Embedded Pragmatic Trials in Dementia Care: Realizing the Vision of the NIA IMPACT Collaboratory
June 26, 2020
Author: Erin Luers
NIA IMPACT Collaboratory Featured in JAGS Special Issue
The Journal of the American Geriatrics Society (JAGS) has published a special issue (Volume 68, S2) focused solely on the National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer’s Disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory and the activities and progress it has made since the September 2019 announcement.
The special issue, published online June 26, includes an introductory article describing the mission and vision of the IMPACT Collaboratory and articles from each of the 10 IMPACT cores and teams describing how they are working to achieve that mission. The introductory article authors are the two IMPACT principal investigators, Susan Mitchell, MD, MPH, senior scientist at Hebrew SeniorLife’s Hinda and Arthur Marcus Institute for Aging Research and professor of medicine at Harvard Medical School and Vincent Mor, PhD, Professor of Health Services, Policy & Practice and the Florence Pirce Grant University Professor, Brown University School of Public Health, as well as the two executive directors, Ellen McCarthy, PhD, MPH, Associate Scientist, Marcus Institute, and Associate Professor of Medicine and Epidemiology, Harvard Medical School, and Jill Harrison, PhD, Assistant Professor of Health Services, Policy and Practice, Brown University School of Public Health.
Mitchell is guest editor for the special issue of JAGS, which includes articles from the IMPACT cores and teams to provide insight into how each is working to improve the quality and effectiveness of ePCTs in PLWD and their care partners. The article titles are:
- Achieving Health Equity in Embedded Pragmatic Trials for People Living with Dementia and Their Family Caregivers
- Building a National Program for Pilot Studies of Embedded Pragmatic Clinical Trials in Dementia Care
- Training the Workforce to Conduct Embedded Pragmatic Clinical Trials to Improve Care for People Living with Dementia and Their Caregivers
- Dissemination and Implementation of Evidence-Based Dementia Care Using Embedded Pragmatic Trials
- Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia
- Transforming Dementia Care Through Pragmatic Clinical Trials Embedded in Learning Healthcare Systems
- Using Healthcare Data in Embedded Pragmatic Clinical Trials among People Living with Dementia and Their Caregivers: State of the Art
- Selecting Outcomes to Ensure Pragmatic Trials Are Relevant to People Living with Dementia
- Engaging Stakeholders in the Design