Project PAUSE (Psychoactive Appropriate Use for Safety and Effectiveness)

Project PAUSE (Psychoactive Appropriate Use for Safety and Effectiveness) is an ad hoc coalition of national patient and professional organizations collectively advocating on clinical regulatory and legislative issues in long-term care. Project PAUSE aims to educate policymakers and the public on effective solutions for improving clinical care in long-term care settings by advocating for streamlined, clinical surveyor training, improved quality measures to appropriately determine antipsychotic drug use in long-term care settings, and other solutions aimed at improving the diagnosis and management of neuropsychiatric symptoms (NPS) in dementia. Project PAUSE is convened by the Alliance for Aging Research and the American Society of Consultant Pharmacists (ASCP).

Membership of Project Pause includes patient and family caregiver organizations, long-term care groups, primary care associations, geriatric and mental health specialty provider associations, and Alzheimer’s disease and other dementia groups as well as mental health organizations.

Project PAUSE activities include:

Educating stakeholders on issues of the treatment of NPS in dementia in long-term care facilities;
Crafting recommendations and comment letters with member organizations;
Working with the Centers for Medicare & Medicaid Services (CMS) on proposals for Medicare and Medicaid program requirements in long-term facilities;
Reviewing Medicare claims to analyze the impact of current Medicare psychoactive clinical regulations;
Educating policymakers on our recommendations; and,
Advocating on legislative packages to help promote better public policies.

As part of Project PAUSE’s work to educate lawmakers and interested stakeholders on appropriate use of antipsychotic medications in long-term care (LTC) settings, our coalition has conducted an in-depth look at clinical best practices and how federal regulations and public-private partnerships define current antipsychotic utilization rates. This analysis and the coalition’s recommendations for improvement are outlined in “Project PAUSE: Effective Solutions for Improving Clinical Care in Long-Term Care Settings.”

If you are interested in learning more and getting involved, please email [email protected].

About the Issue:
There is a large unmet medical need in long-term care settings for the diagnosis and management of NPS in dementia, including: psychosis, wandering, sleep issues, agitation, depression, apathy, and aggression. Effectively managing or preventing behaviors that disturb and cause harm to self and others is valuable to residents, family caregivers, and payors. While cognitive impairment is regarded as the hallmark indicator of dementia, neuropsychiatric symptoms are nearly as universal, with one or more symptoms affecting nearly all people with dementia over the illness course.

Among people with Alzheimer’s disease (AD), depression is the earliest observable symptom in at least one-third of cases. Milder agitation may manifest early and increase in prevalence and severity with worsening of dementia, often leading to an increase in caregiver burden, greater morbidity, poorer quality of life, increased cost of care, early institutionalization, and rapid disease progression. For long-term care staff caring for residents with depression, agitation, and other NPS, these disorders are associated with decreased quality of care, injury, increased workload, lost days of work, burnout, and staff turnover.

While antipsychotics have been used to treat NPS since the 1950s, people with neurodegenerative disorders were previously excluded from trials of psychotropic medications in general, and antipsychotics specifically, despite the fact that both brain changes and biological aging may impact psychotropic dosage needs and response, carrying significant risks.

There are no disease-modifying treatments for dementia; therefore, clinicians focus on decreasing patients’ suffering and improving their quality of life. Nearly all patients with dementia will develop at least one NPS. Because of this complexity, treatment should begin with an assessment to rule out potentially reversible causes of NPS. For mild to moderate NPS, short-term behavioral interventions, followed by pharmacologic interventions, are used. For moderate to severe NPS, pharmacologic interventions and behavioral interventions are often used simultaneously. New ICD-10 codes for dementia-related psychosis and other NPS symptoms should be considered to help prescribers with more accurate diagnosis and provide clearer guardrails for appropriate use. Assessing triggers and selecting strategies, however, is time-intensive and reflects a paradigm shift necessitating a reorganization of dementia care.

Learn More:

In January 2023, Project PAUSE shared a statement in appreciation of the U.S. Department of Health and Human Services’(HHS) attention to the important issue of nursing home safety and transparency and shares the common mission of advancing patient protection, improving health outcomes, and ensuring high-quality care. Read the statement here.
In November 2021, Project PAUSE submitted comment to Senate Finance Committee in response to Request for Information on Unmet Mental Health Needs. Read the letter here.
In June 2021, Project PAUSE submitted comment to CMS on aligning quality measurement to support appropriate use of antipsychotics in nursing facilities. Learn more here.
In May 2020, Project PAUSE submitted comment to Chairman Grassley, Ranking Member Wyden, Chairman Neal, Ranking Member Brady, and Senator Blumenthal, in response to their April 3 inquiry to the Office of Inspector General at the U.S. Department of Health and Human Services to review changes in inappropriate use of psychotropic drugs, examine the adequacy of drug treatment planning/medication monitoring, and determine whether additional legislative or regulatory actions are needed to protect against the inappropriate use of these medications. Read the letter here.
Project PAUSE commented on the Senate Finance Subcommittee on Health Care’s request for feedback on actions to address Alzheimer’s disease in March 2020. Read the comments here.
In response to a November 2019 House Ways and Means Committee hearing on caring for older Americans, several patient advocacy groups sent a letter to Committee Chairman Neal with recommendations for addressing the issue of appropriate care for people experiencing neuropsychiatric symptoms with dementia. Read the letter here.
In September 2019, Project PAUSE submitted comments to CMS on its proposed decision on Medicare and Medicaid program requirements for long-term facilities. Read the comments here.

Project PAUSE Members:

About the Alliance for Aging Research
The Alliance for Aging Research, www.agingresearch.org, is the leading non-profit organization dedicated to accelerating the pace of scientific discoveries and their application in order to vastly improve the universal human experience of aging and health. Founded in 1986 in Washington, DC, the Alliance believes that advances in research help people live longer, happier, more productive lives and reduce healthcare costs over the long term. Access to the latest scientific information empowers people to take control of their health. The Alliance strives to advance science and enhance lives through a variety of activities and initiatives—from policy issues to provider and consumer health programs— that generate knowledge and action on age-related issues.

About the American Society of Consultant Pharmacists
The American Society of Consultant Pharmacists, www.ascp.com, is the only international professional society devoted to optimal medication management and improved health outcomes for all older persons. Founded in 1969, ASCP’s more than 8,000 members have helped definitively shape pharmacy services in senior care for decades. ASCP’s senior care consultant pharmacist and pharmacy members manage and improve quality of life of geriatric patients and other individuals residing in a variety of environments, including nursing facilities, sub-acute care and assisted living facilities, psychiatric hospitals, hospice programs, and home and community-based care.

Project PAUSE is made possible with support from ACADIA Pharmaceuticals Inc., Avanir Pharmaceuticals, Inc., Lundbeck LLC, Merck & Co., Inc. and Otsuka America Pharmaceutical, Inc.