PCRC Issue 1, February 2012

Profiles 3 Recruitment Tips 5 Mission 5 Who’s Who 7 Introduction to Ideas from a seasoned PCRC Mission Meet the PCRC some PCRC sites CRC Statement and team “Field Notes”

Greetings, PCRC members and our expanding PCRC community!

nd welcome to our first newsletter. You can expect to receive future issues, from this point forward, Aevery two months. The newsletter will be our vehicle for informing you of project updates, communicating about progress, sharing best practices, especially as related to our collaborative studies, and learning from one another’s experiences. s the PCRC’s first clinical trial – the “statin discontinuation study” – comes into full swing, our Apurpose in this first newsletter is simply to introduce ourselves to one another, and to begin to share experiences and success strategies. At this point, early in the trial, these relate to recruitment. We thus hope to set the stage for collaboration of the best sort, that is, cooperative effort in which the combination of our separate strengths, perspectives, knowledge, and unique experiences creates a whole (the PCRC) that is much greater than the sum of its parts.

Please note that, as we go to press with this issue, not all PCRC member sites have been able to provide introductory material. We are all so busy! Stay tuned for introductions from other sites in future newsletters.

Duke University Medical Center University of Colorado at Denver Duke Medicine is a large academic medical center located Those of us on the University of Colorado School of Medicine in central North Carolina; it comprises comprising Duke (UCSOM) team are lucky to live in one of the most beautiful University Health System, School of Medicine, and School of states in the nation. The Anschutz Medical Campus is the only Nursing as well as numerous research institutes including the academic medical center in the region, and consists of seven Duke Clinical Research Institute, the world’s largest academic major organizational units: the schools of Medicine, Dentistry, research organization. Duke’s clinical enterprise covers a Public Health and Pharmacy, the College of Nursing, the large portion of our own state as well as drawing patients University of Colorado Hospital (UCH) and Children’s Hospital from neighboring Virginia, South Carolina, and Georgia. Duke Colorado, central services, and administration. The UCSOM has University Health System employs over 22,000 individuals; in a full-time faculty of approximately 700 and a clinical faculty of 2010, it received 1.8 million outpatient visits. 3,700.

In addition to placing high value on research, Duke Medicine Jean Kutner, MD, MSPH, founding Co-Principal Investigator of maintains a strong commitment to community-based care the PCRC, is a Professor of Medicine in the Divisions of General and service. Our Health System includes community hospitals Internal Medicine, Geriatrics, and Health Care Policy and (Durham Regional Hospital, Duke Raleigh Hospital), Duke Research in the Department of Medicine at the UCSOM. She See Duke page 3 See University of Colorado page 3 PCRC Issue 1, February 2012

University of Wisconsin Carbone Cancer Center Tip of the week from Dr. James Cleary, Co-Investigator, and the Palliative Care Supportive Wisconsin Oncology Working Group (PCSOWG) are coordinating the statin When discussing the study with a physician not discontinuation study at the University of Wisconsin Carbone Cancer familiar with the study or Center (UWCCC). with research, make it clear that “the study” decides if The PCRC team in Wisconsin includes Dr. Cleary, Dr. Toby Campbell, the participant should stop Renae Quale, RN (Lead Study Coordinator) and Nancy Gidal, RN or continue statin therapy; (Clinical Research Coordinator). Through our affiliation with PCSOWG, not the (primary) physician. we are working with more than 40 physicians throughout UWCCC to We have lost participants enroll study participants. Dr. Cleary and Dr. Campbell are also very because the primary involved in the Palliative Care Services at UW Hospital and Clinics, and MD stopped their statin this affiliation allows us to enroll non-oncology patients into the study. therapy after we spoke with them about the study. We officially opened the statin discontinuation study at UWCCC on November 28, 2011 and currently have three participants.

