic and varies widely in how it is perceived. Neuropathic pain is complex and can be difficult to diagnose. Related to both nociceptive and neuropathic pain is the phenomenon of sensitization, which is a state of hyperexcitability in either peripheral nociceptors or neurons in the central nervous system (i.e., central sensitization). Sensitization may lead to either hyperalgesia (heightened pain such as an injury or surgical procedure. It has a signs of pain (e.g., tachycardia, grimacing) are from a stimulus that normally provokes pain) or generally short duration, and usually lasts less neither sensitive nor specific for pain and should allodynia (pain from a stimulus that is not normally than four weeks, improving with time.15 Acute pain not replace patient self-report unless the patient painful).16 Sensitization may arise from intense, is one of the most common presenting complaints is unable to communicate. Therefore, talking to repeated, or prolonged stimulation and subsequent in ambulatory care.21 In contrast, chronic pain is patients and asking them about their pain (i.e., upregulation of nociceptors, from the influence defined as lasting more than three months or past obtaining a “pain history”) is integral to pain of compounds released by the body in response the time of normal tissue healing. It can result from assessment. to tissue damage or inflammation, or sometimes an underlying medical disease or condition, injury, The pain history usually is obtained as part as an adaptation to prolonged exposure to opioid medical treatment, inflammation, or an unknown of the patient history, which includes the patient’s analgesics.17 Many patients—particularly those cause.22 past medical history, medications, habits (e.g., with chronic pain—experience pain with both Although pain is expected after injury or surgery, smoking, alcohol intake), family history, and nociceptive and neuropathic components, which the patient pain experience can vary markedly. The psychosocial history. Obtaining a comprehensive complicates assessment and treatment. intensity of pain can be influenced by psychological history provides many potential benefits, including Differentiating between nociceptive and distress (e.g., depression or anxiety), heightened improved management, fewer treatment side neuropathic pain is critical because the two respond illness concern, or ineffective coping strategies effects, improved function and quality of life, and differently to pain treatments. Neuropathic pain, regarding the ability to control pain and function better use of health care resources. for example, may respond poorly to both opioid despite it.23 It may also be shaped by personality, The manner in which information is elicited analgesics and non-steroidal anti-inflammatory culture, attitudes, and beliefs. For example, injured from the patient is important. Ideally, the clinician (NSAID) agents.18 Other classes of medications, soldiers who had positive expectations of pain (e.g., should afford ample time, let patients tell their such as anti-epileptics, antidepressants, or local evacuation and safe recuperation) requested less stories in their own words, and ask open-ended anesthetics, may provide more effective relief for analgesic medication than civilians with comparable questions. Information to be elicited during the 19 injuries who had more negative associations with neuropathic pain. 15 initial assessment of pain includes: Another important dimension of pain is its pain (e.g., loss of wages and social hardship). • Characteristics of the pain (e.g., duration, effects beyond strictly physiological functioning. Assessing pain location, intensity, quality, exacerbating/ Pain is currently viewed as a multi-dimensional, alleviating factors) multi-level process similar in many ways to other Goals and Elements of the Initial Assessment • Present and past pain management strategies disease processes which may start with a specific Important goals of the initial assessment of pain and their outcomes injury but which can lead to a cascade of events that include establishing rapport with the patient and • Past and present medical problems that may 24 can include physical deconditioning, psychological providing an overview of the assessment process. influence the pain and/or its management and emotional burdens, and dysfunctional These processes help to engage the patient, foster • Relevant family history behavior patterns that affect not just the sufferer, appropriate treatment expectations, and promote • Current and past psychosocial issues or but their entire social milieu (illustrated in Figure a coordinated approach to management. The factors that may influence the pain and its 3).1 The pain community is currently discussing clinician’s primary objective is to obtain information management that will help identify the cause of the pain and an expansion of the current definition of pain to • Pregnancy/contraceptive status guide management. A patient history, physical include a biopsychosocial perspective: “pain is a • Functional status examination, and appropriate diagnostic studies are distressing experience associated with actual or • The impact of the pain on the patient’s daily typically conducted for this purpose. potential tissue damage with sensory, emotional, life and functioning cognitive, and social components.”20 Patient history • The patient’s and family’s knowledge of, Acute pain is defined as having an abrupt The patient’s self-report is the most reliable expectations about, and goals for pain onset and is typically due to an obvious cause, indicator of pain.25 Physiological and behavioral management. 4 Assessing the impact of pain on functional of pain through the course of management. The BPI patterns, and mental status. Caregiver observations status and sleep and screening for mental health is self-administered but somewhat time-consuming, and reports are critical to appropriate assessment conditions potentially related to pain or treatment which may limit its role in a busy clinical practice. and management of chronic pain conditions.31 adherence (e.g., depression, anxiety, and memory issues) may provide useful information for pain PEG scale BEFORE MOVING ONTO THE NEXT SECTION, management.26 Depression in older patients, The PEG scale (Pain average, interference with PLEASE COMPLETE CASE STUDY 1 ON THE for example, sometimes presents with somatic Enjoyment of life, and interference with General NEXT PAGE. complaints of pain. Pain complaints may resolve activity) is a three-item tool based on the BPI and is Screening for risk of chronic pain after acute when the underlying depression is treated. Patients practical for clinical practice (Figure 4). Zero-to-10 pain can also be screened for known risk factors for OUD scales are used to assess pain, enjoyment of life, A number of factors have been associated with (see below). and general activity. PEG can be self-administered or done by the clinician and is relatively brief. 29 an increased risk for chronic pain following acute Assessment tools pain or surgery including older age, psychological Many tools have been developed to document Assessing acute pain problems, higher levels of pre-procedural pain and assess pain. Initial approaches to assessing pain Acute pain intensity can be assessed with or pain sensitivity, type and duration of surgery, severity use a visual analog scale (VAS) rating pain unidimensional tools such as the VAS and the severity and number of comorbidities, and use of 32 from 0 (no pain) to 10 (worst pain you can imagine) Wong-Baker FACES Pain Rating Scale (faces post-procedural radiation or chemotherapy. (some scales use a 0 to 100 scale). Such scales are depicting increasing levels of pain). While useful Some tools have been developed to help often used in clinical trials of pain therapies, and the for a quick assessment, these scales alone may clinicians predict the likelihood that a patient will minimal clinically important difference using these not appropriately identify patients with pain-related experience chronic pain following acute injury or scales is generally considered a 20%-30% change suffering driven by functional limitations, worry, or procedures. The 5-item PICKUP model, for example, from baseline (i.e., 2-3 points on a 0-10 scale or other factors, and may not detect some patients showed moderate prognostic performance in a 20-30 points on a 0-100 scale).27 with clinically significant pain.30 derivation study using data from 2,758 patients 33 Multidimensional tools, such as those described Although developed for patients with chronic with acute low back pain. Sipila and colleagues below, include questions relating to quality of life pain, the BPI is also applicable to patients with developed a 6-item screening instrument for risk and participation in daily activities. Such tools acute pain. Completed by the patient, the BPI factors of persistent pain after breast cancer 34 can provide a more comprehensive approach to captures ways that pain impacts function and surgery based on a cohort of 489 women. assessing pain and response to treatment. The quality of life, although, like most multidimensional Screening for opioid abuse risk factors selection of a pain assessment tool must balance questionnaires, it requires more time (about 10 Screening and monitoring in pain management the comprehensiveness of the assessment obtained minutes) and concentration to complete, which may seeks to identify patients at risk of substance with the time and energy required to use the tool in limit its utility in some elderly patients.28 misuse and overdose as well as improve overall a real-world practice setting. Assessing pain in the cognitively impaired patient care. Evaluations of patient physical and Brief pain inventory Although patients with mild-to-moderate psychological history can screen for risk factors The Brief Pain Inventory (BPI) is used frequently dementia can report their pain and its location, and help characterize pain to inform treatment in clinical trials to assess pain. Specifically developed those with severe dementia are often unable to decisions. Screening approaches include efforts to for patients with chronic pain, the BPI more fully communicate their pain experience or request assess for concurrent substance use and mental captures the impact of pain on patient function and medication. In these patients, physicians need health disorders that may place patients at higher quality of life than simple VAS scales.28 By including to observe pain behaviors, including facial risk for OUD and overdose. This includes screening a pain map, the BPI allows tracking of the location expressions, verbal cues, body movements, for drug and alcohol use and the use of urine drug changes in interpersonal interactions, activity testing, when clinically indicated. Figure 4: PEG scale29

1. What number best describes your pain on average in the past week?

0 1 2 3 4 5 6 7 8 9 10 No pain Pain as bad as you can imagine

2. What number best describes how, during the past week, pain has interfered with your enjoyment of life?

0 1 2 3 4 5 6 7 8 9 10 Does not Completely interfere interferes

3. What number best describes how, during the past week, pain has interfered with your general activity?

0 1 2 3 4 5 6 7 8 9 10 Does not Completely interfere interferes

5 Case Study 1 Instructions: Review the mental health assessment tools below and consider the questions that follow. Harold, a 62-year-old African American man, uses a walker to slowly make his way down your clinic hallway. In the exam room, he says he has always been physically active, playing golf and enjoying long walks, but now feels exhausted all the time and has lost his desire for previous activities. He was diagnosed with metastatic prostate cancer 17 years ago, and the cancer has been held in check by a novel chemotherapeutic agent. Now, however, he has severe (8 out of 10) axial lumbar pain due to disc herniation at the L4 – L5 region. For the past four months he says he’s been unable to play golf or do any of his former activities, in addition to being tired from disrupted sleep. He describes breakthrough pain occurring despite the Tylenol #3 he was prescribed. “I just can’t go on like this,” he says. “You’ve got to help me out. I’m at the end of my rope.”

Mental Health Assessment Tools: 1. Which of these tools might be appropriate to use with Harold? • Patient Health Questionnaire –2 (PHQ-2). This is a simple two- item screening tool. If it is positive on either item, the clinician should offer another more detailed questionnaire to better assess the presence or absence of a depressive disorder. Avail- able at: https://www.hiv.uw.edu/page/mental-health-screening/ phq-2 • Patient Health Questionnaire–9 (PHQ-9). This nine-item tool 2. How might Harold’s mental health issues interact with the screens for a depressive disorder, and often is used as a fol- management of his pain? low-up to the PHQ-2. It’s easy to score and use. Available at: https://www.hiv.uw.edu/page/mental-health-screening/phq-9 • Zung Self-Rating Depression Scale (Zung). This is a 20-item written questionnaire. Available at: https://psychology-tools. com/test/zung-depression-scale • Hamilton Depression Rating Scale (Ham-D). This is 21-item 3. What other tools or techniques might be used to better charac- screening questionnaire. Cutoff scores is <7 is normal. Avail- terize Harold’s overall mental and physical functioning? (e.g., able at: https://www.psychcongress.com/hamilton-depression-rating-scale-ham-d taking a psychosocial history; using the mini mental status • Generalized Anxiety Disorder 7-item Scale (GAD). This is a exam; or asking questions aimed at assessing his level of 7-item scale to screen for generalized anxiety. Available at: physical and social functioning.) https://psychology-tools.com/test/gad-7 • Primary Care PTSD (PC-PTSD). This is a four item screening test for Post-Traumatic Stress Disorder. Available at: https://www. ptsd.va.gov/professional/assessment/screens/pc-ptsd.asp

These approaches enable providers to identify and probably at least annually when prescribing Using prescription drug monitoring programs high-risk patients so that they can consider opioids for chronic pain.38 (PDMPs) substance misuse and mental health interventions, Other tools for universal substance abuse As of April, 2019, all U.S. states (except and education materials to mitigate opioid misuse.1 screening include: Missouri) and the District of Columbia have Many tools have been developed for the formal • Single question screening tool for drug use operational PDMPs.39,40 Information available assessment of a patient’s risk of having a substance • Drug Abuse Screening Test (DAST) 10 through PDMPs varies based on reporting misuse problem, some of which are appropriate for • Alcohol, Smoking, and Substance Involvement requirements and restrictions, but may include routine clinical use because they are relatively brief Screening Test (ASSIST) DEA schedules reported, timeliness of pharmacy and easily implemented. Table 1 lists the tools that • Tobacco, Alcohol, Prescription medication, and dispensing information, access, and required appear to have good content, and face construct other Substance use (TAPS) reviews. Recommendations for PDMP use include: • CAGE questionnaire adapted to include drugs validity for assessing patient risks related to chronic • Check the PDMP before starting anyone on (CAGE-AID) opioid therapy, although to date, no single tool has opioid therapy. If results from an assessment tool indicate that a been widely endorsed or thoroughly validated.35 • Review the PDMP periodically throughout patient has misused opioids, probe further using The Screening, Brief Intervention and Referral opioid therapy (at least every 3 months). the “5 A’s” approach: to Treatment (SBIRT) is an evidence-based tool • Look for prescriptions for other controlled 1. Ask specifically about opioid use used to facilitate screening patients for OUD, which 2. Advise patients to use medication-assisted substances, like benzodiazepines, that can typically takes 5-10 minutes to administer.36 SBIRT treatment for opioid use disorder with, or increase risk of overdose death. has been endorsed by the Substance Abuse and without, psychotherapeutic or cognitive- • Review the total MMED. Mental Health Services Administration (SAMHSA), behavioral treatments but should always be paired with referral to 3. Assess the patient’s willingness to enter Some states have specific requirements for treatment.37 SAMHSA recommends universal treatment and diagnose OUD using DSM-5 PDMP use, such as requiring review prior to initial screening with oral or writing-based tools because criteria prescription or any time a specific prescription is 4. Assist patients by connecting them with of the high prevalence of substance use disorders treatment (provide a referral if not available written, such as for hydrocodone ER (Zohydro), in patients visiting primary care settings. In contrast, in-office) therefore clinicians should remain updated about universal screening with urine, blood, or oral fluid 5. Arrange follow-up appointments, either in the specific requirements of their state PDMPs. tests are not recommended.37 In the context of pain person or by telephone care, however, the 2016 CDC guidelines recommend urine drug testing before initiating opioid therapy

6 Table 1: Tools for patient risk assessment Tool Use Who Administers? Length Current Opioid Misuse Measure (COMM) Monitor for misuse by patients currently on Patient self-report 17 items long-term opioid therapy Diagnosis, Intractability, Risk, Efficacy (DIRE) Screen for risk of opioid addiction Clinician 7 items Opioid Risk Tool (ORT) Screen for risk of opioid addiction Clinician or patient self-report 5 yes/no questions Screener and Opioid Assessment for Patients with Pain, Screen for risk of opioid addiction Patient self-report 24 items Version 1 and Revised (SOAPP, and SOAPP-R) Urine drug testing and surgical approaches, procedural therapies reducing body weight because of reduced loads Urine drug testing (UDT) is recommended (e.g., injections, nerve blocks), complementary and physical stresses on the affected joints. The before prescribing any opioid and at least annually therapies, and use of approved/cleared medical goal of body weight reduction is a baseline weight thereafter.38 Providers using urine drug screens devices for pain management. loss of 7%-10% by calorie reduction and increased should be familiar with the metabolites and expected Primary care providers should know about activity using a balanced diet with less than 30% positive results based on the opioid prescribed. the range of treatment options available, the of calories from fat, 15%-20% from protein, and For example, a patient taking oxycodone may test types of pain that may be responsive to those 45%-60% from carbohydrates.47 positive for both oxycodone and oxymorphone (a options, and when they should be used as metabolite).22 UDT often involves both presumptive part of a multidisciplinary approach to pain Passive options (screen) testing, and definitive (quantitative) management.43 Clinicians should also be aware Acupuncture involves the stimulation of specific testing because many synthetic and semisynthetic that not all nonpharmacologic options have the points on the body, most often involving skin opioids cannot be detected by presumptive testing same strength of evidence to support their utility penetration with fine metallic needles manipulated alone.41,42 in the management of pain, and some may be more by hand but sometimes also including electrical If the prescribed opioid is not detected, discuss applicable for some conditions than others. stimulation or low intensity laser therapy. Potential adverse events include minor bruising and bleeding the finding with the patient and, if diversion is 48 confirmed or suspected, re-evaluate the pain Movement-based options at needle insertion sites. management strategy or taper the opioid. If the Movement therapies that may be helpful Massage is the manual manipulation of the patient tests positive for unprescribed drugs in patients with chronic pain include muscle- body to promote relaxation, reduce stress and schedule more frequent follow-up visits, consider strengthening, stretching, and aerobic exercise improve well-being. Handheld devices may also (e.g., walking, aquatics). Recommended exercise provide relief for some patients. Some patients may opioid discontinuation, offer naloxone, or refer for 49 treatment for substance use disorder. Decision programs typically occur one to three times a week report muscle soreness. tools and help with interpreting urine drug testing for a total of 60-180 minutes per week, but any Transcutaneous electrical nerve stimulation results are available at: http://mytopcare.org/udt- regimen must be carefully tailored to a patient’s (TENS) is a machine that generates mild electrical pulses which are applied cutaneously. The electrical calculator/interpret-opiates-test-result. existing level of physical conditioning, comorbidities, and cognitive status.44-46 stimulation from TENS may block or disrupt pain Overview of options for managing pain Additional movement-based options signals to the brain, reducing pain perception. TENS Many pharmacologic and non- include: machines can be used at home or in conjunction pharmacologic approaches to treating pain are • Physical therapy supervised by a licensed with other interventions like physical therapy. available to primary care providers. These options physical therapist, which can include should be employed using the following general resistance, aerobic, balance, and flexibility Cognitive and behavioral options principles: exercises as well as elements of massage, Cognitive behavioral therapy (CBT) is a • Identify and treat the source of the pain, if manipulation, or transcutaneous electrical structured, time-limited (typically 3-10 weeks) possible, although pain treatment can begin nerve stimulation. intervention focused on how thoughts, beliefs, before the source of the pain is determined • Tai chi, a mind-body practice that combines attitudes, and emotions influence pain and can • Select the simplest approach to pain controlled movements, meditation, and deep help patients use their minds to control and adapt breathing. “Chair tai chi” can be an option for management first. This generally means using patients with limited mobility. to pain. This therapy includes setting goals, often non-pharmacologic approaches as much as • Yoga, exercises or a series of postures with recommendations to increase activity to reduce 50 possible and/or trying medications with the designed to align muscle and bones, and feelings of helplessness. least severe potential side effects, and at the increase strength and flexibility. It can also Meditation lowest effective doses relax mind and body through breathing Mindfulness meditation programs typically • Establish a function-based, individualized exercises and meditation. Gentler forms of include a time-limited (8 weeks; range 3-12 weeks) treatment plan if therapy is expected to be yoga that may be more appropriate for older trainings with group classes and home meditation. long-term patients include Iyengar, Hatha, or Viniyoga. The objective is to inculcate a long-term practice that Although these interventions may cause muscle Non-drug approaches helps patients refocus their minds on the present, soreness, increased back pain, or falls, movement- Many nonpharmacologic and self management increase awareness of self and surroundings, and based options are generally considered safe.46 treatment options have been found to be effective reframe experiences.51,52 alone or as part of a comprehensive pain Weight loss management plan, particularly for musculoskeletal Some pain syndromes, such as knee pain and chronic pain.43 Examples include, but are osteoarthritis, are worsened by obesity. For some not limited to, psychological, physical rehabilitative patients, pain due to this condition is improved by 7 Interventions increased risk of renal and cardiac complications. the general population, are currently classified as Several types of injection therapies can help to Side effects with NSAIDs are typically lower with Schedule V by the DEA, and prescriptions for these ease pain and provide durable relief. In the spine, topical formulations. The effects on coagulation and drugs are tracked by some state Prescription Drug multiple pain generators can be targeted: facet renal function are unknown, but likely not clinically Monitoring Programs (PDMPs). Anticonvulsants joints, discs, nerves, and muscles.53 Parts of the significant given limited systemic absorption.61 can be very helpful in patients who have central sympathetic nervous system can be accessed with Some early trials suggested that COX-2 sensitization. therapeutic injections for patients with visceral pain, inhibitors, as a class, were associated with higher Topical lidocaine and capsaicin and injections into specific joints with steroid or risks for myocardial infarction and stroke compared Topical lidocaine inhibits the conduction 53 viscosupplements can reduce joint pain. Epidural to other NSAIDs, and the COX-2 inhibitor rofecoxib of nociceptive nerve impulses. Irritation at the steroid injections, radiofrequency ablation, pulsed (Vioxx) was removed from the market in 2004 application site is the most common side effect. 62 radiofrequency procedures, and neuromodulation because of such concerns. More recent trials and The most common products for chronic pain treatments (spinal cord stimulation, peripheral meta-analyses, however, provide strong evidence management are lidocaine 5% patches, available nerve stimulation) all have an important role in that the risks of CV events with celcoxib are no by prescription, and lidocaine 4% patches available 54-56 reducing chronic pain. greater than those of other NSAIDs, and in 2018 OTC. Capsaicin is an active component of chili two FDA advisory panels recommended that the Non-opioid drug approaches peppers and has moderate analgesic properties FDA change its advice to physicians regarding at 8% concentrations for musculoskeletal and A wide range of medications can be used to 63 treat pain, including: celecoxib’s safety. neuropathic pain.64 The most common side effect • Acetaminophen Selective norepinephrine reuptake inhibitors is a mild-to-severe burning sensation at the • NSAIDs (oral or topical) SNRIs such as duloxetine, venlafaxine, and application site. • Antidepressants milnacipran are characterized by a mixed action Cannabinoid preparations ° serotonin and/or norepinephrine reuptake on norepinephrine and serotonin, though their With medical cannabis now legal in 33 states inhibitors exact mechanism of action for pain reduction is and recreational use legal in 10 states and the ° tricyclic antidepressants (TCAs) unknown. Side effects (e.g., nausea, dizziness, District of Columbia (as of April, 2019)65, there ° selective serotonin reuptake inhibitors and somnolence) may limit treatment. Monitoring has been increased interest among patients for (SSRIs) is required for blood pressure (duloxetine and the use of cannabis or cannabis derivatives (e.g., • Anticonvulsants venlafaxine), heart rate (venlafaxine), and drug cannabidiol [CBD]) for pain relief. The CB1 and • Topical lidocaine or capsaicin interactions (duloxetine). SNRIs can be very helpful CB2 receptors have been shown to mediate the • Cannabinoid-based therapies in patients who have central sensitization. analgesic effects of cannabinoids66 and some • Ketamine TCAs evidence suggests a potential benefit for chronic TCAs inhibit reuptake of norepinephrine and pain. A 2017 National Academies of Science Acetaminophen serotonin, but their mechanism of action for pain report, for example, concluded that “conclusive Acetaminophen is available over the counter relief is unknown. Examples of TCAs studied for the or substantial evidence” supports a beneficial role (OTC) in 325 mg, 500 mg, and 650 mg tablets. management of chronic pain include amitriptyline, for cannabis or cannabinoids for treating chronic Lower doses are recommended to decrease risk of desipramine, and nortriptyline. Side effects, pain,67 and a 2018 Cochrane review of the existing side effects. Patients should not exceed 1000 mg in such as anticholinergic effects (e.g., dry mouth, literature evaluating cannabinoids (cannabis, CBD, a single dose. The maximum recommended dose for constipation, dizziness) and QTc prolongation limit or combinations) suggests that these agents are healthy adults is 4000 mg/day and 3000 mg/day the use of TCAs in elderly patients. The majority of moderately effective for neuropathic pain with for elderly patients.57 side effects occur at the typically higher doses used adverse effects that are less than, or comparable The most severe potential side effect of to treat depression. to, existing non-opioid analgesics.68 acetaminophen is liver toxicity. Acetaminophen But the evidence for a benefit of cannabinoids is the most common cause of acute liver failure, SSRIs 58 on acute pain, is extremely limited and mixed. A accounting for 46% of all cases. Patients should SSRIs, such as citalopram, fluoxetine, and small double-blind, cross-over study in 18 females stay within recommended doses to help prevent paroxetine, block the reuptake of serotonin in and experimentally-induced mild acute pain found side effects and should only be prescribed one the brain, making more serotonin available in the no significant analgesic effect of oral cannabis acetaminophen-containing product at a time. synapse. The mechanism of SSRIs for pain remains extract.69 Another randomized, double-blind Advise patients to read labels of all medications to unknown. Compared to SNRIs and TCAs, there study with 15 healthy volunteers using smoked determine if the product contains acetaminophen. is relatively little evidence to support the use of cannabis found no analgesic effect with low doses SSRIs in treating chronic pain conditions.35 Potential of cannabis, a modest effect with moderate doses, NSAIDs side effects of SSRIs include weight gain, sexual and enhanced pain responses with high doses.70 NSAIDs reduce inflammation by inhibiting dysfunction, and QTc prolongation, especially with The authors of a 2017 review on cannabis and cycloxygenase (COX), either selectively (COX-2 citalopram. pain conclude that cannabis may have a narrow predominantly) or non-selectively (COX-1 and therapeutic window as a pharmacotherapy for COX-2 effects). Chronic use of NSAIDs may be Anticonvulsants chronic pain but that much more research is needed limited by gastrointestinal (GI) toxicity, including GI Anticonvulsants, such as gabapentin, to inform physician recommendations to patients bleeding, upper GI symptoms, ulcers, and related pregabalin, oxcarbazepine, and carbamazepine, regarding the analgesic efficacy of cannabis.71 complications. For high-risk patients, including the are often prescribed for neuropathic pain and are A systematic review of both randomized trials elderly, patients on warfarin or aspirin, and those thought to exert their analgesic effect by inhibiting (47) and observational studies (57) in patients with coagulopathies, adding a proton pump inhibitor neuronal calcium channels. Potential side effects with chronic noncancer pain published through July (PPI) may help reduce the risk.59,60 In addition to GI include sedation, dizziness, and peripheral edema. 2017 found moderate evidence that cannabinoids side effects, NSAIDs have been associated with an Pregabalin and gabapentin have abuse potential in can exert analgesia.72

8 Cannabis preparations, however, may pose both ° Infusion: up to 1 mg/kg/hour need for opioids and disentangling the two, clinically, short-term and long-term risks. Short-term effects • Contraindications can be difficult.80 include impaired memory, motor coordination, ° Poorly-controlled cardiovascular disease For chronic pain, the evidence that opioids and judgment. Paranoid ideation and psychotic ° Pregnancy reduce pain and improve function more than symptoms, while rare, may occur with high doses ° Psychosis placebo is relatively weak. A 2018 systematic review of THC. Possible long-term effects include impaired ° Severe hepatic disease and meta-analysis of 96 trials comparing various brain development in young adults, potential ° Elevated intracranial pressure opioids vs. placebo or non-opioid analgesics in for habituation, and increased risk of anxiety or ° Elevated intraocular pressure 26,169 patients with chronic noncancer pain found depression. Abrupt cessation of marijuana in that opioids may slightly reduce pain and increase long-term users may cause withdrawal symptoms Opioids physical functioning compared to placebo, but not such as anxiety, irritability, craving, dysphoria, and Mechanism of Action compared to non-opioids.13 In 76 trials comparing insomnia. There is an increased risk of chronic Opioids exert their analgesic effects by acting opioids vs. placebo with follow-up ranging from 1 to bronchitis, respiratory infections, and pneumonia on the mu, kappa, and delta opioid receptors. 6 months, the reduction in pain scores with opioids with inhaled products.73 Individual agents may be classified as agonists or (on a 10-point scale) was only 0.69 points, which Nonetheless, the use of cannabis may have partial agonists of those receptors:78 is below the generally-accepted 2-point minimum an opioid-sparing effect at a population level. The • Agonists (e.g., morphine, codeine, clinically important difference for pain. Physical use of medical cannabis has been associated with hydromorphone, hydrocodone) stimulate at function scores (on a 100-point scale) improved a 25% reduction in opioid overdose mortality in least one of the opioid receptors and provide with opioids by 2.04 points, which, again, may not states that legalized medical use.74 continued analgesia with increasing doses. be clinically important. The risk of vomiting with FDA-approved cannabinoids include dronabinol • Partial agonists (e.g., buprenorphine) have opioids, however, was more than 4 times higher (Marinol), indicated for second-line treatment of high affinity at mu-receptors, have a ceiling for than with placebo.13 chemotherapy-induced nausea and vomiting, and analgesic effect, and are less likely to cause The same meta-analysis compared opioids anorexia-associated weight loss in patients with HIV. respiratory depression. to non-opioid analgesics including NSAIDs, TCAs, Nabilone (Cesamet) is indicated for chemotherapy- Opioids are classified by the Drug Enforcement anticonvulsants, and synthetic cannabinoids. No induced nausea and vomiting. Common side effects Agency (DEA) according to their presumed abuse significant differences were found in physical include dizziness/vertigo and euphoria. Dronabinol and addiction potential, although the evidence base functioning scores for any of the comparisons, may cause nausea/vomiting, abdominal pain, and for making these differentiations continues to evolve and no significant differences were found in pain abnormal thinking. Nabilone may cause ataxia and (Table 2). Tramadol, for example, is now known to scores for comparisons with NSAIDs, TCAs, or dry mouth.73,75,76 None of these are indicated for the have as much potential for abuse as opioids in more cannabinoids.13 treatment of pain. When recommending cannabis restrictive classes, although its DEA classification The Strategies for Prescribing Analgesics for patients with chronic pain, clinicians should has not changed.79 Comparative Effectiveness (SPACE) trial randomized inform patients that the analgesic properties of 240 patients with moderate to severe chronic low cannabis are only attributed to the CBD component, Relative effectiveness back pain or knee or hip osteoarthritis to regimens not the THC component. The analgesic efficacy of opioids for treating of morphine, oxycodone, or hydrocodone or non- acute pain has been known for centuries and they opioid analgesics (e.g., acetaminophen, NSAIDs, Ketamine continue to be reliable agents for moderate-to- antidepressants, anti-epileptics) and followed them Ketamine has been used as a general anesthetic severe acute pain, although they are not without for 1 year.14 At 3, 6, 9, and 12 months there were no since the 1960s, but its use in subanesthetic risks. But the evidence for opioid efficacy for acute significant differences in pain scores. At 1 year, pain concentrations for analgesia has grown rapidly pain cannot be extended to chronic pain. Neuronal intensity was significantly better in the non-opioid in recent years, due, in part, to efforts to reduce and physiologic adaptations to long-term opioid group. No differences in treatment response were 77 the risks of chronic opioid use. Ketamine has use can result in reduced analgesic effectiveness, seen in analyses by pain condition. The authors been successfully used to treat such acute pain or even, paradoxically, increased pain or sensitivity concluded that their results “do not support conditions as sickle cell crises, renal colic, and to pain.17 Opioid-induced hyperalgesia is different initiation of opioid therapy for moderate-to-severe 77 trauma. Recently the American Society of Regional pharmacologically from the phenomenon of opioid chronic back pain or hip or knee osteoarthritis Anesthesia and Pain Medicine, the American tolerance, although both can lead to an increased pain.”14 Academy of Pain Medicine, and the American 78 Society of Anesthesiologists released the first Table 2: Common opioids by schedule joint recommendations for subanesthetic ketamine Schedule Description Opioid (including transdermal ketamine) for acute pain Schedule I No medical use, lack of accepted safety, and a high potential for abuse Heroin 77 with the following guidelines: Schedule II High potential for abuse, which may lead to physical or psychological Hydrocodone • Indications dependence Oxycodone ° Perioperative use in surgery with moderate to severe postoperative pain Morphine ° Perioperative use in patients with opioid Hydromorphone tolerance Tapentadol ° Adjunct in opioid-tolerant patients with Methadone sickle cell crisis Fentanyl ° Adjunct in patients with obstructive sleep Schedule III Less potential for abuse than schedules I and II, low to moderate Buprenorphine apnea physical dependence and high psychological dependence Codeine + • Dose acetaminophen ° Bolus IV: up to 0.35 mg/kg Schedule IV Lower potential for abuse than schedule III medications Tramadol 9 Opioid formulations Efforts to create formulations with lower Atypical opioids: tramadol and tapentadol Prescription opioids are available in immediate- risks of abuse have met with limited success. For Tramadol and tapentadol are mu receptor release and extended-release/long-acting (ER/LA) example, ER Oxymorphone was removed from the agonists and norepinephrine reuptake inhibitors. formulations (Table 3). Immediate-release agents market after reports of intravenous abuse of the Their mechanisms of action are unknown, but are recommended in opioid-naïve patients and for all oral formulation.83 Abuse-deterrent or tamper- their analgesic effects are similar to morphine. acute pain conditions, with ER/LA agents reserved resistant formulations do not prevent patients from Patients taking tramadol should be monitored for for patients or conditions in which the longer duration developing opioid dependence, opioid use disorder, nausea, vomiting, constipation, and drowsiness, all of action and smoother pharmacodynamics are or simply taking too much of an opioid by mouth.84,85 of which are similar to side effects with opioids.87 preferred.38 A trial comparing immediate release No prospective randomized clinical trials or rigorous There is potential risk of serotonin syndrome when to an ER/LA opioid did not find evidence that the observational studies have measured the impact tramadol is combined with SSRIs, SNRIs, or tricyclic continuous, time-scheduled use of ER/LA opioids of abuse-deterrent opioids on the risk of abuse antidepressants.88 was more effective or safer than intermittent use or misuse. As of August 2018, eight opioids with As noted above, tramadol is classified as of the immediate-release opioid.81 According to the abuse-deterrent properties have been approved by Schedule IV, which has led some to view it as less FDA, ER/LA opioids should only be used for patients the FDA.86 potent or safer than other opioids. The 2016 who tolerate 60 morphine milligram equivalents per National Survey on Drug Use and Health, however, day (MMED) for at least one week.82 BEFORE MOVING ONTO THE NEXT SECTION, found that 1.7 million people in the U.S. aged >12 PLEASE COMPLETE CASE STUDY 2. years reported misusing tramadol products (e.g., Ultram, Ultram ER, Ultracet) in the previous year.79 In addition, a 2019 cohort study of 88,902 patients Table 3: Immediate-release vs. extended-release/long-acting opioids with osteoarthritis showed increased risks of Immediate-release formulations Extended-release/Long-acting formulations death at one year compared to NSAIDs naproxen, diclofenac, and celecoxib.89 Codeine Buprenorphine transdermal patch Abrupt cessation of tramadol is associated with Hydrocodone + acetaminophen Fentanyl transdermal patch opioid withdrawal, restlessness, and drug cravings Hydromorphone Hydrocodone ER (similar to those associated with other opioids) as well as hallucinations, paranoia, extreme anxiety, Levorphanol Hydromorphone ER panic attacks, confusion, and numbness/tingling Meperidine Methadone in extremities (which are less typical of other Morphine Morphine ER opioids).90 Oxycodone Morphine ER + naltrexone Tapentadol is FDA-approved for treating neuropathic pain, although it is also used for Oxymorphone Oxycodone ER musculoskeletal pain. A 2015 Cochrane review Tapentadol Oxycodone ER + naloxone of 4 randomized trials with 4,094 patients with Tramadol Oxymorphone ER osteoarthritis or back pain found modest reductions in pain with tapentadol vs. placebo.91 Tapentadol ER Tramadol ER

Case Study 2 Instructions: Review the case below and consider the questions that follow.

Ralph is an 83-year-old who lives at home with his wife. He has a history of cardiovascular disease and, 10 years earlier, had successful quadruple bypass surgery. He takes the following medications: fish oil, a statin, a thiazide diuretic, low-dose aspirin, and a non-benzodiazepine sedative to help him sleep. Lately he has been complaining of increasing pain and stiffness in his right knee and hip. He is physically deconditioned due to a lack of exercise, in part because walking is painful. He asks if you can prescribe something to ease his pain.

1. Is Ralph a good candidate for an ER/LA opioid? Why, or 3. Would Ralph’s current medication need to be adjusted if he were why not? to be prescribed an ER/LA opioid?

2. Is he a better candidate for an immediate-release opioid? 4. What kinds of non-opioid treatments might be tried to help Why or why not? Ralph with his pain?

10 Problematic opioid use To ensure clear communication regarding down or control opioid use, and craving or a Although evidence for the long-term medical issues and avoid misunderstandings about strong desire or urge to use opioids, occurring effectiveness of opioids for chronic pain is weak, the nature and risk of addiction, the American within a 12-month period. evidence for opioid-related harms is abundant Society of Addiction Medicine recommends the Combining opioids with sedating drugs such and strong. In a 2007 study assessing behaviors following definitions to help differentiate problem as benzodiazepines or alcohol increases the risk indicative of opioid misuse, many patients in use from normal use of opioids: of respiratory depression and overdose death.22 primary care practices reported having engaged • Abuse - Any use of an illegal drug, or the Benzodiazepines have been linked with overdose in aberrant behaviors with opioids one or more intentional self-administration of a medication, fatalities in 50-80% of heroin overdoses, and 40- times (Table 4).10 It is important to recognize and for a non-medical purpose, such as altering 80% in methadone-related deaths.22,95 Patients differentiate problematic use from adverse side one’s state of consciousness (e.g., getting prescribed benzodiazepines who are being initiated effects of opioids. For instance, tolerance and opioid high). on opioids should have their benzodiazepine withdrawal occur with long term use of prescribed • Misuse - Use of a medication other than as tapered and discontinued whenever possible. opioids. Clinicians should be able to differentiate directed or as indicated, whether willful or For patients being co-managed by mental health this from problematic use. unintentional, and whether harm results or professionals, coordinate a plan regarding Among adults without a prescription, 41% not. continuing or tapering benzodiazepines in the obtained prescription opioids from friends or • Tolerance – when the same dose of a setting of opioid co-prescribing. relatives for their most recent episodes of misuse.92 drug given repeatedly produces a reduced biological response. This is a normal process A 2015 meta-analysis showed that the Other adverse events that occurs with long term use of a prescribed prevalence of opioid abuse in primary care settings In addition to risks of misuse, addiction, opioid. ranged from 0.6%-8%, and the prevalence of respiratory depression, and overdose death, there • Physical dependence - A state of physical opioid dependence ranged from 3%-26%. In pain are many well-known side effects associated with adaptation that is manifested by a drug class- chronic opioid use that can significantly compromise clinics, the prevalence of opioid abuse ranged from specific withdrawal syndrome that can be 93 quality of life, including constipation, nausea or 8%-16%, and addiction ranged from 2%-14%. produced by abrupt cessation, rapid dose vomiting, sedation, pruritus, erectile dysfunction, In eastern Pennsylvania, the lifetime prevalence reduction, decreasing blood level of the drug, menstrual changes, fracture, immunosuppression, of opioid use disorder among patients prescribed and/or administration of an antagonist. Most long-term opioids was estimated at 35%.9 importantly (and most difficult for providers hallucinations, and hyperalgesia. For prescription opioids, long-term therapy to determine) this is not synonymous with Gastrointestinal side effects is associated with an increased risk in accidental addiction. Constipation is one of the most common opioid- overdose and death. A retrospective study • Opioid use disorder (addiction) - related adverse events, affecting most patients to including 9,940 patients who received three or Problematic opioid use leading to clinically at least some degree, and which usually does not more opioid prescriptions within 90 days for chronic significant impairment or distress, with at resolve with continued exposure.35 To mitigate this pain between 1997 and 2005 found that annual least two additional criteria, such as taking side effect, patients should use a mild stimulant more opioids or for longer than prescribed, overdose rates rose significantly as doses exceeded laxative such as senna or bisacodyl and increase the 94 persistent desire or unsuccessful efforts to cut 50 MMED (Figure 5). dosage in 48 hours if no bowel movement occurs. Physicians should perform a rectal examination if Table 4: Behaviors indicative of opioid misuse10 no bowel movement occurs in 72 hours. If there is Behavior Frequency in patients with opioid misuse no impaction, consider other therapies such as an Requested early refills 47% enema, suppository, or magnesium citrate.96 Increased dose on own 39% Medications for refractory, opioid-induced constipation include naloxone derivatives: Felt intoxicated from pain medication 35% naloxegol (Movantik), methylnaltrexone (Relistor), Purposely over sedated oneself 26% or naldemedine (Symproic). Naloxegol is an oral Used opioids for purpose other than pain 18% tablet that is used daily while methylnaltrexone is a subcutaneous injection or oral tablet used daily. Figure 5: Risk of overdose rises with daily milligram morphine-equivalent dose.94 Naldemedine is taken by mouth daily (0.2 mg) and may cause side effects such as abdominal pain or discomfort, diarrhea, and nausea.94 In the COMPOSE-1 trial, patients on naldemedine had significantly more spontaneous bowel movements (defined as ≥3 per week) than those on placebo (47.6% vs. 34.6%, P=0.002).97 For nausea or vomiting, physicians should consider a prophylactic antiemetic, add or increase non-opioid pain control agents (e.g., acetaminophen as an opioid-sparing drug), and decrease opioid dose by 25% if analgesic is satisfactory.

11 Sedation Tamper-resistant/abuse-deterrent opioids • How to safely taper dose to avoid withdrawal Sedation is the first warning sign of a patient One strategy to mitigate the risk of opioid abuse symptoms being at risk for opioid overdose. Take this symptom has been the development of “abuse-deterrent” • Never share any opioid analgesic with another very seriously. If a patient complains of sedation, formulations of opioids that make it more difficult person determine whether sedation is related to the to alter for non-oral consumption (e.g., injecting, • How and when to use naloxone products and opioid, eliminate nonessential depressants (such as snorting, or smoking).102 However, these opioids their various means of administration benzodiazepines or alcohol), reduce dose by 10%- are more aptly named as “tamper-resistant” • Seeking emergency medical treatment if an 15% if analgesia is satisfactory, add or increase formulations instead of “abuse-deterrent” since opioid overdose occurs non-opioid or non-sedating adjuvant for additional they are no less potentially addictive than regular • How to seek help if an opioid use disorder pain to reduce opioid dose. There is insufficient opioids when taken by mouth. develops and what treatments options are evidence to recommend opioid rotation as a Tamper-resistant formulations often contain available if it does possible means of reducing sedation.38 Patients a higher opioid dose than immediate-release • How to report adverse events and should also be co-prescribed naloxone for opioid preparations. Furthermore, most are extended- medication errors to FDA (1-800-FDA-1088 overdose reversal. release and also considerably more expensive than or online at: fda.gov/downloads/AboutFDA/ generic, off-patent opioids.102 As of this writing, ReportsManualsForms/Forms/UCM163919. Fracture only one immediate-release opioid is available pdf) A retrospective cohort study over seven years in an abuse deterrent formulation (oxycodone compared the risk of fracture associated with hydrochloride [RoxyBond]).102 In addition, patients should be educated about starting opioids vs. NSAIDs (2,436 older adults the safe storage and disposal of opioid medications. initiated on opioids and 4,874 older adults initiated Patient education Safe use means following clinician instructions on NSAIDs). Opioids significantly increased the risk Before prescribing an opioid for pain, clinicians about dosing, avoiding potentially dangerous of fracture in a dose-dependent fashion. The opioid should discuss with patients the risks and benefits of drug interactions (e.g., alcohol), and assuring full formulation mattered with much of the risk in the such therapy. An important consideration in framing understanding of how the medication should be first month after drug initiation for short-acting treatment, and a key message to communicate consumed or applied. Remind patients that pain opioids, though fracture increased for both long- to patients, is that the goal is not “zero pain” medications are sought after by many people, and, therefore, opioids should be stored in a locked and short-acting opioids over time.98 but, rather, a level of analgesia that maximizes a cabinet or, if a locked unit is not available a place patient’s physical and mental functioning.108 A multi- that is not obvious or easily accessed by others. Infection modal approach, using both drug and non-drug Proper disposal methods should be explained: Opioids may increase risk of infection in treatments, should be encouraged. older adults. A case-control study of 3,061 older • Follow any specific disposal instructions on Here are some suggested topics for discussion the prescription drug labeling or patient community dwelling adults ages 64-95 years with patients:43 evaluated the association between pneumonia and information that accompanies the medication. • Importance of adherence to prescribed • Do not flush medicines down the sink or toilet opioid use. Current prescription opioid users had a dosing regimen unless the prescribing information specifically 38% increased risk of pneumonia compared with • Patients should use the least amount of instructs to do so. nonusers. The risk was highest for opioid users medication necessary to treat pain and for the • Return medications to a pharmacy, health categorized as being immunosuppressed, such shortest amount of time center, or other organization with a take-back as those with cancer, recent cancer treatment, • The risk of serious adverse events that can program. or chronic kidney disease, or those receiving lead to death • Mix the medication with an undesirable immunosuppressive medications or medications for • The risk of physical dependence that can occur substance (e.g., used coffee grounds or kitty HIV.99 even when product is used as recommended litter) and put it in the trash, or use special • Known risk factors for serious adverse events, drug deactivation pouches that your health Myocardial Infarction (MI) including signs and symptoms of overdose care provider may recommend. A case-control study assessed the risk of MI and opioid-induced respiratory depression, among adults on opioids for chronic pain in the UK GI obstruction, and allergic reactions, among Neuromodulation approaches General Practice Research Database (11,693 cases others Analgesia provided via neuromodulation with up to four matched controls). Current opioid • The most common side effects (e.g., systems can be placed externally, internally (i.e., use was associated with a 28% increased risk of MI implantable), and either on or in the spinal column 100 constipation, sexual dysfunction, respiratory compared to non-use. depression), along with the risk of falls, or peripherally. Transcutaneous nerve stimulation working with heavy machinery, and driving (TENS) is the most common surface external Erectile Dysfunction (ED) peripheral neuromodulation system, and other In a cross-sectional analysis of 11,327 men with • When to call the prescriber (e.g., managing adverse events, ongoing pain) types of approaches are at various levels of back pain, 909 (8%) received ED medications or development and/or clinical use. testosterone. Long-term opioid use was associated • How to handle missed doses with 45% greater use of medications for ED or • The importance of full disclosure of all TENS testosterone replacement compared to patients medications and supplements to all HCPs and TENS is the noninvasive application of low- with no opioid use. Men prescribed daily doses of the risks associated with the use of alcohol voltage current from a battery-operated device 120 mg morphine or more had a 58% increase and other opioids/benzodiazepines to the skin via surface electrodes.109 Most TENS in medication for ED or testosterone compared to • Product-specific concerns, such as not to devices can provide variable frequency, pulse patients without opioid use, suggesting that dose crush or chew ER products; transdermal duration, intensity and type of output (burst or and duration of opioid use were associated with systems and buccal films should not be cut, continuous). ED.101 torn, or damaged before use, etc.

12 Combinations of different stimulation parameters Other injection or interventional approaches A commonly-recommended way to achieve this are used to produce four main modes of TENS: Interventional approaches may play a balance is with multimodal analgesia, in which conventional TENS, acupuncture-like TENS, burst complementary role to other strategies, can be several therapeutic approaches are used, each TENS, and brief-intense TENS.109 Conventional diagnostic and therapeutic, and typically attempt acting at different sites of the pain pathway, which TENS produces paraesthesia in the area under to target the presumed "pain generators." The can reduce dependence on a single medication and the electrodes whereas the production of muscle most common interventional procedures are may reduce or eliminate the need for opioids and twitches is desirable with acupuncture-like TENS. percutaneous injections, whereby small bore attendant risks/side effects.123 The evidence base for the analgesic efficacy of needles are inserted through the skin and directed Multimodal analgesia (e.g., using drugs TENS is limited by a lack of rigorous randomized (often with the assistance of imaging) to the from two or more classes, or a drug plus a non- controlled trials. Systematic reviews have found presumed "problem" site: muscles, joints, nerves. drug treatment) can produce synergistic effects, variable and inconclusive results of efficacy of TENS A pharmacologic agent is then deposited, usually reduce side effects, or both. One example of in chronic pain management.110 Further evidence glucocorticoid and/or local anesthetic. Neural multimodal analgesia is the use of both an NSAID is required to determine the efficacy, parameter "ablation" (with cryoanalgesia or radiofrequency and acetaminophen, plus physical approaches specific effects, and cost-effectiveness of TENS. thermocoagulation, or neurolytic agents such as (e.g., cold, compression, or elevation) to manage alcohol or phenol) is generally reserved for specific postoperative pain. Demonstrated benefits of Spinal cord stimulation pain generating nerves in chronic non-cancer pain, multimodal analgesia include earlier ambulation, In general, spinal cord stimulation (SCS) can or for situations of severe cancer pain (i.e., using earlier oral intake, and earlier hospital discharge be considered for patients with chronic pain who neurolytic agents) where the patient has a guarded for postoperative patients, as well as higher levels have failed conservative approaches. A spinal cord prognosis.115 of participation in activities necessary for recovery stimulator is not effective for all types of chronic pain, Interventional procedures for non-cancer pain (e.g., physical therapy).123 and is not effective for every patient even within the include intercostal nerve blockade, spinal injections categories of pain that may respond to SCS.111 In (epidural steroid injections, selective nerve root Managing patient expectations the U.S., the most common indication for spinal cord injections, and medial branch nerve injections stimulator placement is chronic pain from failed Patients in acute pain are understandably of the facet or zygapophyseal joint), botulinum worried that the pain will persist or get worse back surgery syndrome (FBSS), although SCS may toxin injections, occipital nerve injections, and be effective for pain from other etiologies.112 A 2019 with time. Physicians can reduce such fears multiple other peripheral nerve injections as well and set realistic expectations for treatment meta-analysis of 12 randomized trials including as injections of the sympathetic nervous system. approximately 1000 patients with intractable spine effectiveness and healing with clear, compassionate Injections may provide short-term analgesia for well communication couched in terms patients can or limb pain related to various disorders (i.e., FBSS; selected patients to facilitate physical therapy and chronic back, leg or trunk pain; diabetic neuropathy; easily understand. It can be helpful, for example, peripheral vascular disease; complex regional pain are often repeated in intervals for more continual to share with patients the fact that most forms of syndrome) found that SCS was associated with relief in those patients suffering from chronic pain. acute nociceptive pain (e.g. nonspecific low back increased odds of >50 percent pain reduction, Evidence for significant improvements in long-term pain) are self-limited, subside within weeks, and do 115 compared with continued medical therapy.113 High outcomes is limited. not require invasive interventions. (In a systematic frequency and burst stimulation were associated Managing acute pain review of 15 prospective cohort studies, 82% of with greater benefit than conventional SCS, but It is now becoming clear that many of the people who stopped work due to acute low back evidence also supports a benefit with conventional problems and risks associated with managing pain returned to work within one month.124) SCS, particularly for lumbar radicular pain. chronic pain with opioids are also at work in the A systematic review of 14 controlled trials of Deep brain stimulation management of acute pain with opioids. For example, patient education interventions for low back pain Analgesic neuromodulation of the brain is an a number of studies demonstrate increased risk of showed that structured messaging by providers approach currently under development without a new persistent opioid use in opioid-naïve patients can reassure patients with acute pain more than large evidence base for efficacy. Anecdotal reports after having been prescribed opioids for acute usual care/control education both in the short and of deep brain stimulation (DBS) and motor cortex pain.116-119 Although the risk of opioid misuse in long term.125 Messaging was significantly more stimulation (MCS) have been described for the patients prescribed opioids for acute post-surgical reassuring to patients when delivered by physicians treatment of intractable severe persistent pain or post-procedural pain is relatively small (roughly than other primary care practitioners, and such states.114 MSC involves placing electrodes on the 0.6% per year)120, the volume of such procedures communication reduced the frequency of primary surface of the brain. Guidelines from the European (approximately 48 million ambulatory surgeries care visits. or procedures in 2010)121 translates into large Federation of Neurological Societies about Non-pharmacological treatments for acute numbers of patients (i.e., approximately 160,000) neurostimulation for neuropathic pain suggest that pain motor cortex stimulation is efficacious in central who may develop dependence, abuse, or overdose When possible, non-pharmacologic methods post-stroke and facial pain and that deep brain every year. should be used, alone or in combination with stimulation should only be performed in experienced A central tenet of pain management, whether analgesics, to manage acute pain.24 The degree 114 centers. Deep brain stimulation involves placing acute or chronic, is that the goal of treatment is to which this is possible depends on the severity, the electrodes in the thalamus, periventricular, and a tolerable level of pain that allows the patient type, and origin of the pain, but many non- periaqueductal gray regions. DBS has been used for maximum physical and emotional functioning with pharmacological approaches can be very effective over 40 years to treat certain kinds of unrelenting the lowest risk of side effects, progression to 122 and their use avoids the potential side effects and pain such as brachial plexus avulsion, post stroke chronic pain, or misuse or abuse. This requires risks associated with pharmacological interventions. pain, and cluster headaches. an adroit balancing of patient-related factors (e.g., comorbidities, medical history, risk of abuse) and drug-related factors (e.g., potency, mechanism of action, expected side effects). 13 Physical methods of pain management can be BEFORE MOVING ONTO THE NEXT SECTION, Non-opioid analgesics are not without risk, helpful in all phases of care, including immediately PLEASE COMPLETE CASE STUDY 3. particularly in older patients. Potential adverse after tissue trauma (e.g., rest, application of cold, effects of NSAIDs include gastrointestinal problems compression, elevation) and later in the healing Non-opioid pharmacologic treatments for (e.g., stomach upset, ulcers, perforation, bleeding, period (e.g., exercises to regain strength and range acute pain liver dysfunction), bleeding (i.e., antiplatelet effects), of motion). kidney dysfunction, hypersensitivity reactions, Acetaminophen and NSAIDs Non-pharmacologic methods can include:24 and cardiovascular concerns, particularly in the In general, mild-to-moderate acute pain • Application of cold (generally within first 24 elderly.128 The threshold dose for acetaminophen responds well to oral non-opioids (e.g., hours) or heat liver toxicity has not been established; however, the acetaminophen, non-steroidal anti-inflammatories • Compression Food and Drug Administration (FDA) recommends [NSAIDs], and topical agents). NSAIDs, which • Elevation that the total adult daily dose not exceed 4,000 mg • Immobilization include aspirin and other salicylic acid derivatives, in patients without liver disease (with a lower ceiling • Relaxation exercises and acetaminophen are used in the management for older adults).129 • Distraction/guided imagery of acute pain arising from injury, arthritis, dental • Acupuncture The FDA currently sets a maximum limit of 325 procedures, swelling, or surgical procedures. • Massage mg of acetaminophen in prescription combination Although they are weaker analgesics than opioids, • Electroanalgesia (e.g., transcutaneous products (e.g., hydrocodone and acetaminophen) in electrical nerve stimulation) acetaminophen and NSAIDs do not produce an attempt to limit liver damage and other potential • Physical therapy tolerance, physical dependence, or addiction and ill effects of these products.32 • Yoga they do not induce respiratory depression or Topical capsaicin and salicylates can both be constipation. Acetaminophen and NSAIDs are often Physical therapy may be useful for a range effective for short term pain relief and generally added to an opioid regimen for their opioid-sparing of musculoskeletal issues and can be helpful in have fewer side effects than oral analgesics, but effect. Since non-opioids relieve pain via different recovering from acute pain-producing traumas their long-term efficacy is not well studied.130,131 mechanisms than opioids, combination therapy can initially treated with other methods. A 2018 study Topical aspirin, for example, can help reduce pain provide improved relief with fewer side effects. reported that patients with low back pain who first from acute herpes zoster infection.132 Topical The choice of medication may be driven by consulted a physical therapist were less likely to NSAIDs and lidocaine may also be effective for patient risk factors for drug-related adverse effects receive an opioid prescription compared to those short-term relief of superficial pain with minimal 126 (e.g., NSAIDs increase the rate of gastrointestinal, who first saw their primary care physician. side effects. renal, and cardiovascular events). If acetaminophen Exercise therapy can take many forms, including Topical agents can be simple and effective or NSAIDs are contraindicated or have not walking, swimming or in-water exercise, weight for reducing pain associated with wound dressing sufficiently eased the patient’s pain or improved training, or use of aerobic or strength-training changes, debridement of leg ulcers, and other function despite maximal or combination therapy, equipment. According to a review by the Centers for sources of superficial pain.132 Disease Control and Prevention (CDC), conditions other drug classes (e.g., opioids) are sometimes that may improve with exercise therapy include low used. back pain, neck pain, hip and knee osteoarthritis pain, fibromyalgia, and migraine.127 Case Study 3 Instructions: Review the case below and consider the questions that follow.

Hannah is a 62-year-old woman who has been coping with persistent pain for more than a year since she was involved in a car accident. Her initial severe neck and low back pain was thought to be due to cervical and lumbar sprain/strain. She was prescribed a short-acting opioid, which she said helped with the pain, but led to constipation. After three months of using the opioid, Hannah decided to stop because she did not like the constipation and “brain fog” from the drug. She tried several types of alternative therapies, such as massage and acupuncture, both of which provided short-term relief, although the pain later returned. At 6 months post-accident, X-ray and MRI imaging revealed no obvious spinal pathophysiology, although Hannah reported a sharp, radiating/aching pain spreading to her legs and arms. She describes bilateral pins and needles feeling in her hands. Hannah has a BMI of 31 and has been diagnosed with metabolic syndrome. She is physically inactive but currently takes no medications.

1. Given the subjective nature of pain, how can a clinician more objectively assess the kind of pain reported by patients such as Hannah? Questions for case study:

2. Does the lack of obvious pathophysiology on imaging suggest that Hannah is having psychosomatic pain?

3. Would Hannah be a good candidate for an opioid analgesic? Why or why not?

14 Anticonvulsants pruritus, erectile dysfunction, and fractures, all of A 2019 study of PDMP data from Kentucky, Anticonvulsants, such as gabapentin, which may be more problematic in older patients Ohio, and West Virginia found that rates of multiple pregabalin, oxcarbazepine, and carbamazepine, and occur at higher rates than with non-opioid provider episodes, overall opioid prescribing, and are often prescribed for chronic neuropathic analgesics. overlapping opioid prescriptions all declined after pain (e.g., post-herpetic neuralgia and diabetic A cross-sectional study compared common mandatory PDMP laws were enacted.107 neuropathy) although evidence for efficacy in acute side effects experienced during the first week of pain conditions is weak.133 A 2017 trial, for example, treatment with opioid analgesics vs. non-opioid In Texas Health and Safety Code Section randomized 209 patients with sciatica pain to analgesics in patients over age 65 with acute 481.07636, Part (a) defines acute pain as “the pregabalin 150 mg/day titrated to a maximum of musculoskeletal pain.140 The intensity of six common normal, predicted, physiological response to a 600 mg/day vs. placebo for 8 weeks.134 At 8 weeks opioid-related side effects were significantly higher stimulus such as a trauma, disease, and operative there was no significant difference in pain between with opioids. (A limitation of this study is that it procedures…[which] is time limited.” Part groups (mean leg pain intensity on a 0-10 scale could not assess severe but less common adverse (b) reads, “For the treatment of acute pain, a 3.7 with pregabalin vs. 3.1 with placebo, P=0.19). events associated with NSAIDs and acetaminophen, practitioner may not: (1) issue a prescription for an Potential side effects of anticonvulsants including the risk for gastrointestinal bleeding, opioid in an amount that exceeds a include sedation, dizziness, and peripheral edema. acute kidney injury, and hepatotoxicity.) 10-day supply; or (2) provide for a refill of Pregabalin and gabapentin also have some abuse In a retrospective study of 12,840 elderly an opioid.” However, the patient may see the potential in the general population because some patients with arthritis, opioid use was associated practitioner in a follow up appointment and receive users report euphoric effects, and abrupt cessation with an increased risk relative to non-opioids for another opioid prescription for up to 10 days. The of anticonvulsants may precipitate withdrawal cardiovascular events, fracture, events requiring law does not limit how many times this may occur. For symptoms.133 hospitalization, and all-cause mortality.141 further information on the guidance from the Texas High-intensity prescribing of opioids (high Medical Board, visit http://www.tmb.state.tx.us/idl/ Cannabis doses or high numbers of pills prescribed) for acute B33C8606-F320-3950-CA65-108C5AF1EECC As noted above, the evidence base for pain is associated with greater likelihood of long- cannabinoid efficacy on acute pain, is extremely term opioid use.142,143 In a retrospective analysis Additionally, the Texas Medical Board issued limited and mixed. A small double-blind, cross-over of a national sample of opioid-naïve Medicare the following updated guidance regarding the study in 18 females and experimentally-induced beneficiaries who received emergency treatment requirements to check the PMP: mild acute pain found no significant analgesic effect from 2008 through 2011, initial exposure to an 1. The mandatory PMP check is required of oral cannabis extract.69 Another randomized, opioid was a strong predictor of subsequent long- only when a physician prescribes opioids, double-blind study with 15 healthy volunteers using term use. benzodiazepines, barbiturates, or carisoprodol to smoked cannabis found no analgesic effect with low The risk of prolonged opioid use is particularly the ultimate user for take-home use upon leaving doses of cannabis, a modest effect with moderate high after arthroscopic joint procedures. In a 2019 an outpatient setting, such as a doctor’s office or doses, and enhanced pain responses with high case-control study of 104,154 opioid-naïve adults, ambulatory surgical center, or upon discharge from doses.70 Much more research is needed before 8,686 (8.3%) developed new prolonged opioid use an inpatient setting, such as a hospital admission, cannabis in any form can be recommended for (continued opioid use between 91 and 180 days or discharge from an emergency department visit. treatment of acute pain.71 after shoulder arthroscopy).144 Subgroups at higher A mandatory PMP check is not required before risk for long-term use included women, those with a or during an inpatient stay, such as a hospital Opioids for acute pain history of alcohol use disorder, those with a mood admission, or during an outpatient encounter Reasons for caution disorder, and those with an anxiety disorder. setting, such as an emergency department or Opioids are commonly prescribed for pain, with ambulatory surgical center visit. State policies addressing opioid prescribers nearly two thirds (64%) of the public reporting 2. The physician may delegate the PMP check As of October 2018, 33 states have enacted being prescribed an opioid for pain at some point to any legally authorized personnel the same way laws regulating the prescription of opioids for in their lives.135 However, this approach is not as physicians may delegate other tasks. acute or chronic pain, with allowed durations of safe and effective as once thought, and high-dose 3. A copy of the PMP check may be placed in a prescriptions for opioid-naïve patients ranging from prescriptions or prolonged use not only increase patient’s medical records. 5-10 days, and most states limiting prescriptions to the risk of misuse, addiction, or overdose, they may ≤ 7days.103,104 As of this writing no data exist about actually increase pain and pain sensitivity.136,137 For further information on the updated whether, or to what extent, such laws reduce opioid- Recent evidence suggests that opioids may not guidance, visit http://www.tmb.state.tx.us/ related morbidity and mortality, or whether they are be more effective for moderate to severe pain than idl/83AD8D09-A358-C993-197F-CE2849A9A490 associated with unintended outcomes.105 non-opioid pain regimens.138,139 A randomized trial Another way states are attempting to reduce Opioid choices for acute pain of 416 patients with acute extremity pain found no opioid-related harms is by requiring clinicians to If an opioid is deemed necessary to treat clinically important differences in pain reduction check their state’s Prescription Drug Monitoring moderate-to-severe acute pain, the following at two hours after single-dose treatment with Program (PDMP) prior to any new opioid general principles are recommended: ibuprofen and acetaminophen vs. three different prescription. As of January, 2018, 41 states have • Avoid extended-release and long-acting opioid and acetaminophen combination analgesics some kind of PDMP mandate, although requirements opioids such as methadone, fentanyl patches, (Figure 1).138 for when the PDMP must be checked and for which and ER/LA versions of opioids such as Physical dependence can readily occur after controlled substances, varies by state.106 oxycodone or oxymorphone. use of opioids at a sufficient dose (e.g., 30mg • Avoid co-prescribing opioids with other drugs of oxycodone) for just a few days. In addition, known to depress central nervous system side effects of opioid use include constipation, function (e.g., benzodiazepines) confusion/gait instability, respiratory depression, 15 • Limit the dose and quantity of opioids to and joints tend to be more painful than those • Screen for opioid misuse or abuse using address the expected duration and severity of involving soft tissues.149 history and, ideally, a validated questionnaire, pain (usually less than 7 days). as well as urine drug testing • Combine opioids with other treatments (e.g., Table 5 illustrates the wide range of expected pain • Taper or discontinue opioids when possible non-pharmacologic options such as exercise and associated recommended opioid doses for or cognitive behavioral therapy, NSAIDs, or some common surgeries or procedures. Discussing opioid risks and benefits acetaminophen). Educate patients about the risks and benefits Managing chronic non-cancer pain of opioid use prior to initiating opioids and discuss • Closely monitor patients with impaired hepatic Management of chronic non-cancer pain or kidney function if they are prescribed them at each subsequent visit. For many patients, begins by establishing individualized treatment the risks of opioid therapy outweigh the benefits. opioids, and adjust the dose or duration goals, exploring non-opioid treatment options, and accordingly However, for some patients with nociceptive, or addressing comorbid depression and anxiety, if even neuropathic, chronic pain, intermittent use of Immediate-release agents are strongly present. Pain management goals may include both low-dose opioids on an as-needed basis may be a preferred because of the higher risk of overdose pain and functional targets, with the understanding reasonable approach. associated with ER/LA agents. A cohort study of that being 100% pain free is not realistic. Functional 840,000 opioid-naïve patients over a 10-year span goals should focus on activities that are meaningful Establishing a written treatment agreement found that unintentional overdose was 5 times more to the patient and attainable based on the severity Written documentation of all aspects of a likely in patients prescribed ER/LA agents compared of the painful condition. Multi-modal approaches patient’s care, including assessments, informed to immediate-release opioids.145 that include non-drug and drug interventions are consent, treatment plans, and provider/patient 35 Little high-quality evidence exists to support recommended. agreements, are a vital part of opioid prescription the choice of any one opioid over another for Be aware that comorbid conditions such “best practices.” Such documentation provides a acute pain. However, some opioids are associated as depression and anxiety can impact pain transparent and enduring record of a clinician’s with more adverse events. For example, codeine is management. (In a study of 250 patients with rationale for a particular treatment and provides not preferred due to differential metabolism to the chronic pain and moderate depression, using a basis for ongoing monitoring and, if needed, active ingredient, morphine. It is associated with a antidepressant therapy reduced pain levels before modifications of a treatment plan.122 151 risk of both under-treatment in usual doses (due analgesic interventions were added. ) Many computerized systems are now available to CYP2D6 mutations) and overtreatment (in ultra- For patients with intractable, moderate- for the acquisition, storage, integration, and rapid metabolizers of CYP2D6). 146 to-severe chronic non-cancer nociceptive pain presentation of medical information. Most offer Meperidine is associated with an increased risk unresponsive to non-opioid treatment options, advantages that will benefit both patients and of post-operative delirium147 due to its long half-life a trial of opioids may be indicated guided by the prescribers, such as maintaining up-to-date and its active metabolite, normeperidine, which is a following principles (each detailed below): records, and providing instant availability of central nervous system stimulant.148 • Discuss risks and benefits of opioid use information relevant to prescribing or treatment. • Establish a written treatment agreement Although automation can help, clear documentation Opioid dosing for acute pain • Check or monitor opioid use is not dependent on electronic record-keeping; it The amount of opioid prescribed should relate • Use caution with dose escalation merely requires a commitment to creating clear and to the level of pain expected from the injury or • Prescribe naloxone if at risk for overdose enduring communication in a systematic fashion. procedure. Injuries or procedures involving bones Good documentation can be achieved with the most elaborate electronic medical record systems, with Table 5: Opioid dose recommendations for post-procedural pain150 paper and pen, or with dictated notes. Clinicians Procedure Number of oxycodone 5 mg must decide for themselves how thoroughly, and tablets (or equivalent) how frequently, their documentation of a patient’s Dental extraction 0 treatment should be. Thyroidectomy 5 Informed Consent Breast biopsy or lumpectomy 5 Informed consent is a fundamental part of Lumpectomy plus sentinel lymph node biopsy 5 planning for any treatment, but it is particularly important in long-term opioid therapy, given the Hernia repair (minor or major) 10 potential risks of such therapy. At its best, consent Sleeve gastrectomy 10 also fortifies the clinician/patient relationship. Prostatectomy 10 Prescribers must be able to answer with confidence Open cholecystectomy 15 four key questions when obtaining informed consent in the context of treatment with opioids:152 Cesarean delivery 15 1. Does the patient understand the various Hysterectomy (all types) 15 options for treatment? 2. Has the patient been reasonably informed of Cardiac surgery via median sternotomy 15 the potential benefits and risks associated with Open small bowel resection 20 each of those options? Simple mastectomy with or without sentinel lymph node biopsy 20 3. Is the patient free to choose among those options, free from coercion by the healthcare Total hip arthroplasty 30 professional, the patient’s family, or others? Total knee arthroplasty 50

16 4. Does the patient have the capacity to • Putting all burden on the patient rather than cannot be objectively confirmed. communicate his or her preferences— sharing it between patient and clinician Although a patient’s subjective pain and verbally or in other ways (e.g., if the patient • Framing the agreement in terms of suffering are obviously important factors, only the is deaf or mute)? punishments for possible future crimes or functional impact of the pain can be measured 5. Is there a proxy available if the patient cannot difficulties and used to create objective treatment goals. This provide consent due to cognitive impairment? • Using language that is stigmatizing, impact takes many forms, but typically chronic Documentation related to these key areas can dominating, or pejorative pain erodes foundations of daily life, such as be accomplished by creating a separate paper or • Using coercion in any way physical activity, concentration, emotional stability, electronic informed consent form or by incorporating • Imposing limitations for the clinician’s interpersonal relationships, and sleep. This can, in informed consent language into a larger treatment convenience without clear and substantial turn, degrade functioning at work or in the home, plan or patient/provider agreement. benefit for the patient. which can lead to depression, anxiety, insomnia, • Insisting on behaviors unrelated to actual use and even suicide. Clinicians should know that even of medications Patient-Provider Agreements relatively modest reductions in pain can translate A written agreement between a clinician and a • Using the term “fired” to describe termination of treatment. into significant functional improvements as pain patient about the specifics of their pain treatment rating declines.122 A 20% reduction in a pain score with opioids can help clarify the plan with the • Threatening abandonment or suggesting that patients will not have continued access to non- (i.e., roughly two points on the standard 0-10 pain patient, the patient’s family, and other clinicians who scale) may be acceptable if it produces significant may become involved in the patient’s care.122 Such opioid pain relieving treatments if opioids are terminated functional benefits for a patient. agreements can also reinforce expectations about Framing treatment goals in terms of improved the appropriate and safe use of opioids. Caution To be effective, written agreements must be patient functioning, rather than merely pain relief, must be exercised, however, to ensure that patient- clearly understood by the patient. This may require offers two primary advantages to clinicians: provider agreements are not used in a coercive the provision of agreements in multiple languages. • Prescribing decisions (or decisions to way to unethically place patients in the position All agreements should be written at the sixth- to terminate treatment) are based on outcomes 153 of having to agree to its terms or else lose an seventh-grade level or even lower. Translators that can be objectively demonstrated to both important component of their treatment (or even may need to be provided for speakers of other clinician and patient (and, possibly, to the lose all treatment).152 languages to ensure patient understanding and patient’s family) Although evidence is lacking about the most effective informed consent. A patient who does not • Individual differences in pain tolerance become effective methods to convey the information fully understand the potential risks and benefits of secondary to the setting and monitoring of included in most patient-provider agreements, a treatment cannot be truly “informed” as required treatment goals, since subjectively perceived such agreements have been widely used and are by the legal and ethical guidelines for medical levels of pain are not the primary focus in recommended by regulators and many experts on practice. Time must be allowed for patients to ask determining functionality. treatment guidelines for long-term opioid therapy.35 questions, and for prescribers to ensure patients The Veterans Administration and U.S. Department understand what they are being told. Some, or all, Basing treatment plans on functional goals is of Defense chartered an expert panel to undertake of these tasks may be handled by trained personnel especially valuable in the context of prescribing a systematic review of existing medical literature (or staff members) rather than clinicians. opioid pain medications, because such goals may on this subject. In the clinical practice guidelines Although the term “agreement” is generally help determine whether a patient has an opioid resulting from that work, the panel concluded that perceived as being more patient-friendly than the use disorder because patients with OUD often have opioid treatment agreements are a standard of word “contract,” clinicians should understand decreased functioning, while effective pain relief care when prescribing long-term opioid therapy.152 that, from a legal standpoint, any written or oral typically improves functioning. Provider-patient agreements have many agreement between a prescriber and a patient may Functional decline itself may result from a potential advantages, including:122 be considered a binding “contract.”154 Clinicians range of problems, including inadequate pain relief, • Allowing treatment to start on a note of mutual should ensure that the terms in any agreement non-adherence to a regimen, function-limiting side respect and partnership are understood by the patient, and are acceptable, effects, or untreated affective disorders. Sometimes • Enhancing transparency attainable, and consistent with high-quality practice. impaired functioning is the result of OUD, and • Engaging patients in a collaborative education these objective results may shed valuable light on and decision-making process BEFORE MOVING ONTO THE NEXT SECTION, an otherwise confusing presentation of a patient’s • Helping to set functional goals and clarifying PLEASE COMPLETE CASE STUDY 4 ON THE pain symptoms. the clinician’s and patient’s roles and NEXT PAGE. Functional treatment goals should be realistic. responsibilities in attaining these goals Progress in restoring function is usually slow and Creating individualized function-based pain • Documenting acceptance of treatment risks gains are typically incremental. Chronic non-cancer treatment plans and benefits pain is often marked by long-standing physical Once a patient has been assessed and • Documenting informed consent and psychological deconditioning, and recovery accepted as a candidate for chronic opioid therapy, • Helping avoid misunderstandings that may may require reconditioning that may take weeks, occur over long treatment time periods and after informed consent has been obtained for months, or years. It is much better to set goals that • Providing a foundation for subsequent such treatment, a written plan for implementing the are slightly too low than slightly too high. Raising decisions about changes in medications or treatment should be drafted. Such plans typically goals after a patient has “succeeded” in achieving termination of treatment include a statement of the goals of therapy. These them is far more motivational and encouraging than goals should be written carefully in light of the Clinicians should strive to craft agreements lowering goals after a patient has “failed.” that serve their patients’ best interests and avoid inherent subjectivity of pain. Since pain itself cannot coercive or punitive language. Thus, agreements be measured objectively, framing treatment goals should avoid: solely in terms of pain relief means that such goals

17 Case Study 4

Janet is an 82-year-old Caucasian woman. Her husband died of an ischemic stroke five years ago, and now her son Tim, who lives nearby, looks after her. Janet has had chronic left hip pain ever since a hip fracture repair two years ago developed a serious infection. She comes in to see you with Tim because she is having worsening pain. Although she has always been quick-witted and articulate, in recent years Janet has had memory problems, often pausing in mid-sentence as she searches for a name or word that’s “right on the tip of her tongue.” She views these memory lapses as completely normal, although Tim finds them worrisome. According to Janet, the pain medication she was prescribed (short-acting hydrocodone/acetaminophen) is not enough to quell the pain in her hip (she says both are now hurting). According to Tim, however, Janet often forgets how much medicine she has taken. Tim feels Janet is relying too heavily on the analgesics—he believes strongly that much of Western medicine is misguided, overly invasive, and overly reliant on “pills for everything.” Janet dismisses Tim’s concerns and presses for a long-acting opioid she saw advertised on television.

