Author: Erin Luers

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

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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

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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

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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.

Ira Hofer, MD & Susana Vacas, MD, PhD

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Icahn School of Medicine; Massachusetts General Hospital

Mitigation of Postoperative Delirium in High-Risk Patients

Health Care Systems

Mount Sinai Hospital System

Project Snapshot

Dr. Hofer is a practicing anesthesiologist and clinical informaticist at The Icahn School of Medicine at Mount Sinai. Dr. Hofer has been working in the field of big data analytics for over 15 years in a variety of leadership roles. His research interests involve leveraging the data from the electronic health records (EHR) to understand, quantify and ultimately mitigate risk in the perioperative period. His work includes some of the first papers to apply machine learning techniques for perioperative outcome prediction and has been featured on the covers of Anesthesiology and Anesthesia & Analgesia. Dr. Hofer has a K01 from the National Heart Lung and Blood Institute and serves as an associate editor for Anesthesia & Analgesia. His research focuses on creating featurization techniques to incorporate a wide range of EHR data into machine learning models to improve discrimination and calibration, and establishing multi-center perioperative collaboratives to better share raw and processed EHR data.

Dr. Vacas is a neuroanesthesiologist at the Massachusetts General Hospital, Harvard Medical School. She completed her postdoctoral work at the University of California, San Francisco, where her research focused on the underlying mechanisms and risk factors of perioperative neurocognitive disorders, including postoperative delirium. Incorporating her bench work with the advent of new and emerging technologies, Dr. Vacas seeks to improve patient outcomes after surgery by blocking and/or alleviating perioperative exacerbated inflammation and brain lesions. Her research focuses on vulnerable surgical populations, and her work is helping to understand the pathogenic mechanisms behind these devastating conditions. She seeks to develop strategies that can be applied to prospective surgical patients.

RATIONALE: Postoperative delirium is the most common complication after surgery and a major cause of morbidity in patients with cognitive impairment. Perioperative clinical decision support tools may decrease the incidence of this devastating and potentially preventable condition by increasing adherence to clinical best practices.

OBJECTIVE: To leverage our experience in informatics and postoperative delirium research to perform a prospective randomized controlled embedded pragmatic clinical trial to test the effectiveness of a clinical decision support system to promote adherence to best practices with the goal of decreasing postoperative delirium in patients with baseline cognitive impairment.

SETTING: Perioperative setting at Mount Sinai Health System, an integrated health system that encompasses 130 operating rooms.

POPULATION: Patients with cognitive impairment undergoing surgery.

INTERVENTION: The intervention consists of clinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment. This intervention will promote 12 evidence-based best practices during care for perioperative patients.

OUTCOMES: The primary clinical outcome is the incidence of postoperative delirium. We will also evaluate practice adherence and effectiveness to reduce postoperative delirium in key groups and study the influence of each practice on postoperative delirium prevention.

IMPACT: Our rigorous and innovative approach, based on established methods and executed by an experienced multidisciplinary team with access to unique resources and tested platforms, will lead to insights that are clinically relevant and change clinical practice for postoperative delirium prevention in patients with cognitive impairment.

Lisa Kern, MD, MPH

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Weill Cornell Medicine

Improving How People Living with Dementia are Selected for Care Coordination: Pragmatic Clinical Trial Embedded in an Accountable Care Organization

Health Care Systems

NewYork Quality Care

Project Snapshot

Dr. Kern is an associate professor of medicine at Weill Cornell Medicine. Dr. Kern’s clinical background is in general internal medicine, and her MPH degree included a concentration in health policy and management. Dr. Kern is a health services researcher whose work focuses on improving the delivery of ambulatory care, especially for patients with chronic conditions. She is a national expert on healthcare fragmentation in the ambulatory setting, which occurs when a patient is cared for by many different outpatient providers, but no single provider accounts for a substantial proportion of visits. Dr. Kern recently completed an R01 grant from the National Heart, Lung, and Blood Institute on “Healthcare Fragmentation and Cardiovascular Outcomes” (R01 HL135199). The results of that work helped to shape this demonstration project. Dr. Kern received her undergraduate and medical degrees from Harvard University, and received her Master of Public Health degree from Johns Hopkins University.

RATIONALE: Many people living with dementia (PLWD) and their care partners may benefit from the assistance of a care coordinator, a member of the medical team who facilitates communication among all of the people involved. However, care coordinators’ time is limited, and there is uncertainty about which patients should be selected to receive their help. In a national survey, 31% of care partners for PLWD reported difficulty with coordinating care, but these observations have not been leveraged to improve care.

OBJECTIVE: This pragmatic clinical trial embedded (ePCT) in an accountable care organization (ACO) will determine the comparative effectiveness of two approaches for assigning care coordinators to PLWD.

SETTING: NewYork Quality Care, the ACO that brings together NewYork-Presbyterian Hospital, Weill Cornell Medicine, and ColumbiaDoctors.

POPULATION: Community-dwelling Medicare beneficiaries aged ≥65 years with dementia who have been attributed to the NewYork Quality Care ACO and who have ambulatory care spread out among many providers (which increases the risk of problems with communication among providers).

INTERVENTION: The intervention is a novel approach to assign care coordinators to PLWD whose care partners report problems with care coordination based on a survey of perceptions of care coordination. By contrast, usual care assigns PLWD to care coordinators after hospital discharge.

OUTCOMES: The primary clinical outcome is the combined endpoint of an emergency department or hospital admission over 12 months of follow-up. The implementation endpoints include four measures (acceptability, appropriateness, fidelity, and efficiency), to inform future dissemination.