Mount Sinai

Founded in 1852, Mount Sinai Hospital Sinai. Dr. Morrison’s research focuses is one of the oldest and largest on decision making at the end of life, teaching hospitals in the United States. pain and symptom management in Located in the heart of New York City high-risk and medically underserved (thus representing, in the PCRC, the populations, and quality measures in pinnacle of the urban), Mount Sinai palliative care. He is an active clinician Medical Center encompasses Mount who cares for both healthy older Sinai School of Medicine and Mount adults and for persons living with Sean Morrison Melissa Diamond Sinai Hospital, a 1,171-bed, tertiary- serious and life threatening illness. care teaching facility. Our faculty number Melissa Diamond, MPA, more than 3,400, is our Clinical Research “On the ground” at Mt. Sinai Principal challenge: Finding with affiliations in Coordinator; she has an individuals who meet eligibility 38 clinical and basic extensive background in criteria from the current screening science departments research and has worked pool (Most patients screened are and centers. over 10 years with the either considered “too healthy” or underserved populations have dementia.) R. Sean Morrison, of New York City. Strategies to overcome it: MD, FAAHPM, is Co-Investigator and • working with different Sinai lead for statin discontinuation study Mount Sinai received IRB approval affiliates such as Visiting Docs and at Mount Sinai. He is Director of the for the statin discontinuation study Visiting Nurse Hospice services, National Palliative Care Research on July 7, 2011. Recruitment and with the intention of recruiting Center, a national organization screening for the study started in patients from their rosters devoted to increasing the evidence late November 2011 after our annual • generating a report that actively base of palliative care in the United review was finally approved, but we lists all patients who are currently States, and also the Vice-Chair of have yet to enroll their first study on statins for these affiliated sites Research, Professor of Geriatrics participant. It has been a slow process, and Medicine, and Hermann Merkin as we work diligently on exploring We are hoping to share good news Professor of Palliative Medicine in the different avenues of focus to maximize regarding recruitment with the PCRC Brookdale Department of Geriatrics recruitment. (See text box.) Operations committee very soon, as and Palliative Medicine at Mount we are dedicated the PCRC mission. 2 PCRC Issue 1, February 2012

Duke (Continued from page 1) University of Colorado (Continued from page 1) HomeCare and Hospice, and Duke Primary Care. Many Duke has over 15 years of experience conducting multi-site studies physicians have active clinical and/or research affiliations with in, and providing direct patient care for, the hospice/palliative the Durham Veterans’ Administration Medical Center, adjacent care population. Her primary research focus is improving to Duke University Hospital. symptoms and quality of life for this population and their family caregivers. PCRC Co-Principal Investigator Amy Abernethy, MD, is an Associate Professor of Medicine in Duke’s School of Medicine, Rachael Bennett, MA, the Project Director of both the statin as well as an Associate Professor of Nursing at the School discontinuation trial and the Statistical Center and Data of Nursing. She is founder Management (SCDM) is a and Director of Duke Cancer Research Associate in the School Care Research Program and To boost enrollment… of Medicine and has over 15 At Duke, we have taken several steps to increase our rate of Medical Director of Oncology years managing complicated, enrollment: Quality, Outcomes, & Patient- multi-site, research studies. She centered Care for Duke ❖❖ recruiting in outpatient clinics and treatment centers, has worked on three NIH studies, Medicine. An active clinician- as well as on inpatient units; and a myriad of projects for CMS researcher, she focuses her ❖❖ expanding our recruitment beyond Duke Oncology and ASPE (Assistant Secretary for research on (a) facilitating to other Duke-affiliated sites such as Duke Raleigh Planning and Evaluation) in the evidence-based practice in Hospital; Department of Health and Human palliative care by adapting ❖❖ working with the Duke General Medicine team; Services. or developing innovative ❖❖ introducing the study to the oncoming residents on a clinical trials methodologies, monthly basis; and, Marlene McKenzie, RN, MN, the ❖❖ reaching out to the Duke Clinical Pharmacy team, in and (b) investigating new Clinical Research Coordinator for hopes that they will become a helpful resource to our interventions to improve the statin discontinuation trial, is a PCRC team. symptom control. Dr. Abernethy seasoned recruiter with a proven We are exploring the idea of recruiting participants from is also an internationally track record for enrolling study non-assisted as well as assisted living communities within recognized expert in health participants and over 30 years the area. services research and patient- of nursing and management centered cancer care, and experience. a national expert in cancer health policy and comparative The PCRC’s SCDM group, led by Diane Fairclough, DrPh, and effectiveness research. In fact, she has become known as one Patrick (Jud) Blatchford, PhD, has appointments in Colorado of the main thought leaders working to design an integrated Health Outcomes Research, which is housed in the UCSOM. health care/research environment in which IT-enabled systems With over 40 years of combined experience, these statisticians simultaneously inform clinical care, research, and quality are well-equipped to lead the SCDM. To round out the team, improvement activities. She is a leading voice for developing we have Monica McNulty, our data analyst and MS Access guru, “rapid learning systems” to advance cancer care in America and and Patrick Hosokawa, who runs the randomization website for globally. the statin trial.

Recruitment for the PCRC statin discontinuation trial began at We received IRB approval for the statin discontinuation study Duke in July 2011. Currently we have 18 participants enrolled. on June 3, 2011 and enrolled Our initial recruitment experience helped provide valuable the first study participant “this insight to other PCRC sites as they established and modified on June 7, 2011. To date, is the hardest recruitment strategies to fit their sites’ individual needs. (See we have enrolled 23 study text box.) Duke patients and staff have been very supportive, participants, thanks to the project for which and we believe our expansion prospects will be successful as hard work, persistence, and I have had to well. tenacity of Marlene McKenzie. As she has said, “this is the recruit” hardest project for which I have had to recruit.” Take that to heart as you struggle to meet your sample size goals and find yourself running into roadblocks and gatekeepers!