Instructions: Review the sample controlled substance patient agreement below, then answer the questions on the next page related to the “Janet” scenario above: SAMPLE PATIENT AGREEMENT:

PATIENT NAME: ______

PRIMARY CARE PHYSICIAN/SITE:______

I understand that this agreement between myself; and (insert name of medical office/group) is intended to clarify the manner in which chronic (long- term) controlled substances will be used to manage my chronic pain. Chronic controlled substance therapy for patients who do not suffer from cancer pain is a controversial issue.

I understand that there are side effects to this therapy; these include, but are not limited to, allergic reactions, depression, sedation, decreased mental ability, itching, difficulty in urinating, nausea and vomiting, loss of energy, decreased balance and falling, constipation, decreased sexual desire and function, potential for overdose and death. Care should be taken when operating machinery or driving a car while taking these medications. When controlled substances are used long-term, some particular concerns include the development of physical dependence and addiction. I understand these risks and have had my questions answered by my physician.

I understand that my (insert name of medical group) health care provider will prescribe controlled substances only if the following rules are adhered to:

• All controlled substance prescriptions must be obtained from your (insert name of medical group) primary care provider. If a new condition develops, such as trauma or surgery, then the physician caring for that problem may prescribe opioids for the increase in pain that may be expected. I will notify my primary care physician within 48-hours of my receiving an opioid or any other controlled substance from any other physician or other licensed medical provider. For females only: If I become pregnant while taking this medicine, I will immediately inform my provider and my obstetrician and obtain counseling on risks to the fetus. • I will submit urine and/or blood on request for testing at any time without prior notification to detect the use of non-prescribed drugs and medications and confirm the use of prescribed ones. I will submit to pill counts without notice as per provider’s request. I will pay any portion of the costs associated with urine and blood testing that is not covered by my insurance. • All requests for refills must be made by contacting my (insert name of medical group) primary care provider during business hours at least 3-workdays in advance of the anticipated need for the refill. All prescriptions must be filled at the same pharmacy, which is authorized to release a record of my medications to this office upon request. A copy of this agreement will be sent to my pharmacy. • Pharmacy name/address/telephone: • The daily dose may not be changed without my (insert name of medical group) primary care provider’s consent. This includes either increasing or decreasing the daily dose. • Prescription refills will not be given prior to the planned refill date determined by the dose and quantity prescribed. I will accept generic medications. • Accidental destruction, loss of medications or prescriptions will not be a reason to refill medications or rewrite prescriptions early. I will safeguard my controlled substance medications from use by family members, children or other unauthorized persons. • You may be referred to an appropriate specialist to evaluate your physical condition. • You may be asked to have an evaluation by either a psychiatrist or psychologist to help manage your medication needs. • If your provider determines that you are not a good candidate to continue with the medication, you may be referred for further evaluation or treatment. . • These medications may be discontinued or adjusted at your provider’s discretion.

I understand that it is my provider’s policy that all appointments must be kept or canceled at least 2-working days in advance. I understand that the original bottle of each prescribed controlled substance medication must be brought to every visit.

I understand that I am responsible for meeting the terms of this agreement and that failure to do so may result in my provider no longer prescribing for me.

Patient’s Signature: Date:

18 Case Study 4 (Continued) Questions for case study: 1. Would this agreement be appropriate for use with Janet?

2. Would this agreement need to be modified in any way because of the specifics of Janet’s case?

3. Would it be prudent to include a family member in the discussion about treatment and to serve as a witness to the agreement?

Table 6 illustrates some simple functional goals patient together must decide if this is acceptable or • The experience of intolerable side effects and ways they might be verified. whether changes are needed. • Lack of adequate response to a medication The responsibility for obtaining evidence of As is the case in drafting other types of patient/ in terms of either pain relief or functional success in meeting a functional goal lies with provider documents, patients should be reminded improvement (called therapeutic failure) the patient and should be made explicit in the of the benefits and risks of a chosen therapy. With • Evidence of non-medical use of the medication, prescribing agreement. If a patient is unable to opioids, these include the realities of tolerance abuse, inappropriate use, or OUD document or achieve the progress outlined in a and physical dependence and the potential need treatment plan, this may suggest a need for goal to taper the medication slowly to avoid withdrawal. If inappropriate use of a prescription readjustment. Patients must also be educated about the possibility medication is discovered, treatment may be that opioids may be either ineffective or have suspended, although provisions should be in place Components of an Effective Treatment Plan intolerable adverse effects, and that there is also for continuation of some kind of pain treatment The creation of an effective function-based the possibility of problematic use, which could lead and/or referral to other professionals or members treatment plan must be a collaboration between to misuse, abuse, or, less commonly, OUD. of a pain management team. Some clinicians may patient and clinician. A patient’s pain score will Another critical component of any treatment be willing and able to continue a regimen of opioid be just one of many variables to be considered plan is a description of how treatment with an therapy even after the discovery of aberrant in framing goals. These goals should be realistic, opioid medication might be terminated. Stopping behavior if done with intensified monitoring, meaningful to the patient, and verifiable. The details opioid therapy in cases of chronic non-cancer pain patient counseling, and careful documentation of a function-based treatment plan are necessarily is often more difficult than starting it. Being clear of all directives. This level of vigilance and risk specific to the patient, but one way to initiate the about the conditions under which opioid therapy will management, however, may exceed the abilities process is to begin with the question: “What do you end is important because opioids are not curative, and resources of the average prescriber. In such hope to do as a result of treatment that you can’t have no standard duration of treatment, and may cases, referral to a provider with specialized skill or do now?” be associated with substantial risks. experience in dealing with high-risk patients may be The treatment plan can include a discussion Termination may be required for many reasons, prudent. of, and the setting of expectations about, periodic including: re-assessment of goals. Patients may stabilize at • Healing or resolution of a specific pathology a certain level of function, and the clinician and underlying the pain Table 6: Example of functional goals and evidence used to assess progress122 Functional Goal Evidence Begin physical therapy Letter from physical therapist Sleeping in bed as opposed to lounge chair Report by family member or friend (either in-person or in writing)* Participation in pain support group Letter from group leader Increased activities of daily living Report by family member or friend Walk around the block Pedometer recordings or written log of activity Increased social activities Report by family member or friend Resumed sexual relations Report by partner Returned to work Pay stubs from employer or letter confirming the patient is off of disability leave Daily exercise Gym attendance records or report from family member or friend * Involving other persons requires explicit permission from the patient, and this permission should be documented.

19 The intensity and frequency of monitoring However, simply asking patients how they are using In the context of family practice settings (and recommended in a treatment plan is dependent the medication, how often they take it, how many even pain specialist settings) unobserved urine on an assessment of the patient’s risk for abuse, pills they take at one time, and what triggers them collection is usually an acceptable procedure for diversion, or addiction. Tools and techniques to take the medication, can identify patients who drug testing. Prescribers, however, should be similar or identical to those used during an initial may be misusing opioids or need changes to their aware of the many ways in which urine specimens assessment of a patient’s risk can be used to re- pain management plan. Other ways to objectively can be adulterated. Specimens should be shaken assess or monitor risk on an on-going basis.155 monitor opioid use are checking prescription to determine if soap products have been added, States vary in their requirements for intervals at drug monitoring programs, completing urine drug for example. The urine color should be noted on which follow-up visits are required when controlled screens, or random pill counts. any documentation that accompanies the specimen substances such as opioid medications are Relatively infrequent monitoring may be for evaluation, since unusually colored urine could prescribed. Although federal law allows for a 90- appropriate for low-risk patients on a stable dose indicate adulteration. Urine temperature and pH day supply of prescriptions for patients receiving of opioids (i.e., 1-2 times a year). More frequent or should be measured immediately after collection schedule II drugs (who are otherwise deemed safe intense monitoring is appropriate for patients during when possible.155 to have this amount), state law can vary from 30 the initiation of therapy or if the dose, formulation, One way to reduce the risk of urine test days to 6 months. In cases where state and federal or opioid medication is changed. Patients who may false positives or false negatives is to develop law conflict, the most restrictive rule prevails.155 need more frequent or intense monitoring (i.e., 4-6 a relationship with a single laboratory, become 122 times a year) include: familiar with its testing tools and threshold values, Initiating therapy • Those with a prior history of an addictive and use the same screening (presumptive) and When initiating a trial of opioids, start with disorder, past abuse, or other aberrant use confirmatory (definitive) tests regularly to build immediate-release formulations because their • Those occupations demanding mental acuity familiarity with the range of normal results.155 shorter half-life reduces the risk of inadvertent • Older adults Quantitative testing is not necessary and can not overdose. Prescribe low doses on an intermittent, • Patients with an unstable or dysfunctional be used to determine if a patient is taking a specific as-needed basis. For elderly patients who have social environment dose of a medication. comorbidities, start at an even lower dose (25-50% • Those with comorbid psychiatric or medical Prescribers should be familiar with the of usual adult dose). conditions metabolites associated with each opioid that may Long-term opioid use often begins with It is important to recognize that urine be detected in urine, since the appearance of a treatment for acute pain, and research shows drug testing is expensive and not all insurance metabolite can be misleading (Table 7). A patient that opioids are often over-prescribed for acute companies will pay for frequent testing. Discuss the prescribed codeine, for example, may test positive pain. For example, a study of 1,416 patients in a cost of testing with patients. Also, only order the for morphine because morphine is a metabolite 6-month period found that surgeons prescribed a test that is necessary. It is not necessary to order of codeine. Similar misunderstandings may occur mean of 24 pills (standardized to 5 mg oxycodone) quantitative testing on patients as this test can be for patients prescribed hydrocodone who appear but patients reported using a mean of only 8.1 very expensive. For low-risk patients urine drug positive for hydromorphone or oxycodone and 149 pills (utilization rate 34%). For acute pain, only screening, even done as a point of care test, may oxymorphone. enough opioids should be prescribed to address be sufficient. the expected duration and severity of pain from an Trust is a necessary part of any patient- injury or procedure (or to cover pain relief until a clinician relationship, but studies suggest that in follow-up appointment). Several guidelines about the context of controlled substances, it is unwise to Table 7: Metabolites of common opioid 155 opioid prescribing for acute pain from emergency rely on a patient’s word that medications are being analgesics departments156,157 and other settings158,159 have consumed as prescribed. Although the use of more Drug Metabolites recommended prescribing ≤3 days of opioids in objective ways to monitor adherence to medication most cases, whereas others have recommended regimens is an imperfect science, such methods Morphine Morphine ≤7 days,160 or ≤14 days.161 CDC guidelines suggest remain an essential component of periodic review. Hydromorphone that for most painful conditions (barring major Multiple objective methods to assess adherence Codeine surgery or trauma) a 3-day supply should be exist, but there is no single “best” approach and all enough, although many factors must be taken into such methods have both advantages and potential Codeine Codeine account (for example, some patients might live so drawbacks. Morphine far away from a health care facility or pharmacy that Drug testing should be approached in a Hydrocodone somewhat larger supplies might be justified).38 consensual manner as part of an agreed-upon treatment plan and with the idea that such testing Hydrocodone Hydrocodone Monitoring opioid use benefits both the patient and the provider. The Hydromorphone Follow-up appointments should occur one to potential benefits of clinical drug testing include:122 6-Hydrocodol four weeks after initiation of opioids or with dose • Serving as a deterrent to inappropriate use • Providing objective evidence of abstinence changes; maintenance therapy visits should occur Oxycodone Oxycodone at least every three months. Each visit should from non-prescribed controlled substances • Monitoring response to opioid treatment Oxymorphone include an assessment using a pain and function • Assisting with a diagnosis Hydrocodone tool, questions about side effects, evaluation of • Helping patients allay concerns by family overdose risk, and discussions about how the members, employers, or law-enforcement medication is being used.22 • Demonstrating to regulatory authorities a Many strategies to monitor opioid use and clinician’s dedication to monitoring “best ensure patient safety have been recommended. practices”

20 Opioid rotation and equianalgesic dosing Printed equianalgesic charts are common, and administration and is not the same as OUD, a “Opioid rotation” means switching from one online calculators are also freely available (a condition where patients lose control of their opioid opioid to another in order to better balance analgesia common one can be accessed at clincalc.com/ use or compulsively use opioids. The nature and and side effects. Rotation may be needed because Opioids). The CDC provides a helpful guide to time of onset of this syndrome vary with drug of a lack of efficacy (often related to tolerance), opioid conversions available at: www.cdc.gov/ actions and half-life. Slow tapering of the drug bothersome or unacceptable side effects, increased drugoverdose/pdf/calculating_total_daily_dose-a. (e.g., 10-15% reduction in dosage per day or every dosing that exceeds the recommended limits of pdf. Always work with a clinical pharmacist if you other day) usually avoids the appearance of an the current opioid (e.g., dose limitations of co- do not have a lot of experience with opioid rotation abstinence syndrome. compounded acetaminophen), or inability to absorb as this can be a risk factor for unintentional opioid Although not usually encountered in patients the medication in its present form (i.e., if there is a overdose. without a history of drug abuse, the administration change in the patient’s ability to swallow, switch to of some drugs (e.g., opioids) may cause OUD. Signs a formulation that can be absorbed by a different How to recognize and intervene upon suspicion of drug craving and/or drug-seeking behavior route such as transdermal.) or identification of an OUD (e.g., missed appointments with after-hour calls for Because of the large number of variables Whenever a clinician considers treating pain prescription renewals; solicitation of prescriptions involved in how any given opioid will affect any with a controlled substance, such as an opioid, risk from multiple physicians; reports of lost, destroyed, given patient, opioid rotation must be approached of misuse or diversion is always a possibility, no or stolen medications; selling and buying drugs cautiously, particularly when converting from an matter how remote, and must be assessed. Exactly off the street)164 should alert the clinician to such immediate-release formulation to an ER/LA product. whom to suspect and when to be proactive in a possibility. It is critical that OUD be diagnosed As noted previously, equianalgesic charts must be investigating risk factors is an area of great debate. because it is a serious, but very treatable, condition used carefully, and titration must be done carefully To date, no convincing data exist to support the and failure to treat it will hinder efforts to manage and with appropriate monitoring. In some cases, strategy of focusing on any one specific population pain. because of the risk of potential harm during the or setting—which means that prescribers must be time of rotating from one chronic opioid regimen to vigilant with all patients. The concept of “universal Managing Non-Adherent Patients another, it may be wise to initially use lower doses precautions” has been applied to this approach, Patients who exhibit aberrant drug-related of an ER/LA opioid than might be suggested by which means that any patient in pain could have a behaviors or non-adherence to an opioid equianalgesic charts, while temporarily liberalizing, drug misuse problem—just as any patient requiring prescription should be monitored more closely than 163 as needed, the use of a short-acting opioid.162 This a blood draw for a simple lab test could have HIV. compliant patients. Concern that a patient is non- would then be followed by gradual titration of the Treating everyone with the same screens, diagnostic adherent should prompt a thorough evaluation. LA opioid to the point where the as-needed short- tests, and administrative procedures can help The way clinicians interact with patients can affect acting opioid is incrementally reduced, until no remove bias and level the playing field so everyone the relationship (for better or worse) and influence longer necessary. is treated equally and screened thoroughly. treatment outcomes. A clinician’s negative reactions Equianalgesic dosing charts help clinicians Nonetheless, it is also true that some patient to non-adherence might include anger at the patient, determine the appropriate starting dose of an characteristics are predictive of a potential for drug disappointment and sadness at the apparent opioid when changing routes of administration or abuse, misuse, or other aberrant behaviors. The betrayal of trust, or fear that the patient’s behavior when changing from one opioid drug to another. factor that appears to be most strongly predictive in could expose the provider to legal jeopardy.122 Such charts must be used carefully, however. A this regard is a personal or family history of alcohol Before accusing a patient of not adhering to high degree of variation has been found across or drug abuse.35 Some studies have also shown a prescribed regimen, clinicians should assess the the various charts and online calculator tools, and that younger age and the presence of psychiatric situation fully. Possible reasons for non-adherence may account for some overdoses and fatalities.162 conditions are also associated with aberrant drug- include: The optimal dose for a specific patient must be related behaviors.35 • Inadequate pain relief determined by careful titration and appropriate In evaluating patients with chronic pain for risk • Misunderstanding of the specifics of the monitoring, and clinicians must be mindful that of addiction or signs that they may be abusing a prescription patients may exhibit incomplete cross-tolerance to controlled substance, it may be helpful to consider • Misunderstandings related to lack of fluency different types of opioids because of differences the sets of characteristics listed in Table 8. with English in the receptors or receptor sub-types to which different opioids bind.162 In addition, the patient’s Signs of physical dependence include the • Attempts to “stretch” a medication in order to existing level of opioid tolerance must be taken into appearance of an abstinence syndrome with save money account. abrupt cessation or diminution of chronic drug

Table 8: Characteristics of chronic pain patients vs. patients with an OUD155 Patient with chronic pain Patient with an opioid use disorder Medication use is not out of control Medication use is out of control Medication use improves quality of life Medication use impairs quality of life Wants to decrease medication if adverse effects develop Medication use continues or increases despite adverse effects Is concerned about the physical problem being treated with the drug Unaware of or in denial about any problems that develop as a result of drug treatment Follows the practitioner-patient agreement for use of the opioid Does not follow opioid agreement May have left over medication Does not have leftover medication Loses prescriptions Always has a story about why more drug is needed 21 • Cultural or familial pressure not to take a monitoring, counseling, and careful documentation with immediate-release opioids.145 As noted above, medication if it is deemed in the best interest of the patient. continuous, time-scheduled use of ER/LA opioids • Stigma about taking a pain medication This requires, however, careful consideration and is not more effective or safer than intermittent use • Overmedication and fears about addiction a well-documented risk management plan that of immediate-release opioids, and ER/ LA opioids • Misunderstanding of a prescription by a addresses the greater resources necessary for increase risks for opioid misuse or addiction.38 caregiver who has taken responsibility for opioid continuation following evidence of misuse. The 2016 CDC guidelines suggest that ER/LA daily apportioning of medications If termination of the provider/patient opioids should be reserved for severe, continuous • Confusion between two medications that look relationship is deemed necessary (though it pain and should be considered only for patients very similar to each other rarely is), clinicians must ensure that the patient who have received immediate-release opioids daily is transferred to the care of another provider and for at least 1 week.38 Additional caution is required The use of patient–provider agreements and/ ensure that the patient has adequate medications to when prescribing ER/LA opioids in older adults or or informed consent documents can help clinicians avoid unnecessary risk, such as from uncontrolled patients with renal or hepatic dysfunction because navigate the uncertainties that can arise in cases or unpleasant withdrawal. Practitioners can be decreased clearance of drugs among these patients of real or apparent non-adherence, and may help held accountable for patient abandonment if can lead to accumulation of drugs to toxic levels make the process less confrontational. Consultation with an addiction medicine specialist or psychiatrist medical care is discontinued without justification or and persistence in the body for longer durations. may be necessary if addiction is suspected or if a adequate provision for subsequent care. When an ER/LA opioid is prescribed in the patient’s behavior becomes so problematic that it primary care setting, using an agent with predictable Caution with dose escalation jeopardizes the clinician/patient relationship. pharmacokinetics and pharmacodynamics is When escalating opioid doses, be aware of preferred to minimize unintentional overdose risk 22 Treatment Termination two critical daily thresholds—50 and 90 MMED. (i.e., the unusual characteristics of methadone Reasons for discontinuing an opioid analgesic According to the CDC, doses >50 MMED are and transdermal fentanyl make safe prescribing of can include the healing of or recovery from an associated with more than double the risk of these medications for pain more challenging).38 38 injury, medical procedure, or condition; intolerable overdose compared to patients on <50 MMED. The use of methadone for chronic pain in primary side effects; lack of response; or discovery of For patients on >90 MMED, a 9-fold increase in care should generally be avoided because of higher misuse of medications. Regardless of the reason, mortality risk was observed compared with the methadone-related risks for QTc prolongation and termination should be accomplished so as to lowest opioid doses. Ninety MMED is considered by fatal arrhythmias.38 Equianalgesic dose ratios are minimize unpleasant or dangerous withdrawal several guidelines as a “red flag” dose beyond which highly variable with methadone, making conversion symptoms by tapering the opioid medication slowly, careful assessment, more frequent monitoring, and from other opioids difficult, with attendant increased by carefully changing to a new formulation, or by documentation of expected benefits are required risk of overdose. While methadone-related death effectively treating an opioid use disorder if it has (note, however, that this limit doesn’t apply to rates decreased 9% from 2014 to 2015 overall, developed. Approaches to weaning range from a patients with severe cancer pain or end-of-life pain). the rate increased in people ≥65 years of age.165 slow 10% reduction per week to a more aggressive The total MMED for all prescribed opioids should If methadone is considered, refer patients to pain 25 to 50% reduction every few days.35 In general, be used (MMED is automatically calculated on many management specialists with expertise in using this a slower taper will produce fewer unpleasant state PDMP reports). medication. symptoms of withdrawal; however, this may not be Role of ER/LA opioids and methadone the safe course of action for a patient experiencing BEFORE MOVING ONTO THE NEXT SECTION, ER/LA opioids include methadone, transdermal harmful side effects or who has OUD. PLEASE COMPLETE CASE STUDY 5. fentanyl, and extended-release versions of opioids Opioid therapy must be discontinued or re- such as oxycodone, oxymorphone, hydrocodone, evaluated whenever the risk of therapy is deemed to and morphine. A 2015 study found a higher risk for outweigh the benefits being provided. A clinician may overdose among patients initiating treatment with choose to continue opioid treatment with intensified ER/LA opioids than among those initiating treatment

Case Study 5 Instructions: Review the case below and consider the questions that follow. 1. What steps might you take before agreeing to a trial of an Zeke is a 25-year-old construction worker who is currently taking ER/LA medication for Zeke? workman’s compensation to recover from a compound fracture of his right foot and ankle sustained when a cement block slipped off of a pallet and landed on his foot. The fractures required two surgeries to correct, with the implantation of several internal fixation devices. 2. What specific kind of ER/LA medication might be most appropriate Zeke was prescribed a short-acting opioid after each surgery, which for Zeke if no contraindications were found in the pain and he has continued to use. He has been regularly attending physical substance abuse assessment? therapy sessions to restore muscle tone in his right leg, but has come into the clinic today seeking an ER/LA opioid. The short-acting medication, he says, is “choppy” and allows his pain to return at the end of each dosing cycle. He says friends have suggested that a 3. Name three specific functional goals that might be used as the long-acting opioid would be easier to use and would provide him more basis for a pain management agreement with Zeke. steady pain relief.

22 Protecting against opioid-induced adverse approved by the FDA in April, 2019.167 Primary care consider referring the patient to a pain specialist events providers should prescribe naloxone to patients at (assuming one is available in the geographic area) The Veterans Administration/Department risk of overdose, including those: or other professionals with expertise in specific of Defense (VA/DoD) clinical practice guideline • With renal or hepatic dysfunction areas of need. Some examples of conditions or outlines a number of evidence-based strategies to • Taking opioid doses >50 MMED patients in which referral may be warranted include: reduce opioid-related adverse effects (Table 9).166 • Co-prescribed benzodiazepines or other • Phantom limb pain Prophylaxis for constipation—the most common sedating medications • Severe neuropathic pain opioid-induced adverse event—has been facilitated • With a history of overdose or OUD • Severe low back and neck pain, or radicular by the approval of methylnaltrexone subcutaneous • Starting treatment for OUD pain the arms or legs administration and naloxegol oral administration for Many states allow patients, family members, • Intractable headache patients with chronic non-cancer pain. Other, less caregivers, and/or friends to request naloxone from • Visceral pain expensive medications like senna and docusate, are their local pharmacist. Anyone receiving naloxone • Significant joint pain • Unrelieved chronic pain also effective to guard against constipation. should be taught how to use the device and about • Patients with pain who also have an OUD being Both male and female patients on long-term the common signs of overdose (slow or shallow treated with medication-assisted therapy opioid therapy are at risk for hypogonadism, thus breathing, gasping for air, unusual snoring, pale or bluish skin, not waking up or responding, pin • Patients with mental disorders that interfere current guidelines suggest that the endocrine with their ability to adhere to and/or function of all patients should be assessed at the point pupils, slow heart rate). A variety of naloxone products are available. The intranasal device with comprehend recommended treatments start of long-term opioid therapy and at least • Older adults with polypharmacy and/or annually thereafter. The symptoms of hypogonadism atomizer and intramuscular (IM) shots require the most manipulation in order to administer. Intranasal significant comorbidities for which typical in both genders may include fatigue, mood naloxone and the auto-IM injector are easier to use, analgesics may be contraindicated changes, decreased libido, loss of muscle mass, but vary greatly in terms of price and insurance • Patients with end-of-life pain using levels of and osteoporosis. Although there are insufficient coverage. opioid analgesics that pose a significant risk of data to recommend routine endocrine screening Depending on the opioid involved in the severe or fatal respiratory depression of asymptomatic patients, current guidelines do overdose, more than one dose may be required. recommend such testing for patients exhibiting any All patients who receive naloxone reversal should PLEASE SPEND THE ALLOTTED TIME ON CASE 35 of the aforementioned signs and symptoms. be taken to an emergency room in case additional STUDY 6 ON THE NEXT PAGE. doses of naloxone or other medical support is Naloxone for opioid overdose needed. Naloxone (e.g., Narcan) is an opioid antagonist When to consult a pain specialist or refer that quickly reverses the effects of opioid Many acute or chronic pain conditions are overdose. Naloxone is increasingly available to relatively straightforward and can be effectively first responders, patients, and friends and family treated by primary care clinicians. But some painful members of those prescribed opioids, and a conditions, and some patients, pose considerable generic formulation of nasal-spray naloxone was complexities, and in such cases clinicians should Table 9: Recommendations for preventing or treating opioid-induced side effects166 Constipation Methylnaltrexone or naloxegol Prophylactic mild peristaltic stimulant (e.g. bisacodyl or senna) If no bowel movement for 48 hours, increase dose of bowel stimulant If no bowel movement for 72 hours, perform rectal exam If not impacted, provide additional therapy (suppository, enema, magnesium citrate, etc.) Nausea or vomiting Consider prophylactic antiemetic therapy Add or increase non-opioid pain control agents (e.g. acetaminophen) If analgesia is satisfactory, decrease dose by 25% Treat based on cause Sedation Determine whether sedation is due to the opioid – if so, lower opioid dose immediately Eliminate nonessential CNS depressants (such as benzodiazepines) Reduce dose by 20-30% Add or increase non-opioid or non-sedating adjuvant for additional pain relief (such as NSAID or acetaminophen) so the opioid can be reduced Change opioid Prescribe naloxone Pruritus Consider treatment with antihistamines Change opioid Hallucination or Evaluate underlying cause dysphoria Eliminate nonessential CNS acting medications Sexual dysfunction Reduce dose Testosterone replacement therapy may be helpful (for men) Erection-enhancing medications (e.g., sildenafil)

23 10% until patient is taking 30% of the total initial Case Study 6 dose, then recalculate 10% taper based on the new Instructions: Review the case below and consider the questions that follow. total opioid dose to slow taper.168,170 The rate of opioid taper should be adjusted based on patient- Clara is a 77-year-old who has been diagnosed with lumbar spinal stenosis, which is causing specific factors such as the severity of withdrawal a burning pain that radiates across her back and down into her buttocks. She has stage 2 symptoms. kidney failure, although she is not on dialysis. In the previous two years, she has fallen twice at A structured support program for opioid home, sustaining a subdural hematoma on one occasion and a sprained shoulder on the other. tapering may improve outcomes. A small trial of She lives alone and is fiercely independent, continuing to drive and adequately maintaining 35 patients with long-term opioid use compared a activities of daily living. She has tried numerous non-drug treatments for her pain, including structured intervention including weekly individual physical therapy, acupuncture, massage, yoga, and even medical cannabis (which she said did counseling sessions vs. standard care and found help with the pain, but which she didn’t continue because she didn’t like the cognitive effects). reduced opioid doses in the intervention group at 34 weeks (mean 100 MMED vs. 138 MMED) although the difference was not statistically significant at 34 weeks.171 Pain scores decreased in 1. Would treatment with an NSAID be appropriate for Clara? Why or why not? both groups by about one point on a 10-point scale (not significant). In 2019 the FDA, recognizing the risks associated with abrupt discontinuation of opioid analgesics, required new labeling for opioid analgesics to guide prescribers about safe tapering 2. Would treatment with an ER/LA opioid be appropriate for Clara? If so, what practices.172 The key elements include:172 specific route of administration and/or agent might be best? • Do not abruptly discontinue opioid analgesics in patients physically dependent on opioids. Counsel patients not to discontinue their opioids without first discussing the need for a gradual tapering regimen. • Abrupt or inappropriately rapid discontinuation 3. What aspects of Clara’s case should be considered when thinking about an initial of opioids is associated with serious withdrawal dose selection of an ER/LA medication? symptoms, uncontrolled pain, and suicide. • Ensure ongoing care of the patient and mutually agree on an appropriate tapering schedule and follow-up plan. • In general, taper by an increment of no more than 10-20% every 2-4 weeks. Medically directed opioid tapering • Pause taper if the patient experiences Who are pain medicine specialists? Patients who do not achieve functional goals Pain Medicine is the medical specialty significantly increased pain or serious on stable or increasing opioid doses or those with dedicated to the prevention, evaluation and withdrawal symptoms. unacceptable side effects, should have the opioid treatment of people with chronic pain. While • Use a multimodal approach to pain tapered or discontinued. Patients sometimes resist most physicians, advanced practice nurses, management, including mental health support tapering or discontinuation, fearing increased pain. and physician assistants have some training (if needed). However, a 2017 systematic review found that dose and experience in the management of chronic • Reassess the patient regularly to manage pain reduction or discontinuation resulted in reduced pain pain, Pain Medicine Specialists (physicians) and withdrawal symptoms that emerge and (eight studies), improved function (five studies) and have fellowship training from The American assess for suicidality or mood changes. improved quality of life (three studies).168 A 2018 Board of Medical Specialties (ABMS), the • Refer patients with complex comorbidities or retrospective study of 551 veterans with chronic American Osteopathic Association (AOA), or substance use disorders to a specialist. additional training in pain medicine sufficient pain (mostly musculoskeletal) assessed pain one year before, and one year after discontinuation to obtain ABPM diplomate status. They may Addiction medicine primer use medications, procedural interventions, of long-term opioids (MMED 75.8 mg).169 Pain or sometimes integrative therapies. Current was assessed on a 0-10 scale with higher score Opioid use disorder (OUD) protocols regarding the delineation of indicating worse pain. The mean overall pain score OUD is a problematic pattern of opioid use prescribing authority to and supervision of at the time of discontinuation was 4.9, and pain that causes significant impairment or distress.173 Advanced Practice Nurses with certificate of scores dropped during discontinuation by a mean (Note: OUD was previously termed by DSM-IV fitness for prescribing and Physician Assistants of 0.2 points/month. Patients with moderate pain “opioid abuse,” “opioid dependence,” or “opioid for prescribing to treat chronic pain continue experienced the greatest reduction in pain after addiction,” but in this learning activity we use OUD to apply. Pain Medicine Specialists may deal discontinuation. because this is the term used in the Diagnostic and with patients being treated with more than Recommendations for tapering schedules vary. Statistical Manual of Mental Disorders, 5th Edition 90 milligram morphine equivalents daily dose A 10% decrease weekly is recommended, based on because they are at least eleven times more [DSM-5].) As with other chronic diseases, OUD years of opioid use (i.e., 10% decrease monthly usually involves cycles of relapse and remission. likely to suffer an adverse effect including for patients using opioids ≥4 years). For patients overdose death. on high-dose opioids (i.e., ≥90 MMED), taper 24 OUD is a chronic brain disease resulting from the Methadone Buprenorphine effects on prolonged opioid use on brain structure Methadone is a synthetic, long-acting opioid Buprenorphine is a high-affinity partial opioid and function that causes significant negative agonist that fully activates mu-opioid receptors in agonist at the mu-opioid receptor as well as an personal, economic, and social consequences.174 the brain.179 This activity reduces the unpleasant/ antagonist of the kappa opioid receptor.185 Like Rates of OUD diagnoses have increased 4-5 fold dysphoric symptoms of opioid withdrawal, and, methadone, buprenorphine can relieve opioid in recent years, according to market research and at therapeutic doses, it blunts the “highs” of withdrawal symptoms, and, because of its partial insurance company data.175-177 Most people with shorter-acting opioids such as heroin, codeine, and agonist effect, it can reduce the rewarding OUD, or who misuse opioids, obtain the drugs from oxycodone. effect of other opioids used simultaneous with prescriptions (36.1%) or from friends and relatives Patients do not have to experience opioid buprenorphine. Buprenorphine’s partial agonist (53.1%).79 withdrawal before starting methadone. It may, status also translates into a lower risk of respiratory DSM-5 diagnosis of OUD is based on clinical however, take days to weeks to achieve a therapeutic depression compared to methadone and other evaluation and determination that a patient dose, which requires individualized monitoring in opioids,186 and a therapeutic dose may be achieved has problematic opioid use leading to clinically order to minimize cravings and reduce the risk of within a few days.187 significant impairment or distress involving at least relapse. Buprenorphine is available as sublingual two of the following within a 12-month period:173 In the United States, outpatient methadone tablets, sublingual/buccal films, subdermal implants, • Opioids taken in larger amounts, or for longer treatment for OUD can only be given to persons or extended-release subcutaneous injection (Table periods, than intended enrolled in state- and federally-certified opioid 1). Some film and tablet formulations are combined • Persistent desire or unsuccessful attempts to treatment programs/clinics. (Methadone can with the opioid antagonist naloxone to discourage control or reduce use be provided when patients are admitted to a misuse by crushing and injecting the medication. • Significant time lost obtaining, consuming, and hospital for treatment of other conditions or in (A buprenorphine-only patch [Butrans] is only recovering from opioids emergencies).180 Most patients are required to visit FDA-approved as an analgesic.) Some forms of • Craving or a strong desire or urge to use a methadone clinic every day to receive their dose. buprenorphine can be self-administered by patients opioids Eventually, stable patients may receive take-home after filling their prescription at regular pharmacies. • Failure to complete obligations (i.e., work, doses if they meet certain criteria, such as having a In order to prescribe buprenorphine, physicians home, or school) due to opioids stable period of good functioning without illicit drug in the United States must complete an 8-hour • Persistent or recurrent social or interpersonal use.37 In addition, patients prescribed methadone training and apply for a waiver (informally called an problems due to opioids are usually required to attend regular counseling X-waiver) from the Drug Enforcement Administration • Giving up enjoyable social, work, or sessions with clinic providers. (for details see “Obtaining an X-waiver” section recreational activities due to opioids As a full agonist, methadone sustains opioid below). The Comprehensive Addiction and Recovery • Recurrent opioid use in situations in which it is tolerance and physical dependence, thus missing Act of 2016 authorized nurse practitioners and physically hazardous (e.g., driving) doses may precipitate opioid withdrawal. Overdose physician assistants to be eligible to apply for • Continued use despite a physical or risk is highest in the first two weeks of methadone training and X-waivers, although the associated psychological problem caused by or worsened treatment,181 after which risk is significantly lower required training is 24 hours.188 by opioid use compared to people who are not in treatment.182,183 As with methadone, buprenorphine sustains • Tolerance (unless opioids are being taken as Common side effects of methadone are opioid tolerance and physical dependence prescribed) constipation, vomiting, sweating, dizziness, and in patients, so discontinuation can lead to • Using opioids to prevent withdrawal symptoms sedation. Although respiratory depression can withdrawal—although buprenorphine’s withdrawal (unless opioids are being taken as prescribed) be induced by methadone, the FDA advises that syndrome may be less severe. The most common OUD is not a binary diagnosis, rather it exists methadone not be withheld from patients taking side effects are constipation, vomiting, headache, as a continuum, with DSM-5 describing 3 levels of benzodiazepines or other central nervous system sweating, insomnia, and blurred vision. One risk of severity: depressants because the risk of overdose is even buprenorphine (as well as naltrexone) is the risk • Mild OUD (2-3 criteria) higher among patients not on methadone for of precipitating opioid withdrawal at first dose if • Moderate OUD (4-5 criteria) OUD.184 The other potential harms of methadone the patient has recently used either prescription or • Severe OUD (≥ 6 criteria) include hypogonadism, which is a potential side illicit drugs, due to buprenorphine’s partial-agonist More than 2 million Americans have OUD, effect of chronic use of any opioid, and QTc segment properties high binding affinity for the opioid and the number is growing.79 OUD can be effectively prolongation. receptor.174 managed with medication-assisted treatment (MAT), but only an estimated 20% of adults with Table 10: Available FDA-approved medications for OUD174 OUD currently receive such treatment.178 Buprenorphine Medications to treat OUD • Buprenorphine/naloxone buccal film (Bunavail) The FDA has approved three medications • Buprenorphine/naloxone sublingual film (Suboxone, generics) for treating OUD: buprenorphine, methadone, • Buprenorphine/naloxone sublingual tablets (Zubsolv, generics) and extended-release naltrexone (Table 10). • Buprenorphine sublingual tablets (generics) Buprenorphine and methadone can reduce opioid • Buprenorphine subdermal implant (Probuphine) cravings and all three can prevent misuse.174 Each • Buprenorphine extended-release subcutaneous injection (Sublocade) medication has a unique mechanism of action and Methadone involve different formulations, methods of induction • Tablets (Dolophine, MethaDose, generics) and maintenance, patterns of administration, and • Oral concentrate (MethaDose, generics) regulatory requirements. Naltrexone extended-release injection (Vivitrol)

25 Thus, a patient must be in mild to moderate of depression with daily oral naltrexone compared treatment. MAT is also associated with lower risks withdrawal prior to initiation to avoid precipitating to continuation of methadone therapy,193 and for HIV and other infections, and improved social withdrawal. The risk of opioid overdose depression is not a contraindication to the use of functioning and quality of life compared to people declines immediately when patients with OUD naltrexone. not on MAT.37 initiate buprenorphine treatment.183 The risk A small trial in Sweden randomized 40 adults of hypogonadism is lower with buprenorphine with OUD to daily buprenorphine 16 mg sublingually Naloxone vs. Naltrexone: compared to methadone, and buprenorphine is for one year vs. a six-day taper of buprenorphine What’s the difference? not associated with QTc prolongation or cardiac followed by placebo.195 After one year, 75% of Naloxone (Narcan) is an opioid antagonist arrhythmias.189 patients on buprenorphine remained in treatment given by injection or nasal spray to reverse The various non-oral routes of buprenorphine and were abstinent vs. 0% in the placebo group, overdoses. It acts within minutes and lasts for avoid the significant hepatic metabolism inherent and 20% of those in the placebo group died. only about an hour due to rapid metabolism. with oral administration, and appear to be largely A prospective cohort study following 15,831 Naltrexone has a very similar chemical equivalent in their efficacy for maintaining abstinence patients with OUD treated with buprenorphine for structure to Naloxone and is also an opioid and reducing risk of overdose. For example, a up to 4.5 years showed that the rate of overdose antagonist, but it acts more slowly and lasts randomized trial comparing buprenorphine implant mortality was four times higher in patients who longer. Extended-release naltrexone is used to sublingual buprenorphine found higher levels stopped taking buprenorphine (4.6 deaths per clinically to block cravings for opioids and other of negative urine screens and abstinence with the 1000 person years, 95% CI 3.9-5.4 deaths per drugs. implant, but the differences did not reach statistical 1000 person years) compared to patients who significance.190 (Note that use of implantable agents remained on the medication (1.4 deaths per 1000 require stabilization on sublingual doses first.) Comparative efficacy person years, 95% CI 1-2 deaths per 1000 person A 2016 Cochrane review of six trials (n=607) years).183 Extended-release naltrexone of patients with prescription opioid misuse found Compelling evidence also comes from Naltrexone is not an opioid. It is a full antagonist no significant differences between methadone and population-level studies. Facing rising levels of heroin of the mu-opioid receptor, which blocks both the buprenorphine. overdoses in the 1990s, France, in 1996, increased euphoric and analgesic effects of all opioids, The mean study duration was 24 weeks, and the availability of methadone and buprenorphine by including endogenous opioids (i.e., endorphins) no significant differences were found for days of allowing primary care physicians to prescribe both 185 and also reduces cravings for opioids. Naltrexone unsanctioned opioid use, self-reported opioid use, medications without getting additional certifications does not cause physical dependence, nor does it or positive urine screens for opioid use.194 (both medications were also subsidized by the produce any of the rewarding effects of opioids. government).196 As illustrated in Figure 6, heroin Patients may try to use opioids while on extended- Evidence for the efficacy of medication- deaths declined rapidly as use of MAT increased. release naltrexone, but it is unlikely that they assisted treatment (MAT) Methadone and buprenorphine have also been will experience any rewarding effects from such Abundant evidence from decades of randomized shown to improve treatment retention. One use, unless the binding affinity of naltrexone is trials, clinical studies, and meta-analyses suggests trial randomized 247 patients to three groups: 174 overcome. The most common side effects of that agonist or partial-agonist opioid treatment counseling alone, counseling plus methadone 20 extended-release naltrexone are injection site pain, used for an indefinite period of time is the safest mg/day, or counseling plus methadone 50 mg/ 174,187 nasopharyngitis, insomnia, and toothache. option for treating OUD. (The evidence base day. 197 Both methadone doses were more effective Treatment initiation requires a 7-10 day for extended-release naltrexone is much less than counseling alone at 20 weeks (P<0.05 for both 174 period during which the patient is free from all robust.) comparisons). A trial of buprenorphine/naloxone opioids, including methadone and buprenorphine. As demonstrated by the studies and trials randomized 329 patients to referral alone, a brief This is usually achieved with medically-supervised detailed below, people with OUD treated with intervention, or buprenorphine and found similarly withdrawal followed by at least 4 to 7 days methadone or buprenorphine are less likely to die, significant improvements in treatment retention without any opioids (including methadone and less likely to overdose, and more likely to remain in after 30 days.198 buprenorphine). This process is a very significant 174 barrier to naltrexone use. Figure 6: Impact on heroin overdoses with rising use of methadone and buprenorphine196 Naltrexone is currently available both as a once- 600 daily oral tablet and in a once monthly, extended- 90,000 release depot injection. The oral formulation, 80,000 however, was found to be no better than placebo 500 70,000 in a 2011 Cochrane review of 13 trials with 1,158 191 participants, and only the extended-release 400 60,000 Patients Treated formulation has been approved for OUD by the FDA. 50,000 Patients may have an increased risk of overdose 300 when they approach the end of the 28-day period 40,000 192 of the extended-release formulation. Heroin Overdoes 200 30,000 No special training is required for medical 20,000 providers to prescribe naltrexone. Although Heroin overdoses 100 randomized trials in participants without OUD Patients given buprenorphine 10,000 have shown an increased risk for dysphoria and/ Patients given methadone or depression with naltrexone therapy, a small trial 0 0 1998 1990 1992 1994 1996 1998 2000 2002 2004 of 80 patients with OUD found no increased risk Year

26 Data suggest that MAT is more effective than • Refer patient to a treatment center providing used any opioids for 12 to 24 hours and experiences psychotherapeutic interventions alone, and is just as MAT. mild-to-moderate withdrawal symptoms. effective whether psychotherapeutic interventions • Schedule follow-up visits regardless of referral The Stabilization Phase begins after a patient are used concurrently with medication treatment status. is on a stable dose that reduces illicit use, or not. For example, data from Massachusetts Naloxone is recommended for anyone who: decreases cravings, and minimizes side effects. The Medicaid beneficiary claims between 2004 and • Is in treatment for OUD buprenorphine dose may need to be adjusted to 2010 show significantly lower relapse rates with • Has a history of opioid overdose achieve these goals during this phase. both buprenorphine and methadone compared to a • Is using ≥50 MME/day The Maintenance Phase occurs when a patient behavioral health intervention alone.199 • Is using any opioid and also has COPD, sleep is doing well on a steady dose of buprenorphine. Although the evidence base for intramuscular apnea, other respiratory conditions, renal The length of time of the maintenance phase is naltrexone is less robust than for methadone or or hepatic dysfunction, or a mental health tailored to each patient and guidelines and could buprenorphine, it has been shown to significantly condition be indefinite due to the high risk of relapse (see decrease opioid misuse in patients with mild- • Has a co-prescription for benzodiazepine section below on Tapering Protocols). to-moderate OUD.174 For example, one trial • Has lost tolerance (e.g., recently released randomized 250 patients with OUD who completed from prison or detox program) Psychosocial treatments inpatient detoxification (≥7 days off all opioids) • Is a family member/significant other of person Psychosocial and/or behavioral interventions to 24 weeks of naltrexone intramuscular injection in treatment for OUD can be used in combination with medications in (380 mg/month) vs. placebo.200 At follow-up, 90% A 2019 study found a significant association order to treat the “whole patient” (e.g., comorbid in the naltrexone group were abstinent compared to between the adoption of state laws providing direct psychiatric symptoms, social support needs). The 35% in the placebo group. authority to pharmacists to prescribe naloxone and National Academy of Sciences, however, notes that lower rates of fatal overdoses.201 In states with such psychosocial services may not be available to all patients and recommends that the lack of such “Buprenorphine treatment provides one of policies, opioid-related fatal overdoses dropped by supports should not be a barrier to using MAT.174 the rare opportunities in primary care to see 0.387 per 100,000 people ≥3 years after adoption For example, a 2012 trial randomized 230 dramatic clinical improvement: it’s hard to of the laws. adults with OUD to one of three groups: methadone imagine a more satisfying clinical experience Treatment selection without extra counseling vs. methadone with than helping a patient escape the cycle of Medication choice for treatment of OUD is standard counseling vs. methadone with counseling active addiction.” guided by severity of the OUD, patient need for in the context of smaller case loads.203 At one-year --Wakeman et al. NEJM 2018;379(1):1-4 additional psychosocial support and/or monitoring, follow-up there were no significant differences patient preference, logistical concerns, and patient between the groups in rates of retention in OUD Management willingness to undergo full opioid withdrawal (in the treatment or urine tests positive for opioids. Three Following a diagnosis of OUD, a management case of extended-release naltrexone). Although other randomized trials comparing buprenorphine plan should be created that includes the following MAT is sometimes provided along with behavioral or with medical management alone vs. buprenorphine components:37 cognitive-behavioral therapy, it is so effective that plus cognitive behavioral therapy or extra counseling • Assessment for, and treatment of, medical and it should be offered whether or not psychosocial sessions also found no significant differences in key psychological comorbidities treatment is available.202 The choice of treatment opioid-related outcomes.204-206 • Use of motivational interviewing techniques should always be a shared decision between the Nonetheless, psychosocial, behavioral, and to promote safer behaviors and to encourage health care professional. peer-support interventions may have many patient engagement with treatment profoundly important benefits for patients beyond • Education about opioid overdose Treatment with buprenorphine strictly opioid-related outcomes, such as improving • Naloxone prescription For providers with an X-waiver, the following self-confidence, self-advocacy, general quality of 37 • Education about safer injection drug steps are recommended upon a diagnosis of OUD: life, and improvements in legal, interpersonal, techniques and sources of sterile needles • Determine the severity of OUD using DSM-5 and occupational functioning.174 Some guidelines • In-person follow-up, regardless of whether the criteria. and authors advocate for the use of psychosocial patient was referred for specialty treatment. • Review state prescription drug monitoring interventions, but suggest that the lack of such If a provider cannot prescribe buprenorphine program (PDMP). interventions at a given place or time should not be because they do not have an X-waiver, they can still • Conduct patient history and review of systems. a barrier to the use of MAT.174,207 support the patient’s path to recovery by taking the • Conduct targeted physical exam for signs of following steps:37 opioid withdrawal, intoxication, injection, or Tapering protocols • Assess and treat comorbid conditions. other consequences of misuse. OUD guidelines do not recommend a duration • Use motivational interviewing techniques • Order appropriate laboratory tests including of MAT treatment, which could be for an indefinite to promote safer behaviors and encourage urine or oral fluid drug tests, liver function period of time because of the high risk of relapse participation in MAT. tests, and tests for hepatitis B, hepatitis C, with discontinuation.174 For example, a population- • Educate the patient about ways to reduce and HIV. based retrospective study of 14,602 patients who overdose risk. Buprenorphine treatment typically occurs in discontinued methadone treatment found that • Prescribe naloxone to the patient and/or three phases: only 13% had successful outcomes (no treatment family members. The Induction Phase is the medically monitored re-entry, death, or opioid-related hospitalization) • Inform patients who inject drugs about ways initiation of buprenorphine treatment performed at within 18 months of taper.208 to access sterile injecting equipment (if home by a patient, in a physician’s office, or in a available). certified opioid treatment program. The medication is administered when a person with OUD has not 27 Nonetheless, some patients may want to stop (n=264) found that 54% of respondents thought including low birth weight and fetal distress, while opioid agonist therapy. An ideal time frame for a trial people addicted to opioid pain relievers were to neonatal complications among babies born to of MAT tapering has not been established. Tapering blame for their addiction, 46% felt such people are mothers with OUD range from neonatal abstinence should always be at the patient’s discretion, and all irresponsible, and 45% said they would be unwilling syndrome and neurobehavioral problems to a 74- decisions should be based on a thorough dialogue to work closely with such people.211 fold increase in sudden infant death syndrome.217 between patient and provider. Goals should be A 2014 survey of 1,010 primary care Both methadone and buprenorphine are framed functionally, for example maintaining physicians found similar, or even higher, levels of recommended for treating OUD in pregnancy to employment, avoiding using illicit opioids or other stigma related to people with OUD.212 Interviews improve outcomes for both mother and newborn.174 drugs, continuing with social/emotional support with patients using methadone for OUD confirm The efficacy and safety of methadone treatment programs, etc. that this group experiences high rates of stigma for OUD in pregnant women was established in and discrimination related to their medication use the 1980s, showing that maternal and neonatal Misconceptions about OUD Treatment in interactions with the public and with health care outcomes in women on methadone treatment Stigma and misunderstanding surround the professionals,213 which erodes their psychological during pregnancy are similar to women and infants 174 issues of addiction in general and OUD in particular. well-being and may inhibit them from entering not exposed to methadone.218 These include counterproductive ideologies that treatment.174 More recent research suggests that portray addiction as a failure of will or a moral Health care professionals can combat stigma buprenorphine treatment has similar, or superior, weakness, as opposed to understanding OUD as by examining their own attitudes and beliefs and by benefits in this population. An RCT with 175 a chronic disease of the brain requiring medical consciously and consistently using neutral, “person- pregnant women with OUD found that neonates management, which is no different, in principle, first,” and non-stigmatizing language (Table 12). of women on buprenorphine required 89% less from the approach used to manage other chronic morphine, had shorter hospital stays, and received Pregnancy and OUD diseases such as diabetes or hypothyroidism. Some a shorter duration of treatment for neonatal stigma and misunderstanding may arise from a lack The prevalence of OUD among pregnant women, while low in absolute terms, quadrupled abstinence syndrome compared to neonates of of awareness of how treatment of OUD has evolved women treated with methadone (other outcomes in the past 15 years.209 Table 11 summarizes some from 0.15% in 1999 to 0.65% in 2014, with large variability across states.215 Overdose is one and adverse events were similar between the two common misconceptions about OUD treatment. 219 of the leading causes of maternal deaths in the groups). The safety of extended-release naltrexone has Addressing stigma United States, with the rate of overdose lowest not yet been established for pregnant women, and High levels of stigma persist among some in the third trimester (at 3.3/100,000 person- naltrexone is currently not recommended for the medical professionals and recovery communities days) and highest 7 to 12 months after delivery treatment of OUD in pregnant women.174 toward people with OUD and medications used (12.3/100,000 person-days).216 Pregnant women to treat OUD.174 A 2016 national opinion survey with untreated OUD have up to six times more maternal complications than women without OUD, Table 11: Misconceptions vs. realities of OUD treatment210 Misconceptions Reality Buprenorphine treatment is more dangerous than other Buprenorphine treatment is less risky than many other routine treatments, such as titrating chronic disease management. insulin or starting anticoagulation and easier to administer. It is also safer than prescribing many opioids (e.g., oxycodone, morphine). Using methadone or buprenorphine is simply a “replacement” Addiction is compulsive use of a drug despite harm. When taken as prescribed, methadone addiction. and buprenorphine improve function, autonomy, and quality of life and patients using these drugs do not meet the definition of addiction. Detoxification for OUD is effective. No data show that detoxification programs are effective for OUD, and, in fact, such interventions may increase the risk of overdose death by eliminating tolerance. Prescribing buprenorphine is time consuming and burdensome. Buprenorphine treatment can be readily managed in a primary care setting, and in-office induction or intensive behavioral therapy are not required for effective treatment.

Table 12: Alternatives to stigma-reinforcing words and phrases214 Avoid these terms Use these instead Addict, user, drug abuser, junkie Person with opioid use disorder or person with opioid addiction, patient Addicted baby Baby born with neonatal abstinence syndrome Opioid abuse or opioid dependence Opioid use disorder Problem Disease Habit Drug addiction Clean or dirty urine test Negative or positive urine drug test Opioid substitution or replacement therapy Opioid agonist treatment Treatment failure Treatment attempt, return to use, relapse Being clean Being in remission or recovery

28 Despite this solid evidence base, most pregnant Non-drug options Topical NSAIDs may be as effective as oral women with OUD do not receive any treatment with Evidence demonstrates that exercise and NSAIDs for OA pain. A randomized trial of 282 older medications.220 Among women who do receive physical activity can modestly reduce pain and patients with chronic knee pain comparing oral vs. treatment during pregnancy, many fall out of improve function in patients with OA.224 A recent trial topical ibuprofen found equivalent reductions in treatment during the post-partum period due to randomized 171 adults aged ≥60 years with knee pain.232 gaps in insurance coverage and other systemic OA to a 12-week home-based exercise intervention A meta-analysis of six OA trials comparing 225 barriers. An integrated approach with close plus health education vs. health education only. acetaminophen and NSAIDs found a small, but collaboration between OUD treatment providers The exercise intervention involved group training statistically significant, treatment effect favoring and prenatal providers has been described as the sessions plus at-home strength and flexibility NSAIDs, suggesting that NSAIDs are preferred over “gold standard” for care, and further research is exercises to be done 30-40 minutes/day, three days acetaminophen unless patients have high risk for needed to investigate interventions that could help per week. At 12-week follow-up, mean pain scores gastrointestinal, renal, or cardiovascular adverse to increase treatment retention.174 on the Western Ontario and McMaster Universities effects.233 Osteoarthritis Index (WOMAC) dropped 3.06 Treating acute pain in patients on MAT points in the intervention group vs. 1.46 points in Selective norepinephrine receptor inhibitors Some physicians may not prescribe effective the control group (P=0.007), and stiffness level (SNRIs) opioid analgesia for patients with OUD on MAT due to decreased 1 level vs. no change (P=0.008). concerns about respiratory depression, overdose, A meta-analysis of three trials of duloxetine A meta-analysis of 15 randomized trials in for knee OA showed patients on duloxetine (60 or drug diversion. As a result, this population is at patients with musculoskeletal pain found tai chi or 120 mg daily) were 49% more likely to have a particular risk of under-treatment for acute pain. to be moderately effective in improving both pain Physicians may also mistakenly assume that moderate pain response (≥30% reduction in pain and disability at up to 3 months compared to no 234 acute pain is adequately controlled with the long- intervention.226 intensity). Physical function improved as well. term opioid agonist (i.e., methadone) or partial- A review of 12 studies (including four RCTs) Opioids agonist (i.e., buprenorphine). Although potent involving 589 patients with OA symptoms comparing A Cochrane Review of 22 trials of 8,275 analgesics, methadone and buprenorphine have an a variety of yoga regimens to usual care found patients using opioids for knee or hip OA found small analgesic duration of action (four to eight hours) suggestions that pain, stiffness, and swelling were reductions in pain and improvements in function that is substantially shorter than their suppression reduced (no meta-analyses were conducted due compared to placebo at follow-up periods <16 of opioid withdrawal (24 to 48 hours).221 to clinical heterogeneity). No effect on physical weeks.235 Intermittent, as-needed use is preferred Non-opioid analgesics (e.g., acetaminophen function was observed.227 and NSAIDs) are first-line options for treating acute because time-scheduled use can be associated with A Cochrane review of six randomized trials greater total average daily opioid dosage. As noted pain in this population. For moderate-to-severe evaluating acupuncture in 413 patients with hip OA earlier, however the SPACE trial, which included pain not adequately controlled with non-opioids, (mean age range 61 to 67 years) found conflicting 240 patients with moderate to severe chronic low however, judicious use of opioid analgesics should evidence on its effects on pain and function.228 An be considered. Patients on MAT generally have unblinded trial randomized 221 adults with hip or back pain or knee or hip osteoarthritis, found no a high cross-tolerance for analgesia, leading to knee OA to acupuncture, sham acupuncture, or significant differences in pain-related functioning shorter durations of analgesic effects. Higher opioid mock electrical stimulation.229 After five weeks of comparing regimens of morphine, oxycodone, doses administered at shorter intervals may thus treatment no significant differences pain intensity or hydrocodone to non-opioid analgesics (e.g., be necessary. Concomitant opioids can be given were found for any comparisons. acetaminophen, NSAIDs, antidepressants, anti- for pain to a patient prescribed buprenorphine, Acupuncture trials can be particularly epileptics) at any time points up to 1 year.14 but typically hydromorphone or fentanyl may be susceptible to placebo effects, as illustrated in a the most effective due to competitive binding at the study comparing needle or laser acupuncture to Low back pain opioid receptor. no acupuncture or sham laser treatment in 282 Low back pain (LBP) is one of the most Since extended-release naltrexone will block the patients with chronic knee pain (mean age 63). common reasons for physician visits in the U.S., effects of any opioid analgesics, acute pain in such After 12 weeks of treatments, needle and laser and about 25% of U.S. adults reported having patients (e.g., that associated with dental work, acupuncture reduced self-reported knee pain more LBP lasting at least a day in the past 3 months.236 surgery, or traumatic injury) should be treated with than no acupuncture (control) but not more than Imaging is of limited utility in diagnosing the cause regional analgesia, conscious sedation, non-opioid sham acupuncture, suggesting strong placebo of LBP because most patients have nonspecific analgesics, or general anesthesia.37 effects. The benefits were not sustained at one year findings, and asymptomatic patients often have If opioids are deemed necessary for patients follow up.48 abnormal findings. Magnetic resonance imaging is on methadone or buprenorphine, clinicians should recommended for red flag symptoms (for example, verify the patient’s methadone or buprenorphine NSAIDs Given the inflammatory mechanism of OA, incontinence or saddle anesthesia), radicular dose, and ensure that naloxone is available. 237 NSAIDs are the first-line pharmacologic option for symptoms, or risks for pathologic fracture. Clinicians should inform the program or prescribing Current guidelines recommend trying physician about the addition of new opioids, as this managing OA-related chronic pain. In a network meta-analysis of 76 randomized trials evaluating nonpharmacological options such as exercise, may affect subsequent urine screening. oral celecoxib, ibuprofen, or naproxen vs. placebo multidisciplinary rehabilitation, acupuncture, or Condition-specific analgesic options in 58,451 patients with knee or hip OA, NSAIDs yoga as first-line treatments for chronic low back were associated with small-to-moderate effect sizes pain, followed by pharmacologic treatment with an Osteoarthritis for improvements in pain and function.230 A 2017 NSAID.236 If the patient has an inadequate response, Osteoarthritis (OA) is a common source of Cochrane review of trials comparing topical NSAIDs second-line options are a tricyclic antidepressant pain and disability that affects nearly 70% of those vs. placebo in patients with hand or knee OA found or duloxetine. Opioids, including tramadol, should over 65 years of age.222 The joints involved tend to moderate evidence for analgesia, with greater pain 231 be reserved for patients with pain unresponsive be the hand, hip, and knee, with knee being most relief seen in trials of shorter durations. to all other treatments, with all of the caveats and common. More women than men suffer with OA.223 cautions described previously.

