3b grantees

Jennifer Carnahan, MD, MPH, MA

Posted on by Erin Luers

Indiana University School of Medicine

Embedded Clinical Trial of Patient Priorities Care among Persons Living with Mild Cognitive Impairment and Dementia

Health Care Systems

  • Eskenazi Health
  • Indiana University Health
  • University of Texas

Pilot Study Snapshot

Dr. Carnahan is a geriatrician, an assistant professor of medicine at Indiana University School of Medicine, and a researcher at the Indiana University Center for Aging Research at Regenstrief Institute. She practices primary care geriatrics at the Eskenazi Center for Senior Health and the Roudebush VA Medical Center, where she is a member of the GeriPACT and the LGBTQ Healthcare PACT. She is the current recipient of a K23 career development award from the NIA that examines outcomes of transitions of care from the skilled nursing facility setting to home for persons living with Alzheimer’s disease and related dementias and their care partners.

RATIONALE: People living with dementia or mild cognitive impairment (PLWD/MCI) are a heterogeneous group with varying disease course trajectories and life expectancies. Because of this heterogeneity, PLWD/MCI often receive care that is inconsistent with their goals—often too aggressive but sometimes too conservative. Patient Priorities Care (PPC) helps patients and their care team to identify their health priorities and helps the health professionals to align care with these priorities.

OBJECTIVE: The objective of this pilot study for an embedded pragmatic clinical trial (ePCT) is to demonstrate the feasibility of identifying a diverse cohort of eligible PLWD/MCI – care partner dyads and implementing the PPC program by trained facilitators (e.g., social worker, nurse, or nursing assistant).

SETTING: Geriatrics and primary care clinics in three different health systems.

POPULATION: Community-dwelling PLWD/MCI and their care partners.

INTERVENTION: Clinical staff engage PLWD/MCI and their care team to identify their health priorities using PPC materials. This will be followed by alignment of patient priorities with their medical care plan in collaboration with their physician or advanced practice provider.

OUTCOMES: The primary clinical outcome is days at home. Secondary clinical outcomes are total medications and new referrals to specialists. Implementation endpoints (acceptability, appropriateness, feasibility, fidelity, and potential for future adoption of the intervention) will be assessed through chart review and semi-structured exit interviews with some dyads and clinicians.

IMPACT: This pilot study will demonstrate the feasibility of both implementation of PCC and pragmatic data collection methods as well as establish the acceptability of the intervention to clinicians, PLWD/MCI and care partners in order to conduct a multi-site, embedded pragmatic clinical trial of PPC for PLWD/MCI.

Helen Kales, MD

Posted on by Erin Luers

University of California, Davis

Reducing Inappropriate Medication use for Behavioral and Psychological Symptoms of Dementia and Improving Health Outcomes in People Living with Dementia

Health Care Systems

UC Davis Community Physician Network

Pilot Study Snapshot

Dr. Kales is chair of Psychiatry and Behavioral Sciences at University of California, Davis. As a fellowship-trained, board-certified geriatric psychiatrist, Dr. Kale’s research program is directly informed by clinical work and experiences with patients, families, providers, and systems to diminish the barriers to effective and high-quality care for older patients with mental health issues and/or dementia and their care partners. She is a national and international expert in outcomes related to later-life depression, the risks of using antipsychotic and other psychotropic medications in older adults, and in researching ways to improve dementia care. Dr. Kales was named to the standing Lancet Global Commission on Dementia Care in recognition of her work in the field of dementia care.

RATIONALE: Managing behavioral and psychological symptoms of dementia (BPSD) is one of the most challenging aspects of caring for people living with dementia (PLWD). Behavioral and environmental interventions are the preferred first-line treatment approach to reduce excessive and inappropriate medication use to manage BPSD in PLWD. Despite the promise of these evidence-based interventions, there is relatively little translation into real-world clinical management, particularly in the primary care setting.

OBJECTIVE: To embed and test the feasibility and acceptability of delivering the DICE (Decide-Investigate-Create-Evaluate) model into primary care to manage BPSD among PLWD.

SETTING: Four primary care practices in the Primary Care Network at University of California, Davis.

POPULATION: PLWD and care partner dyads with upcoming appointments identified using electronic medical records or by clinic staff.

INTERVENTION: The DICE model is a low-cost, practical, patient- and care partner-centric,   evidence-informed approach that systematically guides clinicians and care partners through the assessment and management of BPSD and teaches new problem-solving skills. DICE is comprised of in-person and online module-driven training, including a DICE manual, designed for clinicians and care partners of PLWD. The clinical social worker embedded at each primary care clinic serves as the onsite DICE coordinator and meets with PLWD-care partner dyads in-person or by zoom using the DICE approach to assess and manage BPSD.

OUTCOMES: The primary clinical outcome is the rate of psychotropic medication use at 6 months post intervention. Secondary outcomes include hospitalizations, emergency department visits and nursing home placement. Implementation endpoints include feasibility, time required to deliver DICE, and acceptability to PLWD and care partners.

IMPACT: Embedding the DICE model into primary care has high potential to ensure a systematic approach to provide evidence-based care for managing BPSD and reduce psychotropic medication use. Findings from this pilot study for an embedded pragmatic clinical trial (ePCT) will inform the design of a full-scale ePCT to test the effectiveness of the DICE approach to improve outcomes for PLWD in primary care settings.

