This virtual 1.5-day workshop will provide a foundation in practical aspects of designing and conducting ePCTs in Alzheimer disease and related dementias through a combination of panel discussions, small group sessions, and networking opportunities with experts in the field. Workshop modules will focus on integrating health equity into ePCTs, ethical considerations for ePCTs for PLWD and their care partners, and the challenges and opportunities related to conducting ePCTs with care partners of people living with dementia.
The IMPACT Collaboratory is supported by a grant from the National Institute on Aging. Its mission is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.
Vincent Mor, PhD, is a professor of health services, policy & practice and Florence Pirce Grant Professor in the Brown University School of Public Health, and has been principal investigator of 40+ NIH-funded grants focusing on use of health services and outcomes of frail and chronically ill people. He has evaluated the impact of programs and policies including Medicare funding of hospice, changes in Medicare nursing home payment, and the introduction of nursing home quality measures. He co-authored the Congressionally-mandated Minimum Data Set (MDS) and was architect of an integrated Medicare claims and clinical assessment data structure used for policy analysis, pharmaco-epidemiology and population outcome measurement. Dr. Mor developed summary measures using MDS data to characterize residents’ physical, cognitive and psycho-social functioning. These data resources are the heart of Dr. Mor’s NIA- funded Program Project Grant, “Changing Long Term Care in America,” which examines the impact of Medicaid and Medicare policies on long-term care. These data are also at the core of a series of large, pragmatic cluster randomized trials of novel nursing home-based interventions led by Dr. Mor.
Dr. Mor was a co–principal investigator of the Pragmatic Trial of Video Education in Nursing Homes (PROVEN), an NIH Collaboratory Trial. He now serves as a principal investigator of the IMPACT Collaboratory, a program funded by the National Institute on Aging to build the nation’s capacity to conduct embedded pragmatic clinical trials for people living with dementia and their care partners.
The 1-year pilot grant awards will likely be eligible for funding of up to $175,000 in direct costs. The awards will support pilot projects that aim to generate preliminary data for the design and conduct of full-scale embedded pragmatic clinical trials of nonpharmacologic interventions in healthcare systems for persons living with Alzheimer disease and related dementias and/or their care partners. The IMPACT Collaboratory will give preference to applications that address care for traditionally marginalized or underrepresented populations in clinical research and those that promote health equity.
More than 5 million Americans are living with Alzheimer disease and related dementias. They are particularly vulnerable to receiving uncoordinated and poor-quality care, which contributes to adverse health outcomes and misuse of resources. The mission of the IMPACT Collaboratory is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.
The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging.
Longtime NIH Collaboratory investigator Dr. Richard Platt will serve as co–principal investigator of a new embedded pragmatic clinical trial with Dr. Xiaojuan Li as part of the IMPACT Collaboratory. The IMPACT Collaboratory announced Li and Platt as awardees of its NIH Collaboratory Trials Program for their project Co-CARE-AD, the Collaborative Care Coordination Program for Alzheimer’s Disease and Related Dementias.
The IMPACT Collaboratory’s NIH Collaboratory Trials Program is a new funding mechanism to support full-scale, embedded pragmatic clinical trials testing nonpharmacologic interventions for people living with Alzheimer disease and related dementias and their care partners that are linked to the needs of a health care system.
Co-CARE-AD will evaluate the effectiveness of the Dementia Care Consultation program to provide multicomponent care coordination and support for community-dwelling Medicare Advantage plan members. Read more about Co-CARE-AD.
The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging.
NIA IMPACT Collaboratory Jonathan Jackson, PhD Executive Director Community Access, Recruitment, and Engagement (CARE) Research Center Massachusetts General Hospital and Harvard Medical School
GRACE Judith Schlaeger, PhD, CNM, LAc, FAAN Associate Professor, Department of Human Development Nursing Science University of Illinois Chicago
GGC4H Stacy Sterling, DrPH, MSW, MPH Research Scientist Kaiser Permanente Division of Research, Northern California
Guest Moderator:
Emily O’Brien, PhD Associate Professor, Department of Population Health Sciences Duke Clinical Research Institute Duke University School of Medicine
Topic
Inclusion of Diverse Participants in Pragmatic Clinical Trials: Meeting Participants Where They Are – Outreach, Trust, and Consent to Maximize Diversity
Keywords
Participant diversity; Health equity; Outreach strategies; GRACE; Guiding Good Choices for Health (GGC4H); NIA IMPACT Collaboratory; Implementation science
Key Points
Health equity is a matter of scientific integrity. Health equity must be front and center when trials are designed and implemented because, without it, access may be undermined and effectiveness could be misrepresented.