29 Non-drug options 1000 mg acetaminophen four times daily vs. the glucose control may reduce the risk of acquiring In a review of 19 RCTs, exercise provided small NSAID diflunisal 500 mg twice daily for 4 weeks.243 diabetic neuropathy and slow its progression,249 and reductions in pain and improvements in function Another trial randomized 45 patients with either in those who have neuropathy, pain management compared to no exercise.53 Types and duration of acute or chronic LBP to 500 mg acetaminophen may improve quality of life.250 exercise from RCTs included in the meta-analysis vs. amitriptyline 37.5 mg four times daily.244 Current American Diabetes Association were not specified. Although physical therapy has a No significant differences were found between guidelines suggest initial management with role in the management of acute low back pain, no acetaminophen and diflunisal in pain relief or pregabalin, duloxetine, or gabapentin.249 Second- RCTs of physical therapy were identified for chronic reduced disability, and acetaminophen was less line options include TCAs (use cautiously in older low back pain. effective than amitriptyline for reducing pain.245 adults), venlafaxine, or carbamazepine. Opioids, Two trials (n=160 and n=320) found that and particularly tapentadol, are not recommended tai chi reduced pain versus wait list or no tai chi NSAIDs to treat neuropathy due to their risk for addiction although these differences may not be clinically A review of six RCTs for the American College and limited evidence for efficacy.249 Tapentadol is important.238,239 The first trial randomized 160 of Physicians showed that oral NSAIDs are more FDA-approved to treat diabetic neuropathy, but the adults with persistent non-specific low back pain to effective than placebo regarding pain intensity, approval was based on two trials that used a design 246 tai chi (18 sessions, 40 minutes each, over a 10- with a small reduction in pain at 12 weeks. No enriched for patients who responded to tapentadol, week period) vs. usual care. In addition to reducing differences in efficacy between different NSAIDs, therefore the results are not generalizable.249 pain, tai chi reduced “bothersome” back symptoms including non-selective NSAIDs vs. selective COX2 Because tapentadol incurs similar risks of addiction by 1.7 points, and improved self-report disability inhibitors, were identified. and safety compared to typical opioids, its use is by 2.6 points on the 0-24 Roland-Morris Disability generally not recommended as first- or second-line Opioids Questionnaire scale (RMDQ).238 therapy for neuropathic pain, although it could be The risks associated with using opioids for A 2017 Cochrane review of 9 RCTs involving 810 considered if other treatments insufficiently control chronic LBP are likely to outweigh potential participants with chronic low back pain found small pain.249 benefits. A systematic review of RCTs published to moderate improvements in pain and function through November 2016 found that as compared associated with yoga compared to no-exercise Non-drug options to placebo, opioids provided small short-term controls. For pain, a clinically meaningful reduction A small RCT of 39 Korean patients with type pain relief for chronic low-back pain and small in pain score based on the RMDQ of 15 points was 2 diabetes and neuropathy found tai chi improved improvement in function, but had a higher risk not achieved.240 (A 2017 systematic review of 14 quality of life on five domains, including pain, of nausea, vomiting, dizziness, somnolence, RCTs by the American College of Physicians came to physical functioning, social functioning, vitality and constipation, and dry mouth.247 No difference in similar conclusions.)53 a mental component score, compared with usual pain response was observed between immediate A 2017 systematic review of 4 trials evaluating care, but there was no significant difference in release or ER/LA opioid products. None of the 251 acupuncture vs. sham acupuncture in patients neuropathy scores. reviewed trials evaluated the long-term effect (> 1 with chronic LBP found modest improvements in Small studies suggest a possible effect of year) of opioids on either pain or function.247 pain, but no improvements in function.53 A meta- acupuncture and massage on pain and function. A In addition, as noted earlier, the SPACE trial, analysis of 4 trials comparing acupuncture to pilot study of 46 patients found overall symptom which included patients with moderate to severe no acupuncture found larger effect sizes, but the improvement from baseline with acupuncture in chronic low back pain, found no significant quality of the evidence is lower due to the large 77% of patients with 67% discontinuing medication. differences in pain-related functioning comparing placebo effects known to manifest in acupuncture However, the study didn’t have a control group nor regimens of morphine, oxycodone, or hydrocodone 252 studies without a sham comparison.53 did it specifically identify pain as an endpoint. to non-opioid analgesics (e.g., acetaminophen, A 2015 Cochrane review of 25 RCTs compared A 4-week trial involving 46 patients who received NSAIDs, antidepressants, anti-epileptics) at any aromatherapy and massage had reduced pain and massage vs. inactive (e.g., sham treatment or 14 time points up to 1 year. 253 waitlist) or active (e.g., TNES, acupuncture, traction, improved quality of life compared to usual care. A 2014 trial randomized 45 patients to acupuncture physical therapy) controls in 3,096 adults with Other therapies 241 vs. sham acupuncture for 10 weeks and found no LBP. Massage compared to sham massage or Other drug options such as gabapentin, significant differences in pain outcomes.254 Further no treatment showed moderate reductions in pain pregabalin, topical lidocaine, and muscle relaxants studies are required to provide a more clear and disability in the short term (< 6 months), but have little or no data for use in managing chronic understanding of the role of acupuncture and not in the long-term. In studies comparing massage low back pain. For the anticonvulsants pregabalin massage in managing pain in diabetic neuropathy. to active therapies, massage resulted in greater and gabapentin, a small number of low-quality RCTs An analysis by the Agency for Healthcare pain reduction both in the short term, and in the failed to show a reduction in pain or improvement Research and Quality (AHRQ), however, did not long, but no difference in disability reduction was in function compared to placebo.248 No data exist 241 find significant or compelling evidence to suggest observed. to support the use of topical lidocaine for low back TENS was more effective than placebo for diabetic pain without a neuropathic component. While widely Acetaminophen neuropathy.255 prescribed, use of skeletal muscle relaxants for A 2016 Cochrane review of 3 trials with 1,825 chronic LBP is not supported by evidence.247 patients with acute LBP found high-quality evidence SNRIs Both duloxetine and venlafaxine have been that acetaminophen was no more effective than Diabetic neuropathy shown to reduce pain related to diabetic neuropathy placebo for pain, disability, function, and quality of Neuropathy has a lifetime prevalence of 30%- 242 compared to placebo. A network meta-analysis life. 50% in patients with diabetes and most commonly found relatively large effect sizes for pain reduction Two small trials have evaluated acetaminophen affects the distal extremities in a symmetric fashion for duloxetine vs. placebo, and venlafaxine vs. in patients with chronic LBP. A trial conducted causing numbness, tingling, pain, loss of vibratory placebo.256 in the early 1980s randomized 30 patients to sensation, and altered proprioception. Improved

30 A 12-week study randomized 457 patients with Opioids moderate-intensity resistance exercise for reducing painful diabetic neuropathy to three duloxetine Opioid analgesics are ineffective for treating pain, although the quality of the evidence was rated groups (20 mg/day, 60 mg/day, and 120 mg/day) or pain in diabetic neuropathy based on pooled data as low.268 placebo.257 At follow-up, the mean daily pain severity from four RCTs. This analysis excluded tramadol and Tai chi may help reduce pain and other score in the placebo group had dropped 1.91 tapentadol.258 Due to their effect on serotonin and symptoms related to fibromyalgia. One trial points (on a 0-10 scale), with greater reductions in norepinephrine receptors, tramadol and tapentadol randomized 66 patients with fibromyalgia to tai chi the three duloxetine groups.257 may be slightly more effective than other opioids at twice weekly for 12 weeks vs. wellness education reducing pain in diabetic neuropathy. An analysis of and stretching exercises. Tai chi improved scores Anticonvulsants 5 placebo-controlled RCTs (3 of tapentadol and 2 on the Fibromyalgia Impact Questionnaire (FIQ) In a meta-analysis of 16 RCTs with 4,017 of tramadol) showed that these opioids were more that assessed pain, physical functioning, fatigue, patients, pregabalin and oxcarbazepine were effective at reducing pain at up to 12-weeks. morning stiffness, and on the Medical Outcomes 258 effective at reducing pain compared with placebo. Both medications, as noted earlier, are associated Study 36 Item Short Form Health Survey (SF-36) Gabapentin is a commonly prescribed off-label to with all of the risks and adverse events common to both at the end of the intervention (12 weeks) treat diabetic neuropathy. Based on a review of typical opioids. and at 24-week follow-up. At 12 weeks, mean five RCTs with 766 patients, gabapentin had a large between group difference was -18.4 FIQ points overall effect on pain severity, however, the result Fibromyalgia (P<0.001).269 was not statistically significant. Fibromyalgia should be suspected in patients One in five patients with fibromyalgia try The American Diabetes Association recommends having multifocal pain not fully explained by injury acupuncture within two years of diagnosis,270 and using pregabalin, reserving gabapentin for patients or inflammation. Chronic headaches, sore throats, low-quality evidence suggests that acupuncture may unable to afford pregabalin. Other anticonvulsants visceral pain, and sensory hyper-responsiveness be associated with reduced fibromyalgia-related (e.g., carbamazepine, topiramate, valproic acid) are very common. Checking tender points on the pain. A 2013 Cochrane review of 9 RCTs with lack clear evidence of benefit but have documented body may aid in diagnosing fibromyalgia. These 395 adults with fibromyalgia found reduced pain 259 harms. tender points are sometimes confused with trigger and stiffness at 1 month with electro-acupuncture points, which are associated with chronic myofascial compared to either placebo or sham acupuncture, Topical lidocaine pain. The primary difference between tender points but there were no significant differences in pain, Although lidocaine patches are FDA approved and trigger points is that trigger points can produce fatigue, or sleep comparing manual acupuncture for post-herpetic neuralgia, no RCTs of patches referred pain. Previous guidelines suggested to placebo or sham acupuncture (4 trials, 182 have been conducted in diabetic neuropathy. that people with fibromyalgia had pain in at least adults).270 One open-label, 4-week trial of 300 patients with 11 of these tender points when a doctor applies Based on two small trials, myofascial massage painful diabetic polyneuropathy or post-herpetic 261 pressure. New diagnostic criteria, however, have may improve pain over placebo.271 Although data neuralgia evaluated 5% lidocaine medicated plaster made a tender point exam unnecessary. Patients recommending other forms of massage for reducing vs. pregabalin. In post-herpetic neuralgia more are now diagnosed either by physician assessment pain are limited, most styles of massage therapy patients responded to 5% lidocaine medicated 262 or by a self-report questionnaire. A scoring consistently improved quality of life for patients with plaster treatment than to pregabalin (62.2% vs. system has replaced the tender point exam and fibromyalgia. 46.5% [no P value reported]), while response combines a widespread pain index and a symptom Six RCTs failed to show that TENS reduced pain was comparable for patients with painful diabetic 262 severity scale for making the diagnosis. in fibromyalgia.272 polyneuropathy: 66.7% vs. 69.1% (no P value 260 reported). Non-drug options Drug options Exercise training is often recommended for The FDA has approved three drugs for the Cannabinoids for diabetic neuropathy 263 patients with fibromyalgia, not only for potential treatment of fibromyalgia: duloxetine, milnacipran Weak evidence suggests that medical marijuana pain reductions, but for the other known physiologic and pregabalin. Other options used off-label include and cannabinoids may reduce pain related to benefits associated with exercise. The effects of gabapentin, amitriptyline, and SSRIs. diabetic neuropathy. A Cochrane review of 16 exercise in fibromyalgia have been assessed in randomized trials published through November more than 30 trials, with the overall quality rated Duloxetine 2017 comparing cannabis-based treatments to as moderate.264 Some reviews have concluded that A 2014 Cochrane review included six RCTs placebo in 1,750 adults with chronic neuropathic the strongest evidence was in support of aerobic randomizing 2249 adults with fibromyalgia to pain found slight reductions in pain and increased exercise,265 which is the current recommendation duloxetine vs. placebo with 12-week to 6-month numbers of patients achieving 50% or greater by the American College of Rheumatology. follow-up.273 At 12 and 28 weeks, duloxetine was 68 reductions in pain (21% vs. 17). The results, However, resistance training can be of benefit as superior to placebo for pain reduction. Optimum however, are limited by poor trial quality (only 2 well.266 A 2017 Cochrane review of eight RCTs dose is 60-90mg per day. trials were judged high-quality) and heterogeneity (n=456) comparing aerobic exercise training vs. in treatments (10 trials evaluated an oromucosal no exercise or another type of intervention found Milnacipran spray containing THC or CBD, 2 trials evaluated a small improvements (relative to comparators) In a Cochrane meta-analysis of three RCTs synthetic THC, 2 trials evaluated plant-derived THC, in pain intensity (relative improvement 18%), evaluating milnacipran 100 mg daily vs. placebo in and 2 trials evaluate inhaled herbal cannabis). stiffness (11.4%) and physical function (22%).267 1,925 patients with fibromyalgia, milnacipran was There were no significant differences in the rates of A separate Cochrane review of 5 studies with 219 more effective for inducing at least 30% reduction 274 serious adverse events, but more people reported women with fibromyalgia found that moderate-to- in pain. A similar effect on pain relief was noted sleepiness, dizziness, or confusion in the cannabis high intensity resistance training improves function with milnacipran 200 mg daily. groups. and reduces pain and tenderness vs. control, and An updated (data through August 2017) None of the reviewed studies evaluated long- that eight weeks of aerobic exercise was superior to Cochrane review identified additional 7 trials of term efficacy and safety of cannabinoid exposure. duloxetine and 9 of milnacipran.275 31 The updated analysis did not change findings from reductions in pain and improvements in anxiety on • Educational materials should be provided to previous reviews: both drugs were better than the Fibromyalgia Impact Questionnaire (P < 0.05 both patient and caregivers placebo in reducing pain by at least 30%. Both for both outcomes).282 Another trial randomized 31 • The multi-dimensional impact of “suffering” on drugs were also found to improve health-related patients with fibromyalgia and chronic insomnia to both patients and family must be addressed in quality of life, although more SNRI patients dropped nabilone 0.5 mg to 1 mg at bedtime vs. amitriptyline a culturally respectful manner out of trials due to adverse events as compared to 10-20 mg at bedtime for 4 weeks.283 Although placebo. nabilone was associated with improved sleep Cancer Pain Management Strategies quality, no significant effects were reported for pain, Analgesic pharmacotherapy is the mainstay Pregabalin mood, or quality of life. of cancer pain management. Analgesics may A meta-analysis of five RCTs found pregabalin, be delivered in a 3-step framework known as overall, had a small effect on pain (SMD -0.28, 95% the “analgesic ladder,” which entails the use of CI -0.35 to -0.20). Low doses (150 mg per day) Managing cancer pain non-opioid analgesics with or without adjuvant were no different than placebo, but doses of 300 Pain is one of the most common symptoms analgesics in Step 1; non-opioids plus weak mg daily or greater were more likely to result in a of cancer. Pain occurs in about 25% of newly- opioids and/or adjuvant analgesics in Step 2; and 50% reduction in pain than placebo (RR 1.45, 95% diagnosed cancer patients, about 33% of patients non-opioids plus strong opioids and/or adjuvant CI 1.03-2.05).276 undergoing treatment, and 75% of patients with analgesics in Step 3.287 A trial of systemic opioid advanced disease.284 Pain is also one of the most- A crossover randomized trial with 41 patients 285 therapy can be considered for cancer patients with with fibromyalgia found that combining pregabalin feared of cancer symptoms. Unrelieved pain moderate or severe pain, regardless of the known with duloxetine more effectively reduced pain (68% denies patients comfort and adversely impacts or suspected pain mechanism.288 Note that mixed reporting at least moderate global pain relief) vs. motivation, mood, interactions with family and agonist-antagonist opioid analgesics, including either pregabalin (39%) or duloxetine (42%) alone friends, and overall quality of life. Survival itself butorphanol, nalbuphine, and pentazocine, are not 277 may be positively associated with adequate pain (P<0.05 for both comparisons with combination). 286 recommended in cancer pain management because Optimum dose is 300-450 mg per day. control. In order to relieve cancer pain effectively, they are more likely to cause psychotomimetic clinicians must be skilled in the assessment of cancer effects and they can precipitate the abstinence Gabapentin pain and be familiar with cancer pain pathogenesis, syndrome if given to a patient who is physically Evidence supporting the use of gabapentin for pain assessment techniques, common barriers to dependent on a pure opioid agonist. fibromyalgia is limited. A Cochrane review of RCTs the delivery of appropriate analgesia, and pertinent ER/LA opioid formulations may lessen the lasting 8 weeks or longer (searched through May pharmacologic, anesthetic, neurosurgical, and inconvenience associated with the use of short- 2016) identified two trials, one of which was only behavioral approaches to cancer pain treatment. A acting opioids. Patient-controlled analgesia with a conference abstract. The other trial randomized complete review of cancer pain is beyond the scope subcutaneous administration using an ambulatory 150 patients with fibromyalgia to gabapentin of this monograph, but a summary of treatment infusion device may provide optimal patient control 278 1200-2400 mg/day vs. placebo for 12 weeks. goals and strategies follows. Thanks to improved and effective analgesia.288 The full range of adjuvant Gabapentin was associated with a small reduction treatments, more patients are now surviving their medications covered earlier should be considered in pain (mean difference between groups at 12 cancers and this should be taken into account for patients with cancer pain, with the caveat that weeks: -0.92 points on 0-10 point BPI scale, 95% before starting certain treatments, such as long- such patients are often on already complicated CI -1.75 to -0.71 points) but this difference may term opioid therapy. pharmacological regimens, which raises the risk of not be clinically important. Optimum dose is 900mg adverse reactions associated with polypharmacy. three times daily. Treatment Goals Clinical practice guidelines for adult cancer pain If cancer pain occurs in the context of a patient nearing the end of life, other treatment and care Other options of the National Comprehensive Cancer Network recommends the following treatment goals for considerations may be appropriate. Opioids clinicians to follow:285 Physical therapies may improve function or A Cochrane review found no RCTs of opioid • A comprehensive pain assessment should be enhance analgesia (including electrical stimulation, therapy in patients with fibromyalgia lasting more performed for all patients at each contact heat or cryotherapy, pressure stockings, and than eight weeks.279 An observational study followed • Comprehensive pain management is pneumatic pump devices). In addition, all patients a cohort of fibromyalgia patients initiating either required since most patients have multiple can benefit from psychological assessment and 285 opioids or non-opioid treatments for 12 months pathophysiologies support. and found no difference in pain severity between • Analgesic therapy should be administered in Because bone metastases are a frequent the groups, with less reduction in BPI interference conjunction with the management of multiple source of pain in patients with cancer, various scores in the opioids group.280 One RCT suggests symptoms and in the context of the complex strategies aimed at improving bone stability may that tramadol plus acetaminophen may reduce pain pharmacologic therapies typical of cancer be appropriate. These strategies include: external 285 compared to placebo, but the trial duration was treatment beam radiotherapy and bisphosphonates. limited to 91 days, and long-term evidence is not • Pain intensity must be quantified by the patient Surgery may relieve symptoms caused by specific available.281 whenever possible problems, such as obstructions, unstable bony • Reassessment of pain intensity must be structures and compression of neural tissues or Cannabinoids performed at specified intervals to ensure that draining of symptomatic ascites. The potential Two small trials have evaluated the oral analgesia is effective and adverse effects are benefits of surgical procedures in a cancer patient cannabinoid nabilone (a synthetic form of THC) in minimized must be weighed against the risks of surgery, patients with fibromyalgia. One trial randomized • A multidisciplinary team may be needed for the anticipated length of hospitalization and 46 patients to nabilone 0.5 mg to 1 mg twice comprehensive pain management convalescence, and the predicted duration of daily for 4 weeks vs. placebo and found significant • Psychosocial support must be made available benefit.

32 About 5-15% of cancer patients will need outcomes, particularly of complex interventions, Table 13: Potential patient-centered goals advanced procedures such as epidurals, neurolysis, are inherently difficult to predict. In developing of care292 nerve blocks, and pain pumps.289 Advanced plans of care, therefore, clinicians must engage with Longer life interventional procedures can be indispensable the patient (or designated surrogate) to carefully allies for patients when pain is unrelenting, doesn’t consider the patient’s values, beliefs, and priorities Symptom relief respond to medications, or those medications (Table 13). In the end, clinicians can only provide Time at home produce adverse effects that lead to needless the best information and estimates they can. The Ability to travel suffering. patient (or surrogate) must weigh the options and Mental clarity make the decision. Physical mobility Managing end-of-life pain Assessing Pain at the End of Life Ability to interact with loved ones The end of life is often characterized by a Patient-Centered Treatment Goals Minimizing burdens on loves ones reduced level of consciousness or complete lack of Although pain relief is often considered— Personal/Spiritual growth and may sometimes be—an end unto itself, pain consciousness. This can make assessments of pain management and control of symptoms at the end very challenging. If a patient is not alert enough to “Dignity” (though meanings will vary) of life may be more appropriately viewed as means communicate, nonverbal signs or cues must be used of achieving the more primary goal of improving or to determine if the patient is experiencing pain and Some opioids may not be appropriate in the maintaining a patient’s overall quality of life. The to what degree an analgesic approach is effective. end-of-life setting. For example, meperidine is not meaning of “quality of life” varies, not just from In general, even ambiguous signs of discomfort recommended in cancer pain management due to 294 patient to patient, but even between the phases of should usually be treated, although caution must the neurotoxic effects of its metabolites. Mixed 292 an illness experienced by a single patient. be exercised in interpreting such signs. Patients agonist-antagonist opioid analgesics, including A focus on quality of life is important because who are actively dying may groan or grunt in ways butorphanol, nalbuphine, and pentazocine, are not 293 sometimes a patient may have priorities that that suggest they are in pain, although such sounds recommended in cancer pain management. compete with, or supersede, the relief of pain. may, in fact, be the normal expressions attendant to Opioid-related side effects must be considered For example, the end of life can be an extremely the last moments or hours of life. in advance of treatment and steps must be taken important and meaningful time.290 For some Signs of discomfort that are accompanied by to minimize these effects to the extent possible, patients, mental alertness sufficient to allow maximal more rapid breathing or heart rate should be taken since adverse effects contribute significantly to interactions with loved ones may be more important more seriously. Likewise, if physical stimulation of analgesic nonadherence. This is particularly true than physical comfort. Optimal pain management, in the patient (i.e. during bathing) causes signs of for constipation and sedation. Tolerance rarely such cases, may mean lower doses of an analgesic discomfort, increased analgesia may be warranted. develops to constipation and therefore it must be and the experience, by the patient, of higher levels Prolonged rapid breathing (> 20/min.) may be prevented and, if unsuccessful, treated aggressively. of pain. At the end of life, decisions about pain uncomfortable because of muscle fatigue and it A stimulant, such as methylphenidate or relief must be more than usually balanced with a may therefore be reasonable, even in the absence dextroamphetamine, might be added to offset mindful consideration of the patient’s own values of other evidence of discomfort, to titrate a pain sedative effects, typically starting at a dose of and desires. medication with a target respiratory rate of 15 to 5 to 10 mg once or twice daily. One study found 292 Defining clear patient-centered goals of 20/minute. that with proper timing, the administration of 295 care is a first step to developing an optimal pain methylphenidate did not disrupt sleep. Treatment Options Other adverse effects, including respiratory management strategy at the end of life. These Opioids are often valuable for providing effective goals should be guided by four core ethical values depression, are greatly feared and may lead to analgesia at the end of life, and opioid formulations clinician under-prescribing and reluctance by that apply broadly, but are particularly important at are available in such variety in the U.S. that, typically, the end of life:291 patients to take the medication, despite the rarity a pain regimen can be tailored to each patient. 296 • Autonomy of the patient of this event in persons with cancer. Despite this Because there is great between-patient variability fear, studies have revealed no correlation between • Beneficence (the physician’s obligation to in response to particular opioid agents no specific promote patient welfare) opioid dose, timing of opioid administration, and agent is superior to another as first-line therapy. time of death.297 • Justice Although morphine was previously considered the • Non-malfeasance (avoiding harm) ‘‘gold standard,’’ it is now recognized that the most Adjuvant Analgesics These four values are embodied in the appropriate agent is the opioid that works for an Although opioid medications are central to pain 293 question at the core of any consideration of an individual patient. management at the end-of-life, many other classes end-of-life intervention: do the expected benefits Morphine and other opioids are available of medications have proven to be effective and, in outweigh the expected burdens from the patient’s in a wide range of formulations and routes of some cases, preferable to opioids (Table 14). perspective?292 This question applies as much to administration, including oral, parenteral, and Some exert a direct analgesic effect mediated minor interventions such as phlebotomy as to more rectal delivery. Both rectal and transdermal routes by non-opioid receptors centrally or peripherally. complex interventions such as chemotherapy or can be especially valuable at the end of life when Other adjuvant “analgesics” have no direct surgery. the oral route is precluded because of reduced analgesic qualities but may provide pain relief Answering this question requires that clinicians or absent consciousness, difficulty swallowing, or indirectly by affecting organs or body systems 293 understand what a particular patient would to reduce the chances of nausea and vomiting. involved in painful sensations. consider a “benefit” or a “burden” and what the When selecting an opioid, clinicians should also patient’s goals are. The question also can seldom consider cost, since expensive agents can place be answered with absolute certainty since the undue burden on patients and families.

33 Table 14: Adjuvant analgesics of end-of-life pain293 Drug Class Agent Route of Potential adverse effects Indications Administration Antidepressants Nortriptyline Oral Anticholinergic effects Neuropathic pain Desipramine Oral Cardiac arrhythmia Venlafaxine Oral Nausea, dizziness Duloxetine Oral Nausea Anti-epilepsy Gabapentin Oral Dizziness Neuropathic pain drugs Pregabalin Oral Dizziness Corticosteroids Dexamethasone Oral/IV “Steroid psychosis” Neuropathic pain, cerebral edema, spinal cord compression, bone pain, visceral pain Lidocaine Lidocaine patch Topical Erythema (rare) Neuropathic pain Lidocaine infusion IV Perioral numbness, cardiac changes Intractable neuropathic pain NMDA antagonists Ketamine Oral/IV Hallucinations Unrelieved neuropathic pain; need to reduce opioid dose Bisphosphonates Pamidronate IV Pain flare, osteonecrosis Osteolytic bone pain Zoledronic acid IV Cannabinoids THC (Marinol) Oral Dizziness, nausea, tachycardia, Nausea, loss of appetite, spasticity, neuropathic pain Nabilone (Cesamet) Oral euphoria THC (Sativex) (note: not Oromucosal available in the U.S.) spray Corticosteroids can play a valuable role in In recent years there has been a resurgence relaxation, and enhancing a sense of control over treating end-of-life pain related to neuropathic pain of interest in the use of cannabinoids for the relief the pain or the underlying disease. Breathing syndromes, pain associated with stretching of the of pain and the end of life.301 Two oral cannabinoid exercises, relaxation, imagery, hypnosis, and other liver capsule due to metastases, for treating bone preparations are FDA-approved and available in behavioral therapies are among the modalities pain (due to their anti-inflammatory effects) as well the US, and an oromucosal preparation is available shown to be potentially helpful to patients.293 as for relieving malignant intestinal obstruction.298 in Canada and several European countries. These Physical modalities such as massage, use of Dexamethasone produces the least amount of routes of administration avoid the potential hazards heat or cold, acupuncture, acupressure, and other mineralocorticoid effect and is available in a variety and dosing uncertainties involved with inhaled physical methods may be provided in consultation of delivery forms, including oral, intravenous, forms of raw cannabis. with physical or occupational therapy. These subcutaneous, and epidural.293 Cannabinoids have been shown to exert no treatments can enhance patients’ sense of control Local anesthetics may be useful in preventing appreciable effects on opioid plasma levels and may as well as greatly reduce the family caregivers’ procedural pain and in relieving neuropathic augment the efficacy of oxycodone and morphine sense of helplessness when they are engaged in pain. Local anesthetics can be given topically, in patients suffering from a variety of chronic pain pain relief. A 2008 study found that both massage intravenously, subcutaneously, or spinally. Both gel conditions, potentially allowing a reduction in the and “simple touch” induced statistically significant and patch versions of lidocaine have been shown opioid doses used in such patients.302 The authors improvements in pain, quality of life, and physical to reduce the pain of postherpetic neuropathy and of a recent review of the role of cannabinoids in and emotional symptom distress over time without cancer-related neuropathic pain.299 hospice and palliative care concluded: “Many increasing analgesic medication use.304 NMDA antagonists (dextromethorphan, patients in a palliative care setting who are currently Psychosocial interventions for end-of-life amantadine, and ketamine) are believed to exert on long-term opioids for chronic pain could pain may include cancer pain education, hypnosis their analgesic effects by blocking receptors for potentially be treated with either cannabis alone or and imagery based methods, and coping skills glutamate and other excitatory amino acids at in combination with a lower dose of opioids. From training.305 Educational programs are one of the the level of the spinal cord. Ketamine is the most a pharmacological perspective, cannabinoids are most common interventions to address cancer pain commonly-used agent, and can be administered in considerably safer than opioids and have broad barriers, and current studies provide high-quality a variety of routes. A general recommendation is to applicability in palliative care.”301 evidence that pain education is feasible, cost- reduce the opioid dose by approximately 25% to effective, and practical in end-of-life settings.305 50% when starting ketamine to avoid sedation.300 Complementary and Alternative Therapies A wide range of complementary and alternative Although a Cochrane review found insufficient trials Managing pain in intensive care units to determine its safety and efficacy in relieving therapies (CAT) are commonly used in end-of-life care. A 2010 study found that 41.8% of all hospice Several studies show that most US adults cancer pain, case reports and small studies suggest 306 care providers offered some form of CAT.303 More wish to die at home, and yet more than half of that intravenous or oral ketamine can be used in deaths occur in hospitals, most with ICU care.307 adults and children with cancer for the relief of than half of providers that offered CAT offered massage, supportive group therapy, music and pet When curative approaches are not expected to intractable neuropathic pain or to reduce opioid be successful, a transition to primary comfort- doses.300 therapy, and guided imagery and relaxation. CAT interventions are aimed at reducing pain, inducing focused care and the withdrawal of ineffective or burdensome therapies is often necessary. 34 Although guidelines and detailed strategies have the best efforts of pain management providers, • If opioids are indicated, the prescription been developed for analgesic therapy during palliative sedation (also known as terminal, should be for the lowest effective dose and for the removal of life-sustaining interventions, continuous, controlled, or deep-sleep sedation) a limited duration (e.g., < 1 week). communication about what to expect and how things is an option. Palliative sedation is the intentional Children and adolescents may proceed remain paramount to negotiating this sedation of a patient suffering uncontrollable Chronic pain is estimated to affect 5% to 38% of 308 care transition. Some patients and families may refractory symptoms in the last days of life to the children and adolescents.314 These pain conditions be able to have meaningful interactions at the end point of almost, or complete, unconsciousness can be from congenital diseases (e.g., sickle of life, and thus brief interruption of sedatives and and maintaining sedation until death—but not cell disease), where pain begins in the infant or 312 analgesics may be reasonable. intentionally causing death. Although palliative toddler age period; chronic noncongenital diseases Rarely are dying ICU patients able to self- sedation may bring intolerable suffering to an end (e.g., juvenile idiopathic arthritis, fibromyalgia, report information about their pain. Thus it is and allow people to die peacefully, it nonetheless inflammatory bowel disease); or primary chronic incumbent on the critical care health professionals, can be challenging to put into practice and has been pain conditions (e.g., headaches, chronic abdominal 312 perhaps with the assistance of the patient’s family criticized as “slow euthanasia.” pain, chronic musculoskeletal pain). members, to assess pain without self-report input Acknowledging the inherently complex and The origin of pain conditions in the pediatric age from the patient. Two pain assessment instruments subjective nature of decisions about palliative group is important because the developing pediatric have been validated for use in the ICU setting: the sedation, guidelines have nonetheless been nervous system can be especially vulnerable to pain Behavioral Pain Scale and the Critical-Care Pain developed to help guide responsible use of this sensitization and development of neuroplasticity.315 Observation Tool. Both tools describe specific alternative. Guidelines suggest that palliative Data support the finding that early neonatal and 312 observations that the patient’s ICU care providers sedation should only be considered when: childhood pain experiences can alter pain sensitivity (including family members or loved ones) can • The patient is terminally ill in later life. Poor pain management in children can • Death is expected within hours or days make that, when present, could indicate the put them at risk for persistent pain and increased patient is experiencing pain such as grimacing, • The patient is suffering acute symptoms unresponsive to therapy impairment as they transition into adulthood and rigidity, wincing, shutting of eyes, clenching of fists, may even be linked to the development of new 309 • Consent is obtained from the patient or his/ verbalization, and moaning. chronic pain conditions.316 Reports by family members or other people her proxy • The withdrawal of food and water is discussed The application of the biopsychosocial model to close to a patient should not be overlooked. In the • Families are informed that the patient will likely pediatric pain care is therefore vital.1 Psychological Study to Understand Prognosis and Preference for not regain consciousness and will die conditions resulting from chronic disease and Outcomes and Risks of Treatment (SUPPORT) study, • Causing death is not the intention even pain syndromes can contribute to long-term pain. surrogates for patients who could not communicate though it may not be possible to achieve These psychological conditions can include difficulty verbally had a 73.5% accuracy rate in estimating adequate symptom control except at the risk coping, anxiety, and depression. Incorporation 310 presence or absence of the patient’s pain. of shortening the patient’s life of parents and family into pain care is especially Ethical considerations The degree to which palliative sedation is used, important in the pediatric population because A potential barrier to good pain management and the manner in which it is used, must, in the childhood pain can be affected by family and at the end of life is the misconception on the part end, be a matter of clinical judgment on the part of parental factors, including family functioning and of providers, family members, or both, that an individual physicians. parental anxiety, and depression. Appropriate pain management in childhood escalation of pain medications or other palliative Emergency room patients therapies will unethically hasten or cause death. is imperative because children’s early pain Pain is a frequent complaint of emergency experiences can shape their response to pain as Although ethical and legal consensus upholds room (ER) patients, and ER physicians are among the appropriateness of withdrawing unwanted adults. It is of utmost importance to introduce the higher prescribers of opioids to patients comprehensive pain care early in the pediatric age or unhelpful therapies to avoid the prolongation ages 10-40.313 ER physicians, however, face of the dying process and the administration of group to optimize patients’ quality of life now and considerable challenges in determining a patient’s in the future.1 medications with the intent of relieving suffering, appropriateness for opioid therapy. A medical such concerns may mitigate optimal administration history is often lacking, and the physician seldom Older adults of therapies.308 When providers administer pain knows the patient personally. Time constraints, as The prevalence of pain among community- medications and other palliative therapies to a well, can preclude the kinds of careful assessment dwelling older adults has been estimated between dying patient, the intent should explicitly be on and evaluation recommended for responsible opioid 25% and 50%.317 The prevalence of pain in relief of symptoms, and communication with prescribing. Because of this, current guidelines nursing homes is even higher. Unfortunately, the family must stress this goal, even if the from the American College of Emergency Physicians managing pain in older adults is challenging due to: possibility exists that such treatments could hasten include the following recommendations:160 underreporting of symptoms; presence of multiple death.311 • ER/LA opioid medications should not be medical conditions; polypharmacy; declines in liver Contrary to fears among patient and their prescribed for acute pain and kidney function; problems with communication, families, research suggests that aggressive pain • PDMPs should be used where available to help mobility, and safety; and cognitive and functional management at the end of life does not necessarily identify patients at high risk for opioid abuse decline in general. Special considerations exist for shorten life. In fact, pain management may be life- or diversion pain assessment, acute pain management, specific prolonging by decreasing the systemic effects of • Opioids should be reserved for more severe conditions causing persistent pain, medication uncontrolled pain that can compromise vital organ pain or pain that doesn’t respond to other classes, interventional strategies, and managing function.311 analgesics addiction in older adults.318 If a patient experiences intense pain, discomfort or other undesirable states at the end of life despite

35 Acetaminophen is considered the drug of More than 2 million people in the United States 17. Chu LF, Angst MS, Clark D. Opioid-induced hyperalgesia in hu- mans: molecular mechanisms and clinical considerations. The choice for mild-to-moderate pain in older adults are estimated to have OUD. Medication-assisted Clinical journal of pain. 2008;24(6):479-496. because it lacks the gastrointestinal, bleeding, treatment with methadone and buprenorphine 18. Arner S, Meyerson BA. Lack of analgesic effect of opi- renal toxicities, and cognitive side-effects that works: it alleviates withdrawal symptoms, reduces oids on neuropathic and idiopathic forms of pain. Pain. 1988;33(1):11-23. have been observed with NSAIDs in older adults opioid cravings, increases abstinence, and saves 19. Covington EC. Anticonvulsants for neuropathic pain and detox- (although acetaminophen may pose a risk of liver lives. These medications also help people improve ification. 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Keefe FJ, Abernethy AP, L CC. Psychological approaches to taneous electric nerve stimulation in painful diabetic neurop- placebo-controlled, multicenter trial. Arthritis Rheum. understanding and treating disease-related pain. Annu Rev athy: a randomized placebo-controlled study. Pain medicine. 2007;56(4):1336-1344. Psychol. 2005;56:601-630. 2011;12(6):953-960. 272. Gaskell H, Moore RA, Derry S, Stannard C. Oxycodone for pain 299. Weitzen S, Teno JM, Fennell M, Mor V. Factors associated with 249. Griebeler ML, Morey-Vargas OL, Brito JP, et al. Pharmacolog- in fibromyalgia in adults. The Cochrane database of systemat- site of death: a national study of where people die. Med Care. ic interventions for painful diabetic neuropathy: An umbrella ic reviews. 2016;1(9). 2003;41(2):323-335Z systematic review and comparative effectiveness network me- 273. Peng X, Robinson RL, Mease P, et al. Long-term evaluation of 300. Angus DC, Barnato AE, Linde-Zwirble WT, et al. Use of inten- ta-analysis. Annals of internal medicine. 2014;161(9):639- opioid treatment in fibromyalgia. The Clinical journal of pain. sive care at the end of life in the United States: an epide- 649. 2015;31(1):7-13. miologic study. Critical care medicine. 2004;32(3):638-643. 250. Goldstein DJ, Lu Y, Detke MJ, Lee TC, Iyengar S. Duloxetine 274. Bennett RM, Kamin M, Karim R, Rosenthal N. Tramadol and 301. Mularski RA, Puntillo K, Varkey B, et al. Pain management vs. placebo in patients with painful diabetic neuropathy. Pain. acetaminophen combination tablets in the treatment of fibro- within the palliative and end-of-life care experience in the ICU. 2005;116(1-2):109-118. myalgia pain: a double-blind, randomized, placebo-controlled Chest. 2009;135(5):1360-1369. 251. Waldfogel JM, Nesbit SA, Dy SM, et al. Pharmacotherapy for study. The American journal of medicine. 2003;114(7):537- 302. Payen JF, Bru O, Bosson JL, et al. Assessing pain in critically ill diabetic peripheral neuropathy pain and quality of life: A sys- 545. sedated patients by using a behavioral pain scale. Critical care tematic review. Neurology. 2017;88(20):1958-1967. 275. Skrabek RQ, Galimova L, Ethans K, Perry D. Nabilone for the medicine. 2001;29(12):2258-2263. 252. Wiffen PJ, Derry S, Moore RA, Kalso EA. Carbamazepine for treatment of pain in fibromyalgia. J Pain. 2008;9(2):164-173. 303. Desbiens NA, Mueller-Rizner N. How well do surrogates as- chronic neuropathic pain and fibromyalgia in adults. The Co- 276. Ware MA, Fitzcharles MA, Joseph L, Shir Y. The effects of sess the pain of seriously ill patients? Critical care medicine. chrane database of systematic reviews. 2014;10(4). nabilone on sleep in fibromyalgia: results of a randomized 2000;28(5):1347-1352. 253. Baron R, Mayoral V, Leijon G, Binder A, Steigerwald I, Ser- controlled trial. Anesthesia and analgesia. 2010;110(2):604- 304. Bruce A, Boston P. Relieving existential suffering through pal- pell M. 5% lidocaine medicated plaster versus pregabalin 610. liative sedation: discussion of an uneasy practice. J Adv Nurs. in post-herpetic neuralgia and diabetic polyneuropathy: an 277. Goudas LC, Bloch R, Gialeli-Goudas M, Lau J, Carr DB. The 2011;67(12):2732-2740. open-label, non-inferiority two-stage RCT study. Current medi- epidemiology of cancer pain. Cancer Invest. 2005;23(2):182- 305. Verkerk M, van Wijlick E, Legemaate J, de Graeff A. A nation- cal research and opinion. 2009;25(7):1663-1676. 190. al guideline for palliative sedation in the Netherlands. J Pain 254. Wolfe F, Smythe HA, Yunus MB, et al. The American College of 278. National Comprehensive Cancer Network. Guidelines Version Symptom Manage. 2007;34(6):666-670. Rheumatology 1990 Criteria for the Classification of Fibromy- 2. Adult Cancer Pain. September 26 2012. 306. Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss algia. Report of the Multicenter Criteria Committee. Arthritis 279. Cleeland CS, Gonin R, Hatfield AK, et al. Pain and its treat- SR. Characteristics of opioid prescriptions in 2009. Jama. Rheum. 1990;33(2):160-172. ment in outpatients with metastatic cancer. N Engl J Med. 2011;305(13):1299-1301. 255. Chinn S, Caldwell W, Gritsenko K. Fibromyalgia Pathogenesis 1994;330(9):592-596. 307. King S, Chambers CT, Huguet A, et al. The epidemiology of and Treatment Options Update. Curr Pain Headache Rep. 280. World Health Organization. WHO analgesic ladder. http://www. chronic pain in children and adolescents revisited: a system- 2016;20(4):25. who.int/cancer/palliative/painladder/en/. Accessed October atic review. Pain. 2011;152(12):2729-2738. 256. American College of Rheumatology. Fibromyalgia treatment. 29 2018. 308. Schwaller F, Fitzgerald M. The consequences of pain in early 2019; https://www.rheumatology.org/I-Am-A/Patient-Care- 281. Bader P, Echtle D, Fonteyne V, et al. Guidelines on pain man- life: injury-induced plasticity in developing pain pathways. Eur giver/Diseases-Conditions/Fibromyalgia. Accessed May 24 agement. European Association of Urology. 2010. J Neurosci. 2014;39(3):344-352. 2019. 282. Christo PJ, Mazloomdoost D. Interventional pain treatments for 309. Walker LS, Dengler-Crish CM, Rippel S, Bruehl S. Functional 257. Macfarlane GJ, Kronisch C, Dean LE, et al. EULAR revised cancer pain. Ann N Y Acad Sci. 2008;1138:299-328. abdominal pain in childhood and adolescence increases risk recommendations for the management of fibromyalgia. Ann 283. 283. Byock I. Dying Well: The Prospect for Growth at the End for chronic pain in adulthood. Pain. 2010;150(3):568-572. Rheum Dis. 2017;76(2):318-328. of Life. New York NY: Riverhead Books; 1997. 310. Ferrell BA. Pain management in elderly people. J Am Geriatr 258. Jones KD, Adams D, Winters-Stone K, Burckhardt CS. A com- 284. Beauchamp TL, Childress JF. Principles of biomedical ethics. Soc. 1991;39(1):64-73. prehensive review of 46 exercise treatment studies in fibro- 5th ed. Oxford, UK: Oxford University Press; 2001. 311. Cordts GA, Christo PJ. Effective Treatments for Pain in the Old- myalgia (1988-2005). Health Qual Life Outcomes. 2006;4:67. 285. Forrow L, Smith HS. Pain management in end of life: palliative er Adult. New York NY: Springer; 2019. 259. Andrade A, de Azevedo Klumb Steffens R, Sieczkowska SM, care. In: Warfield CA BZ, ed. Principles & Practice of Pain Med- Peyre Tartaruga LA, Torres Vilarino G. A systematic review of icine. 2nd ed. New York, NY: McGraw-Hill; 2004. the effects of strength training in patients with fibromyalgia: 286. Paice JA, Ferrell B. The management of cancer pain. CA Can- clinical outcomes and design considerations. Adv Rheumatol. cer J Clin. 2011;61(3):157-182. 2018;58(1):36.

40 Opioid Analgesics in the Management of Acute and Chronic Pain Self-Assessment Choose the best possible answer for each question and mark your answers on the Self-Assessment answer sheet at the end of this book. There is a required score of 70% or better to receive a Certificate of completion. 1. Which type of pain is characterized by aberrant signal 6. Which of the following topics should be routinely covered as processing in the peripheral or central nervous system? part of patient education about opioid analgesics? A. Nociceptive pain A. Background information about acute vs. chronic pain B. Acute pain B. Criteria for Opioid Use Disorder C. Neuropathic pain C. Safe medication disposal D. Chronic non-cancer pain D. Difference between nociceptive and neuropathic pain

2. What term describes the phenomenon of pain being caused 7. Although the absolute risk for inducing opioid misuse or by a normally innocuous stimulus such as light touch? addiction due to prescriptions of opioids for acute pain A. Allodynia is low, the large number of such prescriptions means that B. Hyperalgesia approximately how many people are at risk each year? C. Hypoalgesia A. 260,000 D. Referred pain B. 160,000 C. 60,000 3. What is the likely physiological basis for opioid-induced D. 6,000 hyperalgesia? A. Upregulation of nociceptive pathways in peripheral and central 8. Non-pharmacologic methods for treating acute pain are nervous systems appropriate for which phase of healing? B. Downregulation of nociceptive pathways in dorsal horn A. Immediately after tissue trauma neurons B. > 48 hours after tissue trauma C. Increased release of substance-P in neuronal synapses of C. Late healing phase for recovery of function peripheral and central nervous system neurons D. Immediately after tissue trauma as well as in late healing phase D. Disinhibition of neuropathic pain pathways in central nervous system 9. Long-acting (LA) and extended-release (ER) formulations of opioids should not be used for ______? 4. Which statement best summarizes the CDC finding about A. Treating acute pain opioids for chronic pain? B. Treating cancer pain A. Opioid analgesics should be confined to use in patients with C. Treating end-of-life pain neuropathic, as opposed to nociceptive, pain syndromes D. Treating chronic non-cancer pain B. Chronic non-cancer pain can be effectively treated with immediate-release opioid agents, but should not be treated 10. What is one suggestion for a way to augment opioid treatment with long-acting or extended-release formulations in order to help improve a patient’s pain and function? C. No evidence shows a long-term benefit of opioids in pain and A. Use an every-other-day dosing pattern for the opioid, function versus no opioids although extensive evidence shows alternating with an NSAID analgesic the potential harms of opioids B. Rotate the route of administration every 6 weeks D. Evidence supports the use of opioid analgesics for long-term C. Add a long-acting opioid to a prescription for an immediate- non-cancer chronic pain except in patients with pre-existing release opioid substance use disorders D. Try concurrent non-pharmacologic approaches such as exercise or cognitive behavioral therapy 5. Opioid pain medications should not be combined with ______? 11. Which of the following is an example of a functional goal? A. Benzodiazepines A. Reduced anxiety about pain B. Stimulant medications B. Reduced need for rescue analgesia C. SSRI antidepressants C. Reduced daily dose of opioid analgesic D. Anti-hypertensive medications D. Walking around the block

41 12. According to the Centers for Disease Control and Prevention, 19. For which of the following must clinicians obtain a special what amount of opioid analgesic is appropriate for most waiver from the DEA prior to being able to prescribe the painful conditions? medication? A. 2-day supply A. Methadone B. 3-day supply B. Buprenorphine C. 5-day supply C. Extended-release naltrexone D. 7 day supply D. Naloxone

13. Which class of patients might require more frequent or 20. Which of the following is a possible reason for prescribing intense monitoring when prescribed an opioid analgesic? naloxone to a patient who has been prescribed an opioid A. Young adults analgesic? B. Older adults A. The patient is taking a dose of an opioid < 50 MMED C. Female patients B. The patient has recently been released from prison D. Patients with hypertension C. The patient has history of hypertension D. The patient has a concurrent prescription for an SSRI 14. Which of the following characteristics is typical of patients antidepressant who are addicted to a pain medication? A. Medication use improves quality of life B. Follows practitioner-patient agreement for opioid use C. Medication use continues or increases despite adverse effects D. Has left-over medication at each visit

15. Most experts agree that opioid dosages should not be increased to ______without careful justification based on diagnosis and on an individualized assessment of benefits and risks. A. ≥50 MMED B. ≥60 MMED C. ≥80 MMED D. ≥90 MMED

16. The availability of naloxone was increased in 2019 by an FDA decision that ______. A. Allowed naloxone to be sold over the counter B. Approved a generic formulation of nasal-spray naloxone C. Allowed registered nurses to prescribe naloxone D. Provided government subsidy to increase production of naloxone

17. Which of the following medications is a full mu-receptor agonist used to treat Opioid Use Disorder? A. Methadone B. Buprenorphine C. Extended-release naltrexone D. Naloxone

18. Which of the following medications can be self-administered by patients with a medication obtained from a regular pharmacy? A. Methadone B. Buprenorphine C. Extended-release naltrexone D. Naloxone

42 A CLINICIAN’S GUIDE TO

RECOGNIZING AND RESPONDING Release Date: 02/2017 1 AMA PRA Enduring Material Review Date: 07/2020 Category 1 CreditsTM (Self Study) TO HUMAN TRAFFICKING IN TEXAS Exp. Date: 12/2022

TARGET AUDIENCE

This course is designed for all physicians, physician assistants and other Read the course materials health care professionals. Complete the self-assessment questions at the end. A score of 70% is required.

Return your customer information/ answer sheet, evaluation, and COURSE OBJECTIVE payment to InforMed by mail, phone, fax or complete online at course The purpose of this activity is to provide clinicians with the strategies for website under NETPASS. identifying, assessing and responding to patients who may be current or past victims of human trafficking. This details venues for human trafficking, techniques for identifying and assisting victims with referrals to multidisciplinary professionals.

LEARNING OBJECTIVES

Completion of this course will better enable the course participant to: 1. Understand the types and venues of human trafficking in the United States 2. Be better able to identify victims of human trafficking in health care settings 3. Know the warning signs of human trafficking in health care settings for adults and minors 4. Identify resources for reporting suspected victims of human trafficking

ACCREDITATION STATEMENT: InforMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

DESIGNATION STATEMENT: InforMed designates this enduring material for a maximum of 1 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. 43 FACULTY Ana E. Núñez, MD Associate Dean for Diversity, Equity and Inclusion Professor of Medicine Division of Internal Medicine Drexel University College of Medicine Leon McCrae II, MD MPH 1 Associate Professor HHSC APPROVED Drexel University College of Medicine HUMAN TRAFFICKING

Stephen Braun Medical Writer Braun Medical Media TEXAS SPECIAL APPROVAL This course is approved by the Texas ACTIVITY PLANNER Health and Human Services Commission (HHSC) to satisfy one (1) hour on Human Elizabeth Thomas Trafficking Training. MSN, WHNP-BC, NP-C

Michael Brooks Per Texas Occupations Code, Title 3, Subtitle CME Director, InforMed B, Sec. 156.060, licensed physicians (MD/DO) and physician assistants (PA) must complete a human trafficking prevention course approved DISCLOSURE OF INTEREST: by the HHSC as part of the hours of continuing medical education required for renewal. In accordance with the ACCME Standards for Commercial Support of CME, InforMed implemented mechanisms, prior to the planning and implementation of this CME activity, to identify and resolve conflicts of interest for all individuals in a position to control content of this CME activity.

FACULTY/PLANNING COMMITTEE DISCLOSURE:

The following faculty and/or planning committee members The following faculty and/or planning committee members have indicated they have no relationship(s) with industry to have indicated that they have relationship(s) with industry to disclose relative to the content of this CME activity: disclose: • Leon McCrae II M.D. MPH • Ana E. Núñez, MD has disclosed that her spouse is a • Stephen Braun salaried employee of Gilead Pharmaceuticals • Elizabeth Thomas • Michael Brooks

STAFF AND CONTENT REVIEWERS: InforMed staff, input committee and any content validation reviewers involved with this activity have reported no relevant financial relationships with commercial interests.

DISCLAIMER *2020. All rights reserved. These materials, except those in the public domain, may not be reproduced without permission from InforMed. This publication is designed to provide general information prepared by professionals in regard to the subject matter covered. It is provided with the understanding that InforMed, Inc. is not engaged in rendering legal, medical or other professional services. Although prepared by professionals, this publication should not be utilized as a substitute for professional services in specific situations. If legal advice, medical advice or other expert assistance is required, the service of a professional should be sought. 44 Introduction They are forced or coerced into prostitution, They are usually beset with physical, domestic servitude, or other types of forced psychological, social, legal, and financial Human trafficking has been called a form labor (e.g., agriculture, construction, fisheries, circumstances that can be overwhelming.3 of modern-day slavery.1,2 It is a crime involving mining industries). Victims can be found in Human trafficking became a federal the exploitation of someone for the purpose legitimate and illegitimate labor industries, crime with passage of the Trafficking Victims of compelled labor or a commercial sex act including sweatshops, massage parlors, Protection Act of 2000 (TVPA) revised and through the use of force, fraud, or coercion.1 agriculture, restaurants, hotels, street updated in 2015.10 The goals of the TVPA were Victims can be women or men, adults or peddling, door to door sales, begging, and to prevent severe forms of human trafficking, children, citizens or noncitizens and occurs domestic service.1 both in the United States and overseas; to across the United States and throughout the protect victims and help them rebuild their world. Human trafficking does not require Although anyone can be at risk for being a lives in the United States; and to prosecute crossing of international or state borders victim of human trafficking, most are women traffickers and impose federal penalties. Prior For clinicians and health care workers, and girls.7 Risk factors for being vulnerable to to enactment of the TVPA, no comprehensive human trafficking can be viewed as a serious human trafficking include:8 federal law existed to protect victims of health risk associated with significant physical • Extreme poverty trafficking in the United States or to prosecute and psychological harms.3 The abuses suffered • Minimal education their traffickers. Congress has reauthorized by people who are trafficked include many • A history of abuse or family instability and amended the TVPA several times, but its forms of physical violence or abuse (e.g., • Being disabled fundamental purpose and legal authorities beating, burning, rape, confinement) as well • Belonging to a marginalized or stigmatized remain the same. as many psychologically damaging tactics gender, ethnic, or cultural group such as threats to themselves or their family “Victim” or “Survivor”? members, blackmail, extortion, lies about Traffickers use various techniques to The terms “victim” and “survivor” can the person’s rights, and confiscation of vital control their victims and keep them enslaved. both be used to refer to individuals who identity documents.3 Some traffickers hold their victims under lock were trafficked. The term “victim” has and key. More frequently, however, more subtle legal implications within the criminal justice What Is Human Trafficking? techniques are used such as:9 process and generally means an individual Human trafficking is defined as “the who suffered harm as a result of criminal 1 recruitment, transportation, transfer, harboring • Isolation from: conduct. or receipt of persons by means of the threat ° The public by limiting contact with “Survivor” is a term used by many in or use of force or other forms of coercion, of outsiders and making sure that any the health services field to recognize the abduction, of fraud, of deception, of the abuse contact is monitored or superficial in of power or of a position of vulnerability or of strength it takes to continue on a journey nature the giving or receiving of payments or benefits toward healing in the aftermath of a to achieve the consent of a person having ° Family members and friends traumatic experience. control over another person, for the purpose of • Control: exploitation.”4 The phrase “human smuggling” ° Confiscation or control of passports or is often confused with “human trafficking” other identification documents Human Trafficking in Texas but they are two quite different crimes. ° Debt bondage through enormous In 2009, the Texas legislature created the Human smuggling involves the provision of a financial obligations or an undefined Texas Human Trafficking Prevention Task Force service—typically transportation or fraudulent or increasing debt to respond to the growing human trafficking documents—to an individual who voluntarily ° Control of the victims' money crisis and designated the attorney general as 5 11 seeks illegal entry into a foreign country. Also • Intimidation/threat: the presiding officer. The Task Force develops sometimes confused is the difference between ° Use or threat of violence toward legislative recommendations to attack the sex trafficking and consensual commercial crime and policies to protect victims. A 2016 victims or their family members sex (sex work). Sex trafficking is when a report by the University of Texas at Austin, person takes part in the sale of sex through ° Shaming victims by exposing School of Social Work estimated that there are threat, abduction, or other means of coercion, humiliating circumstances to their approximately 79,000 minor and youth victims whereas sex work involves the willing and families of sex trafficking and 234,000 workers who consensual exchange of money for sex and ° Telling victims they will be imprisoned are victims of labor trafficking.12 Minor and does not infringe on the human rights of the or deported for immigration violations youth sex trafficking has an estimated economic participants.6 (Note: children cannot technically if they contact authorities impact to the state of nearly $6.6 billion while be prostitutes or sex workers because they labor trafficking victims are exploited at an The life situations of people who are cannot legally consent to commercial sex.) annual cost of almost $600 million.12 In 2019, trafficked are almost always complicated, Many victims of human trafficking are the latest year for which data are available, whether they are under a trafficker’s control, forced to engage in sexual practices through there were 1,080 human trafficking cases trying to leave, or are already out of a threats or other types of coercion, but reported in Texas, 155 arrests for human trafficking environment. In addition, trafficked trafficking also occurs as labor exploitation in trafficking, and 46 convictions.11,13 There were people may not self-identify as trafficked. urban, suburban, and rural areas. Many victims also 100 arrests for compelled prostitution Rather they may feel that these are merely the are lured with false promises of well-paying with 26 convictions.11 jobs or manipulated by people they trust.1 restrictions of their circumstance. 45 Of the 1,080 cases of human trafficking survivors, 88% had at least one encounter with develop a rapport with trafficked persons that in 2019, most were for sex trafficking (805 a health care provider while they were being facilitates trust and frank communication based cases), with labor trafficking being the next- trafficked, with 63 percent of these encounters on their language or cultural commonalities. It most common (111 cases).13 Most victims happening in an emergency department.19 is recommended, therefore, that health care were female (933 cases vs. 116 for men), One study noted that human trafficking organizations think broadly about the types and adult (673 cases vs. 261 cases involving victims in the U.S. may interact with a range of of employees who are appropriate to receive minors). [Note: statistics are non-cumulative health care personnel, including primary care training about human trafficking in order to because cases may involve multiple victims.] providers, sexual and reproductive health care enhance opportunities for identification of and An important caveat to all statistics about workers, dentists, and providers of traditional response to potential trafficking situations.23 human trafficking is the difficulty of obtaining or alternative remedies.9 Trafficking victims A human trafficking victim may develop a accurate data, which is a limitation of research may even be found working within health care mindset of fear, distrust, denial, and conflicting into this issue that has been pointed out in loyalties. Foreign victims of trafficking are the reports of the Texas Human Trafficking facilities. Unfortunately, studies have demonstrated often fearful of being deported or jailed and, Prevention Task Force and other organizations therefore, they may distrust authority figures, working to reduce human trafficking.11 that medical care providers are often unprepared to identify trafficking victims.20,21 particularly law enforcement and government Barriers to acquiring accurate data include officials. Many victims of both sex and labor the avoidance by victims of the criminal justice trafficking fear that if they escape their system due to fears of reprisal, deportation, Identifying Potential Victims of Human Trafficking servitude and initiate investigations against or incarceration; failure of health care workers their trafficker, the trafficker and his/her or emergency responders to ask about human Certain patient behaviors and/or companion behaviors can alert health care professionals associates will harm the victims, the victims’ trafficking or to probe causes of apparent family members, or others. violence; and a lack of coordination and data to a potential human trafficking case.9,22 One integration between the various levels of common clue is the presence of a person governmental agencies (local, state, federal) who seems to control both the patient and the Additional patient situations, behaviors, and other organizations (e.g., non-profits, situation. Survivors report that their traffickers or emotional states may suggest human hospitals) that may have data on human completed health-related paperwork for them trafficking:2 trafficking. These barriers and the limitations and communicated with clinic staff and health of existing data suggest that the true scope of 9 care providers on their behalf. The physical • Paying cash or having no health insurance human trafficking is larger than can be reliably proximity of the traffickers perpetuated their estimated at the present time.8 • Lacking control of identification documents coercion and control of the victims, preventing (ID or passport) them from communicating with health care • Having few or no personal possessions 9 An Essential Role for Healthcare Providers personnel directly. • Being reticent for additional testing or The presence of an overbearing or services due to large debt controlling companion should trigger concern, A number of organizations representing • Inability to: and most recommendations suggest that in healthcare providers have issued statements ° leave home or place of work order to allow patients the opportunity to recognizing human trafficking as a public ° speak for oneself or share one’s own speak for themselves, clinic or hospital staff health issue and acknowledging the importance information should attempt to interview and assess all of building awareness of human trafficking • Feelings of helplessness, shame, guilt, patients privately. This may require the use among health care providers.14-17 The American self-blame, and humiliation of an independent interpreter, since many Medical Association, for example, in its 2015 • Loss of sense of time or space, not survivors have limited English proficiency.9 statement, says: "Physicians should be aware knowing where they are or what city or Trained non-clinical workers could be of the definition of human trafficking and of state they are in instrumental in helping to maintain separation resources available to help them identify and • Emotional numbness, detachment, or during potential victim identification interviews address the needs of victims. The AMA will help disassociation (i.e., “flat affect”) in a manner that does not alert potential encourage the education of physicians about traffickers to victim identification efforts. Non- human trafficking and how to report cases of While not all victims of trafficking have clinical staff, such as receptionists, security suspected human trafficking to appropriate physical indicators that aid identification, many guards, and accounting personnel, who are authorities to provide a conduit to resources to victims suffer serious health issues, which may made sensitive to these matters through 2 address the victim's medical, legal and social include: training, may observe patterns and know when needs."15 • Addiction to drugs and/or alcohol as a way and how to respond if a potential trafficker Healthcare professionals are uniquely to cope with or “escape” their situation, repeatedly presents for multiple patients as positioned to identify and intervene on behalf of or as a method of control used by their a companion, translator, or medical bill payer, trafficking victims. Outside of law enforcement, traffickers regardless of whether these personnel interact healthcare settings are among the few places • Symptoms of post-traumatic stress with the patients themselves. where the lives of human trafficking victims disorder, phobias, panic attacks, anxiety, Multilingual non-clinical staff who may share may intersect with the rest of society, if only for and depression a common language with trafficked persons brief periods.18 In a study of 98 sex trafficking • Sleep or eating disorders of limited English proficiency may be able to

46 • Untreated chronic illnesses, such as • Contact the National Human Trafficking 1. Use a trauma-informed, resilience- diabetes or cardiovascular disease Resource Center (NHTRC) hotline oriented, human rights-focused, and • Signs of physical abuse, such as bruises, (1-888-373-7888) for assistance. culturally sensitive approach to the care broken bones, burns, and scarring Information available at: https:// of all patients. • Chronic back, visual, or hearing problems humantraffickinghotline.org/ 2. Collaborate with and seek advice from from work in agriculture, construction, or colleagues who have been engaged manufacturing If a patient has disclosed that he or she has in anti-trafficking or other violence • Skin or respiratory problems caused by been trafficked:2 prevention work. exposure to agricultural or other chemicals • Ensure that safety planning is included in 3. Partner with advocates, social service • Infectious diseases, such as tuberculosis the discharge planning process providers, case managers, and others and hepatitis, which are spread in • Provide the patient with options for from outside the health sector to improve overcrowded, unsanitary environments services, reporting, and resources. referral services and achieve a more with limited ventilation ° Provide the patient with the NHTRC effective overall response to human • Reproductive health problems, including hotline number. If the patient feels it trafficking. sexually transmitted diseases, urinary is dangerous to have something with 4. Play an active role in self-directed tract infections, pelvic pain, and injuries the number written on it, have them education and training about human from sexual assault or forced abortions memorize the number or designate trafficking. someone in your staff that they can call back to in order to provide that Using a Trauma-Informed Approach Responding to Victims of Human Trafficking number. Victims of trafficking do not often disclose At a glance, it is easy to appreciate the • In situations of immediate, life-threatening their trafficking situation in clinical settings.8 trauma of a massive motor vehicle accident, danger, follow your institutional policies for Health care providers must, therefore, be but a patient who is trafficked is experiencing a reporting to law enforcement. Whenever thoughtful and careful about engaging patients similarly powerful, but far less visible, traumatic possible, try to involve the patient in the if human trafficking is suspected. Before event. The task for clinicians is to recognize decision to contact law enforcement. beginning any conversation with a patient, trafficking when they see it and respond • If the patient is a minor, follow mandatory assess the potential safety risks that may result appropriately. The patient’s experiences can state reporting laws and institutional from asking sensitive questions of the patient. be dehumanizing, shocking or terrifying, can policies for child abuse or serving Recognize that the goal of your interaction is involve singular or multiple compounding not disclosure or rescue, but rather to create unaccompanied youth. Most state laws events over time, and often include betrayal a safe, non-judgmental place that will help you require immediate intervention of the of a trusted person or institution and a loss identify trafficking indicators and assist the trafficked victim is a minor. of safety.24 These experiences can mean that patient.2 This may be challenging in the context • Ensure that any information regarding the ordinary medical procedures, such as asking of busy, time-constrained schedules, but it is patient’s injuries or treatment is accurately a patient to undress for an exam, performing possible. documented in the patient’s records, a gynecological exam, or even simply checking recognizing that, similar to sexual assault blood pressure, can be threatening or anxiety- Clinicians should: examinations, the medical record serves provoking. • Allow the patient to decide if he or she both medical and legal purposes. Trauma-informed care (also known as would feel more comfortable speaking • Legal requirements regarding mandatory trauma-sensitive or trauma-aware care) is one with a male or female practitioner reporting of human trafficking differ from way to provide effective and compassionate • If the patient requires interpretation, state to state, and situations may require care for patients who may be trafficked or are always use professional interpreters who mandatory reporting under related otherwise traumatized. The Substance Abuse are unrelated to the patient or situation statutes even if the situation is not human and Mental Health Services Administration • If the patient is accompanied by others, trafficking (e.g., child abuse or domestic (SAMHSA) defines trauma-informed care as a try to find a time and place to speak with violence). State-specifc Information is program, organization, or system that:24 the patient privately available at: https://polarisproject.org/ • Take time to build rapport with potential resources/state-ratings-on-human- victims, or if you do not have the time trafficking-laws/ 1. Realizes the widespread impact of trauma yourself, find someone else on staff who • Refer to your local or state requirements and understands potential paths for can develop rapport with the patient for additional information regarding recovery • Ensure that the patient understands mandatory reporting. 2. Recognizes the signs and symptoms confidentiality policies and practices, of trauma in clients, families, staff, and including mandatory reporting laws Assessment and Evaluation others involved with the system • Use multidisciplinary resources, such as Four fundamental principles have been 3. Responds by fully integrating knowledge social workers, where available recommended for health care professionals about trauma into policies, procedures, • Refer to existing institutional protocols for who come into contact with people who have and practices victims of abuse/sexual abuse. been, or are being, trafficked:8 4. Seeks to actively resist re-traumatization

47 Trauma-specific intervention programs Examples of probing questions: • Pregnant woman with any injury, generally: 1. Has your identification or particularly to the abdomen or breasts; • Acknowledge the survivor's need to be documentation been taken from vaginal bleeding; or decreased fetal respected, informed, connected, and you? movement hopeful regarding their own recovery 2. What are your working or living conditions • Body tattoos that are the mark of a pimp • Address the interrelation between like? or trafficker trauma and symptoms of trauma such as substance abuse, eating disorders, 3. Where do you sleep and eat? • Occupational injuries not linked clearly to depression, and anxiety 4. Can you leave your job or situation if you legitimate employment • Collaboratively work with survivors, family want? and friends of the survivor, and other 5. Do you sleep in a bed, on a cot or on the human services agencies in a manner that floor? will empower survivors and consumers 6. Do you have to ask permission to eat, The Clinical Goal • Other trauma-informed approaches sleep or go to the bathroom? The clinician’s goal should not be to “get support the need for fundamental safety 7. Can you come and go as you please? a disclosure” from a patient suspected 8 throughout the health care system (e.g. 8. Have you ever been deprived of food, of being trafficked or otherwise abused. the Sanctuary model. Information at water, sleep or medical care? Instead, the health care provider should http://sanctuaryweb.com/) Additional work to create a climate that allows every intervention information can be found in 9. Are there locks on your doors and a manual about trauma-informed care windows? Do you lock them or does patient to feel safe, secure, cared for, published by SAMHSA and available at: someone else? (e.g., so you cannot get validated, and empowered to disclose https://store.samhsa.gov/product/TIP- out) if he or she chooses. Disclosure might 57-Trauma-Informed-Care-in-Behavioral- 10. Have you been threatened if you try to occur later if the patient does not feel Health-Services/SMA14-4816 leave? ready to disclose in the immediate clinical 11. Have you been physically harmed in any setting. Therefore, each individual clinical Taking a History way? encounter should be viewed as a step on No evidence-based recommendations 12. Is anyone forcing you to do anything that a pathway to safety for at-risk patients. guide assessment and evaluation processes you do not want to do? in the context of known or suspected human 13. Has anyone threatened your family? trafficking. Practice-based evidence, however, Physical Examination Documentation has been used to generate recommendations Clinicians should carefully and accurately for screening and inquiry in these situations. A physical examination should be performed carefully and sensitively, guided by the clinical document all findings in the medical record, Survivors of trauma report that disclosure not only because this is standard care for presentation and by information gleaned from may be more likely if health care providers all patients, but because such data may be the history. In cases involving sexual violence are perceived to be knowledgeable about valuable if the patient seek legal redress. The abuse and violence, nonjudgmental, respectful, and other forms of trauma, forensic evaluation patient’s medical history, physical findings, and supportive, and use a trauma-sensitive and evidence collection should be offered 8 oral disclosures, should be documented in approach to evaluation and treatment. Given when appropriate (e.g., if the most recent writing, in an unbiased manner, using direct, the impact of adverse childhood experiences sexual assault has occurred within 120 hours unaltered quotes from the patient, to the extent and other traumatic exposures on later of presentation, and with the patient’s consent possible. Photographic documentation of physical and mental health and well-being, or in conjunction with mandated reporter physical findings may be appropriate, with the some experts recommend embedding specific responsibilities).8 Forensic evaluation and patient’s permission. Images should contain questions about trafficking after a trusting evidence collection should be performed using the patient’s face and the injury or lesion relationship has been established. The length approved sexual assault evidence collection measured with a ruler or other common object of time it takes to establish such a relationship kits. If available in your area, sexual assault/ (such as a coin). Additional photographs can a victimized individual varies widely—it may forensic nurse examiners, who have specific document close up views of each relevant take just a few minutes or require multiple training in forensic evaluation and evidence injury or lesion. Patients should be informed separate visits. collection, should be used. that they have a right to refuse photographic Once rapport has been developed with Abuse and violence, including that resulting documentation altogether or to restrict the patient, and confidentiality (along with from human trafficking, should be suspected photographic documentation to certain specific its limits) has been communicated clearly, when any of these physical findings are noted: areas if they so choose. The words “suspected questions about possible human trafficking and • Bilateral or multiple injuries human trafficking” as a finding, diagnosis, or other forms of coercive control can be asked. problem should be included in the chart when • Evidence consistent with rape or sexual If you suspect human trafficking, try to appropriate.8 assault start with indirect questions. Enlist the help • Evidence of acute or chronic trauma, of a staff member and/or interpreter who especially to the face, torso, breasts, or has knowledge of the patient’s language and genitals culture after confirming there is no conflict of interest. Attempt to interview the patient alone without raising suspicions. 48 Risk Assessment and Safety Planning Quality improvement programs of various Texas Resources If trafficking has been disclosed, clinicians kinds can create and support policy changes can help the patient by: regarding safety and high quality health care Texas Office of the Attorney General • Having the patient assess his or her own systems. One training program specific to [email protected] personal risk human trafficking is SOAR to Health And 512-463-1646 • Making an independent judgment about Wellness Training. (SOAR is an acronym for that risk and communicating this opinion Stop, Observe, Ask and Respond to Human Texas Child Protective Services 800-252-5400 to the patient Trafficking.) The program is available at • Talking about safety planning https://www.acf.hhs.gov/otip/training/soar-to- Texas Department of Public Safety, Victim • Making referrals to appropriate case health-and-wellness-training Services management services for more detailed Legal Considerations 512-424-2211 safety planning and case management dps.texas.gov/administration/staff_support/ “Health care providers are not required to victimservices/pages/index.htm Patients may minimize or deny the danger — and in fact may not — report suspected they face, hence clinicians should note the instances of human trafficking that involve a following “red flag” signs of heightened risk: competent adult victim, without the patient’s National Resources 8 • More frequent or severe threats or express consent.” Clinicians should not involve law Coalition Against Trafficking in Women assaults www.catwinternational.org • New or increasingly violent behavior by enforcement and/or social service providers (e.g., housing/shelter services, legal services, the perpetrator and case management) without first obtaining Human Rights Watch • Increasing or new threats of homicide the explicit informed consent of the patient, or www.hrw.org (or suicide by the trafficker) if the patient unless otherwise required under relevant law. discloses These laws may include mandatory reporting • The presence or availability of lethal laws for children, disabled adults, elders, SOAR to Health and Wellness weapons in the residence and others. Privacy breaches can erode the acf.hhs.gov/endtrafficking/initiatives/soar provider-patient relationship and remove Detailed safety planning and related case HEAL Trafficking the autonomy patients deserve and need for https://healtrafficking.org management are best undertaken by those making informed decisions for their own safety with specific expertise in this area: advocates, and future. As in cases of intimate partner Caring for Trafficked Persons: A Guide for social workers, and case managers. violence, therefore, health care providers must These expert partners are generally Health Providers follow the lead of the patient and respect the http://publications.iom.int/books/caring- equipped with the time and expertise needed decisions of those who decide not to contact trafficked-persons-guidance-health-providers to address each patient’s immediate, short- law enforcement or accept referrals to other term, and long-term needs, and to arrange for services. National Human Trafficking Resource appropriate follow-up with known and trained Domestic as well as international victims Center (NHTRC) community-based resources. of human trafficking have specific legal rights Hotline (24/7): 1-888-373-7888 under federal and state law, but may not know http://traffickingresourcecenter.org/ Safety and Training of Health Care Workers of these rights or be in a position to exercise Since traffickers may be involved in various them. If the patient is willing, a referral to Polaris Project criminal enterprises, protecting health care law enforcement, attorneys, or legal service www.polarisproject.org workers is essential. The following suggestions providers is appropriate. include general safety measures as well as those specifically applicable to health care Conclusion workers who may help victims of human Clinicians, as ”first contacts,” have an trafficking:16 imperative to make a difference for their • Build relationships with local police or patients. Human trafficking poses many security personnel health risks, including physical injury, death, • Review emergency plans periodically and/or long-lasting psychological damage. • Restrict after-hours access In the absence of validated tools to screen • Improve lighting at entrances and parking for victims of human trafficking, health care areas providers may need to consider implementing • Install security cameras, mirrors, and universal methods and policies to create a safe panic buzzers environment for all patients. Clinicians who • Restrict access to all doors except the encounter a trafficked person or other exploited main entrance individual have a unique opportunity to provide • Preprogram 911 into all phones essential medical care and supportive referral options that may be an individual’s first step towards safety and recovery. 49 References 13. National Human Trafficking Hotline. Texas 1. Department of Justice. Federal Strategic Statistics. https://humantraffickinghotline. Action Plan on Services for Victims of Human org/state/texas. Accessed June 25, 2020. Trafficking in the United States, 2013-2017. 14. Emergency Nurses Association. Joint Position 2014. Statement: Human Trafficking Awareness in 2. National Human Trafficking Resource Center. the Emergency Care Setting. https://www.ena. Identifying Victims of Human Trafficking: org/docs/default-source/resource-library/ What to look for in a healthcare setting. practice-resources/position-statements/ 2016; http://www.acf.hhs.gov/endtrafficking/ humantraffickingpatientawareness. Accessed resource/fact-sheet-identifying-victims-of- September 22, 2020. human-trafficking. Accessed November 30, 15. American Medical Association. Policy 2016. Statement: Physicians Response to Victims 3. International Organization for Migration. of Human Trafficking H-65-966. https:// Caring for Trafficked Persons; Guidance for policysearch.ama-assn.org/policyfinder/ Health Providers. Geneva, Switzerland 2009. detail/H-65.966?uri=%2FAMADoc%2FHOD. 4. United Nations Office on Drugs and Crime. xml-0-5095.xml. Published 2015. Accessed Trafficking in persons: universally defined September 22, 2020. in the UN Trafficking in Persons Protocol. 16. American College of Obstetricians https://www.unodc.org/documents/data-and- and Gynecologists. Human Trafficking. analysis/glotip/Annex_II_-_Definition_and_ Committee Opinion No. 507. Obstet Gynecol. mandate.pdf. Accessed September 22, 2020. 2011;118:767-770. 5. U.S. Immigration and Customs Enforcement. 17. Harrison SL, Atkinson HG, Newman CB, et Human Trafficking vs. Human Smuggling. al. Position Paper on the sex trafficking https://www.ice.gov/sites/default/files/ of women and girls in the United States. documents/Report/2017/CSReport-13-1. American Medical Women's Association. pdf. Accessed September 22, 2020. 2014. 6. Stop the Traffik. Sex trafficking vs sex work: 18. Trossman S. The Costly Business of understanding the difference. https://www. Human Trafficking. American Nurse Today. stopthetraffik.org/sex-trafficking-vs-sex- 2008;3(12). work-understanding-difference/. Accessed 19. Lederer LJ, Wetzel CA. The health June 25, 2020. consequences of sex trafficking and 7. United States Department of State. 2019 their implications for identifying victims in Trafficking in Persons Report. https://www. healthcare facilities. Annals of Health Law. state.gov/reports/2019-trafficking-in- 2014;23:61-91. persons-report/. Accessed September 22, 20. Wong JC, Hong J, Leung P, Yin P, Stewart DE. 2020. Human trafficking: an evaluation of Canadian 8. Alpert EJ, Ahn R, Albright E, et al. Human medical students' awareness and attitudes. Trafficking: Guidebook on Identification, Educ Health (Abingdon). 2011;24(1):501. Assessment, and Response in the Health Care 21. Chisolm-Straker M, Richardson L. Assessment Setting. Boston MA: MGH Human Trafficking of Emergency Department (ED) Provider Initiative, Division of Global Health and Human Knowledge about Human Trafficking Victims Rights, Department of Emergency Medicine, in the ED (Abstract). Academic Emergency Massachusetts General Hospital;2014. Medicine. 2007;14(5S):S134. 9. Baldwin SB, Eisenman DP, Sayles JN, Ryan G, 22. Dovydaitis T. Human trafficking: the role of Chuang KS. Identification of human trafficking the health care provider. J Midwifery Womens victims in health care settings. Health Hum Health. 2010;55(5):462-467. Rights. 2011;13(1):E36-49. 23. Grace AM, Lippert S, Collins K, et al. 10. United States Congress. Justice for Victims of Educating health care professionals on Trafficking Act of 2015. 2015; https://www. human trafficking. Pediatr Emerg Care. gpo.gov/fdsys/pkg/BILLS-114s178enr/pdf/ 2014;30(12):856-861. BILLS-114s178enr.pdf. Accessed January 9 24. Substance Abuse and Mental Health Services 2017. Administration. TIP 57: Trauma-Informed 11. Texas Human Trafficking Prevention Task Care in Behavioral Health Services. https:// Force. Report to the Texas Legislature store.samhsa.gov/product/TIP-57-Trauma- December 2019. 2019. Informed-Care-in-Behavioral-Health- 12. Busch-Armendariz NB, Nale NL, Kammer- Kerwick M, et al. Human Trafficking by Services/SMA14-4816. Accessed September the Numbers: The Initial Benchmark of 22, 2020. Prevalence and Economic Impact for Texas. Institute on Domestic Violence & Sexual Assault, University of Texas at Austin; 2016. 50 A Clinician’s Guide to Recognizing & Reporting Human Trafficking in Texas Self-Assessment Choose the best possible answer for each question and mark your answers on the Self-Assessment answer sheet at the end of this book. There is a required score of 70% or better to receive a Certificate of completion. 21. Which of the following is not an industry in which people who 26. What is one possible way to increase the identification in health are trafficked often work? care settings of people who are being trafficked? A. Restaurants A. Install security cameras in waiting rooms. B. Legal affairs B. Train non-clinical staff (e.g., receptionists, security guards) C. Agriculture in ways to identify human trafficking and to communicate with D. Fisheries medical personnel. C. Require all patients to fill out a questionnaire about human 22. What are two common methods used by human traffickers to trafficking. control and manipulate their victims? D. Screen all patients using a validated tool for identifying human A. Sleep deprivation and exposure to loud music trafficking. B. Isolation from family members and debt bondage C. Lawsuits and other legal action 27. If a patient suspected of being trafficked does not speak English, D. Large payments for illicit or illegal behaviors or is not comfortable speaking English, the best approach is: A. Have the patient’s friend or relative translate for them. 23. Which statement best describes the use of the terms “victim” B. Use printed materials that have been translated into other and “survivor” in relation to human trafficking? common languages. A. Both terms may be appropriate depending on the circumstances C. Use a professional interpreter or someone unrelated to the of the person being trafficked. patient. B. The term “victim” is preferred because it emphasizes how much D. Use a language translation phone application to communicate. those being trafficked suffer. C. The term “survivor” is preferred because it recognizes the 28. Before asking a patient questions of a patient about human emotional processes that can occur even after trafficking has trafficking, it’s best if clinicians: stopped. A. Establish a rapport with the patient and separate the patient from D. Neither term is preferred because both are emotionally loaded— any people who may have accompanied him or her on the visit. the preferred term is “person being trafficked.” B. Use a written questionnaire to screen for potential signs of human trafficking. 24. In a study of people involved in sex trafficking, what percentage C. Perform a thorough physical examination. had at least one encounter with a health care provider while D. Check the patient’s immigration status using an online database. they were being trafficked? A. 18% 29. Which statement best describes the clinical goal in relation to B. 45% instances of human trafficking? C. 88% A. To elicit a disclosure of trafficking so that legal action can be D. 95% taken against the perpetrator. B. To stick to the normal responsibilities for the diagnosis and 25. Which statement best summarizes the finding of several studies treatment of physical ailments and illnesses. about the role or behaviors of health care providers relating to C. To create a climate that allows every patient to feel safe and human trafficking? empowered to disclose if he or she chooses. A. Most providers have been educated about the problem of human D. To provide photo documentation that can be used as evidence in trafficking but do not have time to adequately address the needs any legal actions taken by the patient. of trafficked patients. B. Many providers are unprepared to identify trafficking victims 30. Why is it important, in the context of human trafficking, to when they are encountered in clinical settings. train all clinical and non-clinical staff on safety and security C. Many providers can identify trafficking victims, but they often do procedures? not follow up with appropriate referrals to external sources of A. Because victims of human trafficking are often violent. support. B. Because traffickers may be involved in various criminal enterprises D. Most providers are not exposed to the issue of human trafficking and present a threat of violence. in medical school. C. Because victims of human trafficking are more likely to be infected with contagious diseases. D. To conform with local or state laws related to the treatment of victims of human trafficking.

