Partnering with People Living with Dementia and Care Partners in Embedded Pragmatic Clinical Trials

December 2021 – Grand Rounds 22 features a panel of participants sharing their experiences in stakeholder engagement in ePCTs for people living with AD/ADRD and their care partners. Perspectives shared include that of a researcher, a stakeholder engagement expert and people living with dementia.

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Speakers

Gary Epstein-Lubow, MD

Gary Epstein-Lubow, MD
Team Leader, IMPACT Engaging Partners Team
Associate Professor of Psychiatry and Human Behavior
Associate Professor of Medical Science, Alpert Medical School of Brown University
Associate Professor of Health Services, Policy and Practice, Brown University School of Public Health

 


Heidi GilHeidi Gil
Executive Committee Member,
IMPACT Engaging Partners Team

Chief Strategy Officer, LiveWell

Learning Objectives

    • Understand the need/benefits of engaging people living with dementia and care partners in every aspect of dementia care research
    • Identify how all stakeholders can be empowered and engaged as co-partners in research
    • Explore lessons learned and resources available to conduct research differently

Elizabeth Ciemins, PhD, MPH, MA

AMGA

Implementation of MIND at Home Program in Primary Care for People Living with Dementia

Health Care Systems

  • McFarland Clinic
  • CommonSpirit

Dr. Ciemins is a health services research scientist and vice president of Research and Analytics at the American Medical Group Association (AMGA). In her role, she focuses on data-driven population health improvement through comparative and predictive clinical analytics. Prior to AMGA, she served for 10 years as director of the Center for Clinical Translational Research at Billings Clinic where her research focused on improving the quality of care and care transitions across a large, geographically disperse service area in the areas of diabetes, hypertension, palliative care, and health IT. Dr. Ciemins’ areas of research interest include chronic disease management, health information and telehealth technology, palliative care, childhood and adult obesity, care transitions, rural health, mental health, and complexity science approaches to behavior change in health care. Dr. Ciemins holds a PhD in Health Services and Policy Analysis from the University of California, Berkeley, an MPH in Population/Family Health, and MA in African Studies from University of California Los Angeles.

RATIONALE:  People living with dementia (PLWD) represent some of the highest-need and highest-cost individuals living in the community and primary care plays a pivotal in the detection, diagnosis, and delivery of services for this vulnerable patient group. Despite the availability of a range of evidence-based dementia and symptom management approaches, few American PLWD receive adequate care; embedding effective evidence-based interventions and dementia care best practices into primary care settings is needed, but not yet widely done.

OBJECTIVE: To embed and test the feasibility of a novel best practice-based approach, MIND at Home, within primary care to enhance and elevate the role of existing primary care staff to Memory Care Coordinators (MCCs), increase primary care access to interdisciplinary collaborative care, and systematically combine the benefits of clinic-based services with home-based assessment to support family-centered care planning and implementation for PLWD and their care partners.

SETTING: Three primary care clinics in two geographically and demographically diverse integrated health systems.

POPULATION: Community-residing primary care patients with an Alzheimer’s disease and related dementia (ADRD) diagnosis who have at least one caregiver/care partner.

INTERVENTION: MIND at Home is a comprehensive care coordination program that takes an interdisciplinary, collaborative care approach by systematically assessing and addressing a wide range of dementia-care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes. MIND brings a home-based component to what is often exclusively clinic-based care delivery while providing ongoing education designed to build primary care team dementia management capacity through regular interdisciplinary collaboratives with dementia experts.

OUTCOMES: The primary clinical outcome is hospital transfers including admissions, ED visits, and observation stays. Secondary outcomes include overall number of medications, number of anti-psychotic medications, acetylcholinesterase inhibitors and memantine. EHR-based outcomes will be collected pre-, during-, and post-intervention for a total of 7 months.

IMPACT: Embedding a collaborative, best-practice based approach, such as MIND at Home, into primary care is a potentially powerful strategy to organize care, improve quality, reduce costs, and maximize benefit for PLWD.