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Four Seasons Compassion is our Clinical Research for Life is a non-profit, Team Leader. She has community-based, been involved with over hospice and palliative care 150 studies in a variety of provider organization in therapeutic areas. Jennifer longitudinally evaluate Director, leads its Research mountainous western North is the primary Study quality and outcomes, and Department, and serves as Carolina. Four Seasons is Coordinator for the statin coordinate across settings the Principal Investigator an innovator in the field of discontinuation study. She through implementation for all of our studies. She palliative care in that we has been involved with of an IT-enabled data dedicates her research offer services integrated clinical research for seven system. We have an active efforts to helping develop across the continuum of years and has conducted a Research Department, and best practices that will settings in which patients variety of vaccine studies have conducted over 30 enable clinicians to improve are located; we provide and also has experience investigator-initiated studies symptoms and quality of care in three hospitals, all working with Internal and pharmaceutical studies life for individuals with life- 30 area nursing homes, Medicine programs. since 2005. limiting illnesses. 24 assisted living facilities, our own 19-bed inpatient We began enrolling study Janet Bull, MD is the site We have two ACRP certified facility, two clinics, patients’ participants in September Principal Investigator at Study Coordinators, Lisa homes, and schools. We are 2011. To date, we have Four Seasons for the statin Massie and Jennifer Short. working with a Duke team screened 14 patients and discontinuation study. She With 19 years clinical led by Amy Abernethy to enrolled 9 participants. is Four Seasons’ Medical research experience, Lisa ensure continuity of care,

At Four Seasons… 64% success rate! (patients screened/patients enrolled) Recruitment at Four Seasons has been most successful in the hospice population. Recruitment methods: • chart review both in-house and in community offices • lunch-n-learns Janet Bull Lisa Massie Jennifer Short • attending provider meetings • weekly e-mail reminders to providers and nursing staff

The University of North Carolina (UNC) is located just a Investigator; Kathryn Wessell, Project Coordinator; Kelly short trip down “Tobacco Road” from Duke in lovely Chapel Onyenwoke, MPH, Clinical Research Coordinator; and Hill, where the skies are always Carolina blue. UNC-Chapel Charlotte Rowe, NP, AOCN, ACHPN, Research Nurse. Since Hill opened its doors as the nation’s first public university receiving IRB approval on October 7th, 2011, we have in 1795 (yes, older even than Mount Sinai!). UNC Hospitals screened thousands of charts and enrolled six participants. is a public, academic medical The research team is currently center made up of NC Memorial recruiting from the inpatient Hospital, NC Neurosciences Palliative Care consult service, Hospital, NC Women’s Hospital, NC inpatient Oncology, Geriatric, Cancer Hospital, and NC Children’s General Medicine, and Hospitalist Hospital. services, outpatient Oncology and Geriatric clinics, and two hospice organizations. We are The UNC research team for the statin discontinuation also in the process of expanding recruitment into a local study includes Laura Hanson, MD, MPH, site Principal long-term care facility. 4 PCRC Issue 1, February 2012 RECRUITING TIPS PREPARE COLLABORATE • Believe in the study and its potential benefits • Adopt a stance of collaborating with the to the target population. Have confidence patient and family in furthering knowledge. that appropriate, eligible patients are able • Offer the opportunity to participate ina and willing to participate. conversational manner. The message is that • Know the protocol and consent form you are going through the process together. • Practice presenting all study elements ina • Provide copies of materials. friendly, conversational manner. • Keep your voice tone low; speak slowly and loudly enough for seniors to hear. CONNECT • Stop periodically to make sure they • Dress with respect for patients and families. understand, and to allow them to ask • Favor soft colors and comfortable but questions. professional styles, to convey warmth. • Inform patients that you have talked with their • Introduce yourself with a warm entry and physician and he/she has given permission for hello. you to offer this study to them. • Maintain good, but not overbearing, eye • Provide reassurance that participation is contact. Smile. voluntary and that they can discontinue ❖❖ Ask permission and normalize the subject: participation at any time with no “Can I have a few minutes to tell you about repercussions. Build trust. a study we are doing for people like you who ❖❖ Ask: Would you like to or would you be are dealing with advanced illness?” willing to participate in the project? ÊÊ If yes, pull up a chair. Establish by what ÊÊ If no, thank them for their time and name they would like to be called. wish them well. ÊÊ If not a good time, determine when to ÊÊ If yes: obtain required signatures come back (if appropriate). APPRECIATE • Thank them for their time and if appropriate, Marlene McKenzie, CRC on the Colorado PCRC helping us learn so that we can help improve team and an experienced recruiter, offered these care for other people like themselves in the suggestions to optimize recruitment. future. • Reiterate what will happen next, and thank them again.