51 PREVENTING CLINICIAN Release Date: 03/2020 6 AMA PRA Enduring Material BURNOUT Expiration Date: 02/2023 Category 1 Credits™ (Self Study)

TARGET AUDIENCE

This course is designed for all physicians (MD/DO) and other health care practitioners. Read the course materials

Complete the self-assessment questions at the end. A score of 70% is required.

COURSE OBJECTIVE Return your customer information/ The purpose of this course is to educate physicians about the prevalence answer sheet, evaluation, and payment to InforMed by mail, phone, fax of physician dissatisfaction and emotional distress, ways of measuring or complete online at course and quantifying that dissatisfaction and distress (e.g., using indicators website under NETPASS. such as burnout, depression, stress, anxiety, or suicidal ideation), as well as pros and cons of using these different indicators. The course will also cover factors that increase risk for burnout, and factors that can mitigate or reduce that risk. The course reviews the multi-factorial nature of burnout, examining contributory causes at the level of individual physicians, the organizations in which they work, and at higher systems levels, such as the ways that technology can either exacerbate, or reduce, the experience of burnout.

LEARNING OBJECTIVES

Completion of this course will better enable the course participant to: 1. Describe the prevalence of physician stress, emotional distress, depression, and suicide. 2. Explain at least three factors that can increase risk of physician emotional distress, and three factors that can mitigate or reduce risk of emotional distress. 3. Identify technology-related factors related to physician emotional distress and strategies for addressing those factors. 4. Describe interventions that physicians can engage in to improve resilience and wellness and reduce the risk of emotional distress.

ACCREDITATION STATEMENT InforMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

DESIGNATION STATEMENT InforMed designates this enduring material for a maximum of 6 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. 52 FACULTY

Douglas A. Mata, MD, MPH Clinical Fellow Memorial Sloan Kettering Cancer Center Stephen Braun 6 Medical Writer AMA PRA CATEGORY 1 Braun Medical Communications CREDITSTM

ACTIVITY PLANNER This course awards six (6) AMA PRA Category 1 CreditsTM. Michael Brooks Director of CME, InforMed As a prerequisite to license registration renewal, licensed MD/DOs must complete 48 hours of CME and licensed PAs must complete 40 hours of CME every two (2) DISCLOSURE OF INTEREST every two (2) years during their biennial registration period. In accordance with the ACCME Standards for Commercial Support of CME, InforMed implemented mechanisms, prior to the planning and implementation of this CME activity, to identify and resolve conflicts of interest for all individuals in a position to control content of this CME activity.

FACULTY/PLANNING COMMITTEE DISCLOSURE

The following faculty and/or planning committee members have indicated they have no relationship(s) with industry to disclose relative to the content of this CME activity: • Douglas A. Mata, MD, MPH • Stephen Braun • Michael Brooks

STAFF AND CONTENT REVIEWERS

InforMed staff, input committee and all content validation reviewers involved with this activity have reported no relevant financial relationships with commercial interests.

53 Introduction avoid unnecessary requirements, and improve emotional exhaustion, depersonalization, and a workplace efficiencies diminished sense of personal accomplishment.4 The work of a physician can be difficult— • Transformation of poorly-designed These remain the most-commonly used indicators long hours, extensive paperwork, and complex technologies into well-designed and of burnout, although the field is now changing and patients can leave physicians feeling overworked implemented systems that are integrated into this conceptualization is being de-emphasized by and exhausted. Since physicians are high achievers the clinical workflow to improve usability and some researchers who are using other indices by nature, many tend to push themselves to see inter-operability or metrics to measure emotional distress among more patients and do more work than resources physicians, such as depression (see the section on • Actions by medical societies, state licensing allow. Often, there is little time or consideration assessment below for a more detailed exploration for the needs of the physician in this fast-paced boards, specialty certification boards, of these concepts.) environment, which can lead to dissatisfaction and medical education and health care delivery Determining the scope of the physician emotional distress. organizations to reduce the stigma for burnout problem is challenging. There is substantial The field of medicine is in the midst of clinicians seeking help for psychological heterogeneity in the research methods employed by significant technological, regulatory, policy, and distress, and increased assistance for these investigators studying burnout, including variability societal changes that contribute to an increasingly clinicians in the measures used to evaluate burnout symptoms stressful work environment for physicians and other This learning activity will explore in detail each and the approaches to dichotomizing burnout. health care professionals. Physicians can be caught of these areas with a particular focus on steps Studies have also varied widely in sample size, the between the ethics and values they have vowed to physicians can take to manage their own stress types of clinicians included (e.g., single occupation uphold in terms of care for their patients, and the and reduce the risk that they will become a victim versus multiple health care disciplines), practice demands of their work environments that conspire of burnout. settings, participation rates, and in adjustments for to make it ever more difficult for them to adhere potential confounders. A 2018 systematic review to those goals. The resulting stress can lead to Scope of the problem of 182 studies involving 109,628 healthcare emotional exhaustion, depersonalization, and a workers in 45 countries found at least 142 unique loss of a sense of professional efficacy, which, taken The phenomenon of clinician burnout was first definitions of overall burnout, which suggests a together, have been described in the literature as described in 1974 by the psychologist Herbert significant disagreement in the literature about “burnout” although this term has been defined Freudenberger, who often volunteered at a free what constitutes burnout.5 Prevalence estimates of many ways and has not been rigorously articulated clinic for drug addicts the East Village of New York overall burnout ranged widely, from 0% to 80.5% in terms of objective symptoms in the same way City.3 Over time, Freudenberger observed emotional with similarly wide ranges for emotional exhaustion that other mental illnesses (e.g., major depressive depletion and accompanying psychosomatic (0% to 86.2%), depersonalization (0% to 89.9%) disorder) have been.1 symptoms among the clinic’s volunteer staff. He and low personal accomplishment (0% to 87.1%).5 Burnout is harmful to the clinicians themselves, called the phenomenon “burnout,” borrowing the In the past decade, a set of influential national it may impair the quality of care they give to their term from drug-addict slang. Freudenberger defined studies of U.S. physicians found levels of burnout patients, and it is costly for organizations facing burnout as exhaustion resulting from “excessive ranging from 40% to 54%, although these studies workforce shortages and problems retaining high- demands on energy, strength, or resources” in the are subject to various methodological critiques, quality providers. Indeed, high levels of physician workplace, characterizing it by a set of symptoms detailed below.6-9 Much lower levels of burnout burnout are being leveraged by providers of including malaise, fatigue, frustration, cynicism, and among physicians were found in an analysis by “concierge” medical practices, in which patients pay inefficacy: Rotenstein et al., of 9 studies (total n=9,859) that monthly or yearly fees in return for improved access “There is a feeling of exhaustion, being unable used a rigorous definition of burnout—namely, to their doctors, a shift in medicine that some fear to shake a lingering cold, suffering from frequent scores on the Maslach Burnout Inventory (MBI) may be siphoning off high-quality physicians from headaches and gastrointestinal disturbances, emotional exhaustion subscale of ≥27 points and a standard medical practice settings.2 sleeplessness and shortness of breath. The burnout score on the depersonalization subscale ≥10, and Clinician burnout is a difficult problem to tackle candidate finds it just too difficult to hold in feelings. a score on the personal accomplishment subscale because it is complex and multi-faceted. Factors He cries too easily, the slightest pressure makes him ≤33 points (Figure 1). The overall prevalence of contributing to burnout include: high workloads, feel overburdened and he yells and screams. With burnout, using this strict definition across these administrative burdens, and poorly-designed the ease of anger may come a suspicious attitude, 9 studies was about 6%, although the authors technologies (e.g., electronic medical records a kind of suspicion and paranoia. The victim begins cautioned against considering “burnout” as a systems). Regulatory and institutional polices, to feel that just about everyone is out to screw dichotomous phenomenon (i.e., present or absent) payer requirements, and burdensome technologies him. He becomes the ‘house cynic.’ Anything that at all, and instead favored measuring physician all challenge the humanist motivations that energize is suggested is bad rapped or bad mouthed. A sign dissatisfaction and emotional distress using other and give meaning to the work that physicians and that is difficult to spot until a closer look is taken methods. other healthcare workers do every day. Solutions is the amount of time a person is spending in the Although some studies have attempted to and remedies for burnout, therefore, require free clinic. A greater and greater number of physical assess trends in levels of physician emotional transformations at all levels of medicine, from the hours are spent there, but less and less is being exhaustion and professional dissatisfaction, personal to the organizational and political. accomplished. He just seems to hang around and methodological weaknesses limit their In its 2019 report on physician wellbeing and act as if he has nowhere else to go. Often, sadly, he interpretability. When assessed with the MBI, 45.5% the problems of emotional exhaustion and job really does not have anywhere else to go, because of 7,227 physicians reported at least 1 symptom dissatisfaction, the National Academy of Sciences, in his heavy involvement in the clinic, he has just of burnout in 2011, the level increased to 54.4% Engineering, and Medicine called for the following about lost most of his friends.” (of 6,767 physicians) in 2014, and then dropped actions to address key issues:1 —Herbert Freudenberger back to 43.9% in 2017 (the last year for which • Attention to burnout early in professional de- Importantly, Freudenberger’s description data are available) (Figure 2).9 These data should velopment and the implementation of changes of burnout was anecdotal and not determined be interpreted cautiously, however, since the same to reduce stressors in the learning environ- by rigorous clinical observation or modern individuals were not assessed at each time point in ment epidemiological methods. In the following decade these studies. • Engagement of organizational leaders in the the social psychologist Christina Maslach developed external environment to reduce redundancy, a model of burnout consisting of three dimensions:

54 Figure 1. Prevalence estimates from studies using strict definitions of burnout.5 Given these differences, it is also unsurprising that, using a 2-item burnout measure, physicians MBI-HSS EE ≥27, DP ≥10, and PA, ≤33 reported higher levels of emotional exhaustion Golub et al, 2008 14 351 4.0 (2.2-6.6) (36.4% vs. 24.8%), depersonalization (18.0% vs. 13.5%), and overall burnout (39.8% vs. 28.1%) Arigoni et al, 2009 22 368 6.0 (3.8-8.9) compared to the general population.9 Brøndt et al, 2008 10 379 2.6 (1.3-4.8) Even after adjusting for age, sex, relationship Pedersen et al, 2013 10 381 2.6 (1.3-4.8) status, and hours worked per week, physicians remained at increased risk for burnout compared Pedersen et al, 2016 56 1173 4.8 (3.6-6.2) with the general U.S. working population (OR Lesage et al, 2013 170 1440 11.8 (10.2-13.6) 1.39; 95% CI 1.26-1.54). Physicians also had a Goehring et al 2005 62 1755 3.5 (2.7-4.5) significantly lower rate of satisfaction with work/life integration than the general U.S. working population Pantenburg et al, 2016 195 1784 10.9 (9.5-12.5) (40.0% vs. 61.0%), even after adjusting for age, Maticorena -Quevedo et al, 2016 82 2228 3.7 (2.9-4.5) sex, relationship status, and hours worked per 9 Subtotal 621 9859 week (OR 0.77; 95% CI 0.70-0.85). Levels of burnout among physicians vary by

9 practice setting and specialty. Physicians in private Figure 2. Comparison of burnout in physicians and the general population over time practice appear to have a roughly 30% higher risk for burnout compared to those in academic settings.8,9 Data suggest that physicians with substantial direct patient care responsibilities, or who are on the “front lines” of access to health care systems have the highest levels of burnout. Specific fields at high risk include emergency medicine, family medicine, general internal medicine, and neurology.1 Levels of physician burnout may also be related to demographic factors, with younger workers at higher risk than more seasoned physicians. This effect is not, apparently, due to a generational effect since it has been consistently observed in studies over the past 20-30 years. Younger workers face some distinct challenges as they establish their careers and attempt to balance their personal and professional lives, particularly if their personal lives involve caring for children. Women physicians are at increased risk for burnout compared to their male colleagues after adjustment for other personal and professional factors.9,14 Burnout is more likely to manifest as emotional exhaustion in Some studies have attempted to measure symptomatology (which could be secondary to women, compared to men, with men more likely to physician emotional distress using a depressive work stress), they do not always provide accurate experience depersonalization. Life events such as a symptoms paradigm, since major depressive estimations of the prevalence of criterion-defined personal illness, an illness in a loved one, the birth disorder has been very well-characterized as a major depressive disorder.12 of a child, or the death of a close loved one are also mental disorder and instruments for assessing A 2004 meta-analysis revealed that physicians associated with higher risk of burnout.15 depression have been well-validated. A 2016 are more likely to commit suicide than non- systematic review and meta-analysis of 183 studies physicians, and that women physicians are more Assessing burnout evaluating depression, depressive symptoms, and likely to commit suicide than male physicians. The In 1981 the social psychologist Christina suicidal ideation among medical students found an combined results of 25 studies show that suicide Maslach proposed the Maslach Burnout Inventory overall pooled prevalence of screening positive for is 40% more common among male physicians (MBI)4 consisting of three scales (22 items in all) to depression of 27.2% (with significant heterogeneity (compared to the general population) and suicide measure the extent of an individual’s symptoms in among studies).10 The overall prevalence of is 130% higher among female physicians compared 13 each dimension, which remains the most commonly- reporting suicidal ideation was 11.1%. Similar to the general population. used instrument to assess burnout (the MBI has levels of screening positive for depression and Comparisons of working conditions and levels been used in about 88% of burnout research suicidal ideation were found in meta-analyses of of emotional distress between physicians and the 5 11 5 publications). The three dimensions on the MBI studies of resident and attending physicians. general population showed, not surprisingly, that are: emotional exhaustion, depersonalization, and Importantly, these studies assessed the physicians tend to work more than those in other a diminished sense of personal accomplishment. prevalence of individuals who screened positive professions. For example, in 2017, physicians Emotional exhaustion describes feelings of for depression using validated case-finding reported working a mean of 12 hours more per being emotionally overextended and exhausted by instruments, and not major depressive disorder week than those in non-medical fields (mean weekly 9 one’s work. Sample statements about emotional itself, the prevalence of which would be expected hours 52.6 vs. 40.3 hours). Even more starkly, exhaustion include “I feel used up at the end of the to be substantially lower. This is an important 38.9% of physicians (out of 3,906) reported workday,” “I feel like I’m at the end of my rope,” and distinction, because even though validated working more than 60 hours a week compared to “I feel fatigued when I get up in the morning and depression screening questionnaires provide useful only 6.2% (of 5,194) of the general population have to face another day on the job.” and clinically significant information on depressive respondents.

55 Depersonalization describes an unfeeling The OBI assesses the cognitive and physical Assessing depression and/or suicidal ideation and impersonal response toward the recipients of components of exhaustion in addition to the As noted above, some researchers favor one’s care or service. Sample statements about affective component that is included in the assessing depressive symptoms in physicians as a depersonalization include “I’ve become more MBI. The OBI can be used to assess burnout in proxy for work-related dissatisfaction and emotional callous toward people since I took this job,” “I worry all employees, irrespective of their occupation. distress, rather than the more amorphous that this job is hardening me emotionally,” and “I • Copenhagen Burnout Inventory (CBI) (evalu- “burnout.” The Diagnostic and Statistical Manual of don’t really care what happens to some patients.” ates personal burnout [6 items], work-related Mental Disorders, 5th Edition, outlines the following The dimension of personal accomplishment burnout [7 items], and client-related burnout criterion to make a diagnosis of depression (i.e., is a measure of feelings of competence and [6 items]). Availability: proprietary but free for Major Depressive Disorder [MDD]).20 The individual successful achievement in one’s work with people. use with permission. The CBI was developed must be experiencing five or more symptoms during Sample statements about a reduced sense of by Krinstensen et al.,18 and validated during the same 2-week period and at least one of the personal accomplishment include “I don’t deal very the Danish longitudinal PUMA study in 1997. symptoms should be either (1) depressed mood or effectively with my patients’ problems,” “I don’t Like the OBI, the CBI can be used across a (2) loss of interest or pleasure. think I’m positively influencing other people’s lives range of professions. 1. Depressed mood most of the day, nearly every through my work,” and “I can’t easily create a • Stanford Professional Fulfillment Index (a 16- day. relaxed atmosphere with my patients.” item survey that covers burnout [work ex- 2. Markedly diminished interest or pleasure in all, There are multiple questions for each of haustion and interpersonal disengagement] or almost all, activities most of the day, nearly the subscales (22 questions in all on the most and professional fulfillment. Response options every day. frequently-used version) and responses are in are on a five-point Likert scale [“not at all 3. Significant weight loss when not dieting the form of a frequency rating (“never,” “a few true” to “completely true” for professional ful- or weight gain, or decrease or increase in times a year or less,” “once a month or less,” fillment items and “not at all” to “extremely” appetite nearly every day. “a few times a month,” “once a weekly,” “a few for work exhaustion and interpersonal disen- 4. A slowing down of thought and a reduction of times a week,” “every day”). The instructions for gagement items]). Availability: proprietary but physical movement (observable by others, not the use of the MBI specifically warn users not to free for use by not-for-profit organizations merely subjective feelings of restlessness or dichotomize the results (i.e., to avoid artificially with permission. being slowed down). creating two categories of “burned out” and “not • Mayo Clinic Physician Well-Being Index (9-item 5. Fatigue or loss of energy nearly every day. burned out”) and not to combine the scores from self-assessment tool). Availability: proprietary 6. Feelings of worthlessness or excessive or separate subscales into a single “burnout scale.” with price for use dependent on type of pro- inappropriate guilt nearly every day. Instead, the instructions suggest that scores been fession and size of organization. A total score 7. Diminished ability to think or concentrate, or seen as a continuous measure of increasing levels is calculated by adding the number of ‘yes’ indecisiveness, nearly every day. of professional stress for which widely varying responses with responses to meaning in work 8. Recurrent thoughts of death, recurrent approaches to management might be appropriate.16 and satisfaction with work-life balance items suicidal ideation without a specific plan, Nonetheless, many researchers have ignored these resulting in 1 point being added or subtract- or a suicide attempt or a specific plan for recommendations and have defined their own cutoff ed, resulting in a score range of -2 to 9. In a committing suicide. levels for scores indicating “burnout.” sample of physicians, medical students, and Because the 22-item version is not always US workers, every one point increase in score To receive a diagnosis of depression, practical, a 2-question version is sometimes used, resulted in a step-wise increased probability these symptoms must cause the individual with the following questions: “I feel burned out from of distress and risk for adverse personal and clinically significant distress or impairment in my work,” and “I have become more callous toward professional consequence. social, occupational, or other important areas of people since I took this job.” These two items functioning. The symptoms must also not be a result have been shown to have strong and consistent of substance abuse or another medical condition. correlations with key outcomes in medical Importantly, the diagnosis of MDD requires an in- students, residents, and practicing surgeons.17 A World Health Organization Definition of person assessment by a health professional (as response of “once a week” or more on single items Burnout19 opposed to self-assessments or assessments using indicates a high degree of burnout in each domain. In 2019 WHO revised its definition of online survey instruments) which enhances the Variations on the MBI have been developed for burnout, which aligns with, but is subtly reliability of a diagnosis. human services workers, educators, students, and A common and well-validated assessment “general use.” The MBI has been translated into different than, the Maslach paradigm: tool for MDD is the Patient Health Questionnaire-9, dozens of languages and permission to use it can Burnout is a syndrome conceptualized which asks 9 questions with answers scored as: 0 be obtained via mindgarden.com. as resulting from chronic workplace stress points for “not at all,” 1 point for “several days,” 2 In addition to the MBI, the following assessment that has not been successfully managed. It points for “more than half the days,” and 3 points instruments have been used for research or other is characterized by three dimensions: (1) for “nearly every day.” Scores of 4 or lower suggest purposes: minimal depression that probably does not require • Oldenburg Burnout Inventory (OBI) (eval- feelings of energy depletion or exhaustion; treatment and scores above 10 suggest a high uates physical, cognitive, and affective ex- (2) increased mental distance from one’s job, probability of MDD. The PHQ-9 is commonly used haustion and disengagement from work). or feelings of negativism or cynicism related in epidemiological studies of depression in which Availability: proprietary but free for use with in-person psychiatric interviews would be untenable permission. The OBI excludes a measure of to one’s job; and (3) reduced professional efficacy. Burnout refers specifically to due to cost, anonymity, or for logistical reasons. personal accomplishment. It consists of 16 Studies employing the PHQ-9 can generate positively and negatively formulated items phenomena in the occupational context and prevalence estimates of “screening positive for used to evaluate 2 dimensions of burnout, should not be applied to describe experiences depression” (e.g., the proportion of surveyed which can be interpreted as continuums in other areas of life. individuals who scored 10 or higher on the scale) ranging from disengagement to dedication or can produce depressive symptom estimates as a (i.e., the identification continuum) and from continuous variable. exhaustion to vigor (i.e., the energy continuum).

56 As noted earlier, just because an individual person BEFORE MOVING ONTO THE NEXT SECTION, • Reduced job satisfaction screens positive on the PHQ-9 does not mean PLEASE COMPLETE CASE STUDY 1. • Decreased self-esteem that they would meet formal criteria for MDD. • Increased medical errors Nonetheless, screening positive may indicate Symptoms of burnout • Insomnia clinically significant depressive symptoms, which As mentioned above, recent trends in • Withdrawal and isolation could, for example, be due to workplace stress. The the clinical environment may be exacerbating • Decreased productivity PHQ-9 has also been shown to accurately assess a physician burnout, including the industrialization • Anxiety patient’s level of suicidal ideation.21 The PHQ-9 is of health care delivery, using measures of • Being irritable with patients available free at www.mdcalc.com. accountability and transparency without regard • Exhaustion Other commonly-used tools for screening for to the negative consequences on clinicians and • Depression MDD (or assessing depressive symptoms as a patient care, the rapid pace of change, greater • Suicidal thoughts continuous variable) include:22 influence of information technology on the patient • Impaired concentration and attention • Beck Depression Inventory encounter, and changing expectations of patients • Relationship difficulties at home or at work • Hamilton Depression Rating Scale as consumers.24 These changes may create an • Excessive use of alcohol or other drugs, in- • Major Depression Inventory imbalance in which the demands of a clinician’s cluding prescription drugs • Zung Self-Rating Depression Scale job are greater than the resources available to • Feeling detached from peers, patients, family, • Center for Epidemiologic Studies Depression complete the job effectively and induce a range of and friends Scale associated negative symptoms. • Feeling dread before going to work Physicians who are burned out can experience a range of symptoms including:25 • Absenteeism

Case Study 1

Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

Michael R. Rose, a medical student in his twenties in Boston, recalled his first year of medical school as a time when he felt energetic and focused on his studies. But only a year later, he felt constant fatigue and had hypersomnia, lost his ability to concentrate on his studies, lost interest in doing things he used to enjoy (e.g., exercise), and felt depressed, despondent, and passively suicidal. He self-administered an anonymous online version of the 9-item Patient Health Questionnaire and scored >10, indicating that he had screened positive for major depressive disorder. He then self-referred to a clinic where he received a formal diagnosis of major depression after an in-person clinical interview. He started dual therapy with counseling sessions and an SSRI. Over the following weeks he gradually felt better, and his depression went into remission. He reported having two additional bouts/relapses of major depression later in medical school, both of which responded to treatment. He noted that epidemiological studies have demonstrated that approximately one quarter of medical trainees screen positive for depression during a given year, yet only a minority seek treatment.10 After an internal struggle with the stigma that still adheres to depression, Rose wrote an article about his experiences in the New England Journal of Medicine.23 “Once a critical mass of afflicted and stigmatized people begin speaking up, perhaps the environment of fear, shame, and judgment can be extinguished, and norms can change,” he wrote.

1. What are the diagnostic criteria for major depressive disorder, and how does major depression differ from burnout?

Questions for case study: 2. What are some of the risk factors for major depression? How do they overlap or differ with those for burnout?

3. What are some potential reactive and/or proactive interventions that a medical school or hospital could implement to identify and help students like Rose? What are potential barriers to implementing such interventions?

57 Personal and professional consequences of Medical errors will rate a hospital poorly, will not recommend physician emotional distress The association between symptoms of clinician the hospital for care, and will perceive their burnout and medical errors is unclear and the communications with nurses unfavorably.42 Physical and mental health effects evidence base for these associations is weaker In summary, clinician burnout has significant Numerous studies have shown positive than generally appreciated. A meta-analysis of 47 personal and professional consequences as well as associations between physician emotional distress studies conducted between 2002 and 2017 found negative effects on the organizations in which these (quantified as either burnout or depressive that burnout negatively affected quality of care in a clinicians work. In addition to the potentially harmful symptoms) and a range of deleterious physical and number of ways, including an increased risk of self- consequences for patients and clinicians, burnout psychological conditions including increased risks reported patient safety incidents (OR 1.96; 95% CI inflicts substantial costs to society and health care for cardiovascular disease, high cholesterol levels, 1.59-2.4), poorer self-reported quality of care due organizations. type 2 diabetes, musculoskeletal pain, fatigue, to low professionalism (OR 2.31; 95% CI 1.87-2.4), headaches, gastrointestinal issues, respiratory and reduced patient satisfaction (OR 2.28; 95% CI Factors associated with clinician emotional 36 problems, and severe injuries.26 Resident physicians 1.42-3.68). However, the two studies in this meta- distress with burnout have been shown to be at higher risk analysis that used actual objective data on medical Many factors are involved in clinician for needle sticks, bodily fluid exposures, and motor errors (as opposed to self-reported errors) found emotional distress, some at the personal level, 37 vehicle accidents.27 a negative association (Kwah et al, 2016), or no some at organizational levels, and others at higher 38 Studies have also found that physician burnout association (Linzer et al., 2009). It is possible regulatory or system levels. To the extent that is associated with almost a 200% greater chance that the higher rates of self-reported errors such factors are potentially modifiable, a better of suicidal ideation,28 with a dose-response in the observational studies reporting positive understanding of them may allow individuals and relationship between burnout and suicidal ideation associations might result from a misperception of health care leaders to make changes that reduce (independent of depression) found in multiple errors by clinicians who are actually depressed and, the risk of clinician burnout and, thus, reduce the studies.28-30 Clinicians experiencing burnout may thus, hyperaware of the possibility of patient harms negative consequences of that burnout on patients, also have higher rates of alcohol misuse, which may from their attitudes or performance. physicians, and the organizations in which they be related to self-medicating as a way to cope with A 2018 study of 6,586 U.S. physicians in work. job-related stress.31 active practice used multivariate logistic regression The overall health care work environment Burnout frequently co-exists with depressive and mixed-effects hierarchical models to evaluate involves the following components: worker capacity symptoms. Burnout and major depressive disorder associations between burnout, well-being and needs, job content, organizational conditions appear to be distinct, but inter-related, disorders.32 measures, work unit safety grades, and medical and culture, and personal considerations. Factors 39 A prospective longitudinal study suggested that errors. Among the participants 54.3% reported can either increase or decrease the risk of burnout. burnout may predispose clinicians to depression, symptoms of burnout, 32.8% reported excessive For example, the following job demands could rather than vice-versa.33 However, other studies fatigue, and 6.5% reported recent suicidal ideation. increase the risk of burnout: high workloads and have suggested that burnout may be a subtype of Physicians reporting errors were more likely to time pressure, intrinsic aspects of clinical work (i.e., depression, with substantial overlap in predisposing have symptoms of burnout (77.6% vs. 51.5%, the nature of the illnesses being treated), or work factors and symptoms.32 P<0.001), fatigue (46.6% vs. 31.2%, P<0.001), inefficiencies (for example administrative burdens Ironically, some of the same characteristics and recent suicidal ideation (12.7% vs. 5.8%, or ineffective technologies). On the other hand, that allow physicians to excel can make them P<0.001), although, again, these associations may factors such as having meaningful work, control 39 more vulnerable to burnout. For example, many reflect misperceptions influenced by depression. over one’s job, and availability of social support successful physicians attribute their success in A study evaluating emotional exhaustion in from peers and supervisors can reduce the risks of training to their emotional and physical strength, 1,425 physicians and nurses working in intensive burnout (see Table 1). drive for success, and conscientiousness. They are care units found conflicting evidence. Patient rewarded for being the first to arrive, not attending mortality was predicted by emotional exhaustion Table 1. Work system factors involved in to their physical or emotional needs, and being the and length of stay (LOS) was predicted by higher clinician burnout24 last to leave. As valuable as such characteristics can workload, but burnout did not predict LOS and 40 be, they can also act as barriers to seeking and workload did not predict mortality rates. Job demands receiving needed help. Physicians may view taking • Excessive workload, unmanageable work time for self-care or asking for help as selfish, weak, Organizational impacts schedules, and inadequate staffing or irresponsible, or they may fear that coworkers or Clinician emotional distress has costs for • Administrative burden employers will view them in these ways. They may organizations, as well as for society at large due • Workflow, interruptions, and distractions also be concerned about repercussions associated to higher levels of absenteeism, chronic work • Inadequate technology usability with licensure or believe that distress and burnout disability, hospital admissions due to mental and • Time pressure and encroachment on are normal parts of being a physician, an attitude physical disorders, higher turnover, and poorer job personal time that may be reinforced by a professional culture that 33 performance. Clinicians with burnout may also be • Moral distress minimizes distress until it reaches dangerous levels. more likely to leave their profession completely and Many physicians and medical students may • Patient factors 10,34 pursue non-health care-related jobs. Collectively, not even realize they need help. A 2016 meta- these factors make it more difficult for health Job resources analysis of studies evaluating depression in medical care organizations to maintain an adequate and students found that only 15.7% of those students competent professional workforce. A 2019 study • Meaning and purpose in work who screened positive for depression actually • Organizational culture 10 estimated that the economic cost of turnover and sought psychiatric treatment. A 2014 study • Alignment of values and expectations involving 1,150 U.S. surgeons found that their ability reduced productivity due to burnout among U.S. 41 • Job control, flexibility, and autonomy to reliably determine their level of distress was very physicians was roughly $4 billion each year. poor.35 In fact, among those with the lowest levels of Burnout-related impairments in care can also • Rewards well-being, most believed their well-being was at or negatively affect the overall perception by patients • Professional relationship and social above average levels. This lack of awareness may of a hospital or other health care organization. For support lead physicians to ignore signs of burnout when example, a study of emotional exhaustion among • Work-life integration they occur. nurses found an increased likelihood that patients 58 Job demands aspect of the profession. Nonetheless, data The effects of a high workload, however, Job demands are a function of work frequency from studies across a range of industries clearly can be modified by other factors. For example, a and duration, work intensity, and the nature of demonstrate that excessive workload is associated number of studies across professions show that job the work itself, including the environment in which with increased worker stress as well as an increase control and degree of professional commitment, the work is performed.1 Job demands can often in errors and accidents.1 In an 2017 observational may mediate observed associations between be measured by objective metrics such as shift study of 124 intensive care unit (ICU) nurses, an job demands and burnout.52 Other studies show duration, rotation, and frequency, patient load, increase in task demands and in nurses’ subjective that workloads will be perceived as lower when a as well as with measures of patient complexity or report of their workload was associated with higher clinician finds greater meaning in his or her work, acuity. Work schedules and activities (including levels of self-reported medication-related adverse has greater control over the logistics of the job, after-hours work) vary significantly by specialty. events.44 In a survey of pediatric nurses, both feels a sense of community with coworkers, or Emergency physicians, nurses, and pharmacists mental workload (related to interruptions, divided works in a supportive organizational culture.1 are shift workers, whereas surgeons and many attention, and being rushed) and the perception Extended work schedules have been justified specialist internists have more irregular schedules of staffing adequacy were predictors of burnout.45 by the idea that if the same clinician cares for the which include intermittent “call” shifts or other In a systematic review of 71 studies of burnout in same patient for extended periods of time, there after-hours work. Thus, measures of job demand surgeons, total work hours, frequency of call, and will be fewer care transitions (i.e., handovers) and will vary depending on the clinician’s job. For patient load were all associated with high emotional thus a lower likelihood of errors and care gaps. But inpatient nurses, for example, a common metric exhaustion.46 And a 2007 survey of 978 critical evidence does not support this notion. When shift of job demand is the number and length of shifts, care physicians in French ICUs found that workload schedules are actively managed, including using while for work intensity it is nurse-to-patient ratio, (number of night shifts per month and time since structured handovers, there do not appear to be adjusted for some measure of patient acuity. last non-working week) was a strong independent differences in quality of care between extended As a multi-dimensional concept, job demand is predictor of burnout.47 schedules and those with reasonable work breaks. assessed in many different ways, with the results Three components of workload (working more For example, in a study of 45 clinicians in five ICUs operationalized into different descriptive variables than 52 hours a week, taking calls at night, and taking care of 1,900 patients, the clinicians were such as workload, time pressure, and inadequate doing work at home) have been found to correlate cluster-randomized in half-month rotations to either staffing. with higher levels of burnout. A multivariate analysis a continuous schedule (14 consecutive all-day When a work environment is inefficient (and of a survey of 7,288 U.S. physicians showed that shifts) or weekday coverage with weekend cross- especially when it requires many tasks that are for every extra hour worked beyond 51.8 hours per coverage by colleagues (interrupted schedule).53 considered by the clinician to be lower priority week, the odds of burnout increased by about 2 No significant differences were observed between than or a distraction from direct patient care) percent.48 Taking calls at night is particularly taxing, the groups in either patient length of stay or the demands of the job may exceed a physician’s with studies showing that for each additional night mortality. available capacity or skill set.43 Poorly-designed on call per week, the odds of burnout increase For physicians and advanced practice work systems and constantly high job demands between 3 and 9 percent.49 Finally, a study of providers, increasing expectations concerning can exhaust employees, and repeated exposure 1,490 U.S. oncologists found that for each extra productivity and the number of patients seen each to suffering, death, or social inequities without hour spent at home working (e.g., on electronic day have resulted in shorter office visits, and there sufficient structural mechanisms to address them documentation), there was a 2 percent increase in is often not enough time for clinicians to complete can set the stage for emotional exhaustion and the odds of burnout.50 clinical documentation or other tasks (e.g., order burnout. entry) during the workday. The introduction of Other job-related factors in burnout include “Being a physician has been and always will be electronic patient portals has led to increased having a low level of autonomy or flexibility, or a stressful job. This is a fundamental feature of our electronic messages and patient queries, although working in an organizational culture or with leaders profession for a simple reason. We are dealing with evidence is mixed on whether patient portals are that do not support individual work goals. When the hurt, sick, scared, dying people, and their families. linked to improved patient outcomes.54 overall job resources available do not fit with what is Our work takes energy even on the best of days. Some data suggest that the use of patient required to achieve the goal of quality patient care, Our practice is the classic high-stress combination portals may increase patient phone calls and overall burnout can ensue. of great responsibility and little control. This stress workload and create additional work for health care is inescapable as long as you are seeing patients, professionals.55 This often results in professionals Workload no matter what your specialty.” having to perform many tasks outside of regular Physicians have historically had higher-than- --Dike Drummond, MD, family physician51 work hours by remotely accessing the electronic normal workloads, and many physicians have a health record (EHR) to complete professional work “comes with the territory” attitude toward this on personal time.

EMR vs. EHR: What’s the Difference? Electronic medical records (EMRs) are digital versions of the paper charts in clinician offices, clinics, and hospitals. EMRs contain notes and information collected by and for the clinicians in that office, clinic, or hospital and are mostly used by providers for diagnosis and treatment. EMRs enable providers to track data over time, identify patients for preventive visits and screenings, monitor patients, and improve health care quality.

Electronic health records (EHRs) are built to go beyond standard clinical data collected in a provider’s office and are inclusive of a broader view of a patient’s care. EHRs contain information from all the clinicians involved in a patient’s care and all authorized clinicians involved in a patient’s care can access the information to provide care to that patient. EHRs also share information with other health care providers, such as laboratories and specialists. EHRs follow patients – to the specialist, the hospital, the nursing home, or even across the country.

Source: HealthIT.gov. What are the differences between electronic medical records, electronic health records, and personal health records? Available at: https://www.healthit.gov/faq/what-are-differences-between-electronic-medical-records-electronichealth- records-and- personal. Accessed December 5, 2019.

59 Although such work is compensated for hourly Moral distress A survey of 197 practicing physicians found employees, it is typically not compensated for Moral distress is the anguish experienced a prevalence of loneliness of 43% (assessed with physicians, advance practice providers, and other when clinicians perceive that they have participated the 3-item University of California, Los Angeles clinicians. This can often lead administrators to in a morally undesirable situation or been unable to Loneliness Scale, the Abbreviated Maslach Burnout erroneously conclude that they have “increased act in accord with their professional ethical values Inventory, and 2-item Primary Care Evaluation of productivity” without increasing costs when, in under conditions of constraint or duress. Pressure Mental Disorders Patient Health Questionnaire).66 reality, they have simply extended the work week to act contrary to ethical standards can arise from The prevalence of loneliness increased with age, of health care professionals and stolen time from patients or their surrogates, the clinical team, or the ranging from 5% in respondents aged <35 years their families and personal activities.1 Based on external environment. Examples include: providing to 37% of those aged >55 years. Physicians EHR time-stamp data, the average family physician potentially harmful or futile treatment; providing experiencing greater feelings of loneliness were now spends approximately 28 hours per month care that prolongs dying; or witnessing clinicians more likely to report at least one manifestation of completing clinical documentation on nights and who give false hope to patients or family members. burnout (64.8% vs. 35.2%, p <0.01). Loneliness weekends when he or she is not on duty.56 Among nurses, poor communication, insufficient was also associated with increased levels of Clinical documentation and online patient input to clinical decisions, clinical disagreements depression and emotional exhaustion. These messages are not the only professional tasks with physicians, unsafe staffing, and unnecessary relationships between depression, emotional clinicians might perform on personal time. Continuing tests and procedures also contribute to moral exhaustion, and loneliness were maintained even medical education (CME) and the maintenance of distress. Witnessing patient care suffer as a result when adjusted for participants’ sex, age, and duty certification are frequently performed on nights, of a lack of provider continuity was identified by hours. weekends, and even vacation time since most a sample of interprofessional clinicians as a key organizations do not provide dedicated time for driver of moral distress.57 Data from a measure their completion. Clinicians also must complete a of moral distress among health care professionals Distractions and interruptions number of required training modules each year, indicated that the most common sources of moral Although many of the interruptions in the typically mandated by regulators, covering topics distress among physicians were related to a lack of daily life of a physician are clinically relevant and/ such as patient safety, infection control, the Health resources that compromised patient care, and lack or unavoidable, the number and consequences of Insurance Portability and Accountability Act (HIPAA), of administrative action.58 such interruptions can be exacerbated by poorly- and human subjects protections. Independent of Studies of moral distress among designed workflows or EHRs. Excessive (and often CME and maintenance of certification, health care interprofessional clinicians showed that nearly 20 irrelevant) or poorly-timed EHR alerts or “decision professionals must keep abreast of advancing percent of respondents were considering leaving support” prompts lead to “alert fatigue,” divided knowledge in their field by reading the literature. their jobs because of moral distress, which has attention, and burnout.67 A study of 422 family Because the pace at which medical knowledge is implications for workforce sustainability.59 The physicians and general internists found that expanding has accelerated significantly, the time ethical climate of a practice setting, along with adverse workflow (defined in terms of time pressure required to stay current has also increased, which the frequency of exposure to morally distressing and chaotic environments) was associated with is another demand on personal time. situations, are postulated to exacerbate moral symptoms of emotional exhaustion.38 Interruptions Time pressures can be particularly acute for distress. disrupt clinicians’ work flow, are associated with academic physicians who historically have divided Repeated episodes of moral distress can have lower-quality care, add to cognitive burden and their time between clinical work and educational and a cumulative effect over time, causing feelings of forgetfulness, and delay task completion. training work. The performance of these physicians depletion, disillusionment, and despair.60 Several is typically measured using an academic yardstick studies have described a relationship between which requires them to engage in substantial moral distress and burnout among nurses, as Administrative burden educational activities (lectures and presentations) well as among critical care clinicians, with those A common physician complaint is the amount and produce a specified number of manuscripts and having higher moral distress scores being more of time required for tasks that are not direct patient grants in defined timeframes as a requirement for likely to experience burnout.61 in a study of 1,156 care, such as inputting information into EHRs, or retaining their positions. physicians from various specialties, caring for filling out forms for billing or insurance issues. A To increase revenue, many academic centers dying patients was found to be associated with an 2016 study of 57 U.S. physicians observed for 430 have reduced the proportion of time allocated increased likelihood of symptoms of burnout.62 hours found that for every hour they spent with to scholarly pursuits and increased the time Several studies in primary care physicians suggest direct face time with patients, they spent roughly 2 devoted to clinical care without adjusting any of that interactions with patients who ignore medical hours on EHR and desk work.68 An observational the academic performance expectations.1 Most advice, insist on unnecessary tests or treatments, study of 142 family physicians in Wisconsin found academic centers still have a similar set of criteria or exhibit disrespectful behavior is associated that an average of 4.5 hours were spent during the for the publications, presentations, grants, and with greater job dissatisfaction and emotional workday on an EHR, and another 1.4 hours were educational responsibilities that are required to exhaustion.63 spent every day after clinic hours on the EHR.56 retain a position. Accordingly, the requirements for Clinicians tend to view administrative tasks as scholarly activity necessary to preserve job security less meaningful than direct patient care, hence, have been increasingly shifted to personal time on Loneliness to the extent that finding meaning in one’s work nights and weekends. Loneliness is defined as a lack of meaningful mediates burnout, higher levels of administrative All of these variables have led to the interpersonal relationships or interactions and can burden could be expected to correlate with encroachment of professional tasks into personal affect clinicians of all ages and backgrounds. This higher levels of burnout. A 2017 study of 1,774 time for physicians to a much greater degree than subjective feeling of loneliness depends more on physicians bears this out. After adjusting for gender, for most other fields. In most settings, this work the quality of relationships than on the number race, specialty, and years of experience, a higher is not clearly compensated. These professional of people in one’s social network. Loneliness is a percentage of time spent on administrative duties activities steal time from family, relationships, self- subjective distress that has been linked to burnout was associated with decreased career satisfaction care, and personal pursuits, creating problems among internal medicine residents.64 Conversely, and more burnout.69 Study respondents reported with work-life integration as well as with getting increased support from family and friends that administrative tasks adversely affected their adequate sleep, all of which fuel burnout. reduces loneliness among resident physicians and ability to deliver high-quality care and to focus on subsequently helps reduce burnout.65 patient encounters.

60 Another study of 585 physician residents and • Using distraction and redirection to interrupt Drs. Sharon Hull and Karen Broquet, family faculty found that those who spent more than 6 inappropriate behaviors in patients with cog- medicine physicians at Southern Illinois University hours per week after hours using the EHR were nitive impairment School of Medicine have noted that difficult patients almost three times more likely to report burnout.70 • Pairing patients with a history of harassment can be categorized by patient characteristics (e.g., with physicians and nurses of the same sex, if angry or manipulative patients, somatizing patients, Physician harassment by patients appropriate grieving patients), physician characteristics (e.g., Although it is tempting to assume that the power • Reporting a patient to a disruptive behavior fatigued or harried physicians, dogmatic or arrogant in the patient/provider relationship resides with the committee if one exists at their hospital physicians), and situational issues (e.g., language physicians (and, thus, would reduce the tendency • Safety measures within the exam room, includ- and literacy issues).82 They assert that being aware of patients to cross personal boundaries) in fact ing possibly leaving the door open and sitting of these factors and being prepared to address patients can, and do, breach those boundaries and closer to the door than the patient them head-on can help with prevention, particularly engage in verbal, emotional, or sexual harassment, highlighting the importance of “mindful practice” which can add significant stress to already over- Difficult patients and good communication skills (e.g., remaining taxed clinicians.71 Some harassment is inadvertent, Primary care providers typically will experience 76 seated, actively listening, and asking open ended such as when a patient with dementia or delirium 10% to 15% of patient encounters as “difficult.” questions). says or does something that is inappropriate. But Difficult patients were more likely to have mental often the harassment is intentional: patients may disorders, multiple somatic symptoms, more severe BEFORE MOVING ONTO THE NEXT SECTION, repeatedly ask for a date, for example, make sexist symptoms, poorer functional status, more unmet PLEASE COMPLETE CASE STUDY 2 ON THE expectations, and higher use of health services or off-color jokes or references, be inappropriately NEXT PAGE. physical, or become aggressive when rebuffed. (e.g., “frequent fliers”). Encounters with difficult Regardless of the underlying reason, this type of patients may trigger feelings of anger, frustration, Job resources sexual harassment can be harmful to the physician, and despair, potentially leading to emotional 77 the physician-patient relationship, and the care that exhaustion and burnout. Difficult encounters Meaning and purpose in work is given.72-74 frustrate patients as well as providers. Compared Both meaning and purpose are critical to Observational evidence suggests it is not a to other patients, patients leaving difficult visits are clinicians’ professional identity.83 In a sample of trivial problem for physicians and may occur more more likely to have unmet expectations and to feel 1,289 U.S. physicians, “sense of calling” was often than other types of sexual harassment in the dissatisfied with their care. strongly associated with elevated levels of meaning profession. A 2018 Medscape non-randomized Prior studies have shown that medical and in life. In this study, physicians reporting burnout poll of 1,045 physicians and nurses found that psychiatric complexities are associated with PCP symptoms were less likely to report life satisfaction, 78 73% of female nurses and 46% of male nurses perceived visit difficulty, and that the nature and commitment to direct patient care, and high life reported being sexually harassed by patients, extent of patient requests influence perceived meaning.83 In a national study of more than 2,200 and 58% of female physicians and 39% of male difficulty independent of such complexity. U.S. physicians, physicians with burnout were less physicians reported such harassment.75 By Patient requests for diagnostic testing or likely to identify medicine as a calling.84 For nurses, specialty, emergency physicians, dermatologists, treatment occur in approximately half of primary the concept of “calling to nursing” is associated 79 and plastic surgeons were more likely to experience care visits. PCPs often accede to these requests, with improved meaningfulness in work, career harassment from patients, and obstetricians/ and request fulfillment is associated with higher commitment, personal well-being and satisfaction, gynecologists, pediatricians, and radiologists were patient satisfaction. Yet PCPs do not fulfill up to and work engagement.85 least likely.71 one-third of patient requests, and they may even Finding meaning in work can protect clinicians A number of factors can predispose patients decline requests in ways that do not meet patients’ from burnout. A study of 300 Israeli physicians to behave inappropriately, including dementia/ informational or emotional needs. In addition, found that the existential meaning derived from work cognitive impairment, administration of sedative because patient requests may lead to patient– was a significant protective factor against burnout.86 hypnotics (particularly propofol) and patients PCP miscommunication or PCP perception that the In contrast, when dissonance arises between what feeling nervous or embarrassed. Some patients, patient is demanding or controlling, requests may clinicians find meaningful and the reality of their such as those who ask a physician out for a introduce conflict and tension into the encounter, daily work tasks, they may experience increased date, may not understand that the professional regardless of whether they are fulfilled. Patient work stress and burnout. Physicians who report boundaries of the physician-patient relationship are requests for opioid pain medication may be spending less than 20 percent of their time on stricter than those in social situations. especially likely to foster conflict during primary the professional activity they find most meaningful 80 Strategies for dealing with harassment by care encounters, and requests for diagnostic have higher levels of burnout.6 In a related study, patients will vary depending on the presumed tests may introduce tension if the requested test the amount of personally rewarding hours spent etiology of the behaviors, but approaches include:71 is not recommended by clinical guidelines, such as each day was found to be positively associated with • Adopting clear policies that professional con- neuroimaging for uncomplicated headache. more career and life satisfaction and commitment to duct is expected of patients and violations will An observational study of 824 patient visits clinical practice.83 be reported, even in cases where the behav- occurring from June 2010 to March 2012 found Alignment between work activities and what ior is associated with a medication or disease that patients requested diagnostic tests, pain an individual finds meaningful has also been shown state medications, or specialist referrals in 37.2%, 20%, to be related to burnout in samples of nurses. For • Saying something directly to the patient about and 30% of visits, respectively.81 In this study, the example, a better person–job match in six areas of the behavior perceived difficulty of patients was significantly work–life (manageable workload, control, reward, • Documenting all inappropriate behaviors in higher when patients requested diagnostic tests. community, fairness, and values) had a direct the medical record to alert other medical staff The study authors note that “the challenge of protective effect against burnout (i.e., emotional who may deal with the patient and to serve responding to patient request for low-value exhaustion and cynicism) in a cross-sectional as a reference in case of false accusations by tests may be particularly vexing for primary care survey of 215 registered nurses.87 the patient providers.” With increasing use by patients of • Taking extra precautions with a known culprit, internet-based health information services, the rate such as having another physician or a nurse in at which patients make inappropriate demands on an exam room physicians may be increasing and, with it, added stress on the provider/patient relationship. 61 Case Study 2 Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

You are a clinician at a busy ambulatory care clinic with a high patient load, a cumbersome electronic medical record system, and long wait times for patients. Your second-to-last patient of the day is a 45-year-old man who reports difficulty sleeping, headaches, and longstanding lower back pain. After you calm the patient down from his complaints about his wait time, he requests opioid pain relievers for his back pain. When you suggest using an NSAID and exercise, he balks and exclaims that “All you doctors are the same! You don’t take me seriously and you never solve my problems.” In your review of his medical record, you note that he has presented multiple times to the clinic and emergency room over the past year to request opioid pain relievers and anxiolytics, and that he has been diagnosed with a substance use disorder and major depression. You prescribe the patient an NSAID and despite his protests, don’t give in to prescribing an opioid. You then discharge him from the clinic and take a moment to recuperate before seeing your last patient.

1. How could you have handled the difficult patient differently? What tools and interview skills can you employ to de-escalate difficult patient encounters, thereby reducing both patient and clinician stress?

2. What specific skills advocated by Drs. Hull and Broquet could address issues arising from difficult patients? How could you teach the physicians in your practice about these skills?

3. Think of a recent difficult patient in the clinic or in the hospital. How could you have handled the situation differently? To what degree did your personal characteristics as a physician, including your self-perceived wellness, contribute to that encounter? Questions for case study:

“The patient is what is keeping the doctor from (emotional exhaustion, burnout, compassion increase burnout risk. A longitudinal survey in falling further into burnout. The physician–patient fatigue, and stress).1 a sample of practicing primary care physicians relationship and the desire for doctors to help For example, in a sample of more than 2,300 working in a large integrated delivery system found their patients is the core of why physicians entered physicians in Germany, higher satisfaction with that values dissonance along with workload and the work environment was associated with lower job control were the largest drivers of burnout.67 medicine. Yet, a gap is pushing them apart.” 90 —Zohal Ghulam-Jelani88 emotional exhaustion and depersonalization. In a study of 88,605 U.S. Department of Veterans Similarly, in a study of more than 26,000 nurses, Affairs employees, alignment between stated values Organizational culture better work environment quality was associated with and the organization’s behaviors and decisions Perceptions of low organizational support, less burnout and job dissatisfaction after controlling was associated with more favorable perceptions of for wages and other covariates.91 organizational culture, which in turn was related to organizational politics, or insufficient resources 94 offered for professional development may In a retrospective, two-stage study of nurses employee satisfaction and worker engagement. increase the risk of burnout among clinicians. For employed in hospitals between 1999 and A sense of job control is also associated example, having inadequate time for professional 2006, improvements in perceptions of the work with burnout. Several cross-sectional studies of development was an independent predictor of environment were associated with lower adjusted physicians suggest that a low sense of control of rates of emotional exhaustion, job dissatisfaction, the practice environment, having little autonomy, burnout in a multivariate analysis performed on a 92 89 and intent to leave. The 2018 National Survey and a perceived lack of involvement in decision national sample of 783 neurosurgeons. 67 Management and policy decisions and change- of Critical Care Nurse Work Environments, which making all correlate with burnout. A study among management processes influence the daily work involved more than 8,000 acute and critical care obstetricians and gynecologists, for example, found lives of health care professionals and set the nurses, found that nurses working in clinical units that low perceived control over one’s professional tone for decision latitude and interprofessional actively addressing work environment issues rated life was independently associated with burnout the work environment more positively than nurses after controlling for work-life integration, partner collaboration. Another important component of 93 95 an organization’s culture is the ethical climate, who were not working in such units. support, and current work-related stress. And a which influences the way clinicians appraise their In addition, studies suggest that when small longitudinal study of primary care physicians relationships, leadership, and workplace. clinicians believe that their personal values and found that job control was central to the experience Overall organizational culture can be reflected expectations about their work are aligned with the of burnout, suggesting that physicians need to be in a clinician’s satisfaction with the overall work values of the organization in which they practice, involved in practice-related decisions to help reduce job satisfaction increases, which helps to lower organizational-level factors that increase burnout environment. In contrast, healthy work environments 38 67 have been positively associated in nurses with job the risk of burnout. When values or expectations risk. satisfaction, retention, and better patient outcomes conflict between practitioners and their organization and negatively correlated with emotional strain the resulting dissonance can intensify stress and 62 One factor that does not appear related to When work-family conflict was accounted for, the sex Resilience burnout is physician income. In a national sample disparity in the increase in depressive symptoms Resilience is the ability to persevere, remain of about 900 general and subspecialty physicians, decreased by 36%, suggesting that work-family positive, and maintain performance and well- no relationship was found between gross income conflict may be an important potentially modifiable being under adversity. Resilience is considered a and burnout.96 Evidence does point, however, to factor that is associated with elevated depressive continuous, dynamic state that can be nurtured into an increased risk of burnout when compensation symptoms in training physicians. a stronger and more effective attribute, at least up is based on productivity. A 2008 study of 7,900 Both having a recent work/home conflict and to a point. The term resilience includes concepts surgeons reported that incentive pay based entirely solving a work/home conflict in favor of work (rather of self-regulation and mindfulness and also the on an individual’s billings was associated with a 37 than being able to solve in a manner that enables capacity for self-monitoring, limit setting, and percent increased odds of burnout, after controlling one to meet both work and home responsibilities) attitudes that promote engagement with difficult for demographics, years in practice, subspecialty, were associated with burnout for both sexes in a issues at work, hence it is relevant to the study of hours worked per week, number of nights on call, national sample of more than 7,800 U.S. surgeons physician burnout. practice setting, and other professional factors.6 and a smaller sample of 465 academic general Studies suggest that higher levels of resilience Another study, in 1,490 U.S. oncologists, similarly and subspecialist internists.49 A longitudinal study may decrease the risk of burnout among nurses. found that the risk of burnout increased with greater of physicians working in Norway found that a A 2015 survey found that greater resilience was reliance on productivity-based compensation.50 failure to experience a reduction in work/home associated with lower levels of emotional exhaustion Other studies have found that financial stress or interference over a 5-year time span after medical and a higher sense of personal accomplishment concerns about future earnings are independent school graduation was an independent predictor of in a sample of nurses practicing in high-intensity predictors of burnout.89 emotional exhaustion 15 years after medical school settings.105 In another survey of 744 critical care One’s relationships with colleagues can also graduation.100 nurses, high resilience was also associated with either buffer against burnout or exacerbate burnout. a lower likelihood of burnout as well as a lower A study of more than 900 critical care physicians Individual factors related to emotional distress likelihood of posttraumatic stress disorder, anxiety, in France found that impaired relationships with Burnout can be related to a host of factors and depression.106 Higher levels of resilience in physician colleagues was independently linked with that work on an individual basis such as personality, nurses have also been associated with improved higher levels of burnout.47 Poor interpersonal mood, sleep deprivation, relationship issues, health work relationships, increased job satisfaction, relationships between professional disciplines has issues, and prior history of goal achievement. improved professional quality of life, and increased also been associated with higher levels of burnout. People vary in their capacity to adapt to work stress overall well-being.1 For example, conflicts between physicians and and these differences may relate to intrinsic traits Although “mindfulness” is variously defined nurses increased levels of burnout in one study such as gender, personality, and general disposition, in studies, there has been consistent evidence while better relationships with nurses, and the head or temporary circumstances such as mood or for a positive association with this component of nurse, were independently associated with lower attention affected by sleep, use of drugs, or stress. resilience and a lower risk of burnout. A 2018 risk of burnout.47 A separate study in a sample of A prospective study of about 2,000 physicians in survey of 566 surgical residents in the U.S., for orthopedic surgeons found that perceived stress the United Kingdom, for example, found statistically instance, found that high scores on a measure with other faculty and nursing staff was correlated significant associations between high levels of of “dispositional mindfulness” were associated 97 neuroticism or introversion and increased risk with significantly lower levels of burnout, stress, with burnout. 107 of burnout.101 On the other hand, having a sense anxiety, suicidal ideation, and depression. A Work/life balance of control or an easygoing, receptive personality smaller study involving 75 first-year medicine and Compared to other U.S. workers, physicians appears to moderate the effects of burnout-related psychiatry residents found that those classified are less likely to be satisfied with their work/life work factors.102 with burnout (28% of the sample) scored lower on questionnaires assessing mindfulness and coping integration or balance, a finding that remains even Being comfortable with decision making and ability.108 after controlling for work hours and other factors.9 having a strong belief in one’s own self efficacy and Satisfaction with work/life integration among abilities may also reduce burnout risk. In a study of physicians varies substantially by specialty, age, nearly 600 Canadian nurses, a higher level of self- System-level approaches to reduce emotional sex, work hours, and practice setting. The burden efficacy in one’s ability to cope with interpersonal distress of personal responsibilities is also influenced by workplace conflict was correlated with lower levels As detailed above, many factors contributing home dynamics, such as the age of one’s children of burnout.103 A study of 130 physicians in Spain to physician burnout exist at a systems or and having a partner who is employed.98 Lower found that anxiety about decision making was organizational level. Although the leaders of satisfaction with work/life integration is associated associated with burnout even after controlling for health care organizations understandably desire with a higher risk of burnout, and, when struggles age, gender, and patient characteristics, and that a actionable, evidence-based solutions to reduce with work/life integration occur, work/home conflicts more accepting attitude about death (as opposed burnout, such evidence remains relatively limited.1 can occur, and such events also increase the risk to avoidance of the issue) was related to a lower Nonetheless, many efforts have been, and are of burnout. risk of burnout.104 being, made both nationally and worldwide, to Work/home conflicts are commonly experienced Decision making, particularly in the context of create work systems that enhance professional by physicians, especially among women, those chronic or terminal care, can be very stressful. Many well-being and reduce factors associated with in dual-physician relationships, and early career physicians feel helpless in the face of a patient's burnout. Importantly, the few systematic reviews physicians. A prospective longitudinal cohort study struggle with terminal illness. Medical students also and meta-analyses conducted to date suggest that of medical internship in the U.S. (n=3,121 interns) experience patient’s deaths as emotionally draining organization-focused interventions (e.g., schedule even when they were not close to the patients. One changes and workload reductions) are actually evaluated the degree to which work responsibilities common response is simply to disappear, leaving interfered with family life or was associated with more effective at reducing overall burnout than 99 the care of such a patient in the hands of other depressive symptoms. Both men and women members of the health care team or to the family. interventions focused on individuals (for example experienced a marked increase in depressive programs to improve physician resilience), although Another common response to the physician's 109 symptoms during their internship year, with the feelings of helplessness is a need to take control, both types of approaches are probably needed. increase being statistically significantly greater for to fix it. Doctors tend to be most comfortable when Taking a system-level approach has been women. they can do something: prescribe medications, recommended by some authors because it attempts order tests or even develop new communication to target the root causes of burnout rather than skills.104 treating the “symptoms” of burnout. 63 “Health care organizations throughout the Another organizational intervention to build certified medical assistants who worked together to United States are implementing committees and professional relationships and social support was manage a patient panel. In this team-oriented work support groups in an attempt to reduce burnout evaluated in a randomized controlled trial of 74 model, physicians’ assessments of their workload, among their physicians, but these efforts are practicing physicians at the Mayo Clinic in 2014.113 the emotional exhaustion dimension of burnout, and typically focused on increasing resilience and The intervention consisted of a series of facilitated depersonalization were lower after 3 months; at 6 wellness among participants rather than combating physician discussion groups that met for an hour months post-intervention emotional exhaustion and problematic changes in how medicine is practiced about once every other week for 9 months. The 35 depersonalization improvements were sustained, by physicians in the current era.” participants of the intervention group attended an but the improvement in the workload was not. —John Squiers, MD, Baylor University Medical average of 12 of 19 sessions. Topics discussed Similarly, a study of clinician and staff School110 during the group sessions included meaning in perceptions of their work teams showed that work, personal and professional balance, and positive perceptions of team culture were Building social supports caring for patients. The institution provided the associated with less emotional exhaustion among Poor professional relationships and social participants with protected, paid time to attend clinicians. Clinicians who had positive perceptions isolation at work, as noted above, contribute each session. of their team culture and also who routinely worked to clinician burnout, one symptom of which is Compared with controls and a non-study with the same team members, had lower emotional “broken” relationships between people and their cohort, participants in the facilitated small- exhaustion scores.116 work. This suggests that strategies for improving group intervention reported improvement in In contrast, a study of the Veterans Health workgroup civility and social cohesion might help meaning, empowerment, engagement in work, and Administration’s team-based model, the Patient reduce physician burnout. A model program along depersonalization (one of three dimensions of Aligned Care Team (PACT), found that being these lines is the Civility, Respect, and Engagement burnout). Based on these studies it appears that assigned to a PACT team was an independent at Work (CREW) initiative developed by the Veterans initiatives promoting system strategies to foster predictor of higher risk of emotional exhaustion, Health Administration to improve the social climate interprofessional teamwork and civility, reduce as was spending 25–50 percent of one’s time of workgroups.111 Workgroup participants meet disruptive behavior, and build trust among team on work that could be done by someone with less weekly or bi-weekly with a trained facilitator to set members can contribute to reducing clinician stress training and working in a chaotic work environment goals and improve ways in which they work together and promote healthier workplaces. with overwhelming work demands.117 On the other as a unit. The sessions emphasize respectful hand, participants on an adequately staffed PACT interpersonal interactions and building trusting BEFORE MOVING ONTO THE NEXT SECTION, team and those who reported that their teams used relationships between unit staff and management. PLEASE COMPLETE CASE STUDY 3. participatory decision making had significantly lower In a pre–post comparison, the CREW intervention odds of symptoms of emotional exhaustion. Teams was found to achieve significantly greater employee Strengthening teamwork included a primary care provider (physician, nurse civility ratings than the control sites, which showed Strategies that establish or improve efficient practitioner, or physician assistant), a nurse care no improvement. care teams are likely to target multiple work factors, manager, a clinical associate (licensed practice The efficacy of the CREW process was also such as workload, social relationships, job control, nurse or medical assistant), and an administrative demonstrated in a controlled study that examined and autonomy. Using a pre–post quasi-experimental clerk. the impact of CREW on nurses’ empowerment, design, Gregory et al., evaluated an organization- Clinicians with 2 or more years of tenure had experiences of coworker and supervisor incivility, level workload intervention at a primary care higher odds of burnout than those with less than and trust in nursing management.112 Compared with practice within a large, urban, integrated health 6 months on the job (OR range = 2.13–2.68). controls, the intervention group reported greater care delivery system.115 The intervention consisted The authors theorize that this may be a common improvements in access to support, resources, total of a distinct work process and model change within feature of working on a job for a long time—the empowerment, trust in management, and supervisor the primary care clinics. This involved shifting from longer an individual works in the same job, the more incivility as well as improved job satisfaction and a dyad practice structure composed of a clinician emotionally exhausted by it that person may be. significant reductions in the depersonalization/ (physician, advanced practice nurse, or mental cynicism dimension of burnout. The changes in health provider) and a certified medical assistant to emotional exhaustion were not significant. a team-based structure of two clinicians and three

Case Study 3114

Instructions: Spend 5 minutes reading the case study and thinking about whether this type of intervention might be applicable in your setting, and, if so, how such an intervention might be implemented.