Leah Hanson, PhD

HealthPartners Institute

Mindfulness-Based Dementia Care Partner Program to Reduce Depressive Symptoms

Health Care Systems

  • HealthPartners
  • Sutter Health
  • University of Michigan – Alzheimer’s Disease Research Center

Dr. Hanson is a senior research investigator and senior director of research at HealthPartners Neuroscience Center, HealthPartners Institute and co-director of research at the HealthPartners Center for Memory & Aging. For over 15 years, her research has focused on the development of novel therapeutic delivery methods for the treatment and prevention of neurologic diseases, especially those that impact older adults such as Alzheimer’s disease, Parkinson’s disease, and stroke. In 2010, she initiated the Minnesota Memory Project, a longitudinal cohort study of memory changes in adults and associated risk and protective factors, and she continues to serve as the principal investigator. Her experience includes recruitment for clinical research and trials in dementia via electronic medical record and healthcare claims data, conducting trials of non-medication interventions including education and support for patients and caregivers, mindfulness-based stress reduction, and aromatherapy.

RATIONALE: While caregiving and being a care partner to a person living with Alzheimer’s disease or related dementia (PLWD) can be rewarding, care partners often feel high levels of stress and burden, have low mood, and poor health.

OBJECTIVE: To test the feasibility of implementing a mindfulness program to reduce stress and symptoms of depression in care partners. We will pilot test a new way to collect real-world outcomes on care partners through an administrative set of data collected by a community non-profit organization that trains the program instructors.

SETTING: Three memory care clinics located in Minnesota, Michigan, and California.

POPULATION: Approximately 120 care partners of PLWD.

INTERVENTION: The intervention is an adaptation of Mindfulness-Based Stress Reduction for care partners of PLWD called Mindfulness Based Dementia Care (MBDC). Developed by the Presence Care Project (www.presencecareproject.com), a community-based non-profit organization, MBDC offers a bridge between mindfulness practice and the dementia care exchange.

OUTCOMES: The primary clinical outcome is symptoms of depression, and the secondary clinical outcome is care partner burden. Implementation outcomes will measure the feasibility of implementation including the rate of program registration and completion, number of sessions attended, acceptability of virtual instruction, and completeness of data collection.

IMPACT: Findings from this pilot study will guide the design a large real-world trial to test the potential benefits of MBDC.  Mindfulness has the potential to reduce stress and burden in care partners, reduce symptoms of depression, and ultimately improve overall health.

Maggie Ramirez, PhD, MS, MS

University of Washington

Virtual Training for Latino Caregivers to Manage Symptoms of Dementia

Health Care Systems

  • UW Medicine
  • WWAMI Region Practice and Research Network

Dr. Ramirez is an assistant professor at the University of Washington School of Public Health, Department of Health Systems and Population Health. Dr. Ramirez is also an affiliate investigator at the Kaiser Permanente Washington Health Research Institute. She has an interdisciplinary background in learning health systems research, public health, and human-centered design. Her research focuses on how information and communication technology can be used to enhance the delivery of health interventions targeting populations impacted by disparities in health status and healthcare delivery. She currently leads research on a virtual intervention to support the health and well-being of Latinos who provide care to family members living with dementia. Dr. Ramirez lives and works on the traditional land of the first people of Seattle – the Duwamish People, past and present – and she honors with gratitude the land itself and the Duwamish Tribe.

RATIONALE: Latinos are 1.5 times more likely to develop dementia compared to non-Latino White adults. Non-pharmacological interventions have been developed and tested to support caregivers of people living with dementia (PWLD), but they are limited by the persistent underrepresentation of Latinos. STAR-VTF is a virtual adaptation of an efficacious intervention that teaches caregivers skills to reduce behavioral and psychological symptoms of dementia.

OBJECTIVE: The objectives of this study are to 1) integrate Latino cultural values, beliefs, concerns, and language preference into STAR-VTF and 2) pilot test the adapted content among Latino care partners.

SETTING: Washington State

POPULATION: Spanish- and English-speaking care partners of PLWD who self-identify as Hispanic/Latino/a/x.

INTERVENTION: For 6-8 weeks, care partners in the STAR-VTF intervention complete weekly online training modules asynchronously, have weekly phone calls with a coach (e.g., social worker), and receive ongoing support from the coach via secure email messages. This study focuses on pilot testing the adapted asynchronous, online training modules component of the intervention.

OUTCOMES: The primary outcome is the Revised Memory and Problem Behavior Checklist, which measures the frequency of behavioral and psychological symptoms of dementia and the impact these symptoms have on care partners.

IMPACT: This pilot study will enable us to perform and refine adaptations of the STAR-VTF intervention for Latino care partners. The long-term goal is to accelerate wide adoption of STAR-VTF in healthcare systems to improve the quality and outcomes of care for Latino PLWD and their care partners.

Challenges conducting pragmatic trials of interventions for care partners of people living with dementia

November 2021 – In Grand Rounds 21, Drs. Penfold, Hanson, and Fortinsky, describe challenges from three pragmatic trials to share lessons learned and ideas for how to overcome these challenges in future research.

