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Project PAUSE: Effective Solutions for Improving Clinical Care in Long Project PAUSE: Effective Solutions for Improving Clinical Care in Long-Term Care Settings Brought to you by Alliance for Aging Research American Association for Geriatric Psychiatry (AAGP) American Association of Post-Acute Care Nursing (AAPACN) American Society of Consultant Pharmacists (ASCP) AMDA – The Society for Post-Acute and Long-Term Care Medicine Caregiver Action Network The Gerontological Society of America (GSA) National Minority Quality Forum Project PAUSE is made possible with support from our corporate sponsors ACADIA Pharmaceuticals Inc. Avanir Pharmaceuticals, Inc. Lundbeck LLC CONSULTANTPROJECT PAUSE PHARMACIST FORUM Project PAUSE: Effective Solutions for Improving Clinical Care in Long-Term Care Settings Project PAUSE (Psychoactive Appropriate Use for Safety stay nursing home residents who are initiated on an and Effectiveness) is a coalition of national patient and antipsychotic after admission to the skilled nursing professional organizations collectively advocating on facility (SNF) (see figure 1). The National Partnership clinical care regulatory and legislative issues in long- adopted these three excluded conditions as they have term care (LTC) and the community. Project PAUSE aims been recognized under CMS regulations since 2006, but to educate policymakers and the public about clinical it is important to note that these conditions are not the care issues in long-term care and the community and only U.S. Food and Drug Administration (FDA) approved collectively advocate for effective solutions. Members indications for antipsychotic medication use.2,3 Project of Project PAUSE include patient and family caregiver PAUSE has complied a full list of FDA-approved adult organizations, long-term care groups, primary care indications for first-generation antipsychotics (see figure 2) associations, geriatric and mental health specialty provider and second-generation antipsychotics (see figure 3).4 associations, Alzheimer’s disease and other dementia The current measure utilized to determine CMS organizations, and mental health organizations. Project antipsychotic quality measures uses the medication list PAUSE consistently engages with the Centers for Medicare from the minimum data set (MDS), excluding any residents & Medicaid Services (CMS) and congressional leaders diagnosed with schizophrenia, Huntington’s chorea, and/or to promote policies in LTC settings that will curb the Tourette’s syndrome. This current measure does not take inappropriate use of antipsychotics and ensure access and advantage of the interdisciplinary use of the Long-Term appropriate use of these medications by patients who need Care Facility Resident Assessment Instrument (RAI) User’s them. Manual (see figure 4). The RAI is used by nursing homes Project PAUSE is convened by the Alliance for Aging and long-term care facilities (LTCFs) to gather information Research and the American Society of Consultant on a resident’s clinical needs and it allows care teams to Pharmacists. ojectively document care plans. This documentation can To learn more about Project PAUSE, please visit our be used to identify resident strengths and needs and helps website. guide clinical interventions and reinforce best practices. This RAI resource utilizes clinical rationale to determine Executive Summary whether or not a patient requires a gradual dose reduction (GDR) of an antipsychotic medication or whether or not The Centers for Medicare and Medicaid Services (CMS) an antipsychotic mediation is clinically contraindicated. document and report antipsychotic utilization rates in In order for CMS to enforce best clinical practices and long-term care settings throughout the country. In March ensure appropriate antipsychotic utilization in nursing 2012, CMS launched a quality initiative with the goal of homes and LTCFs, the agency should incorporate a decreasing use of antipsychotics in nursing homes by meaningful antipsychotic utilization measure using these 15% by the end of 2012.1 This initiative established the inputs outlined in CMS’ RAI manual. To assist the National current antipsychotic utilization rate quality measure and Partnership and CMS in enforcing the antipsychotic created The National Partnership to Improve Dementia Care utilization measures outlined in the RAI, Project PAUSE (National Partnership). proposes that the agency update the quality measure The National Partnership’s official measure to determine to reflect only those residents using inappropriate antipsychotic utilization rates is the percentage of antipsychotic drugs as determined by their prescriber and long-stay nursing home residents who are receiving consultant pharmacist and verified on the RAI. an antipsychotic medication, excluding those