QuestionsDr. Olufunso for case Odunukan, study: a cardiology fellow in Mayo School of Graduate Medical Education, experienced burnout and fatigue as a resident and witnessed burnout in colleagues. He grew impatient with the lack of support from his organization. “I grew frustrated at the lack of interventions to curb stress and fatigue among residents and fellows and felt we had to do something,” he says. Odunukan developed a program to combat stress and fatigue among medical trainees by providing creative outlets in the arts and humanities. Called the Fellows’ and Residents’ Health and Wellness Initiative (FERHAWI) it introduced programs such as watercolor painting classes, ballroom dancing, origami, and meditation classes held every other week. In a preliminary qualitative analysis, Odunukan says that residents who engaged in FERHAWI activities reported less fatigue and improved work-related motivation compared to their counterparts who were randomized to a usual noon conference. A longitudinal cohort study of the program conducted for three months replicated the initial findings. Odunukan and his colleagues are now hoping to expand this initiative to other training programs within the School of Graduate Medical Education.

64 Alternatively, the authors suggest, these longer- with APNs reported less stress and anxiety during although results of program evaluations may be tenure workers may be more resistant to their shifts, reported receiving assistance to relevant to physicians as well. The Magnet program organizational change, and thus they may feel the develop technical skills, and had more opportunities emerged from a study by the American Academy stress of the PACT transformation more acutely, and and support to develop cognitive skills. Both the of Nursing in 1981 to “examine characteristics of their pre-existing habits and expectations may be APNs and junior doctors reported that the staffing systems impeding and/or facilitating professional more ingrained. structure fostered teamwork and eased many of the nursing practice in hospitals”.120 This study These results point to the need for difficulties seen on overtime shifts. suggested that the key organizational characteristics organizational interventions that are deployed The improvements included better delegation needed to support nurses were empirical over the long run and involve multiple changes of tasks, greater awareness across the team outcomes, transformational leadership, structural that target various work system factors, such as of the patients on the ward, and improved empowerment, exemplary professional practice, and appropriate staffing, participatory decision making, interdisciplinary collaboration compared to shifts new knowledge, innovations, and improvements. and meaning of work (e.g., increased time spent without the collaborative staffing model. Overall, These components form the Magnet model and working at the top competency level or providing the intervention had a greater effect on less serve as a framework for improving nurses’ work care that is aligned with professional values). experienced doctors. The authors hypothesized environment. The model encourages organizations One unanticipated negative consequence was that early experiences of collaboration among to improve the modifiable features of the nurses’ that, although PACT was designed to break down clinicians may play a role in establishing habits work environment, such as staffing adequacy, silos and de-fragment patient care, there was a that extend through the clinicians’ careers and leadership, clinical autonomy, interdisciplinary perception that the individual PACT teams became foster interprofessional practice. Interventions that effort, and professional governance; this parallels silos themselves.118 Understaffing of PACT teams, reorganize the work among team members have many of the work system factors that contribute to which often meant nurses splitting time between the potential to reduce clinician burnout, but team clinician burnout. As of 2019, about 10 percent of two or more PACTs, often made it difficult for these members must have sufficient resources to balance U.S. hospitals have achieved Magnet Recognition individuals to fulfill their assigned roles. Many the demands and expectations put on the team. Program designation.121 respondents reported that patients had a positive With any team-based intervention or redesign, it is There is some evidence that nurses in Magnet view of PACT and felt more involved in their care important to proactively and regularly monitor and, hospitals are less burned out and more satisfied with under the model. However, many also reported that if needed, adjust changes to avoid shifting the work their jobs. A study comparing nurses in Magnet and the model put a strain on staff. Namely, respondents burden from one discipline to another. non-Magnet hospitals found that nurses in Magnet reported insufficient staffing levels, a lack of hospitals rated their work environment better and sufficient training, scheduling complications, new BEFORE MOVING ONTO THE NEXT SECTION, were 18 percent less likely to be dissatisfied and 13 122 duties without promised resources, less time with PLEASE COMPLETE CASE STUDY 4. percent less likely to have high levels of burnout. patients, and team dysfunction when there was a In a longitudinal study assessing improvements weak team member. Promoting positive clinical work environments to the work environment in Magnet–recognized Another team-based care delivery intervention, Two national programs have been designed to hospitals compared with to other hospitals, Kutney- which was assessed in a mixed-methods study, improve the clinical work environment: the Magnet Lee et al., found significant perceived improvements involved assigning advanced practice nurses Recognition Program and the American Medical over time in the quality of the work environment (APNs) to support, coach, and encourage junior Association’s (AMA) Joy in Medicine Recognition (e.g., more collegial nurse–physician relations and 123 doctors during overtime shifts in an urban hospital program. participation in hospital affairs). 119 in Australia. The APNs facilitated collaboration The American Nurses Credentialing Center’s between the junior doctors and ward nurses in (ANCC’s) Magnet Recognition Program is an order to assist with patient management and organizational model designed to improve the delegation of tasks. The junior doctors who worked work environment for nurses in a hospital setting,

Case Study 4114

Instructions: Spend 5-10 minutes reading the case study and thinking about whether this type of intervention might be applicable in your setting, and, if so, how such an intervention might be implemented.

Dr. Greg Feldman, MD, was a star resident in Stanford’s Department of General Surgery. A graduate of Harvard Medical School, he was described as warm, outgoing, and happy. He seemed to be very good at balancing his work and non-work life and cared about getting other residents to have fun both at work and outside the hospital. But in 2011, not long after starting his vascular surgery fellowship training in Chicago, Feldman committed suicide. He was 33. His death shocked the Stanford surgery department. Department leaders decided to take steps to address underlying issues affecting resident physician health. They created the Balance in Life (BIL) program, a holistic, multifaceted effort with the primary aim of facilitating physical and mental health among resident trainees. A “resident-only” clubhouse was created where physicians can have a quiet space to discuss and reflect on their days. They have developed a system that provides protected, weekly time when trainees can meet with a therapist alone or as a group in a confidential setting. They have implemented a curriculum that enhances wellness and teamwork. A strong sense of community has emerged since the initiation of yearly retreats, team sports events, and other outings. Finally, a “big-sib/little-sib” mentoring program that pairs younger trainees with more experienced ones provides guidance for new members of the program. The BIL program creates an environment where asking for help is welcomed, encouraged, and supported and it has become in integral part of the overall training program at Stanford.

65 By the end of the study, nurses in Magnet hospitals Despite these mixed findings, seeking Magnet Only 22 percent of the rules identified were had significantly lower adjusted levels of high designation appears to be one way HCOs can actual statutory and regulatory requirements. The emotional exhaustion (29.7 versus 38.4 percent, improve the clinical work environment, at least for rest were either organization-specific requirements p<0.001), lower job dissatisfaction (21.2 versus nurses. (62 percent) or organization behaviors with little 30.9 percent, p<0.001), and lower intention to In 2019 the AMA launched the Joy in Medicine or no legal or regulatory basis (16 percent). In leave their employer (8.9 versus 13.4 percent, Recognition Program to bring attention to most cases, local organizations could change or p<0.01) than nurses in hospitals that were non- organizations that have tried to improve physician eliminate many of the rules identified in this process Magnet throughout the study period. The authors satisfaction and reduce burnout.127 The program without violating any legal, regulatory, or statutory concluded that better work environments in Magnet grants the AMA Joy Award at three levels (bronze, requirement.128 While the impact of this initiative hospitals was an explanation for improved nurse silver, gold) across six competencies—commitment, on the work environment has not been evaluated, outcomes, including burnout.123 In addition to assessment, leadership, efficiency of the practice it illustrates a relatively simple process by which reduced burnout, job dissatisfaction, and intention environment, team work, and peer support. local organizations can identify eliminate wasteful to leave, there is some evidence that the changes Organizations must meet the criteria for five of six and unnecessary rules that are diverting time and involved with Magnet-recognition are associated competencies at either the bronze, silver, or gold resources and may be contributing to clinician with improved patient safety and lower odds of level to receive the award. The Joy in Medicine burden. patient mortality.124 Recognition Program encourages organizations Although these studies suggest that the to address physician burnout and satisfaction by BEFORE MOVING ONTO THE NEXT SECTION, Magnet model is one way organizations can improve dedicating resources and implementing workplace PLEASE COMPLETE CASE STUDY 5. their work environments, two systematic reviews changes to combat it. Interventions implemented have shown mixed results regarding the association by healthcare organizations to reduce physician Healthy working environments to promote of Magnet Recognition Program recognition and burnout include technology-related changes (e.g., well-being nurse outcomes. In a 2014 systematic review, two collaborative and streamlined documentation, in- The nature of the professional milieu in studies reported higher levels of job satisfaction basket management), and team work changes which the clinicians, staff, patients, and families among nurses in Magnet versus non-Magnet (e.g., small group discussions). experience daily health care delivery is critical hospitals, but a third study failed to find a difference The Joy in Medicine Recognition Program for enhancing professional well-being, improving in satisfaction ratings between Magnet and non- has not yet been formally evaluated to determine 125 patient care, and reducing the risk of burnout. A Magnet hospitals. if the required steps to achieve recognition are “healthy work environment” describes a workplace Another systematic review found mixed results associated with improvements in burnout and that is safe, empowering, and satisfying and that in terms of nurse and patient outcomes in Magnet satisfaction among clinicians. 126 includes effective cross-disciplinary communication, versus non-Magnet hospitals. Among the four An additional national effort is the Leadership collaboration, and decision making; appropriate included studies that assessed nurse outcomes, Alliance, convened by the Institute for Healthcare staffing; recognition; and authentic leadership. three showed improvements in job satisfaction, Improvement, which consists of 40 participating The retention of clinicians and patient burnout, or intention to turnover. The authors of this North American hospitals, associations, and outcomes are significantly affected by the health review noted the lower quality of the research of the other care systems that have developed a set of of the work environment. Aiken and colleagues included studies (which were largely retrospective “radical redesign” principles intended to guide 128 found that nurses who worked in healthier work or cross-sectional) and concluded that it is difficult transformational changes in health care. One environments reported significantly lower levels of to isolate the impact of accreditation programs like of these principles is dedicated to eliminating burnout and job dissatisfaction and better quality- the Magnet Recognition Program from other factors administrative barriers that add little or no value to of-care outcomes.129 For nursing, a healthy work such as potential differences in resources, culture, clinical care, interrupt clinician workflow, frustrate environment is often measured on five dimensions: and leadership between hospitals that choose to patients and clinicians, or are otherwise wasteful (1) nurse participation in hospital affairs; (2) seek Magnet designation and those that do not. It of time and resources. To accomplish this, the nursing foundations for quality of care; (3) nurse is worth noting that the review did not include the participating organizations asked their clinicians manager ability, leadership, and support of nurses; longitudinal study of Kutney-Lee et al. discussed and patients “If you could break or change any rule (4) staffing and resource adequacy; and (5) above. in service of a better care experience for patients or collegial nurse–physician relations.130 staff, what would it be?”

Case Study 5114

Early in his tenure as Dean of Student Affairs at Vanderbilt School of Medicine, Scott Rodgers, MD, a board-certified psychiatrist and alumnus of the medical school, observed how the current structure of medical education nationwide was creating a toxic environment where the emphasis for students was on surviving, not thriving. Students were suffering from depression, burnout, and a lack of mental resiliency. In 2005, Rodgers and a group of students formed the Student Wellness Program, a school-wide effort that has become a model for other medical schools and graduate training programs. The program includes activities such as yoga classes, community service events, healthy cooking classes, forums on nutrition and sleep, and a mentoring program that pairs second-year students with first-year students. Now nearly every student participates in at least two wellness activities during their training. According to Rodgers, the key to the program’s success is “empowering and partnering with those who have the most at stake—the medical students themselves.”

66 Structured descriptors of the characteristics of a result in decreased attention to other aspects of Clinician participation in developing and healthy work environment for other clinicians have care quality, contribute to staff burnout and job implementing solutions for addressing burnout can not been as clearly articulated, although they could dissatisfaction, and even impair clinician health actually be part of the solution to reducing burnout be expected to include many, if not all, of these (e.g., work-related stressors that contribute to since it provides a path for engaging clinicians, dimensions. chronic illness).132 giving them opportunities to work with others As with other major organizational endeavors, There have been calls from various quarters for (social support), to learn from others (meaning in an executive leader is needed to oversee and the coordination and integration of the various goals work), and allows them to exert greater control over coordinate the activities aimed at enhancing (patient safety, occupational safety, professional their work environment (autonomy).136 In addition, professional well-being. Similar to the situation in well-being) into a single comprehensive safety since organizational changes can be stressful, the past decades when the positions of chief medical program.133 Despite the parallels among patient participation of clinicians in the change process officer, chief nursing officer, and chief quality and safety, occupational safety, and clinician burnout, can provide the channels for them to support safety officer were created in response to the these organizational functions within healthcare each other and bring up ideas about how to better recognition of a critical unmet need for leadership organizations tend to be separate, reflecting manage the change. within healthcare organizations, some organizations the largely independent external (e.g., state and BEFORE MOVING ONTO THE NEXT SECTION, are now creating a senior leadership position to federal) infrastructures, regulations, standards, oversee the new suite of responsibilities to address and reporting requirements of these equally- PLEASE COMPLETE CASE STUDY 6 ON THE clinician wellbeing. Much like the chief quality laudable goals. There can be tension between the NEXT PAGE. officer, this new leader must be able to transcend various groups and their goals as well as potential individual silos in order to catalyze progress across constraints with regard to organizational resources. Creating an aura of psychological safety all divisions, departments, and work units and focus While there are likely benefits and disadvantages An essential part of addressing physician exclusively on the professional fulfillment and well- to either an integrative or collaborative approach burnout is the need for health care organizations being of the individuals in the organization. to patient safety, occupational safety, and clinician to support clinicians’ ability to discuss, report, and The title of this position may vary across well-being at the organizational level, the goals address burnout, its sources, and its consequences without fear of shame, retaliation, marginalization, organizations, with the “chief wellness officer” and organizational mechanisms need to be closely 137 being a common choice. Some organizations aligned and coordinated. This should include having or disrespect. An organization’s culture should designate this person as a senior or associate a strong safety culture (broadly defined), educated support an environment in which clinicians feel safe dean or vice president. The key responsibilities and engaged leadership, common organizational (i.e., psychological safety) to report and to receive of the executive leader in charge of professional processes or infrastructure when possible, clear individual support when experiencing burnout or wellbeing include evaluating the current scope of frontline expectations and engagement, and other forms of distress. An initial step is to assess the current state in the problem and reporting the results throughout effective measurement and feedback systems. At order to establish a baseline level of burnout and the organization, benchmarking, designing and a minimum, with organizationally separate entities professional well-being within the organization.1 This implementing an interprofessional organization- there must be effective communication, mutual is typically accomplished through organization-level wide strategy, overseeing broad system-level consideration of requirements, constraints and surveys, but can also include other methodologies. efforts to drive improvement in the dimensions unanticipated consequences, effective coordination, To achieve honest and accurate data, it is most relevant to the local organization, and and a substantial alignment of organizational goals important to attend to psychological safety in 1 communicating with outside entities. Designating and resources at the most senior leadership level. the data collection and reporting processes for an executive leader dedicated to well-being in an Additionally, a shared focus on improving patient both individual clinicians and the organization. organization will be insufficient, however, unless a care can align efforts, reduce competition, and Attending to psychological safety at the individual diverse team and sufficient resources are provided contribute to a healthier work environment. level means that surveys or other data collection to allow collaborative solutions to produce effective should either be anonymous or confidential with interprofessional results. appropriate safeguards in place to ensure that Organizational efforts for tackling clinician Including physicians in decision-making responses cannot be identified by other members burnout should be coordinated with activities Although it might sound obvious, to be effective, of the organization and to alleviate any concerns related to patient safety and employee safety and efforts at the organizational level addressing that an individual’s responses may affect future health because many of the same work system clinician burnout require significant input and status (e.g., credentialing or privileging decisions, factors influence clinician burnout as well as worker genuine involvement from the clinicians themselves. employment) in the organization. and patient safety. For example, extended work This is not unlike approaches recommended in At the organization level, psychological safety hours and fatigue have been associated with both other health care improvement domains including means that the institution’s willingness to ask for medical errors and needle-stick injuries, and high health information technology design and patient honest and unvarnished feedback as a means for workloads, a major contributor to clinician burnout, safety. In this human-centered design approach, improving work environments will not be used to also adversely affects patient safety. clinicians are intimately involved in co-designing damage or tarnish the reputation of the organization For nurses there is good evidence that a interventions to improve their work environment and its leaders. Both practices are necessary to “healthy work environment” is associated with and reduce burnout. create a trustworthy practice environment. improved patient safety, a reduction in occupational The co-design approach with genuine It is important that the results of such surveys 131 clinician participation may foster the development be shared transparently with all members of an injuries, and improved nurse well-being. Patient organization (e.g., those who participated in the safety, employee safety (e.g., occupational injuries) of innovative approaches to reduce clinician 134 survey). This should include both a high-level and clinician burnout are inter-related—they burnout. The most meaningful and sustainable summary of the results for the organization at share contributory factors and may influence or improvements often involve the active participation large and results that are specific to occupation affect each other. On the other hand, improperly of those closest to the work.135 Not only should (e.g., nurses, physicians, pharmacists, advanced designed patient safety or quality improvement clinicians be asked about their degree of burnout, practice providers) and specialty or unit. Individuals initiatives can have adverse effects on employee but they should have an active role in translating should receive reports relevant to them. For safety and clinician well-being as well as on other their insights, experiences, and expertise into example, a physician should receive the results of aspects of patient care. Patient safety interventions identifying, testing, evaluating, implementing, and the aggregate organization-level results, results that increase front-line clinician workload, time continually enhancing proposed improvements that summarizing the experience of physicians in the pressure, or clerical burden can unintentionally foster well-being and a healthy work culture. organization, and the physician’s work-unit-level results. 67 Case Study 6114

In response to signs of burnout, depersonalization, and emotional exhaustion among residents at the University of Alabama at Birmingham Tinsley Harrison Internal Medicine Residency program, a Resident Wellness Committee was created in 2013. To prevent depersonalization, community service projects were organized that specifically did not involve medical care. Examples include working on community gardens, helping with baseball games for children with disabilities, or volunteering for Habitat for Humanity building projects. The goal of these projects was to get residents out of the hospital to see different aspects of their community and spend time together. The community service also aimed to diminish feelings of inadequacy. To address emotional exhaustion, the Committee started a Memorable Patient Lecture series in which faculty share positive stories about patients they may have known for years or decades, a type of relationship residents have yet to experience in their early careers. To combat a lack of autonomy, a problem-solving subcommittee was formed to work on one or two stressors a year with resident-driven solutions.

When results are shared, attention should highly subjective nature of questions about burnout provider groups, public and private payers, be given to creating an atmosphere of learning. and well-being, organizations would have ample employers, and others. The PCMH model includes It is critical that organizational leaders avoid any opportunity to engage in subtle or overt coercion features such as greater care management by perception of blaming frontline staff for the results and manipulation of results. Public reporting could registered nurses and clinical pharmacists, as well or exerting pressure for them to remediate the also influence contracting and the ability to recruit as pre-visit, outreach, and follow-up activities by results. Additionally, when solutions can be co- clinicians. Hence there are tremendous pressures medical assistants and nurses. created rather than imposed, the likelihood of that may prompt euphemistic rather than honest “Team huddles”—short, all-team daily planning meaningful and sustainable progress is possible. reporting when psychological safety is not created meetings—are common as are visual displays to There can be downsides to the public reporting for both individuals and organizations. identify and track issues (see Table 2). In some of survey data, especially for the purposes of models physicians are exempted from productivity- ranking or comparing healthcare organizations. based salary adjustments to encourage care Such public-ranking systems often have negative Using the Patient-Centered Medical Home activities outside of in-person visits. consequences and create negative incentives. For model to reduce burnout A study of 26 clinics using the PCMH model example, the public rating systems of the “best The Patient-Centered Medical Home (PCMH) found that reducing the physician panel size to hospitals” in the United States has led organizations has been proposed as a solution to numerous 1,800 patients, increasing flexibility for longer to try to game the system and the metrics by which challenges facing the US primary care system, patient visits, reducing the number of face-to-face they are ranked, rather than to engage in authentic including a reduction in physician burnout. Originally visits per day, and increasing care team staffing efforts to improve the underlying factors that the promoted by medical professional organizations, it improved work satisfaction and levels of burnout.138 ranking system is intending to capture. Given the has been widely endorsed by health care systems,

Table 2. Components of Patient-Centered Medical Home Model that could reduce physician burnout138 PCMH Component Description

Virtual medicine Use email, Internet, and phone contacts to enhance access for patients, help patients prepare for visits, follow up on appointments, and substitute for in-person visits. Use EHRs to streamline prescription refills, health risk appraisals, and to provide patients with “after visit summaries.”

Chronic care management Create collaborative care plans to guide patients and care-team activities. Promote self-management and support it with group visits, behavior-change programs, and peer-led chronic illness workshops. Use motivational interviewing techniques and brief negotiation skills with patients facing chronic illness.

Visit preparation Contact patients in advance to clarify concerns and set expectations. Prepare physicians with records reviews, patient education materials, and other resources prior to visits.

Patient outreach Use quality-deficiency reports to document unmet care needs and follow up all discharges and emergency or urgent care visits. Telephone call management Redesign telephone call intake systems to bypass administrative options and connect patients directly with care teams.

Care-team huddles Develop short, all-team meetings to collectively plan daily schedules, balance supply and demand, distribute tasks, and trouble- shoot problems. Visual displays Use visual display systems to track team performance, workplace rounds, root-cause analyses, and plan/do/check/act improvement cycles.

68 The percentage of staff reporting that they were to patient data, and by facilitating the delivery of software installation, with physicians, nurses, “extremely satisfied” with their workplace increased quality care.140 pharmacists, dentists, therapists, unit secretaries, from 38.5 percent at baseline to 42.2 percent at Well-designed health IT should be easy to and others shifting documentation tasks among follow up, and levels of reported burnout decreased use and help a clinician do his or her job more themselves with system updates. In many complex from 32.7 to 25.8 percent after implementing the effectively, efficiently, and safely. Patient-centered medical systems, the clinical team is just one PCMH model. technology, such as patient portals that allow stakeholder with limited authority when decisions patients to communicate with their clinicians via concerning the deployment of technology are made. Technology-related factors in burnout secure messaging, can improve both patients’ In most health systems the ultimate responsibility Although the deployment of technology in and clinicians’ experiences by facilitating efficient for capital spending—including health IT—rests medicine has brought many improvements in quality communication outside of the office setting and with the financial and administrative team. of care and efficiency, the rapid change can also be giving patients easier access to their medical When systems are used by all, those leaders associated with risks and negative consequences information.140 While the 2012 Institute of Medicine most often make the judgment call if trade-offs for clinicians and patients. Poorly-designed and (IOM) report Health IT and Patient Safety: Building among user interests are required. While overall deployed technology is a contributory factor in Safer Systems for Better Care described key satisfaction with the EHRs remains low,143 most clinician burnout and professional well-being. attributes of safe health IT, these attributes also clinicians see their value and potential and do Although all types of technologies affect the more broadly apply to effective, efficient, and usable not want to go back to paper documentation. clinical work environment and the experiences health IT:141 However, for a variety of reasons, the EHRs are of clinicians and patients, much of the current • Easy retrieval of accurate, timely, and reliable not as usable or well aligned with clinical workflow literature on technology in the context of clinician native and imported data as most clinicians would desire and are associated burnout focuses on health IT and, more specifically, • Simple and intuitive data presentation with clinician burnout and decreased professional the EHR. Health IT is ubiquitous in modern U.S. • Easy navigation satisfaction.144 In addition to the EHR’s usability health care and involves several factors: • Provides evidence at the point of care to aid issues, over-burdensome administrative and clerical • The frontline care delivery team uses health decision making requirements may make an otherwise well-designed IT throughout the care delivery process—for • Enhances workflow, automates mundane EHR frustrating to use simply because of the time diagnostic coding and billing purposes and tasks, and streamlines work, without increas- required to fulfill the requirements. to communicate with patients and caregivers ing physical or cognitive workload Physicians have reported that well-functioning outside of the clinical setting—and it sends • Easy transfer of information to and from other EHRs can improve professional satisfaction by patients home with technology for their own organizations and clinicians fostering better communication between clinicians use (e.g., test strips, devices, software appli- • No unanticipated downtime and patients (via patient portals, as discussed cations) below), by facilitating better access to patient data, • Health care organizations must make deci- Health IT lacking these attributes will frustrate and by facilitating the delivery of quality care.140 sions about what health IT to adopt, imple- users, lead to workarounds, and may contribute to Physicians also are hopeful that technology can ment, and manage within their organization medical errors and clinician burnout. In contrast, a solve many of the problems they currently face. • The external environment designs, develops, well-designed system that includes these attributes However, understanding how EHR-associated regulates, and at times mandates the use of will be one that clinicians want to use. activities contribute to burnout is a prerequisite for health IT throughout the health care system. EHRs developing solutions. Well-designed health IT will support the delivery Health IT—including, but not limited to, and management of care. By supporting the EHRs—that is well-designed to meet clinicians’ and EHR Adoption individuals involved in the care delivery process— patients’ needs and that is integrated seamlessly Rapid EHR adoption in the United States was both the care delivery team and patients and into care processes will improve both clinicians’ spurred by the Health Information Technology for caregivers—technological innovations can make and patients’ experiences with health care delivery Economic and Clinical Health (HITECH) Act, part of the process of providing and receiving care more and the quality of that care.141 Health IT enhances the American Recovery and Reinvestment Act of efficient and reliable. But poorly designed health the ability of clinicians and patients to collect and 2009. As of 2017, almost all hospitals and nearly IT, while well intentioned, may introduce frustrating retrieve patients’ health-related information. It 80 percent of private practices were using certified 145 processes into the care delivery experience and can also facilitate access to the world’s medical EHRs. The speed at which Congress allocated make the experience more difficult and error prone. knowledge base at the point of care. Additionally, HITECH Act funds led some organizations to quickly For example, compared to handwritten the EHR, has the potential to improve decision expand existing proprietary EHRs, while others paper health records, a well-designed EHR allows making, increase patient safety, and reduce medical purchased and deployed commercially available clinicians to review a patient’s medical history, errors through computerized provider order systems with less than customary deliberation make orders, and document treatment plans and entry, electronic prescribing, and decision support and preparation. Commercial vendors focused on diagnoses more quickly and accurately. A poorly- systems (including alerts and reminders). meeting the rapid new demand with associated designed EHR, however, may require unnecessary Ideally, EHRs would share a common electronic requirements, implementing functionality without 145 work or require clinicians to enter redundant vocabulary that would facilitate the continuity and due regard for usability. In addition, the speed information. This will frustrate clinicians (who coordination of care by providing access to different of action required in this political environment did must spend extra time with the EHR) and patients providers in different locations and contributing to not allow for fostering the framework needed to (whose providers are preoccupied managing the a single version of a patient’s medical record.142 In achieve inter-operability. Though there were many EHR during their encounters). In addition, over- a complex health care delivery system, the EHR has improvements expected with EHR adoption— burdensome documentation requirements may many different users and stakeholders. The EHR is including better quality, less errors, lower costs— make an otherwise well-designed EHR frustrating to not only the primary tool for documenting clinical clear challenges exist, and the full promise has not 139 use simply because the time needed to complete information, it also serves as the documentation been achieved. what is required is overbearing.139 Physicians have source for regulatory compliance, revenue Installation of new systems is often difficult, reported that well-functioning EHRs can improve cycle management and billing, and materials and there has often been a steep learning curve professional satisfaction by fostering better management. associated with the introduction of digital health communication between clinicians and patients Even within the clinical team, documentation records. (via patient portals), by facilitating better access tasks in the digital environment change with each

69 Lin et al. examined associations between the While the impact of the program on clinician In part because of EHR workflow and usability adoption of health IT and Medicare patient mortality burnout was not evaluated, such an organizational deficits, many physicians spend as much, or more, using Medicare data from 3,249 U.S. hospitals intervention seems promising since it removes time working in the EHR fulfilling routine clerical, linked to the American Hospital Association’s annual activities and work that should not be performed, reimbursement, and regulatory documentation hospital survey data on health IT capabilities.146 therefore reducing clinician workload (a major requirements as they do with their patients.68 Overall, they found that in the first year after a contributor to clinician burnout). Similarly, a systematic review of studies on nurses’ hospital’s implementation of basic EHR functionality experiences with EHR adoption found that nurses (operationalized as the number of discrete features Clinical Usability of Current EHRs commonly resorted to workarounds to adapt such as patient demographics, clinical notes, and EHRs with well-designed features that are to changing workflows to meet documentation test results), mortality actually increased. deployed with an attention to clinical workflow can needs.154 Nurses also reported difficulty accessing However, over time and with the adoption improve care effectiveness and safety. Physicians the information they needed to make patient care of increased EHR functionality (i.e., the addition report that such EHRs can facilitate better decisions. of more features), mortality then progressively communication with their patients and improve some A more recent study found that usability among decreased, suggesting that a maturation period aspects of care quality, and there is evidence that nurses continues to be a significant challenge that is needed before the benefits to mortality are EHR use is associated with improvements in clinical has implications for patient care. The authors realized. The greatest adverse effects on patient note quality (compared with paper records). But suggest that nurses are essential collaborators as outcomes in the initial implementation appeared to the picture is complex. For example, well-designed the EHRs and other health IT continues to evolve.155 occur in smaller and less-resourced (e.g., critical and implemented computerized provider order Asynchronous alerts, or inbox notifications within access) hospitals; however, these same hospitals entry (CPOE) can reduce medication errors.149 the EHR, communicate time-sensitive information to saw greater improvements over time thereafter. However, patient outcomes may not improve a clinician regarding patient test results, medication Prior studies on patient outcomes after initial significantly or may even get worse immediately refill requests, or messages from other clinicians. EHR implementation have had variable results. after CPOE implementation, perhaps because Generally these alerts (or messages) do not Nevertheless, this and other literature supports the CPOE implementation is associated with numerous interrupt the work of a clinician but rather appear claim that deliberate national and organizational changes in workflow, clinician communication, and in an inbox that the clinician must check (although investments in iterative improvements in health IT unanticipated consequences.150 local configuration determines the exact way the using a human-centered systems approach can Many studies describe EHR usability problems, alerts behave in the EHR). The alerts, however, reasonably be expected to pay off in terms of both particularly during a clinical encounter, and EHR often go unchecked. better patient and clinician outcomes. usability problems may be contributing to patient In fact, one study showed that the more alerts Regardless of the causes, the EHRs have harm.151 Cluttered visual displays, for example, or there were in a primary care physician’s inbox, become a major source of dissatisfaction as settings with incorrect defaults may make it easier the less likely the physician was to open a newly- well as of burnout among physicians. Although to order the wrong medication or a medication at an received alert, suggesting that the burden of the there is limited evidence that older physicians are incorrect dose. alerts has a compounding effect.156 less satisfied with the EHRs than their younger Some studies suggest there may be a While there is some evidence that EHR use is counterparts, satisfaction with the EHRs is low higher incidence of inaccurate clinical findings associated with improvements in clinical note quality across all age groups.143 Numerous studies have documented in the EHR than in paper records, (compared with paper records), time demands, reported that greater use of the EHR is associated likely due to the inherent challenges of electronic navigation, and the quality of the information in the with more clinician burnout. structured data entry or user interface design EHR are still sources of frustration among many The EHR factors most commonly identified issues.152 While the EHR’s underlying structural clinicians. Copying and pasting information is a as being associated with clinical burnout relate design and user interface design decisions play an common practice when using an EHR and may lead to problems with usability (computerized provider important role because most commercial EHRs are to the erroneous migration of excessive information order entry) and message basket alerts, highly configurable, many usability problems are without the appropriate context and create bloated interoperability, and the increased administrative the result of configuration decisions made at the notes which include redundant or clinically and clerical burdens on clinicians to meet the organizational level. irrelevant information. This makes it difficult and documentation, regulatory, and quality reporting There is some evidence that usability time consuming to locate the clinically important requirements.144 Training in EHR functionality may improvements to the EHR are associated with information, contributes to navigation problems, lead to some gains in sense of usability/control and better cognitive workload and performance among and can contribute to patient safety issues.157 satisfaction with EHR use, but training alone may physicians as well as with prescriber satisfaction not yield improved work efficiency as documented and efficiency.153 However, there are still too few Reduced face-time with EHRs by time spent on the EHR after work hours.147 This published, scientifically valid usability evaluations There are many changes in the team dynamic may be, in part, due to usability issues of the user at various stages of EHR system development. that result from the introduction of the EHRs. One interfaces. The standardized menus for billing, reporting, and that must be taken into account is a decrease in In an effort to reduce technology-related regulatory purposes may also adversely affect face-to-face interaction between doctors and workload and administrative burden, one health usability. Those menus may not accurately reflect nurses, or between doctors of different professional care organization asked its employees “to nominate the uniqueness of a particular clinical situation. This specialties. When this face-to-face interaction is no anything in the EHR that they thought was poorly longer part of the performance of clinical tasks, it 148 in turn forces clinicians to make unnecessary clicks designed, unnecessary, or just plain stupid.” and use a “best fit” approach to move through the becomes necessary to foster team relationships in This program led to multiple changes in the EHR EHR and complete their clinical work, which is one other ways. (e.g., removing 10 of 12 most frequent alerts for factor contributing to clinician dissatisfaction.140 In team care settings, EHR use is associated physicians), additional staff training (e.g., regarding Workflow changes in an EHR implementation with improved access to information within a well- documentation tools), and other organizational may also result in a shift in clinical documentation functioning team, but there can be usability issues changes (e.g., reducing the frequency of required duties, such as additional requirements for associated with the EHRs specific to team-based evaluation and documentation). physicians to order medications or nurses to care.139 For example, in some cases the entire request durable medical equipment. In the past, team (including nurses and non-clinicians) lacks full others closer to the clinical operation, such as access to the EHR when such access would help pharmacy or materials management staff, may have them perform simple tasks involved in clinical care handled these tasks. maintenance or the management of care. 70 It is difficult for clinicians to navigate through notes Furthermore, having insufficient time to use, even in clinical areas not accessible to the from many team members (nurses and other non- complete documentation is also a predictor of public, can add appreciable computer time to a physician providers), and many of the EHRs do not burnout. In the 2019 survey study by Gardner et busy clinicians’ day. This burden is compounded have integrated messaging, which further impedes al., reports by physicians of having insufficient time by multiple log-ins and other screens, especially efficient teamwork. Furthermore, as implemented, for documentation were associated with an almost when multiple non-communicating systems must be EHR systems may allow only one team member at three-fold increased odds of reporting burnout, accessed concurrently during patient care delivery. a time to enter information in a patient’s chart, while reports of spending an excessive amount of Although other solutions for managing the threat of which can result in frustrating delays and workflow time documenting at home were associated with an unauthorized log-in such as by using an RFID interruptions. almost double the odds of burnout.160 device carried by the provider or biometric log- The provider relationship with health IT These requirements on top of poor interaction in capabilities are available, these are not widely remains complicated. For example, providers have design have increased the likelihood of lengthy deployed. reported that finding data and e-prescribing were and often less usable clinical notes. In a recent Early design decisions by major EHR vendors more efficient with EHRs, while information sharing brief report concerning the use of a particular may have contributed to suboptimal user experience and the documentation process have remained commercial EHR system, Downing et al. showed and increased clinician documentation burden. as significant problems with the EHRs over the that U.S. physicians’ clinical notes were, on average, For example, for many current EHR systems, a intervening decade. In particular, the prolonged nearly four times longer than those of clinicians in very early design conceptualization was that the time spent working in the EHR during patient other developed countries—even though they were electronic systems should simply be a paper record visits can adversely affect the clinician–patient using the same EHR system.161 The authors suggest replacement rather than a re-envisioning of care relationship and patient satisfaction.158 that the reason for the difference is that physicians delivery which could have taken greater advantage Physicians perceive EHR use as negatively in other countries are not required to fulfill many of the full benefits of electronic data management. altering patient interactions, and it can interfere of the reimbursement and other documentation Additionally, there remains a general unwillingness with the gathering of psychosocial and emotional regulations that are applicable in the United States. to standardize clinical and operational practices, information, thereby impeding the development Another burden that clinicians face is the not just at a national level, but within organizations of therapeutic relationships with patients.159 time spent on the reporting of quality metrics and even single clinics. Patient interaction is a critical aspect of clinicians’ for healthcare organization, payors, and work; therefore, these perceptions may adversely regulators. Although providers embrace the role New technologies, new challenges affect clinician satisfaction. The usability and of measurement in improvement, legislators, The pace of technological innovation in health interoperability problems with the EHR, combined regulators, and payors often do not agree on care is accelerating. Many developments, such with the demands of documentation and reporting how or what to measure. Even within the same as artificial intelligence (AI), predictive analytics, requirements, create an administrative and clerical institution, there are many needs for quality data genomic medicine, and robotics, have real potential burden for clinicians that allows less time for patient and measurement that are duplicative and too often to both enhance care quality and reduce clinicians’ care or non-work-related activities. According to burdensome. According to one study, practices workload. Other developments, such as social one study, primary care physicians spend more spend more than 15 hours per week per physician media and patient-facing health IT, could connect than half of their work hours interacting with the on quality reporting.162 Despite this, many EHRs do providers and patients and provide new ways for EHRs.56 This study also found that during clinical not include the functionality needed to fully report them to enhance their relationships. visits, primary care physicians spent 44 percent of mandated quality measures. Over time, technology can enhance people’s their time “computer facing” and only 24 percent on Generating tailored electronic reports of lives, but the risk of negative, unanticipated direct patient communication. clinical quality measures is challenging—measure consequences always exists. Technologies on the Another observational study found that specifications are often not customizable, and horizon carry both the promise of positive change ambulatory physicians (n = 57) in four specialties making the needed changes to provide useful quality and the risk of further increasing clinicians’ work spent 37 percent of their time in the exam room reports would be too costly and time consuming stresses and burnout. Furthermore, over the on EHR and desk work versus 53 percent on for individual practices. There is also a lack of past two decades, the increased technological direct patient interaction.68 In the inpatient setting, integration of other mandated administrative tasks sophistication of care in the United States has several time studies have found that medical into the EHR, such as for the Prescription Drug come with exponential increases in health care interns spend at least 40 percent of all inpatient Monitoring Program (PDMP) and pre-authorization, costs. If this latter trend continues, health care work time interacting with the EHR and that these which requires duplicative data entry and slows may be increasingly out of the reach of many. In increased documentation demands are associated workflow. These programs grew out of an urgent addition, the resulting systemic pressures for cost with erosions (12–13 percent) in the amount of societal need to address the opioid epidemic and a containment and greater clinical efficiency could time spent directly interacting with patients. For clinical need for gathering all available Schedule II adversely affect clinician well-being. every hour spent with a patient, physicians spend drug data at the time of prescribing. an additional 1–2 hours on the EHR at work, with The way that data from these initiatives are Artificial intelligence and machine learning additional time spent on the EHR at home after work presented to the prescriber in his or her workflow, Advances in emerging technologies are hours.68 however, is obtrusive and has led to unanticipated occurring at an accelerating rate in the health care Similarly, nurses also may spend up to 50 burdens. Similarly, legitimate concerns for sector and are transforming the clinical practice of percent of their time documenting in the EHR.122 organizational cybersecurity and patient privacy medicine. Physicians report that they hope future Especially in the first year post-implementation, have led to policies and procedures that have had innovations, such as the use of AI and natural clinicians spend more time interacting with current unanticipated and undesirable consequences for language processing, can address many of the EHR systems than they had spent documenting clinicians. frustrations they currently experience in using the in paper health records, although this is likely In isolation, federal policies may be manageable EHRs. dependent on many factors, including EHR in terms of their impacts on workflow. However, For example, current health IT applications are design and local configuration. The increased combined with policies required by cybersecurity increasingly able to recognize clinician’s speech, documentation time associated with EHR use has insurers and intuitional policies driven by local risk identify tumors on radiological or pathological been linked with clinician burnout.70,160 management, well-meaning efforts can become images, and propose differential diagnoses based a heavy weight borne by clinicians at the point of on structured data about patients’ signs and care. For example, the need to log out after each symptoms.

71 Importantly, there are many different AI methods Similarly, healthcare organizations and clinicians Finally, buy-in from both patients and clinicians will that have different goals and that take different may struggle with questions about liability and be essential for this to succeed. Further research approaches to achieving a task or solving problems malpractice associated with technology use, the into acceptability and adoption, particularly at the and consequently have different applications and performance and accuracy of newly adopted care team level, is warranted to ensure that the outcomes. For example, data mining (i.e., the technology, the evaluation of technological choices, innovations are effectively integrated into the care examination of large datasets to draw inferences and staying current with technological advances. AI delivery process. about relationships), often uses AI techniques. applications designed to manage intake and triage Machine learning (ML), a type of AI, can patients based on their reported symptoms and Telehealth be used to direct scarce resources—such as complaints are already in the marketplace and are Telehealth is the use of electronic information population health teams—based on the risk of being increasingly adopted by leading healthcare and communication technologies to provide health hospitalization or worsening disease. ML could organizations. care. Commonly, telehealth is delivered via Internet- be used to remove the burden from providers of While the real-world application of this based video conferencing connecting patients to payer prior authorization or fraud waste and abuse technology is just beginning to emerge and few clinicians in different locations in either real time audits. The most important attribute of this AI AI technologies have received FDA approval, the or asynchronously; however delivering care via method is that the system uses its outputs and new use of AI methods to reduce clinical burden is other modalities, such as by telephone or mobile data to refine or improve its ongoing performance one promising application of the technology in application, is also considered telehealth. without explicit human intervention. The result is an medicine. For example, AI-based applications have Two 2016 reviews, one in primary care and adaptive, dynamic, or learning system. the potential to auto-populate structured EHR fields one in mental health care, found that telehealth Deep learning is an ML approach that typically by extracting pertinent information from open- is both feasible and acceptable to patients across uses multilayered neural networks to achieve ended physician notes, using voice recognition different populations. It can improve efficiency better performance accuracy (but that requires during the patient encounter, identifying relevant and reduce cost and is as effective as in-person more hardware and more training). Deep learning data from older medical records, and interpreting care for appropriate clinical conditions.166,167 is particularly good for elucidating “hidden” but lab results.164 Health systems could also potentially Newer developments in this space include the potentially important patterns within very large use this same technology to automate quality remote delivery of medical procedures (e.g., unstructured datasets. In medicine, deep learning reporting, automate coding and billing, assist in “telesurgery”) and tele-assistive specialty care, algorithms are already performing some diagnostic error detection, and improve diagnostic accuracy. where either human experts or AI systems provide tasks more accurately than physicians.163 The While much of the technology needed to accomplish remote guidance during in-person clinician–patient technology also has the potential to assist clinicians this already exists in other settings, adapting the encounters. by suggesting appropriate, evidence-based clinical technology to do this in a health care setting is still Little published research has examined the actions that align with the latest evidence. This under development. relationship between the use of telehealth by could relieve some of the pressure that clinicians An example of an AI-based clinical tool is clinicians and clinician burnout. In a study of the face in managing emerging medical information— Microsoft’s EmpowerMD, which was developed as use of telehealth for child psychiatry patients in an something that many struggle to keep up with and a virtual scribe that “listens” to clinical encounters emergency room, the length of stay was reduced, that likely contributes to the overall work burden and autopopulates EHRs, allowing the clinician to as was the time that on-call psychiatrists spent and stress. devote his or her full attention to the patient. At traveling.168 The authors noted that the improved Additionally, it is becoming increasingly the end of the encounter, the clinician reviews (and efficiency associated with reducing the psychiatrists’ common for robotic surgery enabled with AI to accepts or modifies) the pre-populated EHR.165 travel burden by more than two hours per day freed assist in microsurgical procedures to help reduce Other innovations, such as the ability to search up time for activities outside of work. In theory, surgeon variations that could affect patient recovery. patient records by voice command (rather than this could reduce stress and reduce burnout. A Precision medicine allows physicians to select clicking and scrolling or typing), automatically small pre–post comparison study of the effects medicines and therapies to treat diseases based on integrating lab results into the patient record, of an overnight telehealth service in a critical an individual’s genetic profile in order to provide the intelligent alert prioritization, and auto-populating care system found that nurses in the intervention most effective treatment for a given patient and thus billing and documentation requirements based on group reported small but significant improvements improve care quality while reducing unnecessary doctors notes, remain aspirational at this point, in communication, in their psychological working diagnostic testing and therapies. While emerging but would also help alleviate some of the burden conditions, and on a burnout sub-scale (although it technologies hold promise in helping to reduce clinicians currently face in using EHRs. was unclear how burnout was measured).169 There clinician burden and are not currently part of the Fundamental changes will be required before were no improvements in the parallel control group. immediate pressures relating to clinician burnout, some of the technological innovations described The effects of telehealth on clinician well- it is possible that they will become a factor within above can become commonplace. Most current being warrant more study; to the extent that the next several years as the technologies mature EHRs were built to facilitate transactions and telehealth reduces the factors known to contribute and their adoption becomes more widespread. In information essential for billing and were not to burnout (e.g., workload, time pressure, work addition to the pace of change, which may be a intended to be fully interactive digital platforms for frustrations, and clerical/administrative tasks) or source of stress for clinicians, the adoption of new supporting patient care. Thus, EHR vendor platforms that it increases physician autonomy, it could be technologies into mainstream medicine will require as well as the national health IT infrastructure beneficial. However, poorly designed telehealth user the integration of such technologies into existing will need to be restructured. Ubiquitous health IT interfaces or unrealistic patient lists, for example, clinical workflows, practice guidelines, and support interoperability and data standards will be required. will likely have the opposite effect. Thus, like any systems. Government regulatory and compliance policies other technology or work process innovation, the The implementation of emerging technologies and rules will need to be modified to accommodate design and implementation are critical factors in its also will require additional education and training automated, albeit more verifiable, documentation. success. of practitioners to ensure that they are properly To encourage vendors to develop the technological using the technologies in the evaluation, diagnosis, solutions, federal processes and policies permitting and treatment of patients. Additionally, patient their use will be essential. There are both human expectations that clinicians should maintain pace capital and financial implications to developing and with state-of-the-art medicine in order to deliver the implementing such complex technological solutions. best available quality of care also may serve as a stressor. 72 Medical scribes scribes has produced improvements in physician the overall increase in efficiency that they bring Medical scribes have been proposed as a way satisfaction, including satisfaction with EHR use leads to a net-revenue gain.172 Scribes can be a of addressing clinician burnout since they can help and clinic workflow and perceptions concerning the meaningful addition to a team-based model and reduce the EHR-related demands experienced by amount and quality of time spent with patients.170 improve how a practice functions. That said, more clinicians and, in particular, by physicians (e.g., In a crossover study of 18 primary care physicians fundamental solutions are needed to address issues the administrative burden of documentation, time in 2 primary care facilities, primary care physicians of EHR design and workflow integration. Thus, it is spent on the EHRs outside of regular hours, the reported spending less after-hours time in EHR important that the increased use of scribes does EHRs interfering with patient–clinician relationships documentation and more time interacting with not distract health care actors from exploring and during encounters). Scribes are trained to assist patients.171 Scribes can help improve the timeliness developing other solutions, such as improvements physicians in documenting patient encounters in of encounter documentation. in the usability of EHR documentation (including the real time. Physicians review and approve the notes In general, patients report neutral or positive use of templates and macros), and the development drafted by scribes. experiences with medical scribes. Whereas the use of assistive technologies (e.g., speech recognition, Scribes can be in-house personnel (e.g., of medical scribes seems to improve work system artificial intelligence tools).173 medical assistants in a primary care clinic) or factors known to increase physician burnout (e.g., outsourced personnel hired through a scribe reducing administrative burden), there is no clear BEFORE MOVING ONTO THE NEXT SECTION, company.170 Scribes have been mostly used in evidence for its impact on physician burnout. PLEASE COMPLETE CASE STUDY 7. emergency departments and primary care settings. While adding scribes to a clinical team requires For instance, in primary care the use of medical a financial investment, there is some evidence that

Case Study 7 Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

In 2016, Dr. Philip Kroth, a specialist in biomedical informatics, hypothesized that the increasing use of health information technology, including electronic health and medical records, could lead to fatigue and burnout among clinicians.174 He decided to use validated surveys to investigate potential associations between electronic health record design and stress and burnout among physicians at several different medical centers. His team identified several concerns about EHR design, including: 1. Excessive data entry requirements 2. Long cut-and-pasted notes 3. Inaccessibility of information from multiple institutions 4. Notes geared toward billing 5. Interference with work-life balance 6. Problems with posture and pain attributed to the use of EHRs These design features accounted for a modest proportion of stress and burnout risk. Possible solutions highlighted by Dr. Kroth included allowing notes to be more geared toward clinical care rather than billing, shortening the length of clinical notes, switching to a “quiet dark” philosophy in which normal clinical and lab data are hidden by default (thus reducing cognitive load on the users), hiring medical scribes, improving ergonomic work conditions, and working with vendors and local information technology teams to speed up the EHR interface. Some healthcare systems, such as Hawaii Pacific Health in Honolulu, have enlisted front-line users to improve the EHR. Melinda Ashton, a physician from that hospital, described a program called “Getting Rid of Stupid Stuff” that asked all employees to review their daily EHR practices and nominate issues that were “poorly designed, unnecessary or just plain stupid.”148 Using these data, they removed 10 frequently-ignored alerts the EHR pushed to physicians.

1. What concerns identified by Dr. Kroth’s team are also issues at your workplace? Are there additional concerns unique to your practice environment that her team didn’t identify?

2. How could the solutions put forth by Dr. Kroth and Dr. Ashton be applied to your institution?

3. Think of three specific daily annoyances with your EHR software that could be fixed or eliminated without adversely affecting patient care. Who would you speak with to request these changes?

73 Emotional distress among medical students Despite evidence of abilities, those suffering including burnout, quality of life, or depressive from IS are unable to internalize a sense of symptoms.187 In a study of third- and fourth- Prevalence accomplishment, competence, or skill. Overall, year medical students, workload characteristics Many medical students, residents, and faculty they believe themselves to be less intelligent and (e.g., number of patients cared for last week, perceive burnout and depression to be an inevitable competent than others perceive them to be. A 1998 call schedule, inpatient/outpatient rotation) and part of education and training.175 Indeed, studies study by Henning et al., found that among medical, the current specialty of the clinical rotation were suggest that they are, in fact, relatively common. dental, nursing, and pharmacy students, 30% not independent predictors of burnout.186 In a A 2016 systematic review and meta-analysis of scored as impostors.182 Within this population, IS study of first-year pharmacy residents, however, 183 studies evaluating depression, depressive was found to be the strongest predictor of general a relationship was found between higher work symptoms, and suicidal ideation among medical psychological distress. A similar study by Oriel et al hours and greater levels of stress.188 And among students found an overall pooled prevalence of found imposterism present in approximately one medical residents, work hours, excessive workload, screening positive for depression of 27.2% (with third of their sample of family medicine residents.183 and overnight call frequency have been shown to significant heterogeneity among studies).10 The This was despite the fact that all the respondents increase the risk of burnout97, but the studies are overall prevalence of suicidal ideation was 11.1%. felt they were receiving the training necessary to inconsistent.176 Similar levels of depression or depressive symptoms succeed in their careers. Although the literature A 2005 study of 684 residents in and suicidal ideation were found in meta-analyses on IS remains preliminary, existing studies suggest otolaryngology–head and neck surgery reported a of studies of resident11 and attending physicians.5 a higher prevalence of IS in foreign-trained strong positive linear relationship between emotional Estimates from a comprehensive narrative residents.184 Other work has found a significantly exhaustion and hours worked which persisted after review of articles about medical student burnout higher prevalence among women as compared to adjusting for potential confounders.189 Additionally, (1990–2015) were that 35 to 45 percent of men.181 no relationship was found between self-reported medical students had high emotional exhaustion, There may be an association between the workload, work hours, call frequency and burnout 26 to 38 percent had high depersonalization, experience of IS and one’s career or training in two longitudinal studies of residents conducted and 45 to 56 percent had at least one symptom stage. Villwock et al., found that fourth year medical in 2003–2008.190,191 Studies also reported mixed of burnout, although the cut-off levels of scores students experienced a significant increase in findings related to resident well-being and the on assessment instruments varied by study and IS.181 This may be due to the students preparing 2011 Accreditation Council for Graduate Medical may not be clinically significant.176 In addition, high for and participating in the match process for Education (ACGME)-mandated changes to shift emotional exhaustion, high depersonalization, residency, a highly competitive and stressful time. length, night float rotations, and protected and overall burnout were more prevalent among This is consistent with the suggestion by Clance that sleep time.192 For example, a study of first-year medical students than in a national sample of age- impostor feelings are most pronounced when faced internal medicine residents found similar year- similar college graduates not studying medicine.177 with new challenges.185 As the student progresses end prevalence of burnout in cohorts that trained A multicenter study of 4,287 U.S. medical students through training, they assume more responsibility before and after the 2011 ACGME changes.193 In found that among the students identified as being and autonomy. For the medical student, this a 2012 single-institution study only 23% of the burned out, only about 25% had recovered after culminates in the first day of intern year, when residents thought that the 2011 duty-hour policy 1 year.29 they are called “doctor” but typically do not feel had a positive impact on their well-being, and most A national study of 3,588 second-year like the knowledge-able physician they desire to thought the policy had a neutral or negative impact residents found that variation in prevalence of be. In addition to the stresses associated with the on patient care.194 burnout by specialty was similar to the variation matching process, it is possible that fourth year In response to concerns raised by medical found in studies of practicing physicians.178 The medical students feel IS more acutely than in prior school program directors about the rigidity of analysis found that training in urology, neurology, years because they are closest to their first day as a its policy, ACGME reviewed the 2011 duty-hour emergency medicine, ophthalmology, and general doctor. IS, especially in relation to burnout, remains standards and revised the policy in 2017. Whether surgery was independently associated with higher an area in need of further investigation among the the changes had any impact on burnout is unclear. relative risks of burnout symptoms relative to medical student population. The 2018 iCOMPARE trial, published in the New training in internal medicine (the RRs ranged from England Journal of Medicine, however, found no 1.23 to 1.48), after controlling for other factors.178 Factors contributing to student/resident significant differences in mean emotional exhaustion One’s risk of burnout, as a medical burnout or depersonalization scores between cohorts of student, may vary by where one trained as an Learning and workplace conditions appear residents in 63 internal medicine programs who undergraduate. The prevalence of burnout among to be important drivers of emotional exhaustion trained under a flexible policy that resembles U.S. medical residents may vary according to and professional dissatisfaction among medical the 2017 ACGME requirements and those who where the individual trained prior to residency. A students, as is true of practicing clinicians. An trained under the 2011 ACGME standard duty-hour study of 16,394 internal medicine residents in the analysis of 1,701 U.S. medical students found that policies.195 The potential impact of a flexible policy 2008-2009 academic year found that international learning climate factors (e.g., being on a hospital for surgical trainees is less clear since studies to medical graduates were less likely to have burnout ward rotation or a rotation requiring overnight call) date have not included a validated measure of (45.1% vs. 58.7%, P<0.001), a finding that were associated with burnout.186 Longitudinal data well-being. However, a qualitative study to explore persisted on multivariate analysis that controlled showed that higher satisfaction with the learning some of these findings in greater depth found that for debt and other factors.179 Similarly, a small environment was an independent predictor of not residents perceived a flexible duty-hours policy to study of 150 medical residents from 13 specialties having burnout at baseline or 1 year later among have several advantages, including giving them the training in two hospitals showed that residents who medical students. ability to scheduled time off for personal needs.196 had completed medical school outside of the U.S. There is conflicting evidence about the The inconsistent evidence for any burnout- had significantly lower emotional exhaustion and relationship of work hours and workload to related benefits from mandated work-hour depersonalization.180 burnout among medical students. A study of first- restrictions may be explained by the possibility that Imposter syndrome and second-year (pre-clinical) medical students the potential benefits are obscured as a result of Related to burnout, but less investigated, is reported no significant association between hours work-compression (i.e., educational requirements the phenomenon of impostor syndrome (IS) or spent in lectures and small groups, hours of clinical and patient care duties remain the same despite a impostorism. This clinical syndrome is characterized experiences, hours and number of exams, or weeks reduction in work hours). by chronic feelings of self-doubt and fear of being of vacation and any measure of student well-being, discovered as an intellectual fraud.181

74 It’s also possible that medical students may feel a which defines its physicians as heroic and invincible potential to undermine both student competency sense of increased stress due to the perception of cannot even conceptualize a need for physician (by cheating and plagiarism) and good patient being less well prepared for clinical tasks (owing to and student self-care. Students disconnected from care (by lying about aspects of the physical exam less repetition and exposure to clinical encounters themselves in this way may be at greater risk of done and tests ordered, etc.).203 Evidence from or impressions given by supervisors). burnout. that study points to the fact that medical students with burnout score lower on measures of altruism Medical school culture of detachment Consequences of burnout and/or depressive Medical students may be susceptible to burnout and integrity, are less likely to endorse correct symptoms among medical students attitudes about managing conflicts of interests with in part because they are exposed to cultural norms Far from being a benign rite of passage, of detachment that promote emotional exhaustion industry, are less likely to have correct attitudes burnout can be a painful and disorienting experience about appropriate prescribing behaviors, and are and depersonalization.175 The culture of medicine and is associated with same kinds of negative can be “technocratic,” meaning it prioritizes less likely to believe that they have a personal consequences on health and the quality of patient responsibility to report impaired colleagues.203 technological progress, hierarchy, and domination care found in studies of burnout in post-licensure and may subtly view patients as “objects,” all of Other studies show that medical students with physicians. burnout have lower empathy, including a multi- which alienates physicians (or medical students) Several studies have found that residents from their patients. Such habits of objectification institutional study of 545 medical students, a with burnout are more likely to report delivering single-institution study of 127 fourth-year medical and dehumanization of patients are modeled and suboptimal care or having committed a medical communicated by physicians to medical students students, and a national study of 1,350 Brazilian error, although, as previously noted, higher levels medical students.1 These findings are important via medicine’s “hidden” curriculum. Patients of self-reported errors among providers who are may be referred to in a derogatory fashion and because empathy during medical school predicts “burned out” may reflect greater levels of rumination subsequent risk of burnout during residency.178 In conceptualized as tasks to finish or objects from associated with depression or depressive symptoms which to learn. Medical students are likely to absorb a longitudinal study of internal medicine residents, rather than objectively-determined levels of medical reduced empathy was an independent predictor of these attitudes, becoming disconnected from their errors.198,199 For example, a study, burnout among patients as human beings. higher odds of self-perceived error in the following a sample of 115 internal medicine residents found 3 months (West et al., 2006).204 A study of 254 Medicine’s principles-based ethics that burnout was significantly associated with self- (emphasizing universal concepts such as autonomy hematology–oncology fellows found high levels of reported suboptimal patient care practices, such burnout (over half reported at least 1 domain of and beneficence) may further serve to distance as dismissing patients from the inpatient service physicians from patients and themselves. Such burnout) and that lower levels of burnout were to make the service more manageable, not fully associated with more compassionate patient care, an approach to ethics teaches students they can discussing treatment options with patients, and “solve” moral dilemmas from afar and ignores the feeling prepared to manage one’s own feelings paying little or no attention to the social or personal about a patient’s illness and death, being able to personal and lived experiences of both patients 200 impact of illness on patients. handle the emotional distress of family members, and clinicians.197 Physicians effectively place Longitudinal studies of internal medicine themselves out of their patients’ lives by identifying and absolving oneself of guilt surrounding the residents have similarly found burnout to be an death of a patient.205 themselves with heroic invincibility and their patients independent predictor of residents perceiving that with illness, suffering and misfortune. While useful Mirroring the data from studies of physicians, they committed a medical error over the subsequent much evidence demonstrates a strong association for assuaging the physician’s own fears of illness 199 3 months. Consistent with this, medical residents between levels of burnout in medical students and and death, physicians and student physicians with burnout are also more likely to report greater may lose touch with their own humanity and their negative impacts on their personal health. Cross- struggles with concentrating at work, which is likely sectional studies in medical students and residents own selves.175 In addition, medical students are due to the fact that negative emotions can impede susceptible to excessive detachment because they show a relationship between burnout and suicidal learning, recall, and the application of knowledge thoughts. A multi-institutional longitudinal study of are still learning how to modulate their emotions. and skills.201 Medical students becoming stuck in a detached and 1,321 U.S. medical students found that burnout was Burnout’s adverse effects on learning and an independent predictor of students developing dissociated mode, a mode that lacks “emotional performance are further supported by a study of 29 coherence” and is perpetually numbing. thoughts of suicide over the course of 1 year. more than 16,000 U.S. internal medicine residents Even medical students without depression were at Emotional detachment is reinforced by cultural that reported a step-wise reduction in Internal norms in which medical students, like physicians, substantially higher risk of developing thoughts of Medicine In-Training Examination (IM-ITE) scores suicide if they had burnout. are expected to not show emotion, even while 179 as burnout symptoms worsened. In addition, in In a cross-sectional study of residents training they witness a steady stream of human distress. a study of 58 emergency medicine residents from 30 107 Unfortunately, the medical culture does not in the Netherlands and the United States , six institutions, residents with burnout showed suicidal thoughts were also more prevalent among acknowledge the physician’s need to experience lower cumulative performance scores on high- and process feelings. A consistent suppression of residents with burnout. As in previously-discussed fidelity simulation scenarios used for assessing research on alcohol use among U.S. physicians, feelings disconnects the medical student from life in 202 performance. Thus available data strongly cross-sectional studies of learners report that general. The consequences of disconnection from suggests burnout among medical students can self and life are profound, particularly for self-care burnout is associated with higher alcohol intake. For impede the acquisition of professional knowledge example, burnout was found to be an independent (i.e., recognizing, relieving, and avoiding stressful and skills and thus diminish the capacity of a situations; healthy eating, living, and sleeping; predictor of alcohol abuse and dependence hospital or clinic to provide the best patient care, in a multi-institutional study of 4,402 medical cultivating supportive relationships; asking for placing patients at risk in both the short term and 206 help; slowing down when one feels ill; grieving; students, and higher emotional exhaustion and the long term for suboptimal care and medical depersonalization scores were associated with and creating meaning from one’s experiences.) errors. Self-care depends upon the ability to reflect, to greater alcohol intake in a study of 168 family Professionalism among medical students medicine residents.207 notice one’s feelings and needs, and to remember and residents suffers with burnout as well, as it one’s unique vulnerabilities. Importantly, self- Some data suggest burnout in learners may does among post-licensure physicians. In a multi- increase the likelihood of them subsequently care can help students acknowledge and seek to institutional study of 2,682 medical students, alleviate their distress before it becomes burnout or developing poor mental health, but evidence from something worse. Unfortunately, a medical culture burnout was independently associated with small studies indicates that poor mental health may self-reported unprofessional conduct, with the not increase the likelihood of burnout. 75 In a study of 218 nursing students, emotional (Note: in 2020, the Federation of State dissatisfaction with the level of faculty support exhaustion scores at baseline predicted Medical Boards and the National Board of Medical was an independent predictor of burnout among psychological well-being 18 months later; however, Examiners announced that the scoring of Step first- and second-year students, while perceptions baseline psychological well-being did not predict 1 exam will change to pass/fail from the current of residents being cynical and the students’ subsequent emotional exhaustion, suggesting that three-digit score, effective no earlier than January dissatisfaction with the level of resident supervision the relationship is not bidirectional.208 1, 2022.)210 were independent predictors of burnout among Concordant with those findings, a multi- Those residents who take a medical leave due third- and fourth-year students.186 institutional longitudinal study of 185 first-year to illness or maternity may experience escalations of On the other hand, students reporting that internal medicine residents found no relation their stress as rigid training requirements constrain education was a priority for faculty members between past psychiatric history and the risk of the time available for self-care and personal life was an independent predictor of “never” having burnout over the course of 1 year.191 Burnout events. In addition, state medical license boards burnout (i.e., not having burnout at baseline or also appears to adversely affect learners’ physical and hospital credentialing and privileging processes 1 year later) and of “recovering” from burnout health. commonly inquire about previous emotional (i.e., having burnout at baseline but not 1 year later) in a separate multi-institutional study A longitudinal study of 340 internal medicine problems, including help-seeking behaviors. 203 residents showed a dose–response relationship Although such questions are well-established of medical students. In a study of residents between burnout and adverse risk to personal barriers to help-seeking for practicing physicians training in the Netherlands, dissatisfaction with the health; each 1-point decrease in a personal experiencing emotional difficulties, less is known emotional support received from supervisors was a strong predictor of emotional exhaustion and accomplishment score was associated with an 8 about their role in learners’ reluctance to seek help depersonalization, and this finding persisted upon percent increase in the odds of a self-reported for emotional problems. multivariate analysis controlling for other factors.214 blood and body fluid exposure in the subsequent It is likely, however, that factors such as a 27 Among 684 surgery residents, greater perceptions 3 months. Moreover, after controlling for fatigue, lack of time, a lack of confidentiality, the stigma of demands from attending physicians and lack each 1-point increase in an emotional exhaustion associated with using mental health services, cost, of independence correlated with higher emotional score or a depersonalization score was associated a fear of documentation on academic record, exhaustion scores.189 with a 3 percent increase or 4 percent increase, and a fear of unwanted intervention are all major 1 Residents with burnout are also more likely respectively, in the odds of reporting any motor barriers to help-seeking among medical students. to describe their relationships with supervisors as vehicle incident in the subsequent 3 months. Data show that medical students are more reluctant stressful. Reports of harassment and belittlement The stress associated with residency programs to seek help for a serious emotional problem are common among medical students, particularly may also take a toll at a cellular and molecular level, than the general population (and age-matched among women and minorities. Not surprisingly, which, in turn, may accelerate the aging process. individuals).211 A 2016 review and meta-analysis perceptions of recurrent mistreatment by faculty A 2019 longitudinal cohort study of 250 first-year of 16 longitudinal studies found that only 15.7% or residents are associated with an increased risk residents at 55 U.S. hospital systems during the of medical students who screened positive for of burnout among medical students.215 In a study 2015-2016 academic year evaluated associations depression actually sought psychiatric treatment.10 of 395 neurosurgical residents, perceptions of between measures of the residency experience and A 2015 study found that perceived stigma likely working with hostile faculty was an independent saliva-measured telomere attrition.209 (Telomeres explains why medical students with burnout do not predictor of burnout that persisted on multivariable are found at the ends of chromosomes and their actively seek help and, in addition, reported that analysis.216 length decreases with each cell replication cycle. faculty and peer behaviors may also influence a Other studies suggest a relationship between When telomeres reach a critically shortened length, learner’s help-seeking,211 which underscores the faculty teaching behaviors and learner burnout. cells no longer replicate and become senescent.) urgency to eliminate barriers to help-seeking for all For example, more favorable ratings of teachers, The study found that mean telomere length students and trainees.211 clear and explicit teaching styles, and direct among participants shortened significantly over observation of goals-of-care discussions was the course of the internship year from 6,465 base Schedule flexibility associated with lower emotional exhaustion scores pairs to 6,321 base pairs at the end of the year, Having some degree of control over their and better overall teaching quality, while more which was a rate 6 times higher than the normal education and daily lives can help to reduce frequent observation of the residents’ skills was attrition rate. Longer work hours were associated medical students’ stress levels. Medical students associated with lower depersonalization scores in with greater telomere loss (p = 0.002).209 who perceive having little control over their daily a sample of hematology–oncology residents.205 schedule or life are more likely to have burnout, and Although the direction of the relationship cannot be Licensure and credentialing issues among a sample of residents from 13 specialties determined from these cross-sectional studies, one The need to pass national standardized in two hospitals, perceptions of a lack of control longitudinal study involving 186 final-year medical examinations to obtain licensure is a known over office processes and schedule increased the students in Sweden found that positive perceptions stressor for medical students because how well they likelihood of burnout.212 A qualitative study of 26 of the first year of residency training environment, perform on these exams can significantly impact residents from seven specialty training programs driven by supervisors who incorporated residents’ their careers. For example, a medical student’s found that schedule flexibility was more important needs for education, feedback, and support, was US Medical Licensing Examination (USMLE) Step to some residents’ sense of well-being than an negatively associated with the development of emotional exhaustion (measured using Oldenburg 1 score has a strong impact on that student’s overall limitation of work hours.213 Overly rigid Burnout Inventory) during residency.217 Similarly, chances of getting a residency within his or her schedules amplify the challenges of completing when residents perceived their relationships desired specialty. The competition within select personal tasks, sending the message that personal residency training specialty programs is steep, with supervisors to be one of mutual support needs are inconsequential, which has been found to and benefit—that is, the resident benefited particularly in more desirable training locations. be a major stressor more often for residents with from a supervisor’s teaching and support, and Although well-accepted as an enormous stressor burnout than for those without. the supervisor benefited from the work done by for medical students, the way in which the USMLE the resident—residents had lower emotional Step 1 exam affects self-care behaviors and mental Quality of faculty support exhaustion and depersonalization scores.218 health has not yet been formally studied. The nature of the student/faculty relationship Residents with burnout are more likely to be can play a role in burnout. In a study of more dissatisfied with mentoring relationships, while than 1,100 medical students attending five a study of residents in a structured mentoring medical schools, Dyrbye and colleagues found that program had lower burnout scores.219

76 Self-care strategies among medical students ensure the protection of confidentiality, the consent Supporting wellness is critically important Medical students use a range of coping and self- of learners, transparency and honesty in reporting, to mitigating burnout. Burnout that begins in care strategies (e.g., exercise, hobbies) to manage and the regular evaluation and improvement of medical training or earlier can continue or worsen stress, and greater use of approach-oriented learner well-being as part of broader learning throughout the years of practice. coping strategies (as opposed to avoidant-oriented environment assessments.1 strategies) was shown to significantly decrease One example of organizational changes Given the potentially tragic consequences the risk of burnout in a cohort of 161 medical aimed at reducing burnout is a set of integrated, of burnout and the growing favorable evidence students.220 Residents who report lacking skills multifaceted, preclinical curricular changes of programs that promote resident well-being, to cope with stress are also more likely to report implemented at the Saint Louis University School of regulatory bodies, hospital systems, and training burnout.180 Exercise may be a particularly important Medicine (see case study below).222 programs need to join together to usher in a new self-care strategy. A study of 4,402 medical era of graduate medical education.229 students found that being compliant with exercise BEFORE MOVING ONTO THE NEXT SECTION, guidelines from the Centers for Disease Control PLEASE COMPLETE CASE STUDY 8 ON THE Conclusions about medical student emotional and Prevention was an independent predictor of NEXT PAGE. distress a lower risk of burnout and higher quality of life As this section has demonstrated, burnout and scores.221 Smaller studies of residents have found depressive symptoms among medical students and associations between greater physical activity and Building well-being into curricula residents are common and have important personal both an improved quality of life and a lower risk of A number of medical schools and residency and professional consequences, including alcohol burnout.207 How best to teach approach-oriented programs have introduced curricula to raise abuse or dependence, suicidal ideation, career coping strategies and if coping skills learned early awareness, promote self-care, and teach positive regret, suboptimal professional development, and, on are transferrable to later practice both warrant coping skills and mindfulness-based stress possibly, sub-optimal patient care. As with post- additional study. reduction in an effort to help learners promote their licensure physicians, medical school burnout can Strategies that increase a medical student’s well-being. In a national study of 27 U.S. medical arise from a mixture of individual, organizational, level of social support (from peers, friends, family, schools, more than half had a well-being curriculum, and societal factors including grading schema, or colleagues) may buffer against burnout, whereas and most offered a variety of emotional/spiritual, suboptimal clinical experiences, inadequate a lack of social supports (for example, because of physical, financial, and social well-being activities preparation and support, supervisor behaviors, a need to move to a distant city for residency) is intended to promote self-care, reduce stress, and peer behaviors, and a lack of autonomy. Although associated with higher levels of burnout.1 build social support for medical students.224 the evidence base for interventions to reduce Resources and infrastructure varied burnout risk remain limited, existing data suggest Organizational strategies to reduce medical substantially across the schools. In a 2012 survey that efforts much continue to improve the learning student burnout of 212 family medicine residency directors, nearly environment, to offer resources to promote well- The following strategies, most of which have all reported that they offered stress management being, and to support those suffering with symptoms little or no evidence to back them up, have been lectures or workshops in addition to residency of burnout and other mental health problems. suggested as ways to reduce the risk of burnout retreats and residency support groups.225 Less among medical students:1 than one-third held seminars in mindfulness or Individual interventions to promote well-being • Building a culture of respect meditation, supported athletic or mental wellness and reduce burnout • Move to pass-fail grading activities, or provided healthy food options. Interventions to prevent burnout (i.e., • Adopt formal advisor/mentor programs Studies on the efficacy of curricula have proactive changes) or improve the treatment or • Provide students with medical scribes to help primarily focused on mindfulness-based stress response to burnout (i.e., reactive interventions) reduce administrative load reduction and have used volunteer learners, with can target different levels of the problem, ranging • Create more ways to link advanced practice the majority reporting a reduction in burnout from the individual to the organizational, and up to providers and students and stress and improvements in mood and the societal. Some of the factors that can promote As part of their overall well-being strategy, empathy. However, most studies did not include physician burnout are out of the direct control of the some medical schools and residency programs an appropriate control group and were vulnerable clinicians who might be suffering from symptoms, assess learner well-being via internally or externally to volunteer bias. Several other studies have not such as the organizational or systems-level factors administered surveys or by reviewing data from found measurable improvements in learners’ stress discussed in previous sections. But some key Web-based self-assessment instruments completed and emotional health as a result of wellness and factors at an individual level can be modified, and stress management courses226 or facilitated small making changes at this level can have many positive by learners or collected nationally by external 227 organizations, such as the Association of American group discussion. A systematic review of the effects, not least making one less prone to burnout. Medical Colleges and ACGME. Doing so can be stress reduction and stress management literature helpful as data suggest that program directors of targeting student nurses concluded that many Enhancing wellness residency programs underestimate the prevalence work-site programs facilitated problem solving, One model of a holistic view of personal health of burnout among their residents and accurately self-management skills including relaxation and and wellness, which can form the basis for individual self-assessing one’s level of distress is challenging.1 interpersonal skills, affective well-being, and work efforts to build resilience and reduce symptoms of Aggregated data from self-assessment instruments performance, although a number of design and burnout, involves 8 inter-related dimensions of 228 34 can provide organizations and programs with just- evaluation inadequacies were identified. wellness: in-time information about the well-being of their Stronger evidence is needed to support the 1. Emotional Wellness involves awareness of learners and can allow for the identification of efficacy of wellness curricula aimed at improving your emotions as they occur, expressing and target groups or areas requiring focused attention learner well-being, and medical schools wanting to processing your emotions in a productive and and resources. Self-assessment can also help integrate wellness curricula should carefully consider positive way, using the insight provided by your learners more accurately self-calibrate their own the use of existing educational sessions so as to not emotions to guide your actions, approaching well-being, which may promote health behavior further overburden learners. In most situations, a life with optimism, creating interdependent change and help-seeking behavior before distress menu of offerings aimed at reaching a variety of relationships that involve trust and respect, learners, rather than required experiences, is likely and using healthy coping mechanisms. is severe. Effective strategies for measuring learner 213,229 well-being use validated measurement tools and to be of most benefit. 77 Case Study 8 Instructions: Spend 5-10 minutes reading the case study below, considering the questions that follow, and thinking about whether this type of intervention might be applicable in your setting.