Study enrollment bias occurs at every level of selection, beyond the participant level. “Healthy worker bias” can occur at the level of the healthcare system too.
Health equity is a crucial and unique aspect of embedded PCTs (ePCTs). While the PRECIS-2 (Pragmatic-Explanatory Continuum Indicator Summary) domains show how pragmatic a trial design is, the tool does not identify biases in the design. For research that is truly effective and generalizable, it is vital to implement PRECIS-2 through an equity lens.
Among the many practices that can maximize diversity in trial enrollment:
Tailored, personalized outreach and community connections
Bilingual, bicultural staff
Balancing fidelity with feasibility and relatability
Cultural and linguistic adaptation
Flexible scheduling
Incorporating a community-based participatory research model in the design of the study can assist in addressing barriers and build trust.
Discussion Themes
Concerns about racism and bias can affect the emotions and behaviors of study participants. Can these topics be incorporated into the curriculum?
What role do broad stakeholder organizations, such as funders and insurance providers, have in advancing outreach and building trust?
Implementation science offers ways to think about the complex aspects of an intervention that may not be captured in the protocol.
The NIA IMPACT Collaboratory will publish a request for applications for pilot grants on August 16, 2021, with letters of intent due September 17, 2021.
The 1-year pilot grant awards will likely be eligible for funding of up to $175,000 in direct costs. The awards will support pilot projects that aim to generate preliminary data for the design and conduct of full-scale embedded pragmatic clinical trials of nonpharmacologic interventions in healthcare systems for persons living with Alzheimer disease and related dementias and/or their care partners. The IMPACT Collaboratory will give preference to applications that address care for traditionally marginalized or underrepresented populations in clinical research and those that promote health equity.
More than 5 million Americans are living with Alzheimer disease and related dementias. They are particularly vulnerable to receiving uncoordinated and poor-quality care, which contributes to adverse health outcomes and misuse of resources. The mission of the IMPACT Collaboratory is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.
The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging.
The NIA IMPACT Collaboratory will publish a request for applications for pilot grants on August 16, 2021, with letters of intent due September 17, 2021.
The 1-year pilot grant awards will likely be eligible for funding of up to $175,000. The awards will support pilot projects that aim to generate preliminary data for the design and conduct of full-scale embedded pragmatic clinical trials of nonpharmacologic interventions in healthcare systems for persons living with Alzheimer disease and related dementias and/or their care partners. The IMPACT Collaboratory will give preference to applications that address care for traditionally marginalized or underrepresented populations in clinical research and those that promote health equity.
More than 5 million Americans are living with Alzheimer disease and related dementias. They are particularly vulnerable to receiving uncoordinated and poor-quality care, which contributes to adverse health outcomes and misuse of resources. The mission of the IMPACT Collaboratory is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.
The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging.
Consuelo H. Wilkins, MD, MSCI
Vice President for Health Equity
Vanderbilt University Medical Center
Professor of Medicine
Vanderbilt School of Medicine
Brent P. Forester, MD, MSc
Chief, Center of Excellence in Geriatric Psychiatry
McLean Hospital
Medical Director, Behavioral Health, Evaluation, and Research
Population Health Management
Mass General Brigham
Ula Hwang, MD, MPH
Professor of Emergency Medicine
Yale School of Medicine
The IMPACT Collaboratory is inviting applications from early- and mid-career researchers for its second annual training workshop, “Building Skills to Conduct Embedded Pragmatic Clinical Trials (ePCTs) Among People Living With Dementia (PLWD) and Their Care Partners.” A limited number of participants will be accepted to attend the event on January 26 and 27, 2022.