Webinar Slides

Robert Penfold, PhD

 

 

 

 

 

Robert Penfold, PhD
Senior Investigator, Kaiser Permanente
Washington Health Research Institute

 

Leah Hanson, PhD

 

 

 

 

 

Leah Hanson, PhD
Senior Research Investigator,
Health Partners Institute

 

Richard H. Fortinsky, PhD

 

 

 

 

 

Richard H. Fortinsky, PhD
Professor and Health Net, Inc. Endowed Chair in Geriatrics and Gerontology
UConn Center on Aging

Learning Objectives

  • Be familiar with some legal, ethical and logistical barriers to recruiting caregivers and measuring caregiver outcomes
  • To gain knowledge about the potential for mindfulness to reduce stress and depressive symptoms in care partners
  • Explain how issues involving consent and HIPAA authorization could be addressed and resolved during the IRB approval process in pragmatic trials compared to more conventional clinical trials.

Dyadic designs, their foundation on theory and analytic methods

October 2021 – In Grand Rounds 20, Dr. Lyons explains a dyadic approach to illness and care, as well as the role of theory and concepts, design and methodological considerations, and family and culture in dyadic research.

 

Speakers

Karen Lyons

Karen S. Lyons, PhD, FGSA (she/hers)

Professor

Boston College
William F. Connell School of Nursing
@KSLCareDyads

Learning Objectives

  • Understand what is meant by “dyad as unit of analysis or focus.”
  • Understand the importance of theory and concepts as foundations to dyadic research.
  • Understand some of the design and methodological considerations in designing and conducting dyadic research.

 

Promises and Pitfalls of Existing Data in Nursing Homes

June 2021 – In Grand Rounds 18, Drs. Teno and Saliba discuss the use of administrative data, including the Minimum Data Set (MDS) in pragmatic clinical trials and share examples of how they have used this data in their own pragmatic clinical trials.

 

Speakers

 

Joan Teno, MD, MS

Joan M. Teno, MD, MS
Professor of Medicine, Oregon Health & Science University
Adjunct Professor of Health Services, Policy, & Research, Brown University School of Public Health Physician Scientist, VA Los Angeles, GRECC and HSR&D COIN

Debra Saliba, MD, MPH

Debra Saliba, MD, MPH
Anna & Harry Borun Endowed Chair, Geriatrics and Gerontology, UCLA
Director, UCLA/JH Borun Center for Gerontological Research
Physician Scientist, VA Los Angeles, GRECC and HSR&D COIN

Webinar Recording

 

Download Webinar Slides

 

Learning Objectives

  • Pros and cons of administrative data for use in pragmatic trials
  • Address potential limitations of using administrative data to infer the quality of care
  • Discuss a controversial claim that pragmatic trials of decision-making for persons with dementia need to consider adding PCROs:
    - Addressing understanding, coercion
    - Addressing safety, “balance measures
  • Identify advantages & challenges of using MDS assessment items
  • Describe some of the MDS data elements and their performance implications for persons with cognitive impairment
  • Understand performance of resident self-report items
  • Identify pragmatic skills for direct interviews

Notice of Intent to publish a new funding opportunity for IMPACT Pilot Grants

The NIA IMPACT Collaboratory plans to publish a Request for Applications (RFA) for Pilot Grants on August 16, 2021 with Letters of Intent due September 17, 2021.

IMPACT funds several one-year awards of pilot pragmatic clinical trials (ePCTs) that test non-pharmacological interventions embedded in health care system(s) for people living with Alzheimer’s Disease (AD) and AD-related dementias (ADRD) and their care partners. Under this mechanism, interventions must be linked to the needs of a health care system. For more information, please see our Pilot Grants page.

All applications will be considered with priority given to applications for interventions in this population that aim to:

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

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). The IMPACT Collaboratory will give preference to applications that address dementia care for populations traditionally marginalized or underrepresented in clinical trials and those that promote health equity. It is anticipated that Pilot Projects will be funded for up to $175,000 in direct costs for a maximum of 12-months.

Stay tuned for updates regarding the release of the RFA, an informational webinar and application deadline. If you have questions related to this funding opportunity, please contact IMPACTcollaboratory@hsl.harvard.edu.

Patient and Caregiver Relevant Outcomes

Patient and Caregiver Relevant Outcomes

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Tip Sheet

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Resources

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Other Suggested Training Modules

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