Dr. Stuart Slavin, the Associate Dean for Curriculum at the Saint Louis University School of Medicine, recognized the mental health challenges facing his medical students and chose to take action by implementing a longitudinal program to improve medical student well-being and mental health at his medical school.223 Starting in 2006, he developed and implemented a simple model with three components: 1. Reduce unnecessary stressors and enhance the learning environment. 2. Teach students skills to better manage their stress and encourage them to use a range of psychological and emotional support resources. 3. Create more opportunities for students to find meaning in their work. Dr. Slavin believed that the following factors made his program successful: • Addressing the problem largely as one stemming from the learning environment. • Developing a deep understanding of the lived experience of students and avoiding making assumptions about what they need. • Reducing students’ cognitive load. • Addressing problematic student mind-sets through a modest resilience curriculum. • Treating students with respect and compassion. He implemented concrete changes to achieve these goals, including changing the pre-clinical grading scheme to pass/fail, reducing curriculum hours by 10%, omitting unnecessary details from lectures, instituting longitudinal elective courses for students, and creating a mindfulness and resilience course. Over the next decade, he and his team tracked the mental health of the students using longitudinal validated surveys and noted an 85% reduction in depressive symptoms and a 75% reduction in symptoms of anxiety among first-year medical students.

1. What kinds of validated questionnaires could one use to track depressive symptoms and anxiety symptoms among medical personnel?

2. How could such a program be implemented in your own medical school? Could such a program apply to more senior physicians, such as resident physicians and attendings?

3. To what extent should an organization be responsible for student and employee mental health? To the extent that it should be responsible, what stakeholders should be involved in the implementation of a well-being program?

2. Environmental Wellness involves living and 5. Occupational Wellness involves finding person- Spiritual wellness does not necessarily mean working in environments that are safe, healthy al satisfaction and fulfillment through work. It having a religion; rather, it focuses on your and facilitate your sense of well-being. Since entails using your talents and skills to their ability to attribute meaning to life and the day- our environments have a big impact on how fullest extent throughout your career as well to-day interactions you experience. we feel, it is important for your environment as understanding the need for and creating a to be pleasing to you, free from exposure to balance between work and personal time. How individual physicians attempt to make toxins and in balance with the broader natural 6. Physical Wellness involves being aware of and lifestyle and behavioral changes (i.e., “self care”) to environment. taking care of your body, including engaging achieve increased levels of health and wellness will 3. Financial Wellness involves accessing your in pleasurable physical activity and eating be as unique as the physicians themselves, but may financial resources and knowledge to direct food that is nutritious. Physical wellness also include one or more of the following components financial decisions and planning. It means involves obtaining regular medical check-ups, (some of which are expanded upon below): knowing how your investments are distributed sleeping well, and living tobacco-free. • Regular aerobic and/or strength-training and whether this is in alignment with your per- 7. Social Wellness involves creating meaningful exercise sonal values and desires. interpersonal relationships that feel support- • Yoga 4. Intellectual Wellness involves engaging in ive and satisfying. Social wellness also involves • Meditation mentally stimulating activities, creativity, and contributing positively to one’s community. • Balint sessions expanding your personal and professional 8. Spiritual Wellness involves having a belief • Setting aside fixed times for connecting with knowledge and skills. Intellectual wellness also system that is meaningful and matches your loved ones encompasses the exploration of new ideas values, establishing a life that feels purpose- • Using stress management techniques, pro- and information. ful, and being compassionate towards others. grams, or courses

78 • Creating “digital-free” times when phone and evaluated these ‘mindfulness-based’ intervention improvement in patient-centered care and self- computers are turned off techniques and showed that they potentially play esteem among general practitioners in both arms • Using the services of therapists or other men- a role in decreasing stress and burnout, although and this was more pronounced in the interactive tal health professionals to help with personal a 2006 Cochrane systematic review and meta- classes; however, both arms failed to decrease or relationship-related issues analysis concluded that evidence is insufficient to burnout scores. • Social activities that do not revolve around support that stress management programs can alcohol or other drugs (e.g., dancing, sports, help in reducing job-related stress beyond the Stress management hiking, or art classes) intervention period in healthcare professionals and Stress management ranges from relaxation • Participation in spiritual groups little evidence exists in long-term interventions with exercises to cognitive-behavioral and various • Exercise booster or refresher courses.235 patient-centered therapies. Evidence has shown A before-and-after study of 70 primary care that healthcare providers who seek help or Medical students and residents may have low physicians in Rochester, NY evaluated the effects who employ positive coping strategies tend to levels of physical activity due to the demands of of an intensive educational program that included experience lower levels of emotional exhaustion 244 their training. A study of 628 residents and fellows mindful meditation, self-awareness exercises, than those who do not. Stress reduction programs at a large academic medical center found that only narratives about clinical experiences, appreciative focusing on cognitive-behavioral techniques, have 31% met recommendations for physical activity interviews, didactic material, and discussions on been used to help prevent and treat burnout in set by the U.S. Department of Health and Human primary care physicians.236 Participants showed healthcare professionals. They can be divided into Services.230 But even modest increases in physical improvements in mindfulness, which was correlated programs focusing on primary, secondary, and activity or exercise have been shown to reduce risk with an improvement in their overall mood, empathy, tertiary prevention, where secondary and tertiary of burnout and enhance well-being. For example, a measure of emotional exhaustion, personal interventions focus on specific needs for each target study that introduced a 10-min stretching exercise accomplishment, and personality over the course group. Long-term effectiveness of these programs in the work place reduced anxiety levels and period with sustained effects of up to 15 months. in preventing burnout depends on providing a exhaustion symptoms while improving the mental Another pre-post study of 93 healthcare combination of psycho-educational treatment and physical well-being of healthcare workers.231 providers (physicians, nurses, psychologists) combined with follow-up booster sessions and Aerobic exercise has been shown to be negatively evaluated four types of formal mindfulness on the duration of the program, the focus on the 240 associated with depression, it helps reduce stress, practices: body scans, mindful movement, walking, problem, and the sustainability of the program. and improves biological markers associated with and sitting meditation, as well as discussions Systematic reviews evaluating stress depression and cardiovascular disease.232 focusing on the application of mindfulness in the management strategies among general medicine In a small pilot study on 12 physicians, 12 one- workplace.237 Scores on the MBI burnout scale practitioners (GPs) reported that relaxation and hour aerobic sessions were administered for 2 or 3 significantly improved after the course for both cognitive-behavioral skills proved helpful, with days weekly to reach the required level of weekly physicians and other healthcare providers in the group methods more cost-effective and more 245 energy expenditure of 17.5 kcal/kg measured by areas of emotional exhaustion, depersonalization, beneficial than individual counseling. Gardiner a calories counter.233 This was found to significantly and personal accomplishment. Mental well-being and colleagues evaluated the effect of 15 hours reduce the participants’ emotional exhaustion and, was also enhanced, but there were no significant of stress management training programs on 85 246 to a lesser extent, their degree of depersonalization, changes in the physical health scores. Australian GPs. The programs focused on stress although there was no significant change in their Similarly, Shapiro et al. and Martin-Asuero et reaction, psychoeducation, relaxation techniques, al., found that mindfulness-based stress reduction sense of personal accomplishment. In a study of and cognitive interventions. The work-related stress interventions effectively reduce psychological levels of participants significantly decreased, while the effects of exercise on burnout symptoms, 245 distress and negative mindsets and encourage medical residents and fellows enrolled in a 12-week, their general well-being and quality of life improved empathy while significantly enhancing physicians’ over a period of 12 weeks following the course’s team-based incentivized exercise program at the quality of life.238,239 Mindful meditative practice can 230 administration. Mayo Clinic. Twenty-nine percent of participants be a cost-efficient method of improving physicians’ reported at least weekly symptoms of burnout. At Skodova et al., showed that socio-psychological well-being and enhancing their approach to patient- training could lessen the level of burnout and the end of the study, quality of life scores were 240 centered care. positively influence the personality factors that are significantly higher among those in the exercise susceptible to burnout among medical students.247 program compared to a matched sample of peers Balint sessions In a similar study among medical residents, who did not enroll (median QOL score 75 vs. Balint sessions are group sessions that train Feld et al. found that an intervention program in 68, P<0.001), and levels of burnout were lower doctors on how to apply a patient-centered approach professional development improved residents’ (24% vs. 29%) although the difference was not with a special focus on doctor-patient relationships. self-awareness and willingness to explore their statistically significant.230 They are known as a common therapeutic strategy feelings. This program consisted of 11 sessions As previously noted, a study of 4,402 medical that reduces stress and burnout symptoms. of open discussions and problem solving within a 248 students found that being compliant with exercise Although rigorous clinical trials are lacking, small flexible, group-determined set of agenda items. guidelines from the Centers for Disease Control and observational studies suggest that Balint sessions McCue et al. concluded that a single, all-day Prevention was an independent predictor of a lower may help to prevent stress and burnout, especially stress management workshop given to medicine 221 among medical residents.241 A qualitative study of and pediatric residents reduced mean levels of risk of burnout and higher quality of life scores. emotional exhaustion for as long as 6 weeks after 9 general practitioners who had attended Balint the intervention.249 Finally, a study conducted Mindfulness meditation sessions for between 3 and 15 years found that among family medicine residents showed that their Mindfulness meditation is typically a self- participants reported increased job satisfaction, emotional exhaustion had eased as a result of a directed practice for relaxing the body and calming improved confidence and sense of professional program of meditation and breathing exercises.250 the mind through focusing on present-moment identity, and increased sense of security as a result awareness.234 The emphasis is staying in the present of their attending Balint therapeutic sessions.242 Computer-based wellness interventions moment, with a nonjudging, non-striving attitude Another study compared the effect of a didactic Although the best strategy to help physicians of acceptance. Mindful meditation represents a problem-based program of reading assignments, improve their well-being is unknown, computer- complementary therapy that has shown promise in lectures and discussions to an “interactive” based, interactive, and individualized interventions the reduction of negative stress and the extraneous program of similar assignments plus Balint groups have been shown to be an effective approach to factors that lead to burnout. Many studies and one-to-one counseling.243 It found measurable promote behavioral change and reduce the risk of burnout. 79 An interactive and individualized intervention based The small group topics included work-life Summary recommendations on the Mayo Clinic Physician Well-Being Index balance, medical mistakes, meaning in work, A number of proposals from both individual (MPWBI) was evaluated in approximately 1100 U.S. and resiliency. Participants completed surveys physicians, wellness officers, and medical surgeons (84% male) in 2013.35 After answering at baseline and then quarterly assessing overall organizations have been made to make progress baseline questions regarding how they believed quality of life (QOL), burnout, depression, meaning against the array of factors involved in the current their well-being compared with their colleagues, from work, social isolation, and job satisfaction. unacceptably-high levels of physician burnout. For participating surgeons completed an online version Of 125 study volunteers, 64 and 61 example, Dr. Tait Shanafelt, Chief Wellness Officer at of the MPWBI after which they received immediate, participants were randomized to the intervention Stanford Medicine, and Dr. John Noseworthy, Chief individualized feedback. Surgeons were then asked and control arms of the study, respectively. At Executive Officer at the Mayo Clinic have proposed a series of follow-up questions regarding the utility baseline, no statistically significant differences were nine strategies to reduce physician burnout that can of the feedback and whether they planned to make observed between the study groups for any well- be adapted for specific organizations:254 specific changes based on the information provided. being variable. Participants in the COMPASS groups 1. Acknowledge and assess the problem—to When surgeons received objective, experienced statistically and clinically significant determine the well-being of the medical staff, individualized feedback on how their well-being improvements in multiple domains of well-being one can begin by assessing any number of compared with normative samples of physicians and satisfaction, including overall QOL, the domains including professional satisfaction, and potential personal and professional risks, they depersonalization and personal accomplishment burnout, engagement, stress, quality of life, recognized the need for a change. Nearly half of domains of burnout, meaning from work, social the study participants indicated that they were isolation, and job satisfaction (Table 3). The results and work/life balance. These can be used to considering making at least one change to reduce suggest that a relatively non-intensive intervention determine a starting point and then tracked to burnout, reduce fatigue, promote work-life balance, involving self-selected physician small group evaluate progress. or promote career satisfaction as a direct result of meetings can be effective in promoting physician 2. Harness the power of leadership—it is the individualized feedback.35 Those with greater well-being, meaning from work, and job satisfaction. clear that leaders who effectively engage their distress were considering a greater number of Another study evaluated the effectiveness of a staff have a major impact on both the risk of changes as a result of the feedback. The authors web-based Cognitive Behavioral Therapy program burnout and professional satisfaction of this study speculated that since physicians have delivered prior to the start of the first year of 3. Develop and implement targeted reached their standing by being high achievers, residency in 199 interns at 2 university hospitals interventions—although many drivers of 252 feedback to those in distress on how their well-being during academic years 2009-10 or 2011-12. burnout are known, each organization and relates to peers may leverage their competitive Participants were randomized to a study group unit within an organization will have its own nature and desire to be successful to help promote (involving 30 minutes of study each week for 4 changes to improve their well-being.35 weeks prior to internship) vs. an attention-control culture and issues. It might be wise to start In 2014, West and colleagues conducted group who got emails with general information in a unit with the highest level of burnout from a randomized controlled trial of a 6-month about depression, suicidal thinking, and local mental an institutional assessment or one that is the intervention involving 12 biweekly one-hour health providers. The PHQ-9 was used to assess greatest outlier from national benchmarks meetings of self-formed groups of 6–8 academic suicidal ideation at 3-month intervals throughout 4. Cultivate community at work—this can be internal medicine physicians, termed COMPASS the year. During at least one time point over the done by restoring formal space for physicians Groups (COlleagues Meeting to Promote And course of the internship, 12% of those in the CBT to gather and by providing resources and Sustain Satisfaction).251 Each intervention session group endorsed suicidal ideation compared to 21% time for professional bonding and friendship. consisted of a brief 15-minute group discussion in the control group—in other words, those in the The creation of COMPASS groups (Colleagues of an assigned topic relevant to the physician CBT group were 60% less likely to endorse suicidal 252 Meeting to Promote and Sustain Satisfaction) experience and drawn from prior physician well- ideation (RR 0.4, 95% CI 0.17-0.91). in which six to seven colleagues at Mayo being literature, followed by 45 min for a shared lunch or other group activity as determined by BEFORE MOVING ONTO THE NEXT SECTION, shared a meal together in the evening, paid each group itself. Each participant received $20 PLEASE COMPLETE CASE STUDY 9 ON THE for by the institution on a biweekly schedule, per session for meal expenses. Control participants NEXT PAGE. improved both belief in the meaning of work were wait-listed to complete their own small groups as well as symptoms of burnout.108 after the initial 6 months to ensure equity in study reimbursement opportunities. Table 3. Between-group changes in well-being measures after 6 months251 Outcome COMPASS group Control group Poor QOL* -13.0 % -6.2 % Overall QOL Score (0–10)* +0.72 +0.20 High Emotional Exhaustion -10.0 % -7.3 % High Depersonalization* -4.4 % +2.4 % Low Personal Accomplishment* -10.2 % +8.8 % Overall Burnout -6.1 % -7.1 % Positive depression screen -7.5 % -8.7 % High Meaning from Work* -0.8 % -8.7 % Social Isolation* -0.15 +0.38 High Job Satisfaction* +15.7 % +7.8 % Likelihood of Leaving in Next 2 Years* +0.7 % +5.8 % * = P < 0.05 for between group comparison 80 Case Study 9114

Mark Linzer, MD, an internal medicine doctor and Director of the Division of General Medicine at Hennepin County Medical Center (HCMC) in Minneapolis, wanted to help physicians sustain their busy workload by applying the findings from the Healthy Work Place cluster randomized trial that he led.253 Following Dr. Linzer’s suggestion, HCMC established a Provider Wellness Committee composed of physicians and advanced practice providers from 12 departments. Their goal was to support and sustain provider wellness. Within one year of implementing the Provider Wellness Committee, reports of provider burnout decreased from 33 percent to 27 percent. All 16 departments at HCMC now have a Wellness Champion who acts as the “face of wellness” for their department and who can be approached with complaints and suggestions. One of the committee’s first major initiatives was to transform selected physical spaces. The former Doctors’ Dining Room was renamed the Provider Dining and Wellness Center and it was transformed into a multi-purpose area open to all physicians, nurse practitioners, physician assistants, psychologists, and dentists. Space was created for exercise equipment, lockers, showers, and a dressing room to accommodate providers who exercise during the day or bike to work. The space is also used for weekly Reflection Rounds, where residents can talk in a safe and supportive environment about the challenges of practicing medicine. A Reset Room was also created for providers who want to have a few quiet moments away from colleagues and residents, as a place they can go if they need to regroup after a traumatic encounter with a patient, or as a place to take a private phone call. The Reset Room is a serene environment modeled after a spa relaxation room. The Provider Wellness Committee also administered an annual wellness survey comprised of 10 questions and one optional open-ended question. Survey results are shared in small meetings with the chairs of each department. Departments with low burnout rates are targeted to learn what makes them function so well. The survey findings are not shared outside of departments or used to compare one department to another. There is also no benchmarking to other organizations or departments across the country. The survey is only used to assess each department’s progress year to year. Committee members and Wellness Champions are given paid time off to participate in the annual wellness retreat which allow members to discuss initiatives, share ideas, connect with others, and brainstorm new interventions.

5. Use rewards and incentives wisely— Linzer and colleagues presented a separate, internally accommodating to external compensation plans that are structured to but related, set of initiatives to prevent burnout stressors. Teamwork, such as in the Patient- increase revenue only can have a profound in general internal medicine practices:255 Centered Medical Home (PCMH), is critically negative effect by leading physicians to 1. Ensure that metrics for institutional success important for burnout prevention through decrease time with patients or work longer include physician satisfaction and well- support and sharing of clinician workload. hours. Flexibility of schedules and protected being. Any system that does not measure, Leaders should assure protected time for time may be a great carrot rather than monitor and optimize clinician well-being and reflection, planning and relationship building monetary rewards. sustainability is at risk. We suggest measuring and provide communication coaching for 6. Align values and strengthen culture— the following metrics: predictors (e.g., work challenging situations. mission statements are typically altruistic but it control, time pressure, pace of work [chaos] 4. Decrease stress from electronic health records is important to evaluate honestly institutional and values alignment between clinicians (EHR). Strategies to address this include and leaders), and outcomes (e.g., physician changing visit length to accommodate the extra choices genuinely reflect the professed values satisfaction, stress, burnout and intent to work that computerized data brings, or adding and be willing to address deviant practices. leave the practice). Tools for these measures “desktop” slots to daily schedules. Additional 7. Promote flexibility and work-life and their relationships with quality of care stresses have arisen from patient portals integration—allowing physicians to adjust have previously been published and short which increase after-hours communication. their schedules for seasons of life will go a measurement tools are in development. We propose measuring workloads, both direct long way toward helping address this driver 2. One mechanism to accomplish this work is (with patients) and indirect, as well as stress of burnout. to form a clinician wellness committee such due to the EHR. These results should be part 8. Provide resources to promote resilience as those at Stanford University and within of an organization’s “dashboard” of clinical and self-care—this will only be well received the Permanente Medical Group of Kaiser outcomes. as part of a larger strategy, but it is important Permanente. These committees are staffed 5. Address challenging work conditions in primary in its own right. with divisional champions from across care clinics, especially those serving minority 9. Facilitate and fund organizational disciplines. Attention to healthy eating, patients. Improving work conditions in these science—study changes made and try to exercise, and efforts to minimize stress hold clinics will require leaders to provide sufficient determine those that effective and those that great promise for decreasing burnout. clinical resources (supplies and equipment), are not. 3. Incorporate mindfulness and teamwork for room availability and access to specialists. trainees and practicing clinicians. Mindfulness, Indeed, these “work condition quality metrics” a known stress reducer, is a means for will be useful for clinics serving all patients.

81 6. Cover predictable life events with clinician defined by altruism and compassion in treating 5. Support clinicians and students by having state “float pools.” A typical internal medicine others. We propose that professionalism be licensing boards, health system credentialing division has 10% fewer full-time-equivalent extended to include how physicians care for bodies, disability insurance carriers, and clinicians because of predictable life events themselves. Physician distress negatively malpractice insurance carriers either not ask among staff. Planning for life events with impacts both physicians and patients. about clinicians’ personal health information float pool coverage may be cost effective, as Adjusting traditional views of the “diligent, or else inquire only about clinicians’ current coverage raises morale and avoids burnout hardworking, self-sacrificing” physician to also impairments due to any health condition. and turnover. prioritize physician self-care will take strong State legislative bodies should create legal 7. Develop practice models that preserve leadership. protections that allow clinicians to seek and physician work control. Many health care receive help for mental health conditions organizations are “standardizing” to Conclusions as well as to deal with the unique emotional reduce variations in physician work (e.g., and professional demands of their work requirements for specific numbers of sessions This learning activity has reviewed the complex without the information being admissible in per week, patients per session, etc.). While issue of clinician emotional exhaustion, professional malpractice litigation. standardization may lead to better work role dissatisfaction, burnout, and depression and 6. Invest in research by having federal agencies has summarized the evidence for its extent, its definition, it also reduces flexibility and control. support studies examining optimal measures nature, and potential approaches to reducing its The “demand-control” model of job stress of occupational stress, burnout, and prevalence, which varies significantly depending on shows that high work demands are mitigated the instruments used to assess it, the criterion by workplace well-being, health care system by work control. To preserve work control, which results are scored, by professional specialty, factors that contribute to distress, and tests standardization must still allow clinicians to and by a host of individual and organizational of system-level interventions. “customize” their schedules to allow space for factors. Briefly, current reports and guidelines about their other clinical and non-clinical activities. burnout suggest the following recommendations References for this activity can 8. Support manageable primary care panel sizes, for eliminating unnecessary clinician burden and lengthened visits and enhanced staffing ratios. supporting professional well-being: be found at references.cme.edu One demonstration project in Seattle reduced 1. Improve work environments to reduce the panel sizes, lengthened visits and supported risk of burnout, foster professional well- teamwork through adequate staffing. This being and a healthy home/work balance, and was accompanied by a sharp drop in burnout, enhance patient care. Organizations should yet costs were neutral and quality preserved. routinely measure clinician burnout and work This suggests that altering staffing ratios may to eliminate factors that erode professional reduce stress and burnout. Leaders in PCMH well-being. care have recently called for “sharing the 2. Create positive learning environments in care” with expanded primary care teams. schools of medicine by evaluating current 9. Address “career fit” so faculty have time to do what they are passionate about. We propose systems that might be contributing to burnout that it is cost effective to provide at least one and by routinely assessing students and the half day per week for clinicians to do what they learning environment to identify risks and are most passionate about. Weekend, evening, potential solutions. and night hours present unique challenges to 3. Reduce administrative burden by having work-life balance, while creating opportunities health care policy, regulatory, and standards- to provide time off during traditional weekday setting entities at the federal and state levels working hours. Successful careers will be systematically assess laws, regulations, more likely in hospital-based medicine if policies, and standards to determine their academic hospitalists are effective in both effects on clinician job demands and resources “systole” (clinical work) and “diastole” (non- as well as the effects on patient care quality, clinical work and time off). safety, and cost. 10. Promote career opportunities and 4. Enable technology solutions by including advancement for part-time physicians. Flexible career policies including part-time clinicians in the design and deployment work and shared medical practices (job of health information technology and by sharing) between two physicians are critical using human-centered design and human for enhancing work/life balance. Part-time factors and systems engineering approaches physicians are satisfied with their careers, to ensure the effectiveness, efficiency, provide high-quality care, and are less likely usability, and safety of the technology. to leave their jobs. The gender differences in Federal policymakers, in collaboration with burnout identified among US physicians are private sector health information technology not seen in the Netherlands, where 75% of companies and innovators, regulators, health women physicians work part-time. Part-time options allow institutions to use a more flexible care organizations, and clinicians, should career life cycle approach to meet the needs develop the infrastructure and processes for of an increasingly diverse workforce and a truly patient-centered and clinically useful prevent burnout. health information systems. 11. Prioritize physician self-care as an element of medical professionalism. Professionalism is

82 PREVENTING CLINICIAN BURNOUT

31. What is the prevalence of burnout among physicians as 36. According to one study, for every hour physicians spend in the United States when assessed using a rigorous in face-to-face time with patients, how many hours do definition of burnout? they spend using electronic health records or doing A. 6% desk work? B. 16% A. 1.5 hours C. 26% B. 2 hours D. 46% C. 2.5 hours D. 3 hours 32. The estimated prevalence of suicidal ideation among physicians is approximately ______? 37. Roughly what percentage of patients could be classified A. 5% as “difficult” and, hence, contribute to physician stress B. 11% and emotional exhaustion? C. 15% A. 2-5% D. 21% B. 5-10% C. 10-15% 33. The prevalence of suicide is significantly higher among D. 15-20% what subpopulation of physicians, compared to the general population? 38. Although income levels are not associated with burnout, A. Attendings what aspect of physician compensation does appear to B. Men increase the risk of burnout? C. Residents A. Tying compensation to productivity D. Women B. Tying compensation to levels of patient satisfaction C. Providing bonuses for higher numbers of procedures 34. Which of the following statements most accurately completed describes an important aspect of burnout among D. Cutting salaries when required to maintain the financial viability physicians? of a health care organization A. Burnout is more common among male physicians than among female physicians 39. Which of the following is an example of systems-level B. Burnout is more likely to manifest as depersonalization in intervention to help reduce physician burnout? women, and as emotional exhaustion in men A. Balint sessions C. Burnout is more likely among older physicians than younger B. Mindfulness meditation physicians C. Interpersonal therapy D. Burnout is more likely to manifest as emotional exhaustion in D. Schedule changes women, and as depersonalization in men 40. What was the goal of the AMA’s Joy in Medicine 35. Which component of physician workload has been Recognition Program? shown to be particularly taxing and associated with A. To identify physicians who have successfully implemented higher levels of burnout? changes in their work/life balance that reduced stress and A. Dealing with terminal patients burnout B. Working night shifts B. To bring attention to organizations trying to improve physician C. Taking calls at night satisfaction and reduce burnout D. Dealing with difficult patients C. To acknowledge hospitals that have reduced documented rates of burnout by 10% or more D. To recognize medical school programs that enhance wellness and emotional health among students

83 41. Which of the following is a component of the Patient- 47. What individual-based practice has been shown to be Centered Medical Home model that could help reduce an independent predictor of lower risk of burnout and burnout? higher quality of life among medical students? A. Collaborative clinical decision making A. Regular exercise B. Streamlined billing procedures B. Avoidance of alcohol C. Electronic medical record integration C. Good sleep hygiene D. Care-team huddles D. Mediterranean diet

42. Which type of technology has been the focus of 48. What is the name of an intervention consisting of group literature about the relationship of physician burnout trainings for doctors about using patient-centered and technology? approaches with the aim of improving the doctor- A. Electronic Health Records patient relationship? B. Patient healthcare “portals” A. Bashur sessions C. Tele-medicine B. Bandura sessions D. Clinician performance-tracking software C. Balint sessions D. Beck sessions 43. What occurred in 2009 that spurred the adoption of electronic health records across the country? 49. ______is an example of a discussion- A. Introduction of new semiconductor chips enabling more group intervention aimed at reducing symptoms of powerful computers and computer networks burnout among internal medicine physicians. B. Congressional passage of the HITECH Act A. MD-Listen C. AMA adoption of the HITECH guidelines for effective use of B. COMPASS groups electronic health records C. Talk About It D. Post-recession price drops in the costs of health-related IT D. HI-QOL sessions equipment and computers 50. A web-based Cognitive Behavioral Therapy program has 44. How much time do primary care physicians typically been shown to ______? spend using electronic health records? A. Increase self-reported resilience among female physicians A. Nearly all of their working hours aside from face-to-face who screened positive for burnout patient interactions B. Reduce self-reported symptoms of depression among B. Approximately one-third of their total working hours physicians C. About one-quarter of their total working hours C. Reduce suicidal ideation among first-year residents D. Roughly half of their total working hours D. Improve psychological wellbeing of first-year medical students

45. Which of the following is an example of an artificial- intelligence-based tool to facilitate better provider/ patient encounters? A. Advanced MD Solutions B. EmpowerMD C. iPatient Care D. Medics Suite

46. What is one proposed solution to the problem posed by the increasing time demands of electronic health records? A. Medical scribes B. Automated reminders to exit EHR systems C. Use of digital video recordings of patient encounters instead of written records D. Use of artificial intelligence systems to identify errors in EHR

84 SUICIDE ASSESSMENT Release Date: 03/2020 6 AMA PRA Enduring Material & PREVENTION Expiration Date: 02/2023 Category 1 Credits™ (Self Study)

TARGET AUDIENCE

This course is designed for all physicians (MD/DO) and other health care practitioners. Read the course materials

Complete the self-assessment questions at the end. A score of 70% is required.

Return your customer information/ COURSE OBJECTIVE answer sheet, evaluation, and payment to InforMed by mail, phone, fax The purpose of this course is to educate physicians about the latest or complete online at course evidence-based practices for assessing suicide risk and managing at- website under NETPASS. risk patients with non-pharmacological and pharmacological therapies. The course includes focused learning on specific populations at high risk of suicide, including Veterans and active-duty military personnel, older adults, and physicians.

LEARNING OBJECTIVES

Completion of this course will better enable the course participant to: 1. Assess a patient’s suicide risk and collaboratively determine the best treatment method. 2. Describe strategies to minimize the risk of future suicide attempts. 3. Explain the concept of patient-centered care in the context of suicide prevention. 4. Describe the specific challenges of managing suicide in the population of Veterans and active-duty military personnel.

ACCREDITATION STATEMENT InforMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Thomas E. Joiner, PsyD Director, Psychology Clinic Department of Psychology Florida State University 6 Stephen Braun AMA PRA CATEGORY 1 Medical Writer CREDITSTM Braun Medical Communications

This course awards six (6) AMA PRA ACTIVITY PLANNER Category 1 CreditsTM.

Michael Brooks Director of CME, InforMed As a prerequisite to license registration renewal, licensed MD/DOs must complete 48 hours of CME and licensed PAs must complete 40 hours of CME every two (2) every two (2) years during their biennial DISCLOSURE OF INTEREST registration period. In accordance with the ACCME Standards for Commercial Support of CME, InforMed implemented mechanisms, prior to the planning and implementation of this CME activity, to identify and resolve conflicts of interest for all individuals in a position to control content of this CME activity.

FACULTY/PLANNING COMMITTEE DISCLOSURE

The following faculty and/or planning committee members have indicated they have no relationship(s) with industry to disclose relative to the content of this CME activity: • Thomas E. Joiner, PsyD • Stephen Braun • Michael Brooks

STAFF AND CONTENT REVIEWERS

InforMed staff, input committee and all content validation reviewers involved with this activity have reported no relevant financial relationships with commercial interests.

Figure 1: Suicides among general U.S. population,on and U.S. Veterans3 Brief history of suicide prevention in the U.S. In 1958, the first suicide prevention center in the United States opened in Los Angeles with funding from the U.S. Public Health Service.14 Other crisis intervention centers followed. In 1966, the Center for Studies of Suicide Prevention (later the Suicide Research Unit) was established at the National Institute of Mental Health (NIMH) of the National Institutes of Health (NIH). This was followed by the creation of national nonprofit organizations dedicated to the cause of suicide prevention. In 1970, NIMH convened a task force in Phoenix to discuss the status of suicide prevention in the United States. NIMH presented the findings in the 1973 report Suicide Prevention in the 70s, which also identified future directions and priorities.

87 In 1983, the Centers for Disease Control and Activity in the field of suicide prevention has state/territorial, tribal, and local levels. As with Prevention (CDC) established a violence prevention grown dramatically since the National Strategy other health promotion efforts, suicide prevention unit that brought public attention to a disturbing was issued in 2001. Government agencies at programs should be culturally attuned and locally increase in youth suicide rates. In response, the all levels, schools, nonprofit organizations, and relevant.14 Secretary of the U.S. Department of Health and businesses have started programs to address Suicide prevention efforts seek to reduce the Human Services (HHS) established a Task Force on suicide prevention. Recent milestones in the history factors that increase the risk for suicidal thoughts Youth Suicide, which reviewed the existing evidence of suicide prevention in the United States include and behaviors and increase the factors that help and issued recommendations in 1989.15 the formation of the National Action Alliance for strengthen, support, and protect individuals from Suicide became a central issue in the United Suicide Prevention, in 2010, and the revision of suicide. Risk factors are characteristics that make it States in the mid-1990s, when survivors of the National Strategy in 2012. These milestones more likely that a person will think about suicide or suicide loss mobilized attention and political will represent continuing progress toward the engage in suicidal behaviors. Although risk factors to prevent suicide in the nation. Using the United prevention of suicide in this country. generally contribute to long-term risk, stressful Nations (U.N.) guidelines for the creation and events, such as relationship problems, financial implementation of national strategies published in Two key initiatives difficulties, or public humiliation could provide the 1996, these grassroots groups launched a citizen- Enacted in 2004, the Garrett Lee Smith impetus for a suicidal act. initiated campaign to encourage the development Memorial Act (GLSMA) was an important legislative Protective factors are not just the opposite or of a national strategy in the United States. These accomplishment in the field of youth suicide lack of risk factors. Rather, they are conditions that efforts resulted in two Congressional Resolutions prevention. The act was named for Oregon Senator promote strength and resilience and ensure that recognizing suicide as a national problem and Gordon Smith’s son, a college student who died vulnerable individuals are supported and connected suicide prevention as a national priority. As by suicide in late 2003. The GLSMA created the with others during difficult times, thereby making recommended in the U.N. guidelines, these groups first significant federal grant program directed suicidal behaviors less likely (although such factors set out to establish a public and private partnership specifically at suicide prevention. Administered by do not ensure protection and should not be overly- that would be responsible for promoting suicide the Substance Abuse and Mental Health Services weighted by clinicians). prevention in the United States. This innovative Administration (SAMHSA), the program provides Risk and protective factors for suicidal public-private partnership jointly sponsored grants to states, tribes, territories, and institutions behaviors can be found at many levels, from the a national consensus conference on suicide of higher education for the implementation of youth individual to the community and society at large. prevention in Reno, Nevada, which developed a list and college suicide prevention efforts. More than The social ecological model (see Figure 2) provides of 81 recommendations. 300 GLSMA suicide prevention grants have been a framework for viewing these factors along The Reno conference is viewed as the founding funded since the program’s inception, including 27 four levels of influence: individual, relationship, event of the modern suicide prevention movement. grants funded through the Prevention and Public community, and societal. The figure lists the major Informed by its findings, in 1999, Surgeon General Health Fund created by the Affordable Care Act. risk and protective factors for suicidal behaviors David Satcher issued his Call to Action to Prevent Another federal law, the Joshua Omvig Veterans identified in the literature. Because these Suicide, which emphasized suicide as a serious Suicide Prevention Act (JOVSPA) of 2007, has factors can vary between individuals and across public health problem requiring attention and supported the development of a comprehensive settings, the examples listed in the figure are not action.16 This document introduced a blueprint for program to reduce the incidence of suicide among comprehensive. addressing suicide prevention through a number veterans. Named for a veteran of Operation Iraqi of efforts organized under the framework of Freedom who died by suicide in 2005, the act Patient-centered care “Awareness, Intervention, and Methodology” (AIM). directed the Secretary of the U.S. Department of Patients bring perspectives, values, and It included 15 broad recommendations consistent Veterans Affairs (VA) to implement a comprehensive preferences to their healthcare experience that can with a public health approach to suicide prevention, suicide prevention program for veterans. differ from those of clinicians. The following ideas along with goal statements and broad objectives. Components include staff education, mental health and suggestions about aspects of care important In 2001 the HHS Secretary released the assessments as part of overall health assessments, to patients at risk for suicide emerged from focus National Strategy for Suicide Prevention, which a suicide prevention coordinator at each VA medical groups conducted as part of the 2019 revision of set forth an ambitious agenda, consisting of 11 facility, research efforts, 24-hour mental health the Department of Veterans Affairs/ Department goals and 68 objectives, organized under the AIM of Defense guidelines on assessing and managing care, a toll-free crisis line, and outreach to, and 4 framework.17 The document was meant to serve as education for, veterans and their families. In the patients at risk for suicide: a wide-ranging catalyst for social change, with the summer of 2009, the VA added a one-to-one “chat • Recognize the importance of trust between power to transform attitudes, policies, and services. service” for veterans who prefer to reach out for the patient and his or her provider and/or care For the broader suicide prevention community, the assistance using the Internet. team and the necessity for the patient to have National Strategy provided a common point of consistent, open, and respectful communica- reference and a resource for advocacy at the state Suicide prevention principles of care tion in the management of his or her care. and local levels, while directing more attention to • Provide patients with comprehensive, digest- the needs of those affected by suicide. Suicide prevention requires a combination ible information regarding available preven- In the years that followed, several other key of universal, selective, and indicated strategies.18 tion interventions and treatment options. developments helped advance suicide prevention Universal strategies target the entire population. • Use a team approach to improve care coin the nation. Among these was the 2002 report Selective strategies are appropriate for subgroups ordination and information sharing among Reducing Suicide: A National Imperative, which that may be at increased risk for suicidal behaviors. providers to ensure that patients receive summarized the state of the science base, gaps in Indicated strategies are designed for individuals comprehensive, individualized, and integrated knowledge, strategies for prevention, and research identified as having a high risk for suicidal care plans that are responsive to their goals, designs for the study of suicide.9 This landmark behaviors, including someone who has made a values, and preferences. report presented findings from a 13-member suicide attempt. Just as suicide has no one single • Involve family members, caregivers, and committee formed by the Institute of Medicine in cause, there is no single prevention activity that support persons in the patient’s care 2000, at the request of several federal agencies. will prevent suicide. To be successful, prevention whenever possible in accordance with patient efforts must be comprehensive and coordinated preferences. across organizations and systems at the national,

88 Figure 2: Examples of risk and protective factors in a social ecological model14

• Encourage a culture shift surrounding suicide be accessible to people with additional needs such Shared decision making risk management within organizations and the as physical, sensory, or learning disabilities. Family The Shared Decision Making (SDM) model community in general to address the stigma and caregiver involvement should be considered, if was introduced in Crossing the Quality Chasm, surrounding suicide. appropriate. a 2001 Institute of Medicine (now called the Providers are encouraged to use a patient- Regardless of setting, all patients in the National Academy of Medicine) report.20 It is readily centered care (PCC) approach that is individualized healthcare system should be able to access apparent that patients, together with their clinicians, to patient needs, characteristics, and preferences. evidence-based care appropriate to their specific make decisions regarding their plan of care and Effective, open communication between healthcare needs or condition. When properly executed, PCC management options. Patients at risk for suicide professionals and the patient is essential and should may decrease patient anxiety, increase trust in require sufficient information and time to be able to be supported by evidence-based information clinicians, and improve treatment adherence.19 make informed decisions. Clinicians must be adept tailored to the patient’s needs. Use of an empathetic Improved patient-clinician communication and a at presenting information to their patients regarding and non-judgmental approach facilitates discussions PCC approach conveys openness and supports treatments, expected outcomes, and levels and/or sensitive to gender, culture, ethnicity, and other disclosure of current and future concerns. As part locations of care. Clinicians are encouraged to use considerations. The information that patients are of the PCC approach, providers should ask each the Shared Decision Making model to individualize given about treatment and care should be culturally patient about any concerns he or she has or barriers suicide prevention goals and plans based on patient appropriate and available to people with limited to high quality care he or she has experienced. capabilities, needs, goals, and preferences. literacy skills. Treatment information should also

89 (The VA and the Education Development Center Some co-occurring medical, mental health Degenerative Diseases of the Central Nervous have jointly developed resources regarding mental conditions, or substance use disorders may require System health and shared decision making that can be early specialist consultation in order to discuss Huntington Disease: The prevalence of found at: https://www.treatmentworksforvets.org/ necessary changes in treatment or to establish suicide is believed to be two to four times greater in provider/.) a common understanding of how care will be individuals with Huntington disease than among the coordinated and delivered. general population.28 The lifetime history of suicide Evaluating Suicide Risk In addition to assessing for co-occurring attempts ranges from 4.8 to 17.7 percent.28 Major health conditions, patients and their families may depressive disorder may be present in up to half of Suicide risk identification remains an imperfect also experience a number of psychosocial factors patients with Huntington’s disease and is thought to science in part because, as concerning as suicide known to be associated with increased suicide be a consequence of the disease itself, rather than rate increases are, death by suicide remains a rare risk. In order to fully assess risk of suicide from a a psychological reaction to having a serious illness, event. Research has demonstrated that there is:3 whole-health approach, key psychosocial factors although the causal arrow in this case can plausibly • No all-encompassing explanation for suicide must be assessed as well and may require an point both ways. In addition, anxiety disorders, • No single path to suicide interdisciplinary team approach. One example obsessive-compulsive disorders, psychosis, mania, • No single path for reducing suicide risk of a highly correlated psychosocial issue is the aggression, irritability, impulsivity, and personality • No single medical cause, etiology, or treatment presence of intimate partner violence (IPV). IPV changes have all been reported in patients with the or prevention strategy significantly affects risk, not only of suicide, but also disease. for homicide. Multiple Sclerosis: Studies confirm an Although risk factors are derived Survivors of IPV are twice as likely to attempt increased risk of suicide among patients with epidemiologically, and as such cannot be used to suicide multiple times and the presence of IPV multiple sclerosis.29 Lifetime prevalence rates of predict individual behavior, evidence supports increases risk of murder-suicides significantly.24 depression range from 37 to 54 percent, and the evaluation of key risk factors as a necessary, but Current assessment trends advocate greater prevalence rate of depression is almost three times not sufficient, component of a comprehensive awareness of these intersections and for the efforts the lifetime prevalence reported in the general suicide risk evaluation. These risk factors include:4 to prevent suicide as well as IPV in a mutually population.30 Generalized anxiety disorder, panic • A prior suicide attempt collaborative manner. disorder, and bipolar affective disorder (manic • Current suicidal ideation episodes) are also present more frequently in these • Recent psychosocial stressors Medical conditions associated with increased patients. • Availability of firearms suicide risk Parkinson Disease: Parkinson disease is • Prior psychiatric hospitalization Several physical illnesses are associated with often associated with one or more psychiatric or • Psychiatric conditions (e.g., mood disorders, an increased risk for suicidal behaviors. The factors cognitive disorders, such as depression, psychosis, substance use disorders) or symptoms (e.g., that may help explain this increased risk vary by or dementia.31 Most of the observations support hopelessness, insomnia, agitation) medical condition but can include chronic pain, the hypothesis that depression is a primary cognitive changes that make it difficult to make consequence of brain dysfunction, although It’s important to bear in mind, however, that decisions and solve problems, and the challenges situational factors may contribute to mood changes these risk factors and others such as family history and emotional toll that can be associated with long- to some extent. Suicide and suicide attempts are of suicide, substance use disorders, loss, or illness term conditions and limitations. uncommon despite the fact that the rates of suicidal also exist among individuals who do not have ideation are elevated.31 Depression seems to be the suicidal thoughts, attempt suicide, or die by suicide. Cancer most important predictor of suicidal ideation. Much research over the last decade has sought to Cancer is one of the most common physical identify which of the known risk factors are most illnesses associated with elevated suicide risk. The Traumatic Injuries of the Central Nervous predictive of suicide, both in the general population National Cancer Institute has identified cancers System and among military/Veteran populations.21,22 These of the mouth, throat, and lung as risk factors for Spinal Cord Injury: Suicide and suicide studies largely confirm that the same risk factors suicidal behaviors.25 While suicide risk tends to attempts occur more frequently in those with spinal at work in non-military populations are present be highest in the first few months after diagnosis, cord injuries (SCI) than in the general population.32 in Veteran/military populations.23 Evidence for risk remains elevated in the first 5 years.26 Fear People with SCI are five times as likely to experience military-related unique risk factors is inconclusive. associated with how the disease is perceived and depression compared with the general population, For example, studies have found contradictory managed, rather than the fear of death itself, is and the rates of depression following a traumatic evidence about the relationship between military a frequent precipitator of suicidal behaviors. The spinal cord injury may be as high as 45 percent. deployment and risk of suicide.3 consequences or side effects of treatment can also Others have found that 10 to 13 percent of SCI result in psychological problems.27 Fatigue and/or patients suffer from anxiety and high levels of post- Co-occurring conditions exhaustion, some of the most frequently reported traumatic stress disorder.33 Co-occurring health conditions are important side effects of cancer treatments, can be risk factors Traumatic Brain Injury: People with to recognize because they can modify the degree for suicidal behaviors. In addition, depression and moderate to severe traumatic brain injury (TBI) of risk and trajectory of an individual’s suicide- anxiety are common in cancer patients. About 63 may have widespread cognitive impairment that related behavior, impact the assessment and to 85 percent of individuals with cancer who die can affect attention, memory, executive functioning, management of suicide risk, influence patient or by suicide meet criteria for severe depression or language and communication, visual-spatial skills, provider treatment priorities and clinical decisions, anxiety. It is not always clear whether these types and processing speed. TBI survivors may also have and affect the overall provider approach to the of mental disorders are triggered by the disease, perceptual deficits and motor deficits. Executive management of suicide risk. Providers should occur as a consequence of the disease, or are an brain dysfunction is a contributing factor related expect that many patients will have one or more co- adverse effect of the treatment itself.27 to suicidal behaviors. A review of the literature occurring health conditions. Because of the nature found that on the whole, there is an increased risk of suicide risk management, which sometimes takes of death by suicide (three to four times greater place in parallel with ongoing care for co-occurring for those with severe TBI), a higher frequency of conditions, it is generally best to manage suicide attempts, and clinically significant suicidal ideation risk collaboratively with other care providers. in 21 to 22 percent of the TBI population.34

90 Other Disorders of the Central Nervous related disorders (e.g., alcohol dependence), (mania) to sadness and hopelessness (depression). System schizophrenia and other psychoses, and personality People with bipolar disorder type I have had at least Epilepsy: Reported suicide rates in patients disorders.41 The prevalence of depressive one manic episode along with periods of major with epilepsy vary widely, from 0 to 25 percent.35 disorders in hemodialysis patients is estimated at depression. Those with bipolar disorder type II have Factors that can affect the rate of suicide include 20 to 30 percent, with a rate of 10 percent for periods of high energy levels and impulsiveness psychological stressors associated with epilepsy, major depression. This subset of patients has been that are not as extreme as mania and also alternate seizure type and frequency, psychic auras, and noted to be the most likely to request withdrawal with episodes of major depression. The estimated the presence of associated psychopathology.36 from hemodialysis. lifetime prevalence of bipolar disorders is 1.3 to 5 Some studies suggest that suppression of seizures percent.45 in longstanding epilepsy may be associated with Arthritis More than 60 percent of suicidal deaths occur suicide risk, and that suicide does not occur Arthritic disorders often co-occur with among individuals with mood disorders. Suicide risk among patients with severe epilepsy. The World other physical conditions, especially chronic is particularly high among individuals with bipolar Health Organization (WHO) states that increased pain conditions including back pain, migraine, disorders, which is strongly associated with suicide suicidal behavior in epilepsy is linked to increased and other chronic headaches.42 The association thoughts and behaviors. Over their lifetime, the impulsivity, aggression, and chronic disability often between arthritis and problems such as anxiety, vast majority (80 percent) of patients with bipolar seen in persons with the illness, and that alcohol substance use, and personality disorders has been disorders have either suicidal ideation or ideation and drug abuse also contribute to a greater risk of demonstrated in large, population-based studies.43 plus suicide attempts.46 In clinical samples, 14 to 59 suicide among these patients.37 The relationship between arthritis and suicidal percent of the patients have suicide ideation, and Migraine: In general, patients with migraine behavior may be largely explained by comorbid 25 to 56 percent attempt suicide at least once in are two to four times more likely to develop mental health disorders alone or in combination with their lifetime.47 depression, two to six times more likely to develop other factors such as level of pain and/or disability Approximately 15 to 19 percent of patients with general anxiety disorder, five times more likely to that are associated with a lower quality of life. bipolar disorders die from suicide. The suicide rate develop obsessive compulsive disorder, and up to among patients with bipolar disorders is estimated seven times more likely to develop panic disorder Asthma to be more than 25 times higher than the rate in the than the general population.38 Furthermore, Adolescents with asthma are more likely to general population.46 Several factors can increase depressed patients are about three times more likely report depressive symptoms, panic attacks, suicidal the risk for suicide among patients who have mood to develop migraine in their lifetime. Migraine with ideation and behavior, and substance abuse when disorders. These factors include a recent suicide an aura is believed to have a stronger association compared with those without asthma.44 It is not attempt and a severe major depressive episode, with psychiatric conditions than migraine without clear whether the association between asthma and often accompanied by feelings of hopelessness and an aura. The relationship between migraine and depressive and anxiety disorders, as well as with guilt, a belief that there are few reasons for living, depression and anxiety appears to be bidirectional, suicidal ideation and behavior, results from a shared thoughts of suicide, agitation, insomnia, appetite with each increasing the risk of the other condition. underlying process or from shared risk factors. and weight loss, and psychotic features.48 The risk of suicidal ideation and attempts is higher Suicidal behaviors among mood disorder among migraine patients, especially in those who Mental conditions and/or substance use patients occur almost exclusively during an acute, 38 48 have migraine with aura. disorders associated with increased suicide severe, major depressive episode. Among patients with major depressive disorder, risk factors risk HIV/AIDS Post-mortem forensic reviews suggest that for suicide include other comorbid psychiatric Most studies among individuals living with most, if not all, of those who die by suicide have conditions, such as post-traumatic stress disorder HIV report lifetime prevalence of suicide attempts an identifiable mental illness, though only about (PTSD), dependent personality disorder, borderline 39 that range from 22 to 50 percent. Individuals one-half of these individuals had received a mental personality disorder, and substance use disorders. with AIDS are 44 times more likely to attempt health diagnosis in the year prior to their death.5 Among those with bipolar disorders, risk factors suicide than those without AIDS. While most studies Some of the major mental conditions or substance include a family history of suicide, early onset of report that persons living with HIV/AIDS have much use disorders associated with suicide are reviewed bipolar disorders, increasing severity of affective higher suicide rates than the general population or disorders, presence of mixed affective states, and below. Table 1, on page 62, summarizes some 49 those with other life-threatening illnesses, studies of the commonly-used (and freely- available) abuse of alcohol or drugs. have reported no significant differences in suicide Major depressive disorder often fails to be questionnaires and assessment scales for these 45 rates between HIV-infected individuals and other issues. recognized, diagnosed, or treated. It is believed groups at risk for suicide, such as injection drug that many men in midlife who have the disorder do not seek treatment for their symptoms, and even users and psychiatric patients. Hence, HIV status Mood disorders may not be the most relevant factor related to Mood disorders are among the most common, when they do, they often drop out of treatment suicide, but rather that other suicide risk factors and may be the most life-threatening, psychiatric before they reach remission. Evidence is mounting that are common among HIV-infected individuals illnesses.45 Major depressive disorder, also that individuals who have had a stroke or heart play a more important role. Studies have shown called major depression or unipolar disorder, is attack and/or have chronic diabetes are likely that suicide attempts and suicide ideation among to develop depression related to their physical characterized by a combination of symptoms, such 14 people with HIV occur most often in those who as sadness and loss of interest or pleasure in once- illnesses. Older individuals with these conditions have a previous psychiatric history and other social pleasurable activities, which interfere with everyday are particularly likely to do so. 40 and environmental risk factors for suicide. Mood, life. It has been estimated that 12 to 17 percent Studies have shown that educating primary anxiety, substance abuse, and personality disorders of individuals will experience a major depressive care providers in the assessment, treatment, and are prevalent among those with HIV. 45 management of depression leads to reductions episode within their lifetime. Although a person 14 may experience only a single episode, more often in suicide. Appropriate acute and long-term Chronic Kidney Disease he or she may have several episodes throughout treatment of depressive disorders, including both The following psychiatric disorders have been his or her life. pharmacological and non-pharmacological methods frequently observed in patients with severe end- Bipolar disorders, previously called manic- (especially cognitive behavioral therapy), greatly stage kidney disease who require hemodialysis: reduces the risk of suicide and attempted suicide in depressive illness, are characterized by dramatic 48 mood disorders, dementia and delirium, drug- mood swings, going from an overly energetic “high” this high-risk population.

91 Table 1. Common assessment tools for mental health disorders or substance use disorders63 Name of tool/measure Number of items Notes Clinically Useful Depression 18 A newer depression severity measure, the CUDOS can be used to monitor symptoms over time Outcome Scale (CUDOS) in routine clinical practice. The CUDOS is longer than the PHQ-9 and includes a broader Likert scale, which provides greater breadth for tracking ongoing improvement. It generally takes only 3-5 minutes to complete. Geriatric Depression Scale-Short 15 Developed specifically for assessing depression severity in older adults, the GDS-SF uses a Form (GDS-SF) simple yes/no format and excludes physical symptoms that may be associated with aging or physical health conditions (and which, therefore, can lead to over-estimations of depression severity). The GDS-SF is a good choice for more frail older adults, those with significant medical or physical health conditions or for those who may have more difficulty with other response formats such as Likert scales. Generalized Anxiety Disorder-7 7 The GAD-7 is a widely-used measure of generalized anxiety disorder that is part of the same (GAD-7) set of measures as the PHQ-9. It has been shown to have good sensitivity and specificity for screening other anxiety disorders, as well as for showing treatment gains or responses. The GAD-7 is brief and easy to use on a repeated basis. Clinically Useful Anxiety Outcome 20 The CUXOS is a recently-developed measure for ongoing monitoring of anxiety symptoms in Scale (CUXOS) routine treatment. Unlike the GAD-7, the CUXOS is a broad measure of anxiety symptoms, which may be particularly useful for symptoms comorbid with depression. PTSD Checklist from DSM-5 20 The PCL-5 is a widely-used measure of PTSD symptoms in the VA healthcare system. It allows (PCL-5) for provisional PTSD diagnosis and monitoring of symptoms changes during or after treatment. Insomnia Severity Index (ISI) 7 The ISI is a widely-used measure of insomnia severity that is brief and simple to complete as a self-report measure of symptoms. Short Inventory of Problems- 17 The SIP-R assesses negative consequences related to substance use that have been shown to Revised (SIP-R) be sensitive to change over time. The measure may be used during initial assessment to help treatment planning as well as to monitor progress or revise treatment plans as needed. Alcohol and Drug Outcome 20 Measure (ADOM) Leeds Dependence Questionnaire 10 The LDQ is a brief measure of substance dependence developed specifically to assess (LDQ) symptoms of psychological, as opposed to physiological, dependence. The LDQ has been shown to be sensitive to change during treatment and can be used repeatedly. Large-scale, long-term, European observational The presence of any anxiety disorder in combination New data have emerged on the effectiveness of studies of former inpatients with bipolar disorders with a mood disorder is associated with a higher psychotherapies specifically designed for patients show that long-term use of mood stabilizers reduces likelihood of suicide attempts in comparison with with BPD.54 Research has shown that Dialectical the risk of suicide, compared to patients who stop a mood disorder alone.51 Among adults in the Behavior Therapy (DBT) is effective in reducing taking medication.14 There is also some evidence general population (i.e., not in the armed forces the self-injurious behaviors associated with BPD.55 that psychotherapies can improve compliance and or Veterans), panic disorder and PTSD have been DBT specifically aims to modify the regulation of increase the effectiveness of pharmacotherapy, found to be more strongly associated with suicide negative emotion. The main outcomes of DBT are thereby possibly providing more protection against attempts when there is a co-occurring personality reduced overdoses, ED visits for suicidal behaviors, suicide risk.48 disorder. frequency of self-directed violence, and hospital admissions. The efficacy of medications for BPD is 14 Anxiety disorders Borderline personality disorder not firmly established. Anxiety disorders affect about 40 million Borderline personality disorder (BPD) is American adults aged 18 and older (about 18 characterized by a pervasive pattern of instability Schizophrenia percent) in a given year. 50 Unlike the relatively in interpersonal relationships, self-image, and Schizophrenia is a severe, chronic disorder mild, brief anxiety caused by a stressful event like emotions. Defining features of this disorder include characterized by disturbances in perception, speaking in public, anxiety disorders last for months an unstable mood, serious problems with emotion thought, language, and social function. The risk for and can become worse if not treated. These regulation, a wide range of impulsive behaviors, suicide in individuals suffering from schizophrenia unstable interpersonal relationships, suicide, and is particularly high in the early stages of the illness disorders include the following: social phobia, 14 simple phobia, generalized anxiety disorder, panic chronic suicidal ideation.52 (first 3–5 years of onset). A meta-analysis of disorder, agoraphobia, PTSD, and obsessive- It has been estimated that between 3 and more than 60 studies found that almost 5 percent 10 percent of patients with BPD die by suicide.53 of schizophrenic patients will die by suicide during compulsive disorder (OCD). 56 The presence of any anxiety disorder is Recurrent suicide attempts, self-injury, and their lifetimes, usually near the onset of the illness. significantly associated with suicidal ideation and impulsive aggressive acts are often associated with Surviving the initial period of heightened risk results BPD and often result in emergency and inpatient in a lesser, although still considerable, risk of death suicide attempts. Anxiety disorders commonly 56 occur along with other mental or physical illnesses, treatment. Suicides in BPD often occur late in the by suicide. including alcohol or substance abuse, which may course of the illness and follow long courses of mask anxiety symptoms or make them worse. unsuccessful treatment.