residents In addition to this critical improvement of the National diagnosed with schizophrenia, Huntington’s Disease, Partnership’s quality measure, Project PAUSE also seeks or Tourette’s Syndrome and the percentage of short- to help identify opportunities for integration of diagnostic Project PAUSE 1 PROJECT PAUSE: EFFECTIVE SOLUTIONS FOR IMPROVING CLINICAL CARE IN LONG-TERM CARE SETTINGS criteria and clinical guidelines into nursing home operator, Among people living with Alzheimer’s disease (AD), medical director, nursing, and surveyor trainings in order depression is the earliest observable symptom in at to improve provider and surveyor knowledge gaps in least one-third of cases.12 Milder agitation may manifest the diagnosis and management of neuropsychiatric early and increase in prevalence and severity with symptoms (NPS). Lastly, Project PAUSE encourages federal worsening of dementia, often leading to an increase in collaboration to recognize all current FDA-approved uses caregiver burden, greater morbidity, poorer quality of life, for psychotropic and antipsychotic medications for the increased cost of care, early institutionalization, and rapid treatment of NPS. disease progression.13 LTC staff caring for residents with depression, agitation, and other NPS often experience A summary list of our decreased quality of life, increased risk of injury, increased recommendations include: workload, lost days of work, burnout, and staff turnover.14,15 1. Removing the requirement to count residents in SNFs Background on Clinical Care for NPS who are appropriately prescribed antipsychotics for FDA-approved indications, from quality metrics for both While antipsychotics have been used to treat NPS since short- and long-term stay residents receiving standing the 1950s, people with neurodegenerative disorders were or as needed (PRN) antipsychotics medications. previously excluded from trials of psychotropic medications 2. Expanding CMS recognition of FDA-approved uses for in general, and antipsychotics specifically, despite the psychotropic and antipsychotic medications for the fact that both brain changes and biological aging may treatment of neuropsychiatric disorders in late-life. impact psychotropic dosage needs and response, carrying 3. Integrating diagnostic criteria and clinical guidelines into significant risks. nursing home operator, medical director, nursing, and In April 2005, the FDA issued a “black-box” warning for surveyor trainings. atypical antipsychotics in the treatment of NPS in older 4. Sponsorship of population health studies which result patients with dementia because of a 1.6- to 1.7-fold in evidence-based clinical guidelines guiding the use higher death rate compared to the placebo. In a pivotal of psychotropic and antipsychotic medications for the randomized control trial (RCT) of patients with dementia treatment of neuropsychiatric disorders in late-life. who were already on first-generation or atypical (second 5. Legislative action to establish minimum care levels generation) antipsychotics, the 3-year survival rate was for nursing homes under Medicare and Medicaid and doubled in those randomized to cease treatment compared additional opportunities for training. to that of patients on antipsychotic therapy.16 However, a large longitudinal observational study published in the Background on Neuropsychiatric September 2013 issue of the American Journal of Psychiatry Symptoms (NPS) of Dementia challenged these findings by showing thatthe primary correlation of adverse outcomes was the psychiatric While cognitive impairment is regarded as the hallmark symptomatology of dementia progression and not indicator of dementia, neuropsychiatric symptoms (NPS) a result of the drugs used to treat the condition.17 are nearly as universal, with one or more symptoms Additionally, a 2015 study in the same journal analyzed affecting nearly all people with dementia over the illness data from the Cache County Dementia Progression course. NPS may include wandering, sleep issues, agitation, Study to examine the link between clinically significant depression, lack of emotion (apathy), aggression, and neuropsychiatric symptoms in mild Alzheimer’s dementia psychosis, and evidence finds such symptoms often result and progression to severe dementia and death, and found in greater impairment in activities of daily living, poorer that psychosis, affective symptoms, agitation/aggression, quality of life, more rapid disease progression, greater mildly symptomatic neuropsychiatric symptoms, and morbidity, an increase in direct cost of care, and earlier clinically significant neuropsychiatric symptoms were all institutionalization.5-10 These symptoms also result in associated with earlier death.18 It is important to note that increased caregiver burden due
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