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“Field Notes” Mayo Clinic

“Hello, PCRC Colleagues! At Mayo, recruitment has been impeded by difficulty in hiring a Clinical Research Coordinator. Once we have our personnel in place, we will begin recruiting ASAP from both of our hospitals and our palliative medicine clin- ic to start. We will likely branch out to our geriatric clinicians as well. We appreciate your sup- port through this process!”

Jeff Sloan, MD, site Principal Investigator

Mission Develop scientifically-based methods that lead to meaningful evidence for decreasing the suffering of patients with advanced or potentially life limiting illnesses and their care givers, including family members and rom the providers of care. Fteam in Denver, “Field Notes” - University of Alabama Birmingham support is The University of Alabama ➟➟ Three participants have Our recruitment strategies: available! Birmingham (UAB), led by been enrolled and Christine Ritchie, MD, site randomized • Utilize study eligibility Principal Investigator for the cards We are here for you, ➟➟ Recruitment sites to date and encourage you to statin discontinuation study, and • Establish rapport in high Will Callans, Clinical Research include UAB Palliative continue to participate Care Unit and UAB volume referral areas in the bi-monthly CRC Coordinator, report that… Inpatient Oncology • Adapt to dynamic patient calls and Investigator ➟➟ IRB approval was obtained on ➟ population Office hours to foster a August 31, 2011 ➟ Future recruitment sites sense of community, learn include hospice agencies from each other, and feel ➟➟ Recruitment began on and Outpatient Palliative the support of those in December 8, 2011 Care Clinic the cooperative group. We are also available to answer data-related questions at

[email protected] Christine Ritchie Will Calans Site PI CRC 6 PCRC Issue 1, February 2012 Who’s Who Operations Committee Duke University Team University of Colorado Team Amy Abernethy, MD Jean S. Kutner, MD, MSPH Co-Chair Co-Chair DUMC Box 3436 Campus Box B180 Durham, NC 27710 Aurora, CO 80045 (919) 699-1989 (cell) (303) 724-2240 [email protected] [email protected]

Assistant: Laura Criscione Assistant: Shaleeta Pearson (919) 681-1729 (303) 724-2261 [email protected] [email protected]

Jordan Lodato Rachael E. Bennett, MA Project Lead PCRC Project Director DUMC Box 3436 MS B180 Durham, NC 27710 12631 E. 17th Ave, Room 8407 (919) 684-0257 Aurora, CO 80045 [email protected] 303 724 6561 (direct) 303 724 2270 (fax) [email protected]

Lynnette Thacker Patrick (Jud) Blatchford, PhD Finance Coordinating Statistician DUMC Box 2732 MS F-443 Durham, NC 27710 13199 E. Montview Blvd., Suite 300 (919) 668-0352 Aurora, CO 80045 [email protected] (303) 724-4352 [email protected]

Rachel Galanos Diane Fairclough, DrPH Data Manager Lead Statistician DUMC Box 3436 MS F-443 Durham, NC 27710 13199 E. Montview Blvd., Suite 300 (919) 681-7491 Aurora, CO 80045 [email protected] 303 724-1168 (direct) [email protected]

Kelly McLaughlin Marlene McKenzie, MN, RN Data Manager Clinical Research Coordinator DUMC Box 3436 MS B180 Durham, NC 27710 12631 E. 17th Ave, 8th Floor (919) 668-1998 Aurora, CO 80045 [email protected] 720 202 6107 (direct) [email protected]

Ursula Rogers Monica McNulty, MS Database Analyst Database Manager and Analyst DUMC Box 2732 MS F-443 Durham, NC 27710 13199 E. Montview Blvd., Suite 300 (919) 668-0246 Aurora, CO 80045 [email protected] (303) 724-1197 [email protected]

If you have any questions or concerns about the following please contact… Administrative Jordan Lodato Budget Lynnette Thacker, Amy Abernethy, MD Contracts Lynnette Thacker Data Collection/Patient Interaction Rachael Bennett, MA Data Entry/Quality/Submission [email protected] Data Management/Statistical Analyses Policies Diane Fairclough, DrPH Data Management/Statistical Trial Specific Issues Jud Blatchford, PhD IRB/Regulatory Jordan Lodato Membership Committees, Charter Amy Abernethy, MD or Jean S. Kutner, MD, MSPH New Research Trial Ideas Amy Abernethy, MD or Jean S. Kutner, MD, MSPH SCDM office physical address (for Fed Ex): SCDM office, 13199 E. Montview Blvd., Suite 300 Aurora, CO 80045 Attn: Jud Blatchford SCDM office for US Postal Service: SCDM, MS F-443, Aurora, CO 80045 Attn: Jud Blatchford 7