92 The greatest indicator of suicide risk among symptoms. In addition, mental disorders associated Numerous cases have been reported in the people with schizophrenia is active psychotic with suicidal behaviors, such as mood disorders, media in which suicide or attempted suicide has illness (e.g., delusions) combined with symptoms PTSD, anxiety disorders, and some personality been attributed to bullying. Empirical research has of depression. Increased risk for suicide is also disorders, often co-occur among people who have also identified bullying as one of the risk factors associated with higher levels of education and been treated for substance use disorders. for suicidality,67 and adolescents frequently cite higher socioeconomic status. Alcohol abuse Crises that are known to increase suicide risk, interpersonal problems as a precipitant of suicidal 68 has been reported in studies examining suicide such as relapse and treatment transitions, may behavior. In a study by Beautrais et al., the most attempts.56 occur during treatment. According to one study, common precipitants of serious suicide attempts Nonpharmacological therapies, such as compared with the general population, individuals were interpersonal conflicts and relationship cognitive enhancement therapy, may have great treated for alcohol abuse or dependence have a 10 difficulties.69 More recent research has examined potential for improving the individual’s social times greater risk of eventually dying by suicide.62 the association between cyberbullying and and occupational functioning.57 Findings from Among those who inject drugs, the risk is about 14 psychopathology, including suicide. Surveys on the an evidence review suggest that an integrated times greater than in the general population.62 prevalence of cyberbullying show that it is relatively psychosocial and pharmacological approach may More is known about the factors that increase common among adolescents.64 The CDC reports be useful, and that treating depressive symptoms the risk of suicidal behaviors among this population that rates of cyberbullying are highest in middle in patients with schizophrenia is an important than about the factors that may be protective. school (33%), followed by high school (30%), component of suicide risk reduction.58 SUDs share many risk factors with suicide: family combined middle/high schools (20%) and primary history of suicide or child abuse; history of mental schools (5%).70 Substance use disorders disorders, particularly mood disorders; history Cyberbullying is unique to other more traditional Suicide is a leading cause of death among of or family history of addiction; impulsiveness; forms of bullying because of the perpetrator’s people with substance use disorders (SUDs). feelings of isolation; barriers to mental health and/ anonymity and ability to harass their victim 24 Substance use may increase the risk for suicide or treatment; relational, social, work, or financial hours a day. Extreme cases of cyberbullying have by intensifying depressive thoughts or feelings losses; physical illness/chronic pain; access to lethal led to adolescent suicide and longitudinal studies of hopelessness while at the same time reducing methods; and prejudice associated with asking for support the view that the effects of bullying can inhibitions to hurting oneself. Alcohol and some help. be long-lasting.71 Children involved in bullying, drugs can cause a “transient depression,” heighten Perceiving that there are clear reasons to live particularly those who were bully victims, at early impulsivity, and cloud judgment about long-term is thought to be an important protective factor in elementary school age and those who were victims consequences of one’s actions. this group. Other protective factors may include: a in their early teens, had more psychiatric symptoms Alcohol abuse is second only to depression and child at home and/or childrearing responsibilities; at the age of 15 years.72 other mood disorders as the most important risk an intact marriage; a trusting relationship with a Strategies exist to reduce the incidence of factor for suicide. A 2019 analysis of postmortem counselor, physician, or other service provider; both bullying and cyberbullying. A comprehensive data shows that the odds of suicidal behavior employment; religious attendance and/or belief guideline for preventing bullying, and, hence, are about three times higher among people with in religious teachings against suicide; and an lowering the risk of bullying-associated suicide, alcohol use disorder (AUD) compared to those 59 optimistic or positive outlook. Sobriety can be a is available from the CDC which include a range without AUD. Women who receive AUD treatment protective factor, along with attendance of mutual of approaches to strengthen youth’s skills and have about a 16-fold risk for suicide compared with support group meetings although roughly half of modifying physical and social environments for women in the general population, whereas men who those who die by suicide had no alcohol in their youth’s protection.73 have received AUD treatment have approximately bodies at the time of death.59 a 9-fold risk for suicide compared with men in the Cultural context of suicide general population.59 Social/environmental factors Suicidal behaviors can be influenced by Among individuals with alcohol use disorders, cultural factors in a variety of ways. First, there suicide frequently takes place within the context of Bullying/cyberbullying may be culture-specific patterns in the triggers or a major depression and interpersonal stressors. precipitants of suicidal behavior. For example, some Aggression, hopelessness, and partner-relationship Bullying among school-age children is now recognized as a major public health problem in individuals of Eastern Asian descent may engage in disruptions are also risk factors. Studies have 64 suicidal behavior after they experience the shame shown that depression is present in 45 percent to the Western world. Bullying has been defined as a situation in which a person is exposed, associated with loss of face because they failed more than 70 percent of those with alcohol and to meet expectations of their families or others.74 substance use disorders who die by suicide.60 repeatedly over time to negative actions on the part of one or more people, which typically involves Second, risk and protective factors for suicidal Although less is known about the relationship behavior may be influenced by cultural context. between suicide risk and other drug use, the an imbalance of power. Bullying falls into four general categories: direct–physical (for example, For example, acculturative stress among Latino number of substances used seems to be more adolescents is associated with higher levels of predictive of suicide than the types of substances assaults or theft), direct–verbal (threats, insults, or nicknames), indirect–relational (for example, thoughts about suicide.75 Third, the characteristics used. Findings from a few initial studies suggest of suicidal and related behaviors may differ that treatment of drug abuse may help reduce the social exclusion and spreading hurtful rumors), 61 and bullying behavior via online communications across cultures, although this possibility has been risk for future suicidal behaviors. 64 understudied. Finally, individuals in various cultural SUDs and chronic substance use can lead to (cyberbullying). Population-based studies indicate that 20% to 30% of school children are involved contexts may view and understand, and hence consequences and losses that contribute to suicide 65 react to, suicidal behaviors in different ways. For risk factors. Individuals in treatment for substance in bullying, either as bullies or victims. In a cross- national study of 113 000 students aged between example, suicidal thoughts or behavior may not be use disorders and/or transitioning between levels of recognized as a problem as readily among African care may be especially vulnerable.62 A large number 11 and 15 years from 25 countries, involvement in bullying varied from 9% to 54%.66 Bullies and Americans because of a perception among blacks of people in treatment have co-occurring mental that they are not at risk for suicidality.76 disorders that increase suicide risk, particularly victims of bullying are more likely than children uninvolved in bullying to suffer from a wide variety Culture may also affect each of the stages of mood disorders. At the time these individuals help-seeking behaviors that can lead to the use of enter treatment, their substance abuse may be out of problems, including low self-regard, depression and anxiety, and violent behaviors. mental health services for prevention or treatment of control, they may be experiencing a number of of suicidal behaviors. life crises, and they may be at peaks in depressive 93 In the first stage of help-seeking, behaviors or However, several studies support the use of As noted above, no evidence suggests that the difficulties need to be recognized as a problem, the PHQ-9 as a universal screening instrument to act of screening for suicidal thoughts and behavior but suicide attempts may be perceived, labeled, or identify suicide risk.82,83 Item 9 on the PHQ, as well increases negative affect or the risk of experiencing tolerated differently in different cultural groups.77 as possible responses are as follows:84 suicide-related thoughts and behavior.4 Further, Even if a behavior is recognized as problematic, Item 9: “Over the past two weeks, how often no studies have identified any risks or harms cultural factors may affect decisions about whether have you been bothered by thoughts that you would associated with specific suicide screening programs to seek mental health assistance. For example, be better off dead or of hurting yourself in some or tools. Because of this, providers and healthcare some cultural groups may not seek formal services way?” systems are encouraged to administer screening because of stigma or concerns that mental health Possible Responses: “Not at all,” “Several programs for suicide-related thoughts and behavior. services will be contrary to cultural values (e.g., days,” “More than half the days,” or “Nearly every Indeed, findings from patient focus groups confirm among young American Indian adolescents, stigma day.” that some patients will not voluntarily disclose their and embarrassment were associated with not Louzon et al. evaluated patients who received suicidal thinking, but would report it accurately if seeking help when suicidal). Finally, culture may the PHQ-9 across care settings and found that they had been asked about it directly.4 influence the decision about the type of services higher levels of suicidal ideation, as identified As limited data exist regarding implementing or help to seek. For example, recently-immigrated by responses on item 9, were associated with the PHQ-9 in large healthcare settings, future Latino and Asian families may lack familiarity with increased risk of death by suicide. 82 Responses on research regarding feasibility and acceptability the health care system or may believe that problems the items were related to risk as follows: “several are warranted. Nonetheless, there are sufficient such as suicidal behaviors should be dealt with by days” – a 75% increased risk for suicide, “more data to encourage use of item 9 to screen for the family or faith community rather than specialty than half the days” – a 115% increased risk risk, particularly in non-mental health settings, as mental health services.77 for suicide, and “nearly every day” – a 185% a component of system-wide suicide prevention Suicidal behavior and help-seeking occur in increased risk. Nonetheless, 71.6% of deaths by efforts. a cultural context and are likely associated with suicide during the study periods were among those The U.S. Preventive Services Task Force different precipitating factors, different vulnerability who reported “not at all,” highlighting that use of (USPSTF) recommends that physicians screen and protective factors, differing reactions to and item 9 alone is likely to result in a number of at risk teens and adults for depression when appropriate interpretations of the behavior, and different patients being missed.82 systems are in place to ensure adequate diagnosis, resources and options for help-seeking. Awareness Similarly, Simon et al. examined the relationship treatment, and follow-up and part of an overall of the interface of culture, adolescent suicidal between PHQ-9 scores and death by suicide among approach to preventing suicide.13 More information behavior, and help-seeking is essential for culturally civilian outpatients receiving care for depression in can be found at: www.uspreventiveservicestaskforce competent professionals and an important step mental health and primary care clinics, and found org to developing effective, culturally sensitive, that endorsement of responses were predictive of Further research on the topic of suicide interventions to reduce suicidal behaviors. both suicide attempts and deaths within the year screening has been recommended, including: post- administration.83 However, as with the Louzon • Assessing and improving temporal accuracy Approaches for assessing suicide risk et al. study, there were a notable number of suicides of screening and assessment tools. This in- Numerous methods of identifying suicide risk among those who denied thoughts of death or self- cludes development and evaluation of screen- have been investigated. These include traditional harm ideation. ing tools to predict suicide behaviors occur- approaches (e.g., expert review of cases, face-to- As many individuals are seen by healthcare ring across various timeframes (e.g., less than face interviews, clinician-administered screening providers in the weeks and months prior to their one month versus long-term risk). questions, self-report screening tools, gatekeeper deaths by suicide, strategies for early identification • Identification of suicide risk subtypes (e.g., training and education) as well as novel approaches within diverse clinical settings are warranted. acute versus chronic risk). (e.g., predictive models based on historical data, Emerging data suggest that one strategy to • Development and testing of strategies to pre- machine learning algorithms of social media, improve early identification is screening for suicide dict and stratify risk that integrate multiple biomarkers). Regardless of the screening and risk in both primary and specialty care settings. risk prediction methods and data sources, for identification method, accurate identification of Implementation of such screening procedures example combinations of self-report, predic- suicide risk remains elusive.78,79 These screening will require the development and implementation tive analytics models which use data from the and identification efforts are often hampered by low of tools (e.g., templated evaluation forms) and electronic health record, and/or other data positive predictive values, high false negative rates trainings, as well as work flow strategies to address sources. (roughly 50%) and high false positives. Combined the needs of patients who screen positive. Despite • Further assessment of alternative methods with the low base rate of suicide, this pattern of its weaknesses, current guidelines endorse the for administering suicide screening questions. findings results in limited actionable information PHQ-9 as a screening tool since it is positively • Determination of the appropriate frequency that can be used to guide or develop effective associated with the degree of risk for suicide- of screening, including evaluation of whether population-based screening programs that can related behavior.4 over- screening has an impact on the positive be implemented in clinical and community-based The evidence base for screening programs and negative predictive values of the instru- settings. However, evidence suggests that the and tools is limited by small sample sizes, data from ment, as well as on patient satisfaction, trust, screening for suicidal thoughts and behaviors does non-adult cohorts, truncated follow-up windows and engagement. not increase risk for suicide.80,81 that were too short to determine if the screening tool or process could accurately identify or predict Predictive Analytics Screening suicidal thoughts and behavior, and the use of proxy The availability of large healthcare datasets and As noted above, most suicide screening tools outcomes for suicide and suicide-related behavior. machine learning analytics, coupled with modern yield an unacceptably high false-positive prediction For example, the Columbia Suicide Severity statistical modeling, computing, and database rate (i.e., many of those determined to be “at Rating Scale (C-SSRS) was evaluated in only 124 technologies have introduced opportunities to risk” never experience clinically significant suicidal adolescents.85 In their conclusions the authors develop predictive models of suicide and suicide- thoughts or behavior) alongside an unacceptably noted, “There were too few studies to assess the related behavior. These machine learning algorithms low degree of accuracy when identifying true cases diagnostic accuracy of the C-SSRS.” Studies that hold the potential to use existing healthcare and (i.e., a substantial portion of those individuals who use larger samples, adult cohorts, mortality as other large-scale data repositories to analyze die by suicide were not identified by the screening the key outcome, and employ prolonged follow-up patterns that allow for outcome identification and tools).4 periods are needed. improved classification accuracy.86 94 However, attempts to predict suicide using is needed. Indirect warning signs (e.g., agitation, This approach is consistent with current clinical machine learning algorithms and predictive hopelessness, insomnia, shame) are thoughts, models and best practices (e.g., therapeutic risk analytics tend to have low clinical utility. Suicide feelings, and/or behaviors that may, or may not, be management), which highlight the importance prediction models, in their current state, yield good associated with suicidal thoughts and behavior. of using multiple tools and methods, such as overall classification accuracy (among individuals Patient-specific warning signs can be assessed structured clinical interviews augmented with valid classified as “not at risk,” the algorithm will be by asking patients to describe thoughts, feelings, and reliable self-report measures, as part of an correct over 99% of the time), but are poor at and behaviors experienced prior to the most recent evidence-based process for evaluating suicide risk.4 accurately predicting future suicide events (among exacerbation of suicidal ideation or behavior. If a Recommended questions to ask in the those classified as “at risk,” the algorithm will be patient reports experiencing any common warning assessment of suicidal intent include:3 correct only about 1% of the time). In other words, signs, the provider can then directly ask the patient • Are you currently thinking about or have you these models can accurately determine who is if they are experiencing thoughts of suicide. (See recently thought about death or harming your- not at risk for suicide (a high base rate outcome the management algorithms below for guidance self? representing the vast majority of the population about how to follow-up with a patient who presents • Have you thought about how you would harm and data in the system), but are generally unable with current warning signs.) yourself? What is your plan? to determine who is at elevated risk for suicide- • Do you have access to a method of suicide related behavior (a rare outcome).4 The nascent Evaluation (e.g., gun and bullets, poison, pills)? literature on this topic already suggests that this It is rare for suicidal ideation to be the chief • What has kept you from acting on these finding is consistent across the military, VA, and problem in the outpatient setting.88 More often, thoughts? civilian healthcare systems, and is directly related patients have symptoms that may ultimately be • Do you have any intention of following through to, and limited by, the suicide mortality rate in the related to suicidal ideation. For example, a patient with the thoughts of self-harm? population of interest. The inability to predict who may have gastrointestinal upset related to increased • What are your plans for the future? will experience the targeted outcome is the fatal flaw stress or depression. On further assessment, • Have you or a family member ever attempted for most predictive algorithms. Use of these models additional risk factors for suicide may be present. suicide in the past? is likely to result in high rates of false positive Evidence shows that inquiring about suicide • Have you or a family member ever been di- identification as high risk (potentially leading to does not increase suicidal ideation or attempts. agnosed with or been treated for anxiety, de- wasted resources, mistrust of healthcare systems, In a randomized trial of 443 adult patients with pression, or other mental health problems? and discrimination), as well as an unacceptable depression, there was no statistical difference • Are you currently using alcohol or drugs (illicit risk of false negatives (the occurrence of suicide in suicidal ideation or behavior between or prescription)? among those that the model determined to be “not participants assigned to early questioning about • Have there been any changes in your employ- at risk”). suicidal thoughts and those assigned to delayed ment, social life, or family? Additionally, the application of predictive questioning.89 • Do you have friends or family with whom you analytics to rare healthcare-related outcomes is Direct inquiry concerning suicidal ideation in are close? Have you told them about these so new that critical ethical and practical concerns patients with risk factors is associated with more thoughts? have yet to be fully addressed, including what effective treatment and management because it interventions should be provided to those who are allows the physician to gain necessary information Additionally, behavioral observations may classified as being at risk for suicide, especially if while potentially alleviating patient anxiety.90 provide information about the severity of symptoms the majority of the cases being classified as “at Risk factors to be included as part of a and level of risk. Patients who present with a risk” represent false positive identifications.87 comprehensive evaluation of suicide risk are disheveled appearance or poor hygiene, or who Recognizing that suicide is not predictable summarized in Table 2. seem withdrawn or agitated, along with recent or in the near term does not exclude other clinical The evidence base in support of factors that current suicidal ideation may be at increased risk imperatives. Regardless of suicide or suicide can protect against suicidal behavior is limited. of suicide attempts. A mental status examination attempt as an eventual outcome, patients’ pathways Nonetheless, evaluation of such factors, particularly can be used to assess patient functioning and to distress and decompensation always warrant those associated with reasons for living, should be inform the course of treatment. Although the individualized support and treatment. included in a comprehensive suicide risk evaluation. USPSTF found insufficient evidence to recommend Potential benefits of a suicide risk evaluation for or against routine screening for suicide risk Acute Warning Signs include improved likelihood of a therapeutic alliance in a primary care setting, screening instruments In addition to predictive analytics and routine and improved prediction of suicide risk. for depression, anxiety, and alcohol use further screening, patients at risk for suicide can be As noted, evidence reviews have not identified substantiate the severity of symptoms. Because identified via the presence of acute warnings signs a specific risk evaluation instrument or method no validated predictive tools exist, clinical judgment for suicide. Warning signs are individual factors that (e.g., structured clinical interview, self-report guides the decision-making process.88 signal an acute increase in risk that the patient may measures, and predictive analytic models) that engage in suicidal behavior in the immediate future is sufficient to determine future risk of suicide.4 Eliciting suicidal ideation (i.e., minutes to days). However, performing suicide risk evaluation is a No single method or “best practice” exists for Recognition of warning signs is the key to critical function for mental health providers, as well eliciting suicidal ideation from patients. Although creating an opportunity for early assessment as primary care, emergency department personnel, some patients may tell their physician about suicidal and intervention. Three direct warning signs are and other providers. Currently, there are many thoughts without prompting, this is not common. particularly indicative of suicide risk: assessment tools and methods used by providers Often patients feel shame or embarrassment about 1. Communicating suicidal thought verbally or in to evaluate and manage suicide risk. These suicidal thoughts, or they may simply not want to writing assessment tools provide a standardized way of share them because they are, in fact, intent on 2. Seeking access to lethal means such as completing the act. Clinicians should, therefore, firearms or medications eliciting information from individuals that can help inform risk management strategies. raise the topic by using open-ended questions 3. Demonstrating preparatory behaviors such as 91 putting affairs in order Given the lack of evidence supporting the and gradually focusing on direct ones. It may be use of a single instrument or method, clinicians easier to broach the subject while exploring mood The presence of one or more of these warning should be cautious when conducting a suicide risk symptoms or discussing negative feelings. signs is a strong indication that further assessment evaluation, and not rely on any of these tools alone.

95 Table 2. Factors to consider during a comprehensive evaluation suicide risk4 Factor Category Factors to Consider Self-directed violence-related • Current suicidal ideation • Prior suicide attempt(s) • Preparatory behaviors • Past or present suicidal intent • Non-suicidal self-directed violence behaviors Current psychiatric conditions/current or past mental health treatment • Mood disorders • Anxiety disorders • Psychotic disorders • Personality disorders • Substance use disorders • Eating disorders • History of psychiatric hospitalization Psychiatric symptoms • Hopelessness • Depressed mood • Anxiety/panic • Insomnia • Problem solving difficulties • Agitation • Anger • Rumination • History of alcohol use • Decreased psychosocial functioning • Hallucinations

Recent bio-psychosocial stressors • Loss of a relationship (e.g., break-up, divorce, death) • Loss of job • Risk of losing stable housing/homelessness • Exposure to suicide • Traumatic exposure (e.g., bullying, IPV, sexual assault, physical assault, emotional abuse) • Social isolation • Legal/disciplinary issues • Financial problems • Transition of care (e.g., discharge from inpatient, change in medication, change in therapist) • Barrier to accessing care

Availability of lethal means • Access to firearms • Access to other lethal means

Physical health conditions • History of traumatic brain injury (TBI) with moderate to severe TBI being greater than mild (concussion) • Cancer diagnosis

Demographic factors • Lesbian, gay, bisexual, or transgender sexual orientation or gender identity

96 A step-wise approach to eliciting suicidal Risk stratification different levels of risk, likely contributed to the ideation is illustrated in Figure 3 in which the While it is an expected standard of care, there inconsistent findings. Thus, the evidence for risk clinician begins by asking a general question about is insufficient evidence to recommend for or against stratification remains inconclusive. whether the patient has ever had any thoughts of the use of risk stratification to determine the level Nonetheless, providers should not be death or felt that he or she is better off dead. A of suicide risk. A valid and reliable tool to classify discouraged from completing comprehensive positive response to this question prompts the next the degree of risk that accurately represents a assessments to determine level of risk and question—whether the patient has thoughts of patient’s suicide-related thoughts and behavior appropriate risk mitigation strategies. Risk self-harm. If there are no thoughts of self-harm, (i.e., risk stratification) remains elusive. stratification, when completed as part of a the patient is said to have passive suicidal ideation. In a study by Large et al. just over half of comprehensive evaluation, enables providers to The primary care practitioner should then explore the suicide-related deaths observed occurred formulate a clinical impression of a patient’s suicide and mitigate any additional risk factors for suicide, among patients in the high-risk category who risk, which can help inform risk mitigation strategies and help the patient get in touch with relevant were admitted to inpatient psychiatric facilities.92 and treatment decisions. community resources, such as crisis helplines. The odds ratio for suicide in the high- risk group Additionally, as patients move between With the patient’s permission, the patient’s risk compared to the low-risk group was 7.1, but this providers, relocate, progress through levels of can be made known to a family member or close is in the context of a patient population that all care, and transition from military service to Veteran friend. Conversely, if thoughts of self-harm are met criteria for admission to inpatient psychiatry. status, it is useful to have a consistent lexicon for present, the patient is said to have active suicidal A 2016 study described similar findings in patients identifying and communicating a patient’s level of ideation and should be given a same-day psychiatric seeking psychiatric services who had a suicide risk (i.e., high, intermediate, or low acute or chronic assessment. The primary care physician should ask attempt, demonstrating a 56% sensitivity (correct risk). Therefore, consistent and standardized further questions to look for behavior that suggests identification of true positive cases) and 79% approaches to suicide risk assessment and intent (e.g. making a suicide note or distributing specificity (correct identification of true negative stratification, such as those depicted in the personal belongings), or whether there is a specific cases) of a high-risk categorization.92 In both algorithms below, can enhance the clinical utility plan to carry it out. Any patient who communicates systematic reviews, however, approximately half and feasibility of conducting risk stratification in an a specific intent or plan for suicide requires urgent of all suicide-related deaths occurred in the low- equitable and replicable manner. psychiatric referral and should be transported to risk categories. Methodological variations across the emergency room. these studies with respect to the patient population, as well as criteria and methods for determining

Case Study 1 Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

Gabriela, age 19, has been brought to the local emergency department after being found unconscious on the floor of her mother’s living room, an empty pill bottle nearby. The bottle is a prescription for a tricyclic antidepressant made out to the patient’s mother. Gabriela is breathing shallowly and has no spontaneous movement, although she reacts to deep, noxious stimuli by opening her eyes and moving her extremities. She is admitted to intensive care and intubated to protect her airway from aspiration in the event of vomiting. The friend who found Gabriela says that Gabriela had only been living with her mother for a couple of days because her boyfriend recently left her. The friend reports that Gabriela is currently unemployed and had dropped out of college after two years. Thirty-six hours after admission, you visit Gabriela as her primary care physician. She has been extubated and is awake, sitting up, and talking to a young man at her bedside. You have known Gabriela for many years, and know that her parents divorced when she was 11 years old. Two years later she became depressed and was briefly under psychiatric care for suicidal ideation. She has a history of periods of anger and despondency, but has not tried to commit suicide until now. As you enter the room, Gabriela smiles sheepishly and asks, “Can I go home now?”

1. What would your initial approach be to obtain information you need to determine if, in fact, Gabriela should be released?

Questions for case study:

2. Would an around-the-clock “sitter” in her room be justified as a suicide prevention strategy?

3. What kinds of referrals would be appropriate to offer Gabriela as supports for coping with the life issues she is facing?

97 Figure 3. Step-by-step assessment of suicidal ideation91

98 BEFORE MOVING ONTO THE NEXT SECTION, (Figures 4, 5, and 6) allows the provider to assess PLEASE COMPLETE CASE STUDY 1. the critical information needed at the major decision points in the clinical process. Decision-making algorithms The algorithms include: • An ordered sequence of steps of care Figure 4 depicts the first in a set of algorithms • Recommended observations and examinations designed to facilitate decision-making processes • Decisions to be considered used in managing patients at risk for suicide. The • Actions to be taken simplified approach depicted by the algorithms

Figure 4: Algorithm A for identifying suicide risk4

99 Figure 5. Algorithm B: Evaluation by Provider4

100 Figure 6. Algorithm C: Management of patients at acute risk for suicide4

101 After assessing a patient at risk and Short-term management Suicide prevention contracts have not been shown following the appropriate steps as recommended After necessary medical stabilization (in the to reduce suicide attempts and should generally be in the algorithms above, physicians should assign event of a suicide attempt), an environment that avoided.93 the patient a risk category (i.e., acute vs. chronic provides adequate patient protection must be Inpatient admission should be offered for risk, and, within each class, high, intermediate, selected. Patients who have suicidal ideation, but patients with specific plans for suicide who have or low risk). Tables 3 and 4 summarize the no plan or means in place, and who have good the means to complete their plan. In many states, main features of each category and the actions social support may be treated as outpatients.88 With involuntary admission is an option. Physicians recommended for each. patient permission, close family or friends should be should be aware of the statutes related to suicide involved to ensure patient safety and adherence.90 risk in their jurisdictions.

Table 3. Essential features and action steps for patients with acute suicide risk4 Level of Risk Essential Features Action High Acute Risk • Suicidal ideation with intent to die by suicide • Typically requires psychiatric hospitalization • Inability to maintain safety, independent of to maintain safety and aggressively target external support/help modifiable factors • These individuals may need to be directly Common warning signs: observed until they are transferred to a • A plan for suicide secure unit and kept in an environment with • Recent attempt and/or ongoing preparatory- limited access to lethal means (e.g., keep behaviors away from sharps, cords or tubing, toxic • Acute major mental illness (e.g., major substances) depressive episode, acute mania, acute • During hospitalization co-occurring condi- psychosis, recent/current drug relapse) tions should also be addressed • Exacerbation of personality disorder (e.g., increased borderline symptomatology)

Intermediate Acute Risk • Suicidal ideation to die by suicide • Consider psychiatric hospitalization, if • Ability to maintain safety, independent of related factors driving risk are responsive to external support/help inpatient treatment (e.g., acute psychosis) These individuals may present similarly to those at • Outpatient management of suicidal thoughts high acute risk, sharing many of the features. The and/or behaviors should be intensive and only difference may be lack of intent, based upon include: frequent contact, regular re-assess- an identified reason for living (e.g., children), and ment of risk, and a well- articulated safety ability to abide by a safety plan and maintain their plan own safety. Preparatory behaviors are likely to be • Mental health treatment should also address absent. co-occurring conditions

Low Acute Risk • No current suicidal intent AND • Can be managed in primary care • No specific and current suicidal plan AND • Outpatient mental health treatment may also • No recent preparatory behaviors AND be indicated, particularly if suicidal ideation • Collective high confidence (e.g., patient, care and co-occurring conditions exist provider, family member) in the ability of the patient to independently maintain safety Individuals may have suicidal ideation, but it will be with little or no intent or specific current plan. If a plan is present, the plan is general and/or vague, and without any associated preparatory behaviors (e.g., “I’d shoot myself if things got bad enough, but I don’t have a gun”). These patients will be capable of engaging appropriate coping strategies, and willing and able to utilize a safety plan in a crisis situation.

102 Table 4. Essential features and action steps for patients with chronic suicide risks4 Level of Risk Essential Features Action High Chronic Risk Common warning sign: These individuals are considered to be at chronic • Chronic suicidal ideation risk for becoming acutely suicidal, often in the context of unpredictable situational contingencies Common risk factors: (e.g., job loss, loss of relationships, and relapse • Chronic major mental illness and/or person- on drugs). ality disorder These individuals typically require: • History of prior suicide attempt(s) • Routine mental health follow-up • History of substance use disorders • A well-articulated safety plan, including • Chronic pain lethal means safety (e.g., no access to guns, • Chronic medical condition limited medication supply) • Limited coping skills • Routine suicide risk screening • Unstable or turbulent psychosocial status • Coping skills building (e.g., unstable housing, erratic relationships, • Management of co-occurring conditions marginal employment) • Limited ability to identify reasons for living

Intermediate Chronic Risk • These individuals may feature similar chronic- These individuals typically require: ity as those at high chronic risk with respect • Routine mental health care to optimize to psychiatric, substance use, medical and psychiatric conditions and maintain/ enhance pain disorders coping skills and protective factors • Protective factors, coping skills, reasons for • A well-articulated safety plan, including living, and relative psychosocial stability sug- lethal means safety (e.g., safe storage of gest enhanced ability to endure future crisis lethal means, medication disposal, blister without engaging in self-directed violence packaging) • Management of co-occurring conditions

Low Chronic Risk • These individuals may range from persons • Appropriate for mental health care on an with no or little in the way of mental health as needed basis, some may be managed in or substance use problems, to persons with primary care settings significant mental illness that is associated • Others may require mental health follow- up with relatively abundant strengths/ resources to continue successful treatments • Stressors historically have typically been endured absent suicidal ideation • The following factors will generally be missing: ° History of self-directed violence ° Chronic suicidal ideation ° Tendency towards being highly impulsive ° Risky behaviors ° Marginal psychosocial functioning

When in doubt regarding the need for admission, should monitor the patient frequently. During Treatment of underlying psychiatric or inpatient care is the more prudent option. However, inpatient admissions, patients may need to stay substance abuse disorders should be initiated as if a patient is referred for admission, but not placed in a locked unit where they do not have access to early as possible and should be tailored to individual in the hospital, he or she may experience additional stairwells, light fixtures, and other installations that patients. This treatment should generally consist of stress and increased feelings of helplessness.88 could be used for hanging. some form of pharmacotherapy plus psychological Regardless of the treatment setting, ensuring Frequent contact with staff can help in the evaluation and treatment. patient safety is a primary concern. Caregivers identification of suicide warning signs.88 should be told to remove weapons and medications that could be used for deliberate self-harm and 103 Although most of these treatments are not in CBT but would likely need some additional training No Evidence for No-Suicide Contracts customarily administered by primary care providers in how to employ a CBT intervention specifically in the office, patients can be referred to behavioral focused on suicide prevention. “No-suicide contracts” or “No-harm health providers for them. The primary care contracts” are a relatively common suicide provider can play a continuing supportive role in the Dialectical Behavioral Therapy prevention intervention. No-suicide care of these patients by monitoring them during Dialectical Behavior Therapy (DBT) was contracts are not the same as safety plans. the process, providing follow-up, and coordinating originally developed to treat individuals with They involve statements from patients with other care providers. borderline personality disorder, a subpopulation at promising not to harm themselves or that heightened risk for non-suicidal and suicidal self- they will contact someone in the event Cognitive behavioral therapy directed violence. DBT combines elements of CBT, that they are unable to maintain their Cognitive behavioral therapy (CBT) teaches skills training, and mindfulness techniques with patients to identify and change problematic thinking the aim of helping individuals develop skills in: (1) own safety. Although commonly used, the and behavioral patterns with the expectation that emotion regulation, (2) interpersonal effectiveness, practice of forming no-suicide contracts this will impact their emotional experience.96 This is and (3) distress tolerance.4 should be discouraged, as there is no typically done by having patients identify proximal Based on a growing body of research, DBT evidence to suggest that such contracts thoughts, images, and core beliefs that were has been found to reduce non-suicidal and suicidal reduce suicide tendencies. activated prior to self-directed violence. Cognitive self-directed violence among patients with BPD They may instead be used by and behavioral strategies are then typically applied and recent self-directed violence. A systematic patients to hide their actual suicidal to address the identified thoughts and beliefs. review by Hawton et al. included five trials that intents. Development of a relapse prevention plan is assessed the effectiveness of DBT in participants typically conducted near the end of therapy. Typically diagnosed with borderline personality disorder patients attend fewer than 12 CBT sessions. referred to outpatient services following a suicide Source: Ng CWM, et al. Depression in Four systematic reviews/meta-analyses have attempt.96 One small trial included in the Hawton primary care: assessing suicide risk. Singapore examined the effect of CBT on suicide-related review compared a DBT-oriented psychotherapy Med J. 2017;58(2):72-77. outcomes.96-99 Seven studies (with a total of 988 with client-oriented therapy.102 At post-treatment, participants) that were included in these reviews there was evidence of a significant treatment effect specifically targeted suicide risk as part of the for DBT compared to client-oriented therapy for Long-term management intervention. Although there are some mixed suicidal ideation and repetition of self-directed Even after initial stabilization and improvement findings, there is moderate evidence overall violence among patients diagnosed with borderline of suicidal ideation, the patient remains at that CBT-based interventions focused on suicide personality disorder. increased risk. Patients who attempt suicide have a prevention are effective at reducing repeat incidents Similarly, McMain et al. evaluated the clinical risk of death in the following year 100 times greater 94 of self-harm. For example, Brown et al. found that effectiveness of brief DBT skills training as an than that of the general population. Therefore, it patients who had presented to the hospital following adjunctive intervention to treatment as usual for is important to involve the patient’s social support a suicide attempt and received Cognitive Therapy patients with borderline personality disorder at high system in assisting with management. In addition to for Suicide Prevention (CT-SP) as compared to risk for suicide.103 At the conclusion of the study, frequent contact with the primary care physician, those who received usual care, were 50% less the DBT group demonstrated significant reductions the patient should have access to behavioral health likely to report a repeat suicide attempt during the in non-suicidal and suicidal self-directed violence specialists, as well as community programs such as follow-up period.100 Another randomized trial of a compared to those in the active waitlist condition. Alcoholics Anonymous or Narcotics Anonymous if suicide-specific, individual, brief CBT intervention Despite general consistency in the evidence substance abuse or dependence is involved. for suicide prevention conducted with active duty supporting DBT to reduce self-directed violence and For patients with personality disorders, soldiers found that soldiers who received the suicidal ideation among individuals with borderline particularly borderline, histrionic, and narcissistic intervention, as compared to those who received personality disorder who have reported recent self- disorders, suicidal gestures and intent may become treatment as usual, were 60% less likely to make directed violence, there is some variability in provider common and chronic in nature. The physician must a suicide attempt in the follow-up period.101 While and patient preferences regarding this treatment. be vigilant in taking each threat seriously, because there is evidence that CBT has positive effects DBT appeals to both providers and patients due gestures may become lethal. Physicians should in terms of reducing suicide attempts, there is to its multifaceted components (e.g., mindfulness, regularly assess for suicide risk level and coping insufficient evidence at this time to suggest that interpersonal effectiveness) that emphasize patient resources, and help patients identify problem- CBT reduces suicide, (the quality of the evidence engagement and autonomy. Moreover, findings solving techniques. If the patient remains at a high in studies looking at this outcome is low).96 There from focus groups indicate that patients have had risk of self-harm, referrals to emergency services were no harms related to receiving CBT reported in positive experiences with treatment modalities that and specialty care are recommended. the systematic reviews/meta-analyses that included include various complementary and integrative these studies. therapies such as mindfulness, which is an integral Evidence-based non-pharmacological treatments There may be variability in provider and patient component of DBT.4 to reduce suicide risk preferences regarding this type of treatment. DBT is typically delivered as a multimodal While many patients and providers appreciate the treatment package that includes a manualized DBT Most effective treatments to reduce risk for structured nature of CBT, and generally find it skills group, individual psychotherapy, and 24-hour 13 suicide attempt include psychotherapy. In fact acceptable, some patients find the homework to crisis response (when needed). As such, it offers a systematic review by the USPSTF found that be challenging and burdensome, and some decline patients the opportunity to benefit from group psychotherapy reduces the risk of suicide attempts to participate. Yet, as compared to patients not discussions, and is aligned with patient preferences 95 by 32% compared with usual care in adults. receiving evidence-based treatments, patients for one-on-one interactions with providers. Although The most commonly-studied psychotherapy receiving CBT tend to get more consistent and the clinical utility and acceptability of DBT among interventions are cognitive behavioral therapy lengthier (per session) care. CBT is also typically providers and patients are well established, access and related approaches, including dialectical time-limited, which is appealing to many patients. to standard DBT may be restricted due to limited behavior therapy, problem-solving therapy, and Most behavioral health therapists in VA and resources and a shortage of clinicians who have developmental group therapy. Other approaches Department of Defense (DoD) settings are trained been trained in the full model of DBT. include psychodynamic or interpersonal therapy. 104 The body of evidence supporting DBT for There is no evidence in the literature or in Considerations for patient safety are part of a suicide prevention includes limitations such as risk clinical expert opinion that there is any harm with comprehensive treatment plan in behavioral health of bias due to blinding procedures and imprecision completing a crisis response plan. This process environments with the highest risk period for suicide with respect to the degree of uncertainty (based is collaborative and should be patient centered. attempts occurring up to 12 weeks after discharge on variance or sample size) around an outcome’s As there is no empirical evidence to support the from the hospital. The transition from inpatient to effect size. usage of “no harm” or “no suicide” contracts, outpatient behavioral health care is a particularly implementing crisis response plans and safety plans susceptible time and current standards of care Collaborative Assessment and Management of are the preferred strategies. include safety planning as an important component Suicidality At a minimum, a crisis response plan involves of discharge planning to help patients maintain Collaborative Assessment and Management of a collaboration between a patient and clinician that safety as they transition out of inpatient care. Suicidality (CAMS), provides a method for therapists includes the following components:4 The evidence supporting Crisis Response to join with the patient in a collaborative endeavor • A semi-structured interview of recent suicidal Planning and Safety Planning Interventions is to develop a shared understanding of the suicidal ideation and history of suicide attempts limited by small sample sizes and confounders in the episode, explore the degree of risk for self-harm, • Unstructured conversation about recent analyses. Even though evidence quality is low, these and develop a plan for ensuring the patient’s stressors and current complaints using sup- interventions do not require specialized training and safety. Studies to date have shown promise for portive or reflective listening techniques are not setting-dependent. Patient focus groups this approach, including evidence suggesting • Identification of clear signs of crisis (behavior- revealed the importance of a patient-centered, that patients resolve suicidality more quickly al, cognitive, affective, or physical) collaborative process that encourages family and using this approach compared with conventional 104 • Self-management skill identification including friend involvement and respectful relationships interventions. things that can be done on the patient’s own with providers which is consistent with the crisis An open-trial, case-focused pilot study to distract or feel less stressed response plan. Patients tend to be satisfied with assessed an inpatient adaptation of CAMS, spread 105 • Identification of social supports including this intervention. There were improved outcomes over a period averaging 51 days. The intervention friends, caregivers, and family members who in suicide attempts, fewer inpatient days, and no was provided via individual therapy to a convenience have helped in the past and who they would potential harms or adverse events identified. sample of 20 patients (16 females and four males, feel comfortable contacting in a crisis average age 36.9 years) who were hospitalized • Review of crisis resources including medical BEFORE MOVING ONTO THE NEXT SECTION, with recent histories of suicidal ideation and providers, other professionals, and the suicide behavior. Results showed statistically and clinically PLEASE COMPLETE CASE STUDY 2 ON THE lifeline NEXT PAGE. significant reductions in depression, hopelessness, • Referral to treatment including follow-up ap- suicide cognitions, and suicidal ideation, as well as pointments and other referrals as needed improvement on factors considered “drivers” of Problem-Solving Therapy suicidality. Treatment effect sizes were in the large Problem-Solving Therapy (PST) is one type A crisis response plan is similar to a Safety of cognitive-behavioral psychotherapy specifically range (Cohen’s d > .80) across several outcome Planning Intervention, which has also been measures, including suicidal ideation.105 aimed at improving an individual’s ability to cope with associated with a reduction in suicidal behavior stressful life experiences through active problem and increased treatment engagement among 108 Crisis response plans solving. A 2000 systematic review by Hawton Completing a crisis response plan has been suicidal individuals. A large-scale study (n=1,640), et al. reported a trend towards reduced repetition found to decrease suicide attempts among involved a cohort comparison design using the of deliberate self-harm for patients enrolled in individuals with an acute history of suicidal ideation Safety Planning Intervention plus follow-up services PST, although the difference was not statistically during the past week and/or a lifetime history of and was associated with about 50% fewer suicidal significant due, perhaps, to the heterogeneity of 109 suicide attempts. A study by Bryan et al. found a behaviors over a six-month follow-up and more outcome measures across the included studies. than double the odds of engaging in outpatient More recent research, however, supports PST statistically significant difference in the number 107 and proportion of suicide attempts, favoring crisis behavioral health care. See Table 5 for a on the outcomes of reduced repeat self-directed response planning over treatment as usual.106 comparison of Crisis Response Planning and the violence and suicidal ideation among patients with This intervention was associated with significantly Safety Planning Intervention (SPI). a history of self-directed violence. Notably, the fewer inpatient days than the Contract for Safety majority of this research has been conducted on Intervention. patients with a “history of self-harm.” Table 5. Comparison of Crisis Response Planning and Safety Planning Intervention Crisis Response Planning Safety Planning Intervention • Semi-structured interview of recent suicidal ideation and chronic history • Semi-structured interview of a recent suicidal crisis of suicide attempts • Recognizing warning signs of an impending suicidal crisis • Unstructured conversation about recent stressors and current com- • Recognizing how an increase and decrease in suicidal risk provides an plaints using supportive listening techniques opportunity to engaging in coping strategies • Collaborative identification of clear signs of crisis (behavioral, cognitive, • Employing internal coping strategies without contacting another person affective or physical) for distraction from suicidal thoughts • Self-management skill identification including things that can be done on • Using social contacts and social settings as a means of distraction from the patient’s own to distract or feel less stressed suicidal thoughts • Collaborative identification of social support including friends, care- • Using family members, caregivers or friends to help resolve the crisis givers, and family members who have helped in the past and who they • Contacting mental health professionals or agencies, including crisis would feel comfortable contacting in crisis intervention services • Review of crisis resources including medical providers, other profession- • Limiting access to lethal means als and the suicide prevention lifeline (1-800-273-8255) • Consider prescribing naloxone for patients at risk for opioid overdose • Referral to treatment including follow-up appointments and other referrals as needed 105 Case Study 2 Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

Stephanie is a 29-year-old female elementary school teacher. She is doing well at work and is rated highly on her performance evaluations; however, away from the office, she struggles with several personal issues. During an annual meeting with her principal, Stephanie is not as cheerful as usual, her mood is down, and she does not want to talk about her personal feelings. Concerned, the principal encourages Stephanie to contact the school district’s confidential health service. Stephanie calls the program to schedule an appointment. Stephanie presents for her appointment on time and appropriately dressed, although she appears tired and depressed. She completes a detailed, computer-assisted intake tool that includes an assessment of physical and mental well-being, which includes the PHQ-9 question: “Over the past two weeks, how often have you been bothered by thoughts that you would be better off dead or of hurting yourself in some way?” She answers “Several days.” During her in-person interview Stephanie reports that she experienced physical and mental abuse as a child, and that she has severe anxiety as well as great difficulty connecting with others and maintaining stable relationships as a result of the abuse. She admits to the clinician that she has thought about suicide in the past but she is vague about how acute her feelings about suicide are currently.

1. How would you categorize Stephanie’s suicide risk?

2. What approach would you take to help reduce Stephanie’s risk? Questions for case study:

3. What non-pharmacological therapy, if any, might be appropriate to suggest to Stephanie to help her cope with her anxiety and suicidal thoughts?

“Self-harm” was studied as the primary outcome, studies, but all were less than 10 sessions. There patients are uncomfortable. This treatment has however these studies have not differentiated were no harms related to PST reported in the high feasibility and acceptability to patients, but between suicidal versus non-suicidal self-harm. literature. providers must be trained in the specific protocol. The strongest evidence for PST comes from a The “Window to Hope” (WtoH) group treatment Patient focus groups revealed that group formats randomized clinical trial conducted by Hatcher et al. intervention (a type of problem-solving therapy) may be burdensome to patients, and individual with approximately 1,000 patients who presented to was developed for patients with at least moderate treatments are sometimes preferred. There is a hospital after self-directed violence.110 The primary levels of hopelessness and with a history of limited access to this treatment, as there are few outcome was additional hospital presentation(s) moderate to severe traumatic brain injury. It has providers with adequate training. with self-directed violence at one year. By design, been found to improve hopelessness in patients Although the evidence base for PST is limited the study included separate analyses for first-time at risk for suicide.111 WtoH is structured around by small sample sizes and confounders in some and repeat presentations at the index episode. As four core therapeutic strategies: (1) behavioral analyses, it is a pragmatic approach, suitable compared to usual care, neither the total sample activation, (2) cognitive restructuring, (3) problem for a sizeable proportion of patients at risk for who received PST, nor the subsample of participants solving, and (4) relapse prevention. Brenner et suicide.4 The intervention can be relatively easily whose index visit was their first presentation with al. reported significant patient improvement in taught, is usable by a range of clinicians, brief, self-directed violence had significantly different hopelessness but not suicidal ideation. Findings and is comparatively inexpensive. PST is also rates of repeat self-directed violence at 12 months. from this trial support the efficacy of WtoH as a consistent with patient values and preferences by Among participants for whom the index episode was psychological intervention to reduce hopelessness inherently incorporating consistent and lengthier a repeat event, however, those who received PST among those with moderate to severe traumatic (per session) care and continuity with a single care were significantly less likely to present again with brain injury. provider. Although not all providers are trained in self-directed violence. This sub-group had a 39% The WtoH intervention is a manualized 16- PST, and some patients may find the homework lower risk of a further presentation for self-directed 20 hour group treatment intervention delivered challenging, most providers and patients find PST violence after a year. Additionally, patients who in 8-10 group sessions composed of group to be an acceptable treatment option. received PST (regardless of type of self-directed formation, behavioral activation, CBT and cognitive violence history) reported more significantly restructuring, problem solving, compensatory BEFORE MOVING ONTO THE NEXT SECTION, reduced suicidal ideation as compared to those who techniques to address existential challenges PLEASE COMPLETE CASE STUDY 3 ON THE received usual care at three months and one year associated with the recovery process, and relapse NEXT PAGE. follow-up.110 prevention. Additional studies, with much smaller samples, Patients engaged with the WtoH intervention Enhanced Care, Care Bridging, and Case have examined the effect of PST on self-directed tend to get reliable and lengthier (per session) 4 Management violence and suicidal ideation with mixed results. care which is consistent with their values and Case management services link the healthcare Three studies provide additional evidence for PST’s preferences. The WtoH program was delivered in system to the patient and coordinate the service benefit on repeat self- directed violence and five the dyad format, which provided benefits of peer- components so that patients can achieve successful studies support a reduction in suicidal ideation. based normalization and validation of experiences community living. Of note, the delivery of PST varied across these without the larger group format with which some

106 Case Study 3 Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

Jeremy is a 32-year-old single, college-educated black male. He lives with a roommate and works as a graphic artist. He is talented, gets jobs easily, but has trouble keeping them. He experiences intense shame about the quality of his work. Jeremy periodically engages in non- suicidal self-injurious behaviors by cutting himself without suicidal intent on his upper arms with a knife. He has never tried to end his life but has had intermittent active suicidal ideation with a plan to jump from the roof of his building. On two occasions, he has gone to the roof and contemplated jumping but did not. Jeremy uses alcohol, and binges on cocaine. He has aggressive episodes (e.g., gets into verbal confrontations with strangers). Jeremy reports being physically abused by his older brother until he was 10 years old. Jeremy had 3 years of outpatient therapy for depression and has been to the ED twice for non-suicidal self-injurying behavior and active suicidal ideation. His ideation and urges to self-harm fluctuate.

1. How would you categorize Jeremy’s suicide risk?

2. What kinds of referrals might be appropriate to help Jeremy address his issues surrounding substance use and history of physical abuse?

Questions for case study: 3. What non-pharmacological therapy, if any, might be appropriate to suggest to Jeremy to help him cope with his feelings of shame and inadequacy at work?

Nurse and social work case management and care interventions across heterogeneous populations of treatment in adults was associated with reduced coordination provide an enterprise-wide effort that at-risk individuals, to identify specific components suicide risk, while initiation of pharmacotherapy did ensures high-quality, integrated behavioral health of the modalities most strongly associated with a not lead to an exacerbation of suicide risk.113 care. positive effect, and to assess their impact on a wider In people aged over 75 years with depression, Case management is a complex process set of outcomes. there is a clear beneficial effect of pharmacotherapy involving many different activities. It is an Future research could explore the following topics: on the risk of attempted and completed suicide. important behavioral health service delivery model • Non-pharmacologic interventions to mitigate In children and adolescents, increased risk of composed of a number of different activities suicide risk assessed across varying settings suicidal thoughts has to be taken into account when for nurse and social work case managers. The (e.g., outpatient, inpatient, residential) and starting pharmacotherapy for depression. However, case management model includes selecting contexts (e.g., individual, dyad, group), and given the increased risk of suicide in untreated cases, identifying and assessing patient needs, with different types of clinical providers. depression and the absence of an increased developing plans, providing needed services, and • How best to disseminate and implement CBT risk of suicide associated with pharmacotherapy, monitoring and evaluating provided services. The for patients with a history of self-directed vi- currently available evidence does not support Case Management Society of America identifies a olence. the avoidance of initiation and continuation of set of case management practice standards.112 • Evaluation of WtoH among more general at- pharmacotherapy for depression in children and This includes assessment, planning, facilitation, risk populations of Veterans and service mem- adolescents.113 In addition to antidepressants care coordination, evaluation, and advocacy for bers. ketamine, lithium, and clozapine may offer benefits the comprehensive needs of individuals’ families • Assessment of the effectiveness of DBT in for reducing suicidal thoughts in selected patients and caregivers. Case management activities include populations other than patients with border- (see detailed discussions below). The impact of resource use and management, sociopsychological line personality disorder. medication-assisted treatments for opioid use and financial support, rehabilitation activities, • Evaluation of strategies to implement proto- disorder, alcoholism, or nicotine addiction (e.g., effectiveness evaluation, and ethics and law. Clinical col-adherent DBT in DoD and VA settings. buprenorphine, naltrexone, methadone, topiramate, nurse and social work case management has • Clarification of which components of safety acamprosate, varenicline) on suicide outcomes been shown to decrease psychiatric readmission and crisis response planning interventions is a particularly important area of inquiry given rates, decrease family burden, improve family and contribute most directly to reduction in risk for the increased risk of suicide among those with a caregiver satisfaction with services, decrease cost suicidal thoughts and behaviors (e.g., disman- substance use disorder. of care, and improve continuity of care.4 tling studies). Ketamine Summary of non-pharmacological treatments Evidence-based pharmacological treatments to Ketamine infusion as a single dose at 0.5 and future directions reduce suicide risk mg/kg has moderate evidence for acute symptom Although evidence supports the use of a improvement of suicidal ideation within 24 hours of variety of non-pharmacologic treatments for Data support the use of a few pharmacological treatment, with a moderate effect size that continues individuals with suicidal ideation and/or a history interventions in suicide prevention. In a 2016 large- for one week114 and even up to six weeks.115 of self-directed violence behavior, additional scale meta- analysis of various suicide risk reduction research is needed to assess the impact of these approaches, antidepressant pharmacotherapy

107 In a meta-analysis of ketamine trials, 55% of systematic reviews have shown lithium maintenance for death by suicide, which was highlighted in the patients after 24 hours and 60% at seven days to be associated with fewer suicidal behaviors and meta-analysis.119 The importance of weighing the reported no suicidal ideation.114 Evidence indicates deaths.4,113 Cipriani et al. noted that the effects of potential benefits of clozapine, which may reduce there is a risk of a transient elevation in blood lithium were not specific to a patient population risk for suicide and suicidal behavior in a high-risk pressure in a small number of patients that resolved with suicidal ideation, broadening the population population, is critical to long-term management of without significant sequelae. in which lithium may be considered an appropriate risk. Evidence also indicates some level of harm Despite general consistency in the evidence treatment beyond those who present with acute associated with clozapine. While study results supporting ketamine for treatment of suicidal suicidal ideation.117 suggest that antipsychotic medications may protect against suicide risk, the evidence appears to be ideation in an acute care setting, there is some Despite general consistency in the evidence most favorable for clozapine. An additional review variability in provider and patient preferences supporting the use of lithium, there is some found that treating depressive symptoms in patients regarding this treatment. Ketamine infusion was variability in provider and patient preferences with schizophrenia is a vital component of suicide administered in inpatient hospital settings to regarding this treatment. Lithium discontinuation risk reduction.120 patients who predominantly were admitted to due to a variety of side effects (e.g., gastrointestinal It is possible that some of the success receive the therapy and released 24 hours following upset, tremor, polyuria, polydipsia, weight gain, attributed to clozapine can be attributed to the positive response to treatment. Recommendations hypothyroidism, leukocytosis) contribute to a large surveillance approach required by the Clozapine for patient management following discharge are variation in adherence. Toxicity with lithium may Risk Evaluation and Mitigation Strategy (REMS) uncertain because there are no long-term studies result in lithium overdose as a serious adverse monitoring program. The REMS program mandates assessing the utility of ketamine on suicidal ideation effect, as well as additional presentations of side frequent visits to healthcare providers for following initial infusion. These studies were done effects that may not resolve with removal of lithium monitoring laboratory results before dispensing in populations with major depressive disorder and including thyroid abnormalities, polyuria, and renal medication refills. Because of significant risks suicidal ideations; other comorbidities were not toxicity leading to reduced renal clearance. Its associated with clozapine such as agranulocytosis, addressed. use is also limited by the low therapeutic index of it is most often used as the antipsychotic of last Considering the potential risk of addiction, lithium and the potential for toxicity with concurrent resort. Patients may be unwilling to commit to continued repeat administration of ketamine is not disease management. Lithium should be used with the level of monitoring and blood draws required recommended.4 Ketamine has known dissociative significant caution with elderly patients and patients for the REMS program. Repeated blood draws on effects and other emergence reactions that could with comorbidities (e.g., seizure disorder, chronic a weekly basis are not only inconvenient for the exacerbate psychotic symptoms. However, as there kidney disease). Achieving target blood levels patient, but may also cause pain and discomfort. are few interventions that result in such a rapid requires blood monitoring, which may negatively Other significant adverse effects of the medication response with as large an effect size, the benefits impact the feasibility of using lithium and decrease include: weight gain, lipid abnormalities, sialorrhea, of offering this treatment to patients with suicidal patients’ and providers’ assessment of its benefits. somnolence, and the rarely occurring but serious ideation make it a potentially important tool for Renal adjustments to dosage are required for adverse events of myocarditis and cardiomyopathy. providers to have available. creatinine clearance ≤50 mL/min. There are significant challenges to clozapine At the same time, this must be balanced with The body of evidence for lithium is limited by use in certain subgroups of patients, such as important barriers to ketamine therapy as patients conflicting results on the primary outcome when the elderly and the homeless, both because may not be receptive to receiving an infusion an active pharmacologic control was used.117 When of the medication’s side effects and difficulties administered in an inpatient setting, and ketamine prescribing lithium to patients at risk for suicide, it accomplishing the required monitoring through the therapy may not be an option for patients living in is important to consider extended release versus REMS program. In the specific population of patients rural areas, where its availability may be limited. (In immediate release formulations, and to pay attention for whom the drug is indicated, the evidence may be 4 March, 2019, the U.S. Food and Drug Administration to the risk of overdose by limiting the amount of considered sufficient with small benefit. approved a ketamine nasal spray which may reduce lithium dispensed. Consider methods to reduce risk Antidepressant medications 116 some of these patient barriers. ) Finally, an of toxicity in overdose, such as dispensing smaller As noted above, a large-scale meta-analysis important treatment consideration is that there quantities and safe medication storage options found that antidepressant pharmacotherapy are no current data to support ketamine’s effect (e.g., having a caregiver or family member store the treatment in adults was associated with reduced on suicide attempts or deaths; further research is medication for the patient). If overdose is identified suicide risk, while initiation of pharmacotherapy needed on long-term outcomes. as a lethal means for the patient, consider an did not lead to an exacerbation of suicide risk.113 The body of evidence supporting ketamine alternative to lithium for treatment. These relatively recent data harmonize previous use for suicide prevention has some limitations, Clozapine conflicting evidence from meta-analyses of earlier including a very narrow, targeted effect on the trials about whether antidepressants trigger The antipsychotic medication clozapine has symptom of suicidal ideation, with unknown impact suicide attempts in adults with major depression. been found to reduce suicidal behaviors in patients on the outcomes of suicide attempt or suicide. The 118 Some meta-analyses of randomized controlled evidence base would benefit from more diversity with schizophrenia or schizoaffective disorder. trials (RCT) found significantly elevated rates of in study populations; most participants in existing Other studies have also demonstrated a lower (attempted) suicide in antidepressant arms relative ketamine studies have a primary diagnosis of mood overall risk of suicidal behaviors compared to to placebo,121,122 whereas others did not.123,124 A disorder and patients with substance use disorders other treatments. A 2005 meta-analysis found a study by Khan et al. likewise found no statistically or psychotic disorders are excluded. Given the lower risk of death by suicide, suicide attempts, significant differences between antidepressants and suicidal behaviors during long-term treatment and placebo, but their study was based on patient harms versus the benefits, caution should be used 119 for repeated administrations or in other populations. with clozapine. In 2003 as a result of these exposure years (PEY), an approach that has been Additionally, the window of effect is a short duration, findings, the FDA approved an indication for questioned since the vast majority of attempted with no evidence to support repeated administration reducing risk of suicidal behaviors in patients suicides in randomized trials occur within the first 125 for persistent suicidal ideation. diagnosed with schizophrenia or schizoaffective 3–4 weeks of acute treatment. illness. Unfortunately, the quality and consistency Some clinicians have advocated for the use of the studies are highly variable, with only Lithium of antidepressants, either as single agents or combined agents (i.e., two antidepressants from Lithium has been shown to reduce the risk one randomized trial of moderate quality that different antidepressant classes, such as an atypical of suicide in patients with unipolar depression compared clozapine to an alternative antipsychotic, antidepressant added to a selective serotonin or bipolar disorder. Several cohort studies and olanzapine. This population was found to have a twelve times greater risk than the general population reuptake inhibitor).126 108 Antidepressants may still be used to treat mood consideration of expectations of a time-sensitive Despite general consistency in the evidence disorders in these high-risk populations; however, response, such as text communications versus supporting home visits for increasing treatment they should be accompanied by patient education letters. Overall, caring communications are a low- engagement among those recently discharged from and additional monitoring (e.g., scheduled visits, cost, low-risk intervention that has been associated psychiatric inpatient care, there is some variability telephone calls). with lower rates of suicide death, attempt, and in provider and patient preferences regarding this ideation. treatment. The patient focus group revealed an Post-acute care for those at risk of suicide or who The sample messages below are illustrative interest in including family members, caregivers, or have attempted suicide of the caring communications approach and can support persons in treatment discussions. In line be adapted for use by a range of health care with this preference, home visits could provide an Communication professionals.130 opportunity to interact more directly with family Sending periodic caring communications members, to involve them in discussions, and to (e.g., postcards, letters) following a psychiatric Sample 1: problem solve around barriers to engaging in hospitalization for suicidal ideation or suicide attempt outpatient treatment. A single home visit is unlikely has been found to reduce the rate of suicide death, Dear (first name), to be burdensome to patients and is consistent with attempts, and ideation for individuals receiving a patient-centered approach. Home visits, on the the communications. The caring communications It has been a little while since you were at other hand, may increase burden on the healthcare intervention was originally studied by Jerome Motto. (name of practice or organization), and we hope system. Issues related to provider safety also need In a 2001 randomized trial, periodic caring letters things are going well for you. If you would like to to be considered. were sent to participants who had dropped out send us a note, we would enjoy hearing from you. The body of evidence had some limitations of treatment within 30 days after discharge from including confounders in the analysis and how psychiatric inpatient care.127 The letters were sent Best wishes, a home visit was defined. Other considerations at least four times a year for five years. Analyses (Name, title, and either mailing address or email regarding this recommendation included the fact revealed a significantly lower suicide rate (p=0.04) address for correspondence) that the benefits of improving treatment engagement for those receiving the letters for the first two years. during an especially high-risk period (i.e., transition The letters were short, non-demanding, and sent at Sample 2: from inpatient to outpatient care) outweigh the regular intervals. potential harm of adverse events, which was small. A 2016 trial randomized 2,300 patients who Dear (first name), Patient values and preferences regarding home had attempted self-poisoning to receive follow- visits and check-ins post-acute care were not up postcards plus usual treatment.128 Following It was great to meet you at (name of practice specifically addressed in the focus group. However, discharge, eight postcards were mailed at 1, 2, 3, or organization). We hope you are doing well. We a home visit may prove a more natural opportunity 4, 6, 8 and 12 months with a ninth postcard sent on just wanted to send a quick note to let you know we to involve family members, caregivers, or support the patient’s birthday. Among postcard recipients are thinking about you and wish you well. If you’d persons for patients who have this preference. there was a significant reduction in suicidal ideation like to reply to us or send us an update, we would Along these lines, some patients may have a from 58.6% to 46.6% and a reduction in suicide be happy to hear from you. strong preference not to include family members, attempts from 9.1% to 6.2%.128 caregivers, or support persons especially if family Chen et al. randomized 761 patients who had Best wishes, relations are a notable source of stress. Although attempted suicide to receive case management (Name, title, and either mailing address or email this recommendation focuses on a very specific services alone or case management services with address for correspondence) subset of those at increased risk of suicide, namely the receipt of a single postcard (n=373) sent at P.S. Please note the following resources that are those that have recently discharged from inpatient the three-month conclusion of case management available to you care but did not attend their initial outpatient services. The postcard contained a list of unique (Brief list of local and national suicide prevention appointment, home visits will incur additional costs coping strategies for the patient as well as a list of services. See Appendix A of this learning activity for and burden for the healthcare system. Feasibility resources.129 Chen et al. observed that sending the examples.) will vary across systems of care and certain patient single postcard had no effect. populations (e.g., those who are homeless) will not Based on research findings from randomized Home visits be able to access this type of follow-up care. trials, the receipt of periodic caring communications A single home visit has been shown to increase WHO Brief Intervention modality (e.g., postcards, letters) has been shown to reduce outpatient treatment engagement among patients The World Health Organization (WHO) Brief the rates of suicide death, attempt, and ideation for recently discharged from psychiatric inpatient care. Intervention and Contact (BIC) treatment modality those receiving the communication versus control Specifically, among patients who failed to attend consists of a one hour individual information session groups that did not receive the communications. The their initial outpatient appointment, a single home as close to the time of discharge as possible and, research further indicates that receipt of a single visit by a nurse resulted in a subsequent increase after discharge, nine follow-up contacts (phone postcard does not have an effect on outcomes. The in treatment compliance compared to those who did 131 calls or visits, as appropriate) according to a common factors for caring communications showing not receive a home visit (51.2% versus 39.8%). specific timeline up to 18 months (at 1, 2, 4, 7 an effect were periodic communications over a Findings from another study showed that an initial and 11 week(s), and 4, 6, 12 and 18 months), period of time of at least 12 months. home visit followed by weekly or biweekly phone conducted by a person with clinical experience The evidence supporting caring contacts resulted in higher treatment engagement 132 (e.g., doctor, nurse, psychologist).”133 WHO BIC communications is limited by the varying than those in the control group. Other studies has been found to significantly decrease suicides communication intervals and cultural adaptations focused on the delivery of time- limited interventions among patients with a history of suicide attempt in across studies. Other considerations regarding in the home setting post-acute care (i.e., discharge low- to middle-income countries (e.g., China, Iran, this recommendation include: communication from ED or inpatient psychiatric unit) showed mixed 4 India, Brazil, Sri Lanka).98 In the three trials of the format (e.g., postcard, letter, email, text); use of results for reducing self-directed violence behavior. WHO BIC intervention, there were significantly fewer non-demanding, supportive, culturally adapted These studies did not differentiate between suicidal suicides in the group that received the intervention messaging; communication delivery barriers for and non-suicidal behavior and the interventions compared to those receiving usual care (3 versus population subsets; and logistical considerations offered in the home setting ranged from case 24 suicides; p <0.0001).98 of staff availability to reply to communications with management to brief psychodynamic interpersonal therapy. 109 The WHO BIC protocol demonstrates that • Effective implementation strategies of WHO evidence of impact on suicidal ideation across systematic long-term contacts after discharge in BIC in the U.S. the studies included in the Leavey and Hawkins addition to usual care can have a positive impact • Cultural adaptation and modernization of car- systematic review that assessed electronic delivery on preventing subsequent deaths by suicide among ing communications (e.g., caring texts) of CBT compared to face-to-face delivery or those presenting to the ED following a suicide treatment as usual. Although a sub-analysis of eight attempt. Technology-based interventions studies included in the Witt et al. systematic review, Generalizability of the intervention to high- Telehealth modalities reflecting moderate quality of evidence, suggest the income countries where psychiatric treatment and/ Available research on technology-based digital interventions were associated with decreased or referral is a component of usual care following interventions to reduce the risk of suicide is post-treatment suicidal ideation, only one of the ED presentation for suicide attempt, may be limited. relatively limited and has focused on electronic studies directly compared electronic to face-to-face Thus, the added benefit of WHO BIC to usual care delivery of treatment protocols in lieu of face-to- treatment delivery. Although this body of evidence in higher income countries is unclear. However, even face delivery. None of the available studies assessed suggests digital interventions may lead to short- in high-income countries, regular follow-up after the effectiveness of telehealth as it is practiced in term decreases in suicidal ideation compared to no ED discharge for suicide attempt is not routine, some private or public organizations (i.e., face-to- active treatment, it does not support an assumption and when it does occur, can vary substantially with face treatment delivered in a virtual environment). of equivalence with face-to-face treatment delivery. respect to the frequency and duration of follow-up Studies assessing electronic delivery of Despite insufficient evidence for or against contacts. The WHO BIC protocol provides structure treatment protocols included a systematic review by technology-based behavioral health treatment for follow-up contacts, while offering flexibility Witt et al. of stand-alone digital interventions (e.g., modalities over face- to-face delivery, the benefits because the follow-up contacts can occur either in CBT based, acceptance based, problem solving, slightly outweigh the harms of considering these person or over the phone and can be made by a interpersonal, mood monitoring, crisis planning) for modalities as a vehicle for delivering treatment range of providers. The follow-up contacts occur the self-management and/or treatment of suicidal protocols to individuals with suicidal ideation, over a period of 18 months, which can be resource ideation or behaviors compared to a variety of control especially when there exist substantive barriers to intensive, and it is possible that some patients may conditions.134 At follow-up, no significant between- in-person care. Individuals participating in patient experience this as burdensome. group differences were observed in reporting of focus groups had limited experience with telehealth The body of evidence has some limitations suicidal ideation or suicide attempt. However, at the modalities, but expressed enthusiasm for their use including attrition and selection bias, limited post-intervention assessment there was evidence and felt these interventions would improve their validity of source of data for suicide deaths, and of a reduction in suicidal ideation in sub-analyses access to high-quality care. Participants reported confounders in the analysis. The benefits of this of three pre-test/post-test observational studies frustration with seeing multiple providers, both intervention, including reductions in suicide deaths, and five RCTs. Only one of the RCTs assessed the within a treatment facility due to provider availability outweigh the potential harm of adverse events. intervention against face-to-face delivery, finding and across locations due to frequent travel, Patient values and preferences were somewhat no difference in suicidal ideation scores.135 The resulting in decreased continuity of care. varied and generalizability to high-income countries authors noted that treatment adherence was poor Telehealth as a mechanism for providing face- is unclear. in a majority of the included studies. Similarly, a to-face treatment for suicidal thoughts and behaviors systematic review by Leavey and Hawkins found no may provide opportunities for improved access to Summary and future directions difference in suicidal ideation or suicidal behavior and continuity of care for patients regardless of Growing evidence in the area of post-acute at follow-up with e-health CBT interventions (e.g., geographic location, travel, deployment status, etc. care points to potential benefits of close monitoring internet, computer, telephone delivery) compared The availability of telehealth across a variety and follow-up as well as strategies to improve to face-to-face CBT or treatment as usual.97 of platforms (e.g., internet based) may also continuity of care and treatment engagement One RCT assessed whether web-based CBT increase access by decreasing stigma related among those recently hospitalized or following an with and without telephone support is effective in to seeking behavioral healthcare in a specific ED visit. Along these lines, there are several areas reducing suicidal ideation in callers to a helpline building/location. Important considerations, 136 for which evidence is either emerging or lacking compared with treatment as usual. No significant however, include accessibility of and comfort using including the effectiveness of different modalities between-group differences in suicidal ideation were technology- based interventions; concerns about for conducting follow-up (e.g., telehealth methods), observed at 6- or 12-month follow-up; however, Health Insurance Portability and Accountability Act dose-response (number of follow-ups and timing), suicidal ideation declined significantly over the (HIPAA) compliance and patient safety; network who should conduct follow-ups (clinician versus 12-month study period for all groups. The authors security and vulnerabilities; and comfort with using peer support), and assertive outreach for those note this may represent regression to the mean smartphones or other handheld devices/tablets. who do not engage in outpatient treatment or because both study groups had high initial levels Older populations and individuals living in rural or follow-up care. Research on the impact of brief of suicidal ideation. The quality of evidence for remote areas with less reliable internet may not be interventions in the ED, such as safety planning, this study is low. Another RCT examined the effect able to effectively access services. combined with repeated follow-up contacts on of an online intervention, eBridge, on readiness suicide specific outcomes (i.e., suicide and suicide to engage in treatment among college students Technology as adjunct to routine prevention attempts), is also needed. The following areas are screening positive for suicide risk through an online Studies evaluating the effect of technology- priorities for future research: survey.137 This intervention included personalized based interventions as adjuncts to routine suicide • Buddy- or peer-delivered post-discharge sup- electronic feedback and optional online exchanges prevention treatment are rare and the two available port following psychiatric hospitalization on with a counselor delivered in accordance with studies did not include the critical outcomes of treatment engagement motivational interviewing principles. Although not a suicidal ideation or suicide attempt as primary • Case management and care facilitation primary outcome of the study, suicidal ideation was study outcomes.138,139 A randomized pilot study • Telehealth monitoring following psychiatric assessed at follow-up with no difference observed by Kasckow et al. assessing the feasibility of hospitalization between the intervention and control group. The post-discharge telehealth monitoring (Health • Interventions to facilitate treatment engage- study did find a significantly higher readiness to Buddy) in addition to Intensive Case Monitoring ment (including dose-response) following ED engage in treatment in the intervention group. (ICM), compared to ICM alone, in Veterans with visit or psychiatric hospitalization for suicidal Overall, although the body of evidence did schizophrenia hospitalized for suicidal ideation ideation or attempt not demonstrate a favorable impact on critical found no group differences using remission (i.e., outcomes, there was no evidence of harm with Beck Scale for Suicidal Ideation Score = 0) as the any of the interventions. This was based on the outcome.139 110 Findings did support, however, the feasibility of with minimal or no direct provider interaction, show • Enhancing clinical and community preventive implementing a telehealth monitoring system for promise at reducing suicidal ideation in pre-test/ services monitoring post-discharge suicide risk in Veterans post-test observational studies and RCTs using • Promoting the availability of timely treatment with schizophrenia and suicidal ideation. waitlist or attentional controls. However, variability and support services Bush et al. conducted a parallel-group RCT in interventions, inclusion criteria, control groups, Proximate risk factors for suicide have been with two groups of Veterans in active mental health and outcomes hinders assessment of efficacy and exhaustively identified, however, using the results of treatment who had recently expressed suicidal determination of effect size. Studies assessing these studies to create effective, community-based ideation.138 Participants were randomized to use technology-based adjuncts to routine behavioral prevention has been elusive in military and Veteran either the Virtual Hope Box (VHB); a smartphone health care were also rare and limited. Findings populations which, as noted previously, have seen app to improve stress coping skills, suicidal ideation, suggest these approaches may be feasible and increases in suicide rates concomitant with the and perceived reasons for living; or printed materials acceptable, but further research is required to establishment of federal suicide prevention efforts. about coping with suicidality. Both interventions assess their impact on the critical outcomes of were provided to supplement treatment as usual. suicidal ideation and behavior. While much research Lethal means safety VHB users reported significantly greater ability to is required, these approaches represent potentially Implementing lethal means safety, including cope with unpleasant emotions and thoughts at important avenues for increasing access to and firearm safety, reducing access to poisons and three and 12 weeks compared to the control group, augmenting existing care. Priorities for future medications associated with overdose, and barriers but no between-group differences were observed research include: to jumping from lethal heights, are ways to reduce for suicidal ideation or any of the other outcome • Assessing the equivalence or non-inferiority population-level suicide rates. measures. Participants also reported high levels of of real-time virtual clinical encounters versus Access to firearms is a risk factor for death by satisfaction with the intervention. in-person delivery of established non-phar- suicide. Firearms are used in half of suicides in the U.S., and approximately 90% of suicide attempts Although evidence to date does not demonstrate macologic suicide prevention interventions 140 a favorable impact on critical outcomes, the studies (e.g., CBT), including whether the effective- involving firearms result in death. Recent reviewed demonstrated feasibility and acceptance ness of these interventions varies by suicide studies have shown that differences in state laws of technology-based adjuncts to augment routine risk level, population characteristics (patient regulating firearms access, and that higher state- level firearms ownership rates,141 are associated treatment. Bush et al. demonstrated significant and provider), and/or treatment type with firearm-related and overall suicide rates, even improvement in coping with unpleasant emotions • Assessing the equivalence or non-inferiority after accounting for important demographic and and thoughts at all time points in the VHB study and of self-guided digital receipt versus in-person geographic factors.142,143 Veterans and military observed a 79% completion rate in the intervention delivery of established non-pharmacologic service members are more likely to use firearms group.138 A large proportion of VHB users reported suicide prevention interventions (e.g., CBT) as a method for dying by suicide compared to the regular and frequent engagement with the material including whether the effectiveness of these general population.144 Military service members and felt it was easy to use, helpful, and beneficial interventions varies by suicide risk level, pop- often have ready access to firearms, and Veterans in dealing with stress and emotional difficulties.138 ulation characteristics (patient and provider), have higher rates of firearm ownership compared There was also no evidence of harm with any of and/or treatment type to their civilian counterparts.145 the interventions, and technology-based adjunct • Assessing the feasibility, acceptability, barri- Weapons restrictions in individuals are treatment may help with patient engagement and ers, and facilitators to using virtual modalities, buttressed by state and Federal law and policy self- management. including telehealth (e.g., telephone, video) or measures. For instance, felons cannot own or carry This body of evidence was limited by serious self-guided digital interventions for both pa- weapons. Sentences of over one year in courts- imprecision. Other considerations include the lack tients and providers martial result in a report to a national database that of evidence of harm, alignment with patient values • Assessing the efficacy and effectiveness of ad- prohibits weapons purchase and ownership. and preferences, accessibility and patients’ comfort junctive technology-based interventions (e.g., Population-based weapons restrictions have with technology-based interventions; concerns digital/ mobile applications used for symptom been effective in a Western military population, even about HIPAA compliance and patient safety; monitoring or augmenting treatment) for sui- if limited in generalizability by geographic variability network security and vulnerabilities; and comfort cide prevention, including whether the effica- and changes in gun statutes, cultural attunements, with using smartphones or other handheld devices/ cy/effectiveness of these interventions varies and greater rates of weapons ownership in the U.S. tablets. Older populations and individuals living in by suicide risk level, population characteristics compared to other Western nations. A naturalistic rural or remote areas with less reliable internet (patient and provider), and/or treatment type epidemiological study in the Israeli Defense Forces may not be able to effectively access services, • Assessing the feasibility, acceptability, barriers, ascertained the effect of unit-by-unit weapons however in other groups technology-based adjunct and facilitators to using adjunctive technolo- storage on bases for 18-21 year old soldiers on treatment may help with patient engagement and gy-based interventions for both patients and weekend leave, showing a dramatic reduction in suicide death on weekends, but not weekdays, self-management. Further research is required to providers 146 support recommendations for or against the use in this population-based cohort. Randomized of technology-based interventions as an adjunct to Population & Community-based Interventions studies have yet to systematically ascertain effects usual care. of population-based weapons restrictions. Means safety counseling (MSC; also referred Background to as “lethal means counseling”) approaches have Summary and future directions Over a half-century of public health strategy has been developed in an effort to reduce deaths Evidence to date is limited to recommend for focused on population-level and community-based by firearms and other means. MSC consists of or against technology-based behavioral health interventions for suicide prevention. A National discussions between clinicians and persons at treatment, monitoring, and assessment modalities Strategy for Suicide Prevention, renewed in 2012, elevated risk for suicide. Less than half of U.S. gun in lieu of traditional face-to-face care. Notably, encompasses three community-based strategic owners report safely storing their firearms (defined none of the included studies assessed the efficacy directions, wrapped around an all-encompassing 14 as all guns stored in a locked gun safe, cabinet, or of face-to-face treatment provided in a virtual, or emphasis on surveillance and research: case; locked into a gun rack; or stored with a trigger “telehealth,” environment as currently practiced. • Creating supportive environments that pro- lock or other lock).147 Studies assessing the use of digital delivery of mote healthy and empowered individuals, fam- established treatment protocols (e.g., CBT) for self- ilies, and communities management of suicidal thinking and behaviors,