IMPACT: This ePCT has the potential to show that an innovative, yet pragmatic change in the way care coordinators are deployed can reduce emergency department visits and hospital admissions compared to usual care.

Multiple IMPACT members contribute to publications highlighting results of the 2021 NIA consensus conference, Pragmatic Trials in Long-Term Care: A Consensus Conference

Posted on by Erin Luers

Multiple IMPACT members participated in the National Institute on Aging (NIA) R13 consensus conference, Pragmatic Trials in Long-Term Care: A Consensus Conference, held virtually on March 10, 2021.  The event was funded by the NIA and led by editors of three leading geriatrics journals:  JAMDA (The Journal of Post-Acute and Long-Term Care Medicine), JAGS (The Journal of the American Geriatrics Society), and Geriatric Nursing.

The goal of the conference was to identify priorities and best practices for pragmatic trials in long-term care, with a focus on care for persons with dementia.  The target audience was providers, researchers, and policy makers who aim to promote better care in nursing homes, assisted living communities, and other residential settings that serve older adults. Speakers included internationally renowned research experts, directors of national long-term care organizations, and leaders of national associations and societies. IMPACT Member Participants include Joe Gaugler, PhD, David Gifford, MD, MPH, Laura Hanson, MD, MPH, Vince Mor, PhD, Kathleen Unroe, MD, MHA, Sheryl Zimmerman, PhD.

Three papers that resulted from the event are featured in the March 2022 edition of JAMDA.  Due to the importance of the topic and the fact that the conference was sponsored by three journals, the resulting papers are being published in JAMDA, JAGS, and Geriatric Nursing.

IMPACT Collaboratory Announcing Release of RFA for Cycle 4A of Pilot Program Funding Opportunity

Posted on by Erin Luers

The National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer’s Disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory is happy to announce a Request for Applications (RFA) for the Pilot Grants Program Cycle 4A.

In this cycle, the IMPACT Collaboratory will fund up to five 1-year awards for pilot pragmatic clinical trials (ePCTs) that test non-pharmacological interventions embedded in health care system(s) for people living with AD/ADRD and their care partners. Pilot Studies will be funded for up to $175,000 in direct costs for a maximum of 12-months. For more information, please see our Pilot Grants Program page.

The goal of the pilot projects is to generate the preliminary data necessary to design and conduct a future full-scale Stage IV effectiveness ePCT (based on the NIH Stage Model) funded through other grant mechanisms (NIH or other sources)

The IMPACT Collaboratory will consider all applications for pilot ePCTs that evaluate non-pharmacological interventions to improve the care of people living with AD/ADRD and their care partners. This grant cycle will prioritize applications for interventions in these populations that aim to:

  • Improve care through behavioral economics “nudge” interventions;
  • Reduce inequities in health care;
  • Reduce potentially inappropriate medications through de-prescribing; or
  • Improve care in emergency departments.

Informational Webinar

An optional informational webinar will be hosted to provide investigators with an overview of application details and an opportunity to ask questions. Pre-registration is required using the link below.

Monday, February 14 at 2:00 pm ET: Registration closed.

Letters of Intent (LOI) Due – Required

Interested applicants are required to submit an LOI. LOIs are accepted on a rolling basis through March 4, 2022 @ 5pm ET

Full Applications Due – By invitation only

Applications selected for further consideration will be invited to submit a full proposal due June 17, 2022 @ 5pm ET

IMPACT Collaboratory Funds Three Pilot Study Awards

Posted on by Erin Luers

The IMPACT Collaboratory is happy to announce the recipients of Cycle 3A of the IMPACT Pilot Grant Award Program. Recipients were selected from an impressive group of competitive applications.

IMPACT Collaboratory Pilot Grant Award Recipients (RFA 2021)

  • Elizabeth Ciemins, PhD, MPH, MA, American Medical Group Association (AMGA)
    Implementation of MIND at Home Program in Primary Care for People Living with Dementia
  • Leah Hanson, PhD, HealthPartners Institute
    Mindfulness-Based Dementia Care Partner Program to Reduce Depressive Symptoms
  • Maggie Ramirez, PhD, MS, University of Washington
    Virtual Training for Latino Caregivers to Manage Symptoms of Dementia

Additional details on these recipients and their pilot studies can be found on the IMPACT Collaboratory website.


About the IMPACT Pilot Grant Program
The IMPACT Collaboratory funds several one-year pilot studies annually, which are meant to generate the preliminary data necessary to design and conduct future full-scale, stage 4 effectiveness ePCTs funded through other grant mechanisms. Awards are for single Principal Investigator applications for one year and are non-renewable.


Current and Upcoming IMPACT Funding Opportunities

Pilot Grant Program

Applications for Pilot Grant Cycle 3B opened August 16, 2021. The application process is a 2-step competitive process. The first step, a required LOI, was due September 17, 2021.  Selected investigators were invited to submit a full application due January 14, 2022.  Request for applications for Cycle 4A anticipated in early February 2022.

Requests for applications will open for two IMPACT funding programs on January 10, 2022.

Career Development Award Program 

The Career Development Award Program supports the development of early-stage investigators building careers in the design and conduct of ePCTs for people living with AD/ADRD and their care partners.

HCS Scholars Program

The Health Care Systems Embedded Research Scholars Program offers investigators an opportunity to work directly with health care systems interested in improving care provided to people living with AD/ADRD and their care partners. The goal of the HCS Scholars Program is to embed investigators in health care systems to strengthen collaborations and learn how to successfully implement new programs that may lead to pilot studies or demonstration projects.

Additional information is available on the IMPACT website.  Please join our mailing list to receive news and invitations to events and Grand Rounds.