Donovan Maust, MD, MS

Posted on by Erin Luers

University of Michigan

A Patient-Facing Tool to Reduce Opioid, Psychotropic Polypharmacy in People Living With Dementia

Health Care Systems

• University of Michigan – Department of Internal Medicine
• Henry Ford Health System

Pilot Study Snapshot

Dr. Maust is an associate professor of psychiatry at the University of Michigan Medical School and research scientist with the Center for Clinical Management Research of the VA Ann Arbor Healthcare System. Dr. Maust is a board-certified geriatric psychiatrist and health services researcher. His research focuses on understanding determinants and outcomes of potentially inappropriate psychotropic prescribing to older adults, with particular interest in benzodiazepines, antipsychotics, and psychotropic/opioid polypharmacy in both the outpatient and long-term care settings. His other area of interest is in understanding how caregivers of people living with dementia shape how the person with dementia interacts with the health care system. Dr. Maust earned his medical degree from Johns Hopkins University and completed his training in psychiatry and geriatric psychiatry at the University of Pennsylvania.

RATIONALE: Central nervous system-active polypharmacy (CNS polyRx; i.e., overlapping prescriptions of ≥3 psychotropic and opioid medications) is common among people living with dementia (PLWD) even though the evidence base to support use of even single agents in this population is limited. Direct-to-patient education (e.g., EMPOWER) has demonstrated efficacy to prompt deprescribing among older adults but has not focused on PLWD and their care partners previously.

OBJECTIVE: To adapt direct-to-patient education to use with PLWD and engaged care partners and specifically address CNS polyRx; pilot the feasibility of using the electronic health record to identify PLWD experiencing CNS polyRx with engaged care partners and then implement the direct-to-dyad education; and ascertain any prescribing changes in the electronic health record.

SETTING: Four primary care clinics at the University of Michigan Health and Henry Ford Health systems.

POPULATION: Primary care patients living with dementia experiencing CNS polyRx with engaged care partners.

INTERVENTION: A direct-to-dyad educational tool sent by mail that presents potential risks of the currently prescribed regimen, with the goal of prompting a conversation with their pharmacist or prescribing clinician.

OUTCOMES: The primary clinical outcome is a change in the burden of CNS-active prescriptions. Implementation endpoints include: establishing enrollment feasibility (i.e., PLWD experience CNS polyRx for whom we can also identify a care partner) and implementation feasibility (i.e., documented evidence of discussion with a clinician about these medications after the tool is sent to those eligible).

IMPACT: If successful, this pilot study will establish the feasibility of a large-scale embedded pragmatic clinical trial to test this type of direct-to-dyad education to address potentially inappropriate prescribing. Given the potential harms and related costs associated with CNS polyRx, this low-touch intervention could have significant impact even if the effect is relatively small.

Elizabeth Phelan, MD, MS

Posted on by Erin Luers

University of Washington

Deprescribing to Reduce Injurious Falls among Older Adults with Dementia (STOP-FALLS-D)

Health Care Systems

Kaiser Permanente Washington
Benjamin Balderson, PhD, Site PI

Pilot Study Snapshot

Dr. Phelan is professor of gerontology and geriatric medicine at the University of Washington (UW) School of Medicine, adjunct professor of health systems and population health at UW School of Public Health, and affiliate investigator at Kaiser Permanente Washington Health Research Institute. She is director of the Northwest Geriatrics Workforce Enhancement Center and founding director of the UW Medicine Fall Prevention Clinic. She is a clinically active, board-certified geriatrician whose clinical work encompasses the inpatient and outpatient settings and involves teaching principles of internal medicine and geriatric medicine to students, residents, and fellows. Dr. Phelan's research aims to promote health and prevent functional decline in community dwelling older adults by improving quality of care for geriatric syndromes (falls, dementia). She worked closely with the Centers for Disease Control and Prevention (CDC) as their content expert to develop the STEADI (Stopping Elderly Accidents Deaths and Injuries) fall prevention toolkit for healthcare providers. Her research typically involves collaborative partnerships with healthcare and community organizations that serve older persons.

RATIONALE: Falls among older adults are a major public health concern, and older people living with dementia (PLWD) have disproportionately higher fall rates. The use of medications that affect the central nervous system (CNS) is a key modifiable risk factor for falls. CNS-active medications are often considered potentially inappropriate for older adults, especially for older PLWD, and guidelines recommend avoiding their use. However, use remains common and is higher among older PLWD compared to those without dementia. Few deprescribing interventions have targeted older PLWD in primary care.

OBJECTIVE: Adapt an evidence-based, health-system-embedded, patient-centered deprescribing intervention called STOP-FALLS, which focuses on reducing use of CNS-active medications among older adults living with dementia, and conduct a pilot study for an embedded pragmatic clinical trial (ePCT) with older PLWD, their care partner(s), and their primary care providers (PCPs).

SETTING: Kaiser Permanente Washington, an integrated healthcare delivery system in the Northwest United States.

POPULATION: Community-dwelling older PLWD, their care partners, and their PCPs.

INTERVENTION: Educational brochures for PLWD and their care partners and decision support for the PCPs.

OUTCOMES: The primary clinical outcome is medically treated falls. Secondary outcomes include: all-cause emergency department visits and hospitalizations, and nursing home placement. Implementation endpoints include: feasibility of reaching older PLWD and their care partners, acceptability of the intervention, and whether the intervention was implemented as intended.

IMPACT: Improving the quality of prescribing is imperative to reduce adverse outcomes and optimize quality of life for older PLWD. With the rapid growth in numbers of PLWD, effective strategies are urgently needed. STOP-FALLS–D will provide important new evidence about the feasibility of deprescribing CNS-active medications in partnership with PLWD, their care partner(s), and their primary care providers. This work will lay the foundation for a future large-scale ePCT.