111 Also, compared to a resilience retreat, the ASIST Lessons from the United Kingdom training was associated with a slightly higher The adoption of the following 9 suicide prevention recommendations by mental health systems likelihood of reporting suicidal ideation. across England and Wales has greatly reduced suicide rates among patients. One non-comparative study examined the 1. Providing 24-hour crisis teams feasibility of using an online gatekeeper to direct 2. Removing materials that could be used for suicide individuals searching for suicide-related keywords 3. Conducting follow-up with patients within 7 days of discharge to a website encouraging use of an e-mail 4. Conducting assertive community outreach, including providing intensive support for people with consultation service. The results were limited, and severe mental illness strength of evidence was very low, but modest 5. Providing regular training to frontline clinical staff on the management of suicide risk levels of treatment engagement and improvement 6. Managing patients with co-occurring disorders (mental and substance use disorder) in mood were seen.4 7. Responding to patients who are not complying with treatment No studies that address the effects of crisis 8. Sharing information with criminal justice agencies lines or peer-to-peer counseling lines met inclusion 9. Conducting multidisciplinary reviews and sharing information with families after a suicide. criteria. These lines have existed for decades, yet In 1998, few of the 91 mental health services in the study were carrying out any of these there is insufficient evidence to comment on their recommendations. By 2006, about 71 percent were doing so. Over time, as more recommendations effectiveness in reducing population-level suicide were implemented, suicide rates among patients declined. Each year, from 2004 to 2006, mental rates. health services that implemented seven or more recommendations had a lower suicide rate than those The body of evidence had limitations including implementing six or fewer. Among all recommendations, providing 24-hour crisis care was linked to the confounders in the analyses. Community-based largest decrease in suicide rates. interventions, including gatekeeper training and Source: While D, Bickley H, Roscoe A, et al. Implementation of mental health service recommendations in buddy support, had insufficient evidence upon England and Wales and suicide rates, 1997-2006. Lancet. 2012;379(9820):1005-1012. which to make recommendations. There was a lack of evidence that potential benefits (e.g., definitive management of suicidality resulting in an aggregate Talking about guns at home decrease in death) outweigh the potential harm How a question about guns is posed can made a difference to how open and forthcoming a patient is of adverse events, which could include fostering about this key piece of information. Instead of asking: “Do you have access to a gun?” contagion or bypassing evidence-based care. Consider one of the following questions: Patient values and preferences for care emanating 1. “Lots of people in (name your state) have guns at home. Research shows that a suicidal person from community-based training can vary greatly, is safer if they don’t have access to guns. What some gun owners in your situation do is store with a balance needing to be struck between their guns away from home until they’re feeling better, or lock them and ask someone they trust to potentially stigmatizing care delivered in the hold the keys. If you have guns at home, I’m wondering if you’ve thought of a strategy like that.” healthcare system and confidential care delivered 2. “I don’t know if you have guns at home, but if you do, research shows that a suicidal person is by non-privileged community gatekeepers. safer if they don’t have access to guns. What some gun owners in your situation do is store their Currently, the most robust evidence for guns away from home until they’re feeling better, or lock them and ask someone they trust to population-level interventions to prevent suicide hold the keys. If you have guns at home, I’m wondering if you’ve thought of a strategy like that.” is lethal means reduction, particularly those Source: Caring for adult patients with suicide risk: a consensus guide for emergency departments. Suicide supported by legislation (e.g., firearm regulations, Prevention Resource Center (SAMHSA), 2015. pesticide availability, changes to packaging of analgesics) and environmental interventions Examples of MSC recommendations, depending Community-based suicide prevention may be (e.g., structural barriers at suicide hot spots). on level of risk, include storing firearms in locked constrained, however, by the immense complexity There continues to be limited evidence for other cabinets, using gunlocks, giving keys to these of population processes, including sociocultural public health and community-based interventions, locks to family, caregivers or friends, temporarily variables, and historically suboptimal interactions including gatekeeper training, targeted media transferring firearms to someone legally authorized between healthcare systems and suicide prevention campaigns, and 24/7 crisis lines, on population- to receive them, removing firing pins, or otherwise programs. Gatekeeper training is illustrative. An level suicide outcomes. disabling the weapon. MSC approaches have not initial systematic review of studies published from More research is needed on the effect on suicide been shown to reduce suicide, but have been shown 1980-1995 found that knowledge about suicide rates of these programs, particularly those tailored to impact firearm storage practices.148,149 improved in gatekeeper training but there were to service member and Veteran populations. Given Another commonly used method for suicide is both beneficial and harmful effects in terms of that many of these programs and interventions are poisoning, including medication overdose. Access help-seeking, attitudes, and peer support.153 Mann delivered concurrently as part of a multi-faceted to opioid medications has been associated with et al. made a qualified endorsement of gatekeeper suicide prevention approach, research in this increased rates of intentional and unintentional training, provided that formalized roles and care area requires special methodological approaches overdose death.150 One study demonstrated that pathways were available.154 The review noted to examine the potential synergistic effects of increased access to acetaminophen was paralleled some community-based awareness programs are combining multiple strategies. with increased rates of suicide attempts and death not evidence-based and do not reflect current Research is also needed to understand the by suicide via overdose in the United Kingdom.151 knowledge of suicide prevention or provide routine impact of universal or selective application of Gatekeeper training for suicide prevention—a evaluation of effectiveness and safety for preventing specific lethal means safety interventions (e.g., key tool for increasing engagement into preventative suicidal behavior. No RCT showed that gatekeeper blister packaging medication, distribution of gun services for suicide, which includes programs such training alone affects suicide rates.113 locks and other safe storage mechanisms) on as Question, Persuade, and Refer (QPR) and Research gaps exist in community-based suicide and suicide attempts. Along these lines, Applied Skills in Suicide Training (ASIST)—has not interventions as mechanisms to reduce suicide examining the impact of provider- or peer- driven been found to improve population-level suicide risk. A Canadian RCT in First Nations community lethal means safety counseling on individual safety rates in each of the U.S. states.152 members—family members, police, teachers, and behaviors (e.g., use of safe storage mechanism, Every state has fostered a community-based clergy—demonstrated that the ASIST training had removal of a weapon from home during times of approach to suicide prevention since the turn of the no positive impact on self-reported gatekeeper crisis) and suicide outcomes is also needed. century. skills.155 112 Summary of strategies and approaches to “The toilet and sink faded to nothingness in my 45,000 Veterans and active-duty service members prevent suicide field of vision and my focus narrowed. My hands killed themselves between 2013 and 2019, which is were pale next to the black of the handgun, and more than 20 deaths a day (Table 6).159 The number As noted, suicide occurs in response to the cuticles I shredded under stress stood out on of Veterans and service members lost to suicide in multiple biological, psychological, interpersonal, my white skin, red and raw. I took a deep breath one year now surpasses the total American military environmental and societal influences that interact to steady myself, still my sudden trembling. This deaths in Afghanistan and Iraq, as of 2019.159 with one another, often over time. Thus efforts to gun, this choice. It offered me a way out, and (Note: other epidemiological data relevant to prevent suicide must encompass multiple levels freedom from the fear that nothing would change. Veterans and the military were presented in the of focus including the individual, relationships, The thought of nothingness descending upon my Introduction to this learning activity.) communities, and society as a whole. Figure 7, from consciousness seemed like it would be a relief—all Two frequent co-occurring conditions in those the CDC, summarize the strategies and approaches the stress and fear and anger and confusion gone, who attempt suicide are mental illnesses and reviewed in detail earlier. replaced by blessed nothingness.”158 substance use disorder. Among Veterans who died Williams stepped back from the brink. With the by suicide in 2017, 58.7% had a diagnosed mental Specific at-risk populations help of counseling for both herself and her husband, health or substance use disorder.3 Suicide rates she recovered, rebuilt her marriage and career, and were highest among Veterans with bipolar disorder Members of the Armed Forces and Veterans 3 Kayla Williams had been home only a few wrote two books about her experiences both in or who had an opioid use disorder (Figure 8). months after serving as an Army sergeant and and out of the military. She is now the director of Suicide rates among Veteran users of Veterans Arab linguist in the Iraq War, but her marriage (to the Military, Veterans and Society program at the Health Administration (VHA) services have been a combat-wounded Veteran with post-traumatic Center for a New American Security. She lives near found to be affected by economic disparities, stress disorder) was falling apart. Now she was in Washington DC with her husband and two children. homelessness, unemployment, level of military her bathroom with a gun in her hand, contemplating In recent years suicide has claimed more lives service connected disability status, community suicide.157 among military personnel than combat. More than connection, and personal health and well-being.

Figure 7. Suicide prevention strategies and approaches156

113 Figure 7. Suicide prevention strategies and approaches156 (Continued)

Exercise 1 Instructions: Spend 5-10 minutes reviewing Figure 7, then consider the following questions: 1. Which of the strategies and approaches are feasible in primary care settings?

2. Which strategies might be appropriate for the population of Veterans or military service personnel?

3. Which strategies might be appropriate for individuals at risk of suicide who are already hospitalized or in a mental health care institution of some kind?

114 The following details highlight VHA Veteran Isolation has been shown Table 6: Total and daily average numbers Social Connection: experiences across these domains:3 to be a risk factor for suicide. Among VHA patients, of suicide deaths among Veterans, 2005- 3 Economic Disparities: Veterans enrolled in suicide rates have been found to be highest among 2017 VHA care were less likely to be employed and had those who were divorced, widowed, or never Year Suicide Average Per lower income levels than Veterans not receiving VHA married and lowest among those who married. Also, Day care. Some Veterans report difficulty in transitioning among VHA patients, suicide rates were elevated 2005 5,787 15.9 to civilian positions. Their highly developed skills among individuals residing in rural areas. obtained in the military may not translate to higher- Health and Well-Being: VHA Veterans 2006 5,688 15.6 level positions in the civilian world. In addition, who died by suicide were more likely to have 2007 5,893 16.1 unemployment and poverty are correlated with sleep disorders, traumatic brain injury, or a pain homelessness among Veterans. diagnosis. In addition, mental health diagnoses 2008 6,216 17.0 Homelessness: In January 2017, the U.S. (including bipolar disorder, personality disorder, 2009 6,172 16.9 Department of Housing and Urban Development substance use disorder, schizophrenia, depression, 2010 6,158 16.9 Point-in-Time Count estimated that 40,000 Veterans and anxiety disorders), inpatient mental health care, were homeless and just over 15,300 were living prior suicide attempts, prior calls to the Veterans 2011 6,116 16.8 on the street or unsheltered on any given night. Crisis Line, and prior mental health treatment were 2012 6,065 16.6 Homelessness appears to play a role in suicide also associated with greater likelihood of suicide. 2013 6,132 16.8 for VHA patients. VHA patients with indications of In summary, the sociocultural context of homelessness or who received homelessness- suicide provides a complex entwining of factors 2014 6,272 17.2 related services had higher rates of suicide than associated with, but not directly predictive of, 2015 6,227 17.1 other VHA patients. suicide. Therefore, meaningful improvement of 2016 6,010 16.4 Service Connection: VHA patients with military suicide prevention efforts is possible only through service connected disability status may have lower a systematic and unified public health approach 2017 6,139 16.8 risk of suicide than other VHA patients. addressing international, national, and community- level issues and resources paired with individualized Figure 8. Suicide rates per 100,000 among Veterans with mental health or support, care, and personal responsibility. substance use disorders3 Veteran-focused suicide prevention initiatives Between fiscal years 2013 and 2019, the U.S. congress appropriated more than $1 billion for suicide prevention programs in the Department of Defense and Veterans Affairs Administration.160 VA suicide prevention strategies are organized into three levels of strategic focus.3 First, universal strategies aim to reach all Veterans. These include public awareness and education campaigns regarding the availability of suicide prevention resources for Veterans and the promotion of responsible media coverage. Second, selective strategies are designed for some Veteran subgroups that may be at increased risk for suicidal behaviors. Examples include targeted outreach to women Veterans, to Veterans with substance use challenges, and to Veterans with recent separation from military service. And third, indicated strategies are designed for the relatively few individual Veterans who are identified as having high risk for suicide. Indicated strategies include referral to the Veterans Crisis Line and clinical review and outreach for those Veterans in the highest tier of predicted statistical risk. Unfortunately, many Veterans are not aware of the services available to them or of the many initiatives designed to reduce suicide risk. Mental health treatment is a mysterious “black box,” with their knowledge and perceptions of mental illness and treatment shaped largely by often inaccurate or incomplete media portrayals and anecdotal information or references from peers.63 A summary of current DoD/VA initiatives follows: Veterans Crisis Line The Veterans Crisis Line is the world’s largest provider of crisis call, text, and online chat services.

115 The 27/7 service is used by approximately 650,000 Mental Health Treatment Coordinators if limited in generalizability by geographic variability people each year. As of 2018, approximately 1.3 million and changes in gun statutes, cultural attunements, Veterans has an assigned Mental Health Treatment and greater rates of weapons ownership in the U.S. Suicide research Coordinator who is tasked with the job of ensuring compared to other Western nations. A naturalistic The VA supports clinical research into continuity of care between providers and who epidemiological study in the Israeli Defense Forces evidence-based psychotherapy techniques, provides the Veteran with a consistent and reliable ascertained the effect of unit-by-unit weapons medications, and behavioral, complementary, and point of contact, especially during care transitions. storage on bases for 18-21 year old soldiers on alternative approaches to treating PTSD and other weekend leave, showing a dramatic reduction in mental health conditions associated with suicidality suicide death on weekends, but not weekdays, among Veterans. Expansion of evidence-based treatments in this population-based cohort.146 Randomized More than 12,700 VA mental health clinicians studies have yet to systematically ascertain effects Community partnerships have been trained in evidence-based treatments, of population- based weapons restrictions. The VA has expanded partnerships with including prolonged exposure (PE) and/or cognitive Means safety counseling (MSC; also referred hundreds of organizations and corporations at processing therapies, as well as medication to as “lethal means counseling”) approaches have national and local levels to raise awareness of treatments indicated for a variety of conditions. been developed in an effort to reduce deaths suicide prevention resources and to educate people by firearms and other means. MSC consists of about how they can support Veterans and service Care related to military sexual trauma discussions between clinicians and Veterans at members in their communities. One example is the In 2017 every VHA health center provided elevated risk for suicide. Approximately one third 2018 Mayor’s Challenge, an initiative co-sponsored free military sexual trauma (MST) outpatient care of Veterans store at least one firearm loaded or with SAMHSA, launched in 24 cities to provide tools to both women and men. More than 1,325,000 unlocked.162 Examples of MSC recommendations, and technical assistance for addressing Veteran MST-related outpatient visits were provided, a 9% depending on level of risk, include storing firearms suicide.161 increase from 2016. in locked cabinets, using gunlocks, giving keys to these locks to family, caregivers or friends, Clinical partnerships Women’s Mental Health temporarily transferring firearms to someone The VA is partnering with community-based A national network of Women’s Mental Health legally authorized to receive them, removing firing mental health providers to expand the network of Champions in nearly every VA health care center pins, or otherwise disabling the weapon. MSC local treatment resources for Veterans in need who exists to facilitate consultations, and develop local approaches have not been shown to reduce suicide, live in remote locations without access to existing but have been shown to impact firearm storage resources to support gender-sensitive mental 148,149 VA locations. health care. In addition the VA has developed many practices. clinical training resources for providers who treat Another commonly used method for suicide Outreach women Veterans, including a monthly teleconference among Veterans and military Service Members is There are more than 400 VA Suicide Prevention series, and web-based training courses that include poisoning, including medication overdose. Access Coordinators and their teams located at every VA live demonstrations and role- playing exercises. to opioid medications has been associated with Medical Center, which work to connect Veterans with increased rates of intentional and unintentional care and to educate the community about suicide overdose death.150 Lethal means safety for Veterans and military prevention programs and resources. One study demonstrated that increased access service members to acetaminophen were paralleled with increased Assessment of VA mental health services As noted earlier, Veterans and military rates of suicide attempts and death by suicide via The VHA Strategic Analytics for Improvement service members are more likely to use firearms overdose in the United Kingdom.151 and Learning program (SAIL) provides a as a method for dying by suicide compared to the Gatekeeper training for suicide prevention—a standardized way to assess the quality of mental general population.144 Military Service Members key tool for increasing engagement into preventative health services in VA facilities. Facilities with lower- often have ready access to firearms, and Veterans services for suicide, which includes programs such than-average levels of access and quality, as have higher rates of firearm ownership compared as Question, Persuade, and Refer (QPR) and indicated by the SAIL program, have been shown to their civilian counterparts.145 Applied Skills in Suicide Training (ASIST)—has not to improve those services within 6 months, and One systematic review reported statistically been found to improve population-level suicide facilities with excellent access and quality have significant increased risk of suicide with presence rates in each of the U.S. states, VA, and DoD.152 generally maintained performance over the years. of firearms in the house.113 Department of Defense Buddy support, incorporated into programs such healthcare providers, like their VA and civilian as Comprehensive Soldier Fitness, which have a Integration of mental health professionals into VA counterparts, have no restrictions regarding practical and theoretical nexus to military suicide inquiries and recommendations pertaining to prevention and resilience programming, does not primary care weapons ownership or carriage. The Department have a sufficient evidence base to demonstrate The Primary Care-Mental Health Integration of Defense has long had mechanisms for leaders efficacy in preventing suicide, suicide attempts, or (PCMHI) program embeds mental health providers to arrange sequestration of military and civilian- suicidal ideation.163 in primary care settings to improve same-day issued weapons in armories, for operational access to services. Since tracking began in 2008 units during leave periods, for individuals under Coping skills the VA has served over 2 million patients through treatment for behavioral health conditions, or for A range of skills have been shown to improve PCMHI, and mental health visits increased 20% any individual exhibiting behaviors of concern. the ability of Veterans to cope with stress, anxiety, between 2014 and 2017. Weapons restrictions in individuals are difficult life situations, and other factors plausibly buttressed by state and Federal law and policy associated with increased suicide risk. Clinicians Universal screening measures in both VA and Department of Defense. may want to offer training on the skills summarized In 2018 the VA implemented the largest For instance, felons cannot own or carry weapons. below in consultation with the Veteran and in light standardized suicide risk assessment in U.S. health Sentences of over one year in courts-martial result of factors such as the patient’s existing coping skills care. More than 1.8 million Veterans received in a report to a national database that prohibits and abilities, the complexity of the skill, patients this screening, with approximately 84,000 (3%) weapons purchase and ownership. preference and other personal factors such as the reporting suicidal ideation. Population-based weapons restrictions have nature of the Veteran’s current distress or impaired been effective in a Western military population, even attentional, affective, or interpersonal functioning and current maladaptive coping tendencies.63 116 The skills below are organized hierarchically from breathing is typically new to most individuals and exacerbated by systematic muscle tensing. With more basic and easily-learned skills to more replaces habitual thoracic breathing, the provider such individuals, an alternative approach that has complex skills. It is generally recommended to should note that this skill may feel unnatural at first been shown to be effective is to instruct the patient start with the easiest skills and progress to more but becomes much easier with dedicated practice. to imagine tensing and relaxing specific muscle challenging skills upon mastery of the fundamental (A tutorial on diaphragmatic breathing and its groups. skills. By reducing physiological arousal, these skills effects on the stress response system is available may also facilitate the implementation of higher- in the Breathe2Relax mobile application developed Mindfulness meditation order skills in therapy. by the Department of Defense National Center for Mindfulness Meditation has received extensive Telehealth and Technology. The app is free to use and rigorous empirical examination, with a spate of Basic relaxation skills and may be accessed at: www.t2health.dcoe.mil/ studies in recent years demonstrating the significant Relaxation skills are among the most apps/breathe2relax.) utility and efficacy of Mindfulness Meditation for a straightforward for patients to practice and variety of mental health and other issues, as well A second component of Meditative Breathing 63,164 implement and generally have quick and noticeable involves adding a simple meditative element. After as additional studies currently underway. effect. Providers should encourage Veterans to use the patient is taught diaphragmatic breathing, they Mindfulness Meditation often involves focusing one or more of the Basic Relaxation Skills both for are instructed about the meditative component. attention on internal experiences, sensations, and reducing acute stress in stress-provoking situations Before leading the patient through this, the provider aspects of self, and it uses specific techniques. and in an ongoing manner for lower one’s “emotional should describe this component so the patient can Mindfulness Meditation requires repeated practice temperature.” The latter use of Basic Relaxation anticipate what to expect and natural challenges and discipline to maximize impact and utility. Skills can have the effect of improving mood and they may encounter (e.g., intrusion of thoughts). For thousands of years, the practice of increasing one’s stress tolerance threshold by, Then, the provider asks the patient to sit straight mindfulness has served as a powerful tool for for example, lowering levels of cortisol, the stress up in a comfortable position, close their eyes, and increasing attentional focus and living in the present hormone, and stimulating the parasympathetic begin engaging in diaphragmatic breathing, inhaling moment. In recent years, practitioners of modern nervous system. through their nose and exhaling out of their mouth. medicine have embraced mindfulness for helping While doing so, they are instructed to focus on their patients to manage stress, cope with illness and Meditative breathing breathing and to redirect their thinking back to their medical procedures, and promote overall healthy Meditative Breathing is a core relaxation skill breathing (including the sound, rate, temperature living. Mindfulness practice has been incorporated that patients can cultivate to develop a sense of of each breath of air), when they find their mind into many different areas of health care, including controllability during states of agitation or arousal wanders. The provider guides the patient through oncology, chronic pain and disease, sports and to achieve a general sense of calm. This skill the exercise, with periodic and soothing reminders medicine, and pre- and post-surgical contexts. involves two components—diaphragmatic (or to “focus only on your breathing” and to notice Moreover, mindfulness practice has recently been abdominal) breathing and a meditative component. the sound, temperature, and path of each breath. adopted by employers to promote employee well- First, the provider teaches the patient how to The provider periodically notes that “if your mind being and organizational performance. Within engage in diaphragmatic breathing (a process also wanders, gently guide your thinking back to your mental health, mindfulness has received significant referred to as “breathing retraining”). breathing.” interest and attention over the past three decades. Prior to teaching the skill (and relaxation More recently, mindfulness practice has skills in general), it is important for the provider to Progressive muscle relaxation increasingly been incorporated as a specific briefly educate them about the underlying rationale Progressive Muscle Relaxation (PMR) is an component or adjunct to treatment and has and physiology, rather than just teaching the skill. empirically supported skill in which patients tense been shown, in some contexts, to be a promising Patients are taught that diaphragmatic breathing, and then relax various muscle groups to reduce standalone intervention, with additional research or breathing from the belly, involves a deeper, muscle tension and achieve a sense of calm.63 PMR currently underway. healthier way of breathing. Most people breathe targets increased muscle tension that accompanies Mindfulness practice generally involves three from the chest or thoracic cavity (known as thoracic amygdala activation, which is often interpreted components: (1) remaining focused on the present, breathing), which is a much shallower type of by patients as a sign of danger. Specifically, PMR rather than ruminating over the past or anxiously breathing. involves tensing of different muscle groups for anticipating the future, (2) being intentional in Patients should be informed that the two approximately five to seven seconds, followed whatever activity is being pursued, and (3) being types of breathing have very different physiological by gradual relaxation of muscle group and focus nonjudgmental, refraining from affixing labels like effects on the body. Diaphragmatic breathing on the sensation of warmth and relaxation for “good” or “bad” to one’s experience. activates the parasympathetic nervous system, approximately 30 to 40 seconds. Mindfulness Meditation involves the specific practice turning off the body’s stress response (sympathetic The provider leads the patient through each of mindfulness that can be easily taught and nervous system) and resulting in a slowing of one’s muscle group while the patient is in a seated incorporated into Veterans’ lives. The goal of these heartbeat and lowering of blood pressure. Shallow position, though the provider may note that the exercises is to help cultivate mindful awareness breathing, on the other hand, often contributes to patient may engage in the exercise at home while of the present moment and increase attentional stress and activation of the sympathetic nervous lying on their back. As the provider leads the Veteran control. This, in turn, promotes acceptance of system. through the exercise, they may state, “Now I’d like emotional experience, sensation, and thought, After educating the Veteran about the you to make a fist with your right hand, holding it facilitating adaptive responses to negative emotion rationale, function, and effects of diaphragmatic as tight as you can, holding and focusing on the and coping with stress and physical pain. breathing, the provider demonstrates thoracic vs. tension,…continuing to hold and focus on the Mindfulness Meditation practices and guided diaphragmatic breathing by placing their right hand tension” and “Now I’d like you to release your fist, exercises exist for many different areas of focus on their stomach and left hand on their chest and letting go of all the tension out of your fingertips, and individual needs (e.g., general stress, anxiety, inviting the patient to do the same, observing which feeling the warmth that emerges when you let go of sleep, self-compassion, happiness, frustration, hand moves with each type of breathing. Next, the the tension and focusing on it as it dissolves away.” blame, guilt) and may be tailored to individuals’ provider leads the patient through the diaphragmatic Like diaphragmatic breathing, patients practice experiences. Some Mindfulness Meditation exercises breathing exercise, instructing the Veteran to inhale relaxation for homework in between sessions. have features in common with and build on the more through the nose, causing the belly to expand PMR is generally contraindicated in individuals general Meditative Breathing exercise described and fill with air, hold for three seconds, and then with arthritis or physical pain that may be above; however, whereas Meditative Breathing is exhale through the mouth. Because diaphragmatic focused on promoting relaxation, 117 Mindfulness Meditation is focused on increasing Cognitive Defusion broadened view of the situation and the resulting awareness. Relaxation may be a by-product of Cognitive Defusion involves specific techniques change in the Veteran’s emotional reaction. Mindfulness Meditation, but it is not the primary designed to help individuals observe the process outcome targeted. of thinking and notice thoughts as thoughts, rather Command consultation Prior to introducing Mindfulness Meditation, it than take them as fact or allow them to overly Military commanders expect to be cognizant is important to explain the purpose of and rationale influence behavior.167 Cognitive Defusion helps of major events in the lives of Service Members for mindfulness practice, noting the benefits of patients to become less “fused” with their thinking under their charge. Command consultation is an important aspect for treatment of behavioral nonjudgmental awareness and acceptance of by teaching them to look at thoughts instead of from health conditions and is a relevant part of military internal experiences (e.g., emotions, thoughts, thoughts, viewing thoughts as thoughts rather than 4 literal truths. In this way, Cognitive Defusion teaches treatment planning. Command involvement in the sensations) on both mental and physical health. care of the Service Members is always considered This includes but is not limited to increased patients a new way of relating to their thoughts. The strategy does not involve changing or reshaping in the context of balancing split fiduciary roles, to affect tolerance, adaptability, and overall coping both patients and commands, in military medicine. capacity, as well as improved concentration and the content of maladaptive thoughts but engaging in mindful observation and disentanglement from In order to foster a culture of support focus, which can help with getting the most out throughout the Department of Defense and dispel of treatment. Ultimately, through mindful practice, these thoughts. Cognitive Defusion has been shown to be effective as a standalone stress management the stigma of seeking mental health care, military patients may come to see thoughts and feelings as healthcare providers employ a presumption, technique. Cognitive Defusion can be used in transient experiences. This can help to decrease buttressed in Department of Defense instructions conjunction with Basic Relaxation Skills, as well as identification with a momentary affective state, addressing mental health evaluations and command facilitating greater self-understanding and self- with Mindfulness Meditation, as part of helping interactions to minimize stigma, to defer notification compassion. In noting the benefit of mindfulness, patients to engage in nonjudgmental awareness of a Service Member’s commander indefinitely the provider may specifically note the effectiveness of their thoughts, situation, and surroundings and unless the deferral is overcome by notification of mindfulness with Veterans, referring to either to remain in the present moment. Veterans who standards listed in Department of Defense policy. clinical experience and/or empirical research. For take particularly well to Mindfulness Meditation In disclosure to commands, clinicians provide a and the concept of nonjudgmental awareness instance, mindfulness-based interventions have minimum amount of information—only enough to may be especially well-suited to learning and using been shown to reduce symptoms of anxiety, PTSD, satisfy the purpose of the disclosure. Cognitive Defusion. depression, and suicidal ideation and improve Healthcare providers notify commanders under mental health functioning in Veterans.165,166 Cognitive reappraisal the following circumstances: harm to self, harm When introducing Mindfulness Meditation, it Cognitive Reappraisal involves adjusting or to others, harm to mission, inpatient care, acute can be useful to ask the Veteran what, if anything, reframing the meaning one gives to a situation medical conditions interfering with duty, substance they know about mindfulness. Getting a sense of the in order to alter their emotional response.168 abuse treatment, command-directed mental health patient’s preexisting knowledge and beliefs can help Although often used synonymously with cognitive evaluations, treatment of personnel in sensitive with knowing how much and what to emphasize in restructuring, Cognitive Reappraisal is a more basic positions, or circumstances when execution of the the rationale and introduction. technique that lends well to use as a general coping military mission outweighs the interest served by Some individuals have a highly inaccurate strategy. Cognitive restructuring, a central strategy avoiding notification. understanding of mindfulness and meditation, often of CBT, involves changing maladaptive thoughts by mistaking them for something religious or mystical. systematically identifying and examining the validity BEFORE MOVING ONTO THE NEXT SECTION, Although it has its roots in Eastern philosophy and and function of thought, as opposed to the more PLEASE COMPLETE CASE STUDY 4 ON THE practice, Mindfulness Meditation is largely used as basic process of reappraising or reframing of the NEXT PAGE. a skill in mental health prevention and treatment situation. Learning Cognitive Reappraisal skills can and is not promoted in most health arenas as either Suicide in prisons and child welfare settings provide Veterans with foundational cognitive coping Suicide is a common cause of death in secure religious or mystical, but secular (i.e., not regarded abilities that can be useful for subsequently learning as religious, spiritual, or sacred). As well, patients justice settings. More than 400 suicides occur cognitive restructuring or extending in CBT or other annually in local jails at a rate three times greater may express more openness and confidence in treatment. practicing Mindfulness Meditation after engaging than among the general population, and suicide Providers may teach Cognitive Reappraisal is the third leading cause of death in prisons.169 in the previously described coping skills, such as by indirectly guiding patients in reappraising a Meditative Breathing and Progressive Muscle Youth involved in the juvenile justice and child specific situation in their lives and demonstrating welfare systems have a high prevalence of risk Relaxation. In fact, Mindfulness Meditation can how they appraise—and reappraise—situations be introduced as a skill designed to build on the factors for suicide. Juveniles in confinement have that affect how they feel. Through the use of life histories that put them at higher suicide risk, previously introduced skills, although it is important Guided Discovery, the provider helps the Veteran including experiences such as mental disorders and to remind the patient that mindfulness is not about to develop new perspective on or a new way of substance abuse; physical, sexual, and emotional achieving a relaxed state; rather, it is about being looking at the situation. First, the provider identifies abuse; and current and prior self-injurious behavior. aware. a scenario where the patient formulated an extreme Youth in foster care share many of these At the conclusion of any Mindfulness Meditation or narrow appraisal resulting in a strong negative traumatic experiences. In one study, children in exercise, the provider should discuss the Veteran’s reaction. Next, the provider inquires about the foster care were almost three times more likely to reactions to the exercise and explore how they might emotional or other (e.g., physiological) effect of have considered suicide and almost four times more incorporate these practices and exercises into their the patient’s appraisal in order to help the patient likely to have attempted suicide than those who had daily life. Many high quality, free mobile applications gain awareness of the impact of their thinking on never been in foster care.170 Suicide among youth now exist that make it simple to practice and how they feel. Using non-directive questioning, in contact with the juvenile justice system occurs incorporate Mindfulness Meditation in one’s routine, the provider then helps the patient develop a new, at a rate about four times greater than the rate with many applications able to provide a reminder modified, or broadened appraisal of the situation among youth in the general population.171 Research at specific times and offering brief exercises that based on the facts of the situation, being mindful suggests that youth engage in more than 17,000 may be completed virtually anywhere. Providers are not to convince the patient or reject their thoughts incidents each year in juvenile facilities, that more encouraged to become familiar with different apps and feelings about the situation. After helping than half of all detained youth reported current and to review in session one or more that appear to the patient through the process of reappraisal, suicidal ideation, and that one-third also had a be a good fit for particular patients. the provider highlights the patient’s alternate or history of suicidal behaviors.171

118 Case Study 4 Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

Reggie is a 58-year-old retired Army Warrant Officer who completed four tours in the Middle East—two in Iraq, and two in Afghanistan. He retired from active duty due to service-connected injuries including migraines, nerve damage, and back and neck pain. He is unable to work due to these medical conditions and has 80% disability through the VA. Reggie and his family (wife and three children) recently moved into a small rental house after they lost their home to foreclosure. Reggie’s wife works two jobs to “make ends meet” and frequently expresses dissatisfaction with the marriage and, more generally, their life together. His oldest child, age 20, was recently arrested for possession of marijuana with intent to sell, his second arrest in the past two years. Reggie describes his two younger children as “doing OK,” although he worries about the impact of the move to the smaller house on the children, and he feels distant from them due to his medical and other struggles. Reggie was referred to Mental Health by his neurologist who was treating his migraine headaches. Reggie completed a psychodiagnostic evaluation session, which revealed that he meets criteria for major depressive disorder, with an onset soon after he announced his retirement. Reggie reported that he does not know what to do with himself now that he is retired, remarking, “I have no purpose now.” Although he says he does not sleep well, he indicated that he gets a total of 10–12 hours of sleep per day because he takes frequent and lengthy naps during daytime hours. Reggie indicated that he has little interest in pursuing activities that he used to enjoy, such as playing drums and following NASCAR, and remarks that he has so much difficulty concentrating that he probably would not be able to do these activities anyway. He stated that he has no intent to harm himself, although he commented that this could change if his wife were to leave him. Reggie denied a history of depression or symptoms of PTSD (despite experiencing combat-related injuries on two of his tours in the Middle East, and despite previously trying psychotherapy).

1. What types of strategies might help Reggie cope with some of the issues in his life?

2. What pharmacological treatment options might be appropriate for Reggie?

Questions for case study:

3. How might Reggie be monitored for signs of increased suicide risk?

Risk factors for suicide among both juvenile by the U.S. Department of Justice recommend that Recent efforts for suicide prevention for youth and adult inmates include: a history of or existing all sites develop and implement comprehensive involved in the juvenile justice system include: mental illness and substance abuse; a history of policies and programming addressing suicide targeting state-level juvenile justice agency suicidal behaviors; lack of mental health care; a prevention, intervention, and care in the aftermath directors/administrators with training developed history of abuse (e.g., emotional, physical, sexual); of a suicide death or attempt.14 to encourage comprehensive policy development; family discord/abuse; impulsive aggression; a These policies and programs should include: training direct care staff working in juvenile history of interpersonal conflict; prior involvement initial and annual training for all direct care, facilities; improving data collection and research in special education; legal/disciplinary problems; medical, and mental health personnel; initial intake within the population; increasing collaboration family history of suicide; poor family support; prior and ongoing assessment of incarcerated persons; between mental health and juvenile justice systems; offenses; referral to juvenile court; and coming from enhanced communication along the continuum of and improving policy and programming. a single-parent home.14 justice system; levels of supervision for persons at Protective factors against suicide among risk of self-harm and suicide; appropriate suicide- LGBTQ individuals juvenile and adult inmates include: a sense of control resistant housing; intervention; reporting; mortality/ Studies over the last four decades suggest over one’s own destiny; problem-solving and conflict morbidity incident review; and critical incident that individuals who are lesbian, gay, bisexual, resolution skills; adaptable temperament; support 172 transgender, or queer (LGBTQ) may have an stress debriefing. Because inmates can be at 14 from and connections to family and community; risk for suicide at any point during confinement, the elevated risk for suicide ideation and attempts. positive school or employment experience; specific biggest challenge for those who work in the justice Across many different countries, a strong and plans for the future; religious/spiritual/cultural system is to view the issue as requiring a continuum consistent relationship between sexual orientation beliefs that protect against suicide; housing that is and nonfatal suicidal behavior has been of comprehensive suicide prevention services 173 “suicide-resistant” (i.e., free of protruding objects aimed at the collaborative identification, continued observed. A meta-analysis of 25 international and means/methods for suicide) and that is proximal assessment, and safe management of individuals at population-based studies found the lifetime to staff and peers; and availability of mental health risk for suicidal behaviors. prevalence of suicide attempts in gay and bisexual services that are provided consistently by qualified, male adolescents and adults was four times that of A dramatic reduction in the rate of suicide 174 trained, and supportive staff who provide strong within county jails throughout the United States in comparable heterosexual males. community linkages and referrals and ensure Lifetime suicide attempt rates among lesbian 14 the past 20 years has been attributed to increased continuity of care. staff training, better identification of inmates who and bisexual females were almost twice those of Experts theorize that jail suicides may have two may be at risk for suicidal behaviors, and the heterosexual females. Lesbian, gay, and bisexual primary causes: (1) jail environments are conducive implementation of comprehensive programming.14 (LGB) adolescents and adults were also found to be to suicidal behaviors; and (2) the inmate faces a crisis almost twice as likely as heterosexuals to report a situation. Studies conducted by the National Center suicide attempt in the past year. on Institutions and Alternatives and commissioned 119 A later meta-analysis of adolescent studies that promote resilience, including family acceptance data are available at this time to identify a particular concluded that LGB youth were three times more and school safety; changing discriminatory laws and evidence-based suicide prevention approach likely to report a lifetime suicide attempt than public policies; and reducing suicide contagion. targeting men in midlife. heterosexual youth, and four times as likely to make Collaboration between suicide prevention a medically serious attempt.175 Across studies, and LGBTQ organizations is needed to ensure Older men 12 to 19 percent of LGB adults report making a the development of culturally appropriate suicide Several factors can increase the risk for suicide attempt, compared with less than 5 percent prevention programs, services, and materials, and suicidal behaviors among older men, including the of all U.S. adults; and at least 30 percent of LGB to facilitate access to care for at-risk individuals. presence of a mental disorder. Research suggests adolescents report attempts, compared with 8 to that older adults who die by suicide are more likely 10 percent of all adolescents. Men in midlife to meet criteria for affective disorders (especially Most studies have found suicide attempt rates Men in their adult years, from their early 20s major depressive disorder) than younger adults. through their 50s, account for the bulk of suicides to be higher in gay/bisexual males than in lesbian/ 179 Other important risk factors include physical illness bisexual women, which is the opposite of the gender and the majority of years of life lost due to suicide. and functional decline. Finally, an extensive body pattern found in the general population. As in the Yet there has been relatively little research on this of literature indicates that social disconnection overall population, there is some evidence that the demographic group, when compared with the increases risk for death by suicide in older men.184 number of studies conducted with adolescents and frequency of suicide attempts may decrease as 14 Suicide in late life is qualitatively different than LGB adolescents move into adulthood,176 although older adults. in younger adults. Older adults are more likely patterns of suicide attempts across the lifespan of Although research exploring the recent surge in than younger adults to die by suicide as a result sexual minority people have not been conclusively suicide in midlife is lacking, existing studies suggest of their first suicide attempt, in part because older studied. Within LGB samples, especially high suicide that the factors that may increase the risk for adults are more likely than younger adults to use attempt rates have been reported among African suicidal behaviors in this group are similar to those highly lethal means to attempt suicide.184 Another American, Latino, Native American, and Asian among other age groups and in both sexes: mental important difference is that older adults are less American subgroups.177 illness that can be discerned from retrospective likely than younger adults either to have reported Suicidal behaviors in LGBTQ populations analyses (particularly mood disorders), substance suicidal ideation or to have sought mental health appear to be related to “minority stress,” which use disorders (particularly alcohol abuse), and treatment prior to their deaths. Research suggests, stems from the cultural and social prejudice access to lethal means. However, these factors however, that most older adults who die by suicide attached to minority sexual orientation and are likely to be exacerbated by other risk-related are seen by primary care physicians in the last three gender identity.178 This stress includes individual characteristics that occur more frequently among months of life.10 experiences of prejudice or discrimination, such as males, such as the underreporting of mental health Although many suicide prevention efforts have family rejection, harassment, bullying, violence, and problems, a reluctance to seek help, engagement targeted youth, older adults have also become a victimization. Increasingly recognized as an aspect in interpersonal violence, distress from economic focus of suicide prevention. Many national and hardship (e.g., unemployment), and dissolution of of minority stress is “institutional discrimination” 14 regional conferences have featured the topic, and resulting from laws and public policies that create intimate relationships. More research is needed many states have broadened or are in the process inequities or omit LGBTQ people from benefits on the pathways and mechanisms that contribute of broadening their suicide prevention strategies and protections afforded others.14 Individual and to suicide among midlife men, using developmental to include older adults. Some states (e.g., Oregon institutional discrimination have been found to be approaches that examine the occurrence and timing and Maine) have separate plans for this age group. associated with social isolation, low self-esteem, of risk factors as they are expressed across the life Mental health parity for Medicare is now being negative sexual/gender identity, and depression, course. phased in so that seniors in the United States will anxiety, and other mental disorders. These Prevention efforts are especially challenging have the same copay (20 percent) for mental health negative outcomes, rather than minority sexual for men because they are less likely to show signs care as for physical health care. orientation or gender identity per se, appear to of depression, report suicidal ideation, or seek help Several interventions appear to offer significant be the key risk factors for LGBTQ suicidal ideation or accept it from others, and they often hide their promise for the prevention of suicide in late life. Most and behavior. An additional risk factor is contagion suicide plans or preparations. Several projects have of these interventions have focused on treating focused on organizational-level components for 184 resulting from media coverage of LGBTQ suicide 180-182 depressive symptoms. Because older men do not deaths that presents suicidal behavior as a normal, early intervention and education. Although generally seek mental health treatment, the most rational response to anti- LGBTQ bullying or other studies in other countries point to the positive effective methods of treating mood disorders in experiences of discrimination. Further research protective effects of means restriction, no such older adults may involve integrating evidence-based is needed to explore the pathways to suicidal programs have been successfully implemented in depression treatment into the work of primary care behaviors for transgender individuals, including the the United States. In terms of changing individual- offices, social service agencies, and aging services impact of prejudice and discrimination. level trajectories toward suicide, early classroom organizations that focus on addressing the needs of Factors that foster and promote resilience interventions to enhance interpersonal skills have older adults. Research has shown that collaborative been shown to reduce suicidal behaviors in early in LGBTQ people include family acceptance, 183 care models that combine pharmacological and connection to caring others and a sense of safety, adulthood. psychosocial treatments for depressive symptoms positive sexual/gender identity, and the availability Additional targets for intervention include: may be particularly useful. Finally, there is evidence of quality, culturally appropriate mental health preventing exposure to violence in early that interventions that attempt to decrease social treatment. Strategies for preventing suicidal developmental periods, such as bullying/peer isolation and disconnection in late life may reduce behaviors in LGBTQ populations include: reducing victimization, childhood abuse, and domestic risk for death by suicide.184 sexual orientation and gender-related prejudice violence; enhancing academic engagement and and associated stressors; improving identification reducing school drop-out rates; mitigating or BEFORE MOVING ONTO THE NEXT SECTION, of depression, anxiety, substance abuse, and other preventing persisting alcohol and drug misuse; PLEASE COMPLETE CASE STUDY 5 ON THE mental disorders; increasing availability and access and developing a diverse array of community- NEXT PAGE. to LGBT-affirming treatments and mental health based programs that engage men who otherwise services; reducing bullying and other forms of would not seek care in traditional health settings victimization that contribute to vulnerability within or in settings that provide care for mental or families, schools, and workplaces; enhancing factors substance use disorders. Many of these efforts now are being focused on Veterans. However, few 120 Case Study 5 Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

Sharma is an 84-year old retired professor of business at the local university. He is married with three grown children and 3 grandchildren. You have been his primary care physician for many years and know Sharma well. Although Sharma has been exceptionally healthy most of his life (he is vegetarian, exercises regularly, and does not smoke) he was diagnosed with ALS 16 months ago. The disease first manifested as a “floppiness” in Sharma’s left foot, which was at first attributed to minor nerve damage. But then Sharma’s wife noticed some slight slurring in his speech, which triggered the complete assessment that resulted in his diagnosis. Since the diagnosis the disease has progressed steadily. Sharma has lost 40 pounds due to muscle atrophy and resultant inactivity, and, in the past 3 months swallowing became very difficult, often resulting in choking episodes that left him gasping and coughing for many agonizing minutes. His speech is now very slow and slurred, but he can still make himself be understood. To minimize the risk of choking, he was given a percutaneous endoscopic gastrostomy 3 weeks ago, and he is now using it with a “Liquid Hope” nutritional fluid. Although his body is failing, Sharma’s mind is as quick, clear, and stable as ever. He does crossword puzzles, reads, and listens to music. Sharma has requested this meeting, and one of his daughters has accompanied him. He says he has come to thank you for your care over the years, but that he has decided to end his life by stopping eating and drinking. “I only agreed to this tube so that I could live long enough to say my goodbyes,” Sharma says, slowly. “You know me, doctor. I always said that if life became miserable, I would simply end it. Well, that time has come. This is no way to live. I’m going to stop eating this Sunday when my son can come and all three of my children can care for me at home. In my condition, it shouldn’t take long.” You notice tears well up in his daughter’s eyes.

1. How would you respond to Sharma’s decision?

2. Would it be appropriate to prevent Sharma’s suicide by involuntarily admitting him to a hospital?

Questions for case study:

3. What could you ethically do to support Sharma, physically and emotionally, in the coming days?

Suicide among physicians Medical Association, and American Psychiatric The physician should be prepared to support the Physicians die by their own hands at a rate Association.188 Such questions may make physicians family members through this difficult transition. much higher than that of the general public.185-187 afraid that seeking help for a mental health issue will Survivors have reported that their needs vary The suicide rate among female physicians is affect their ability to practice medicine or damage from formal counseling with professionals to more approximately 130 percent higher than that of the their professional reputation. informal social support from friends, family, and general female population. For male physicians, the Organizations and employers can help by support groups.191 suicide rate is approximately 40 percent higher than creating a forum for physicians to openly recognize In situations in which the physician must face that of the general male population.185 Although and discuss issues in medicine that impact their an angry family, prudent steps include careful there is no single cause for suicide, it most often mental health. For example, more than 440 health documentation; notification of hospital, managed occurs when a person’s life circumstances, stressors, care organizations around the world offer The care, and malpractice risk management teams; and and health issues—especially inadequately treated Schwartz Center’s Schwartz Rounds program taking care to compassionately give condolences to or untreated mental health issues—lead to feelings (www.theschwartzcenter.org) in an effort to the family without assigning blame.190 of hopelessness and despair. provide a safe space for physicians and other Some physicians who have had a patient die Physicians may be vulnerable to suicide health care professionals to honestly share their by suicide report feelings of guilt and personal because of high self-expectations, intense experiences, thoughts, and feelings about topics responsibility, as well as descent into a mood professional pressure, a prevailing culture of self- drawn from actual patient cases. This type of open disorder. This is particularly common among those reliance, and ready access to (and knowledge about) communication may help normalize the often difficult who think they missed warning signs or could have lethal means.188 The Medscape National Physician realities of medicine and make counseling available done more to protect their patient.192 If physicians Burnout & Depression Report 2018 showed for physicians in a safe and confidential place, at a develop suicidal ideations, they may be at increased that 66% of male physicians and 58% of female time the physicians can actually access it.188 risk of a suicide attempt because of their advanced physicians who reported burnout, depression, or medical knowledge and access to lethal means. To both had never received professional help, were Coping with suicide cope with this stress, physicians should have access not currently seeking professional help, and did not to social support and medical and psychological plan to seek professional help.189 A suicide puts stress on the patient’s loved ones care.193 An exacerbating factor in physician suicide may as well as health care workers who were involved in Caring for survivors be the fact that most U.S. state medical licensing the care of the patient. These stressors may include boards include questions about the physician’s personal and legal ramifications. Bereavement after The impact of suicide can be profound and mental health history on their applications, despite suicide is similar to that after other causes of death; sometimes devastating for those who are left new recommendations to the contrary from the however, survivors are more likely to feel shame behind. Each year, more than 13 million people Federation of State Medical Boards, American and to blame themselves for the loss.190 in the United States report that they have known someone who died by suicide that year.194 121 Moreover, exposure to suicide carries risks for Reducing the number of suicides requires the Appendix A: Patient Resources elevated rates of guilt, depression, and other engagement and commitment of people in many psychiatric symptoms, complicated grief, and social sectors in and outside of government, including Suicide in America—Information brochure, isolation. There is also compelling evidence that public health, mental health, health care, the National Institute of Mental Health. http://www.nimh. individuals bereaved by suicide (also referred to as Armed Forces, business, entertainment, media, and nih.gov/health/ publications/suicide-in-america/ “survivors of suicide loss”) may have an increased education. Physicians and other health care workers index.shtml 195 risk for suicide completion themselves. Therefore, play vital roles as well in the overall effort to prevent NIMH Publications—Webpage of National helping those who have been bereaved by suicide is suicide, and this learning activity has presented the Institute of Mental Health; order free brochures and a direct form of suicide prevention with a population most up-to-date information available to guide booklets on depression and other topics. known to be at risk. decision-making, compassionate care, and effective After an Attempt: A Guide for Taking Care of The term “postvention” was coined by Dr. Edwin management for those struggling with forces in Yourself After Your Treatment in the Emergency Shneidman who described it as “appropriate and their lives that seem to leave them with no option Department— Brochure, Substance Abuse and 196 helpful acts that come after a dire event.” Rather but suicide. Mental Health Services Administration, also available than just being support for survivors, he posited in Spanish. Available at: http://store.samhsa.gov/ that focus should also be put on the alleviation of Bottom line messages: shin/content/SMA08-4355/SMA08-4355.pdf the effects of stress in the survivors whose lives After an Attempt: A Guide for Taking Care are forever altered by suicide. One of the earliest 1. Suicidal patients are more likely to see a of Your Family Member After Treatment in the comprehensive suicide postvention programs was primary care physician than a psychiatrist in Emergency Department—Brochure, Substance the LOSSteam program developed by the Baton the months preceding their death. Primary Abuse and Mental Health Services Administration, Rouge Crisis Intervention Center in Baton Rouge, care physicians are therefore in a unique Louisiana.197 The LOSSteam program is unique also available in Spanish. Available at: http://store. position to identify at-risk individuals and in that it is an “active postvention” program. The samhsa.gov/shin/content/SMA08-4357/SMA08- LOSSteam goes to the scene of a suicide to help possibly intervene. 4357.pdf survivors cope with their loss. LOSSteam volunteers 2. Acknowledging and discussing suicide may With Help Comes Hope—Support webpage provide referrals to a variety of support resources. help to reduce suicidal ideation and identify for persons living with suicidal thoughts There is, however, insufficient evidence for or high-risk patients who require urgent and suicide attempts. Available at: http:// against the principles employed in this program in intervention—it will not increase the risk that lifelineforattemptsurvivors.org/ regard to suicide outcomes.4 a patient will think of, or attempt, suicide. National Suicide Prevention Lifeline—24- The Tragedy Assistance Program for Survivors 3. Use the PHQ-9 and/or other tools for hour/7-day-a-week telephone hotline (800-273- (TAPS) provides a comprehensive military and assessing suicidality or depression. The 8255) or chat via text by accessing the link at Veteran suicide postvention program that addresses information acquired can add to the overall suicidepreventionlifeline.org each of the key principles of the Survivors of Suicide information obtained during a thorough The Way Forward: Pathways to Hope, Recovery, Loss Task Force National Strategy outlined above.4 and Wellness with Insights from Lived Experience— suicide assessment. Since beginning their suicide support program 10 Suicide Attempt Survivors Task Force of the National years ago, TAPS has provided postvention support 4. Some suicidal risk factors are amenable to Action Alliance for Suicide Prevention. Available at: for over 9,000 military family survivors. TAPS uses intervention, whereas some are not. http:// actionallianceforsuicideprevention.org/sites/ a three-phase approach including stabilization, 5. Apart from strategies to reduce the risk actionallianceforsuicideprevention.org/files/The- grief work, and posttraumatic growth. There is factors for suicide, interventions should also Way-Forward- Final-2014-07-01.pdf insufficient evidence for or against the therapeutic aim to strengthen protective factors. principles employed in this program in regard to 6. Eliciting suicidal ideation requires a step-wise suicide outcomes.4 approach, by first using open-ended questions References for this activity can and gradually focusing on direct ones. Conclusions be found at references.cme.edu 7. All persons with clear-cut, active suicidal Many people know a friend or a loved one who ideation should be sent to the designated has attempted or died from suicide or have been hospital for urgent psychiatric care. affected as a result of a suicide in their community, 8. Safety plans should be discussed and school, workplace, or place of worship. As this developed with all patients who are at risk of learning activity has demonstrated, even though suicide. suicide is relatively uncommon at a population level, 9. Depressed or suicidal patients should be the 45,390 people who died by suicide in 2017 connected to available community resources. translate into roughly one suicide death every 11 minutes in the U.S. For every American who dies by suicide, many others attempt suicide, and many more suffer the despair that leads them to consider taking their own life. Suicide exacts a heavy toll on those left behind as well. Loved ones, friends, classmates, neighbors, military comrades, faith leaders, and colleagues all feel the effect of these deaths. The largest number of suicidal deaths each year occurs among middle- aged men and women, sapping the workforce of individuals needed to sustain the economy. The fact that suicidal behavior occurs among some of our most marginalized citizens is also troubling.

122 SUICIDE ASSESSMENT & PREVENTION

51. In 2017, what was the rank of suicide as a cause of death in 57. Which of the following is a true statement about suicide risk? the United States? A. Suicide risk is highest in young people and lowest in older A. 2nd leading cause adults B. 5th leading cause B. Suicide tends to develop in discrete steps of increasing risk C. 10th leading cause C. There is no single path for reducing suicide risk D. 14th leading cause D. Evidence shows that the PHQ-9 question is the most accurate way to identify people at risk for suicide 52. About how much higher is the suicide rate among Veterans as compared to the non-Veteran population? 58. Which of the following is a true statement about suicide risk A. 1.5 times higher in Veteran and non-Veteran populations? B. 2 times higher A. The same risk factors for suicide are at work in non-Veteran C. 2.5 times higher populations as in Veteran and military populations D. 6 times higher B. Some risk factors, such as exposure to trauma, are more important in Veteran populations compared to non-Veteran 53. The three levels of strategies for suicide prevention are and military populations ______, ______, and ______. C. Being deployed to a combat zone is a unique risk factor for A. Federal, state, and local suicide among Veterans B. Community-wide, organization-wide, and individual D. Chronic pain is a suicide risk factor more common among C. Universal, selective, and indicated Veterans than non-Veteran populations D. Universal, selective, and individual 59. Which of the following is a direct warning sign of acute 54. What is the name of the conceptual model that frames suicide suicide risk? risk as a balance between protective factors and risk factors A. Being diagnosed with major depressive disorder at different levels? B. Demonstrating preparatory behaviors such as putting affairs A. Psycho-social risk model in order B. Suicidality risk model C. Getting divorced or experiencing the break-up of a long-term C. Multi-level social risk model relationship D. Social ecological model D. Withdrawing from previously-enjoyed social situations

55. Which of the following is a tenet of the Patient-Centered Care 60. Which of the following is true about asking patients about model for suicide prevention? suicide or suicidal thinking? A. Provide patients with access to medical and mental health A. Since suicide is difficult to predict, it is best to ask all patients services about suicide on a regular basis B. Provide patients with occupational and social services B. Inquiring about suicide is a less reliable approach to supports to minimize suicide risk assessment than standardized questions such as the PHQ-9 C. Provide patients with comprehensive, digestible information C. Asking about suicide may plant the seeds of suicidal thinking regarding available prevention interventions and treatment in a patient’s mind options D. Inquiring about suicide does not increase suicidal ideation or D. Provide patients with appropriate medico-legal counseling attempts related to suicide risk factors

56. What is one of the advantages of adopting a Patient-Centered Care model of suicide prevention? A. Decreased risk for depressed mood B. Improved adherence to treatment C. Decreased rate of completed suicides D. Increased use of social support services

123 61. When attempting to elicit suicidal ideation from a patient, it 66. Which pharmacological therapy has been shown to reduce is best if clinicians ______? suicidal behaviors in patients with schizophrenia or A. Use a step-wise approach starting with general questions schizoaffective disorder? about mood and moving to more specific questions as indicated A. Quetiapine B. Obtain verbal consent before asking about suicide, since this is B. Risperidone a potentially traumatizing line of inquiry C. Clozapine C. Avoid using the phrase “suicide” and, instead, use “self- D. Olanzapine harm,” or “self-inflicted harm” D. Begin with specific questions about self-harm and move to 67. What post-acute care modality has been shown to reduce the broader questions about risk factors, such as life situations, rate of suicide death following a psychiatric hospitalization as indicated for suicidal ideation/attempt? A. Home visits by social workers 62. What would be an appropriate course of action for a patient B. Cognitive behavioral therapy determined to be at an intermediate level of acute suicide C. Periodic caring communications risk? D. No-suicide contracts A. Direct observation until transfer to a secure medical or psychiatric unit 68. Which therapeutic modality may allow treatment for suicidal B. Intensive outpatient management of suicidal thoughts and/or thoughts and behaviors regardless of geographic location or behaviors access to traditional care facilities? C. Rapid initiation of evidence-based pharmacological treatments A. Telehealth for reducing suicide risk B. Suicide chat hotlines D. Management in primary care setting with focus on co-occurring C. Webinar suicide education programs conditions D. App-based coping skills programs

63. Which non-pharmacological treatment modality has been shown to reduce the risk of suicide attempts by helping 69. Which kind of suicide-prevention initiative has not been patients identify and change problematic thinking and found to improve population-level suicide rates, either in the behavioral patterns? general U.S. population or among Veterans? A. Cognitive behavioral therapy A. Gatekeeper training programs B. Dialectical behavioral therapy B. Lethal means counseling C. Interpersonal cognitive therapy C. Telehealth modalities D. Psychodynamic psychotherapy D. Universal suicide screening programs

64. Which non-pharmacological treatment modality focuses 70. In an effort to dispel stigma and foster a culture of support on helping patients cope with stressful life experiences by throughout the Department of Defense, which policy has actively working on difficulties? been put into place? A. Problem-solving therapy A. Outreach efforts to encourage confidential meetings between B. Dialectical behavioral therapy service members and military mental health staff C. Psychodynamic psychotherapy B. “Don’t ask/don’t tell” policies related to disclosure of suicidal D. Crisis response planning thoughts or behaviors C. 1-month delay in notifying commanders about a service 65. Which pharmacological therapy has been shown to improve member’s disclosure of suicidal thoughts unless such delay is acute suicidal symptoms for up to a week after only a single overcome by existing notification standards. dose? D. Indefinite deferral of notifications to a commander about a A. Methylphenidate service member’s use of mental health services unless such B. Selective serotonin reuptake inhibitor deferral is overcome by existing notification standards. C. Ketamine infusion D. Lithium

124 NOTES

125 NOTES

126 LEARNER RECORDS: SAMPLE

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OPIOID ANALGESICS IN THE 12. 23. 35. 48. 60. MANAGEMENT OF ACUTE & CHRONIC PAIN 13. 24. 36. 49. 61. (PG. 41-42) 1. 14. 25. 37. 50. 62. 15. 26. 38. SUICIDE ASSESSMENT & 63. 2. PREVENTION (PG. 123-124) 3. 16. 27. 39. 51. 64. 4. 17. 28. 40. 52. 65. 5. 18. 29. 41. 53. 66. 6. 19. 30. 42. 54. 67. PREVENTING CLINICIAN 7. 20. BURNOUT (PG. 83-84) 43. 55. 68. A CLINICIAN’S GUIDE 8. TO RECOGNIZING AND 31. 44. 56. 69. RESPONDING TO HUMAN 9. TRAFFICKING IN TEXAS (P. 51) 32. 45. 57. 70. 10. 21. 33. 46. 58. 11. 22. 34. 47. 59.

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TX160CME

128 LEARNER RECORDS: EVALUATION You must complete the program evaluation and applicable activity evaluation(s) in order to earn AMA PRA Category 1 CreditTM, MOC points, or participation in MIPS. For each of the objectives determine if the activity increased your: SECTION 1 - OPIOID ANALGESICS IN THE MANAGEMENT OF ACUTE & CHRONIC PAIN: A B C D 1. Assess patients in pain and identify the range of therapeutic options for managing pain ...... 2. Safely and effectively manage patients on opioid analgesics in the acute and chronic pain settings ...... 3. Recognize when to incorporate emergency opioid antagonists into prescribing practice...... 4. Identify and manage patients with opioid use disorder ...... 5. Please identify a specific change, if any, you will make in your practice related to safe prescribing of opioid analgesics.

6. What do you see as a barrier to making these changes?

SECTION 2 - A CLINICIAN’S GUIDE TO RECOGNIZING AND RESPONDING TO HUMAN TRAFFICKING IN TEXAS: A B C D 7. Recognizing the types, venues and identify victims, adult and minor, of human trafficking in health care environments ...... 8. Techniques for identifying and assisting patients that are victims of human trafficking...... 9. Utilization of referrals to appropriate multi-disciplinary to assist victims of human trafficking ...... 10. Please identify a specific change, if any, you will make in your practice related to human trafficking.

11. What do you see as a barrier to making these changes?

SECTION 3 - PREVENTING CLINICIAN BURNOUT: A B C D 12. Recognize symptoms of burnout in yourself and take steps to reduce your risk of burnout...... 13. Use technology appropriately and in ways that minimize your risk of burnout while also engaging in individual practices that improve your resilience and wellness...... 14. Please identify a specific change, if any, you will make in your practice related to preventing clinician burnout.

15. What do you see as a barrier to making these changes?

SECTION 4 - SUICIDE ASSESSMENT & PREVENTION: A B C D 16. Assess patient suicide risk ...... 17. Utilize strategies to reduce suicide risk ...... 18. Use proper evidence-based strategies for the treatment and management of patients at risk for suicide...... 19. Please identify a specific change, if any, you will make in your practice related to suicide assessment and prevention.

20. What do you see as a barrier to making these changes?

PROGRAM EVALUATION: Yes No If no, please explain: 21. The program was balanced, objective & scientifically valid ...... 22. Do you feel the program was scientifically sound & free of commercial bias or influence? . . 23. How can this program be improved?

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25. For which activities would you like to use your participation as a clinical practice improvement activity (CPIA) for MIPS? Section 1 Section 2 Section 3 Section 4 None TX160CME 129 CUSTOMER SERVICE

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130 1015 Atlantic Blvd #301 | Jacksonville, FL 32233 2021 TEXAS MEDICAL LICENSURE PROGRAM SATISFIES NEW OPIOID AND HUMAN TRAFFICKING CME REQUIREMENTS

PROGRAM SATISFIES: 2 HOURS PAIN MANAGEMENT/OPIOIDS (NEW)* 1 HOUR v HHSC APPROVED *NEW MANDATORY CME REQUIREMENTS MUST HUMAN TRAFFICKING (NEW)* BE COMPLETED PRIOR TO NEXT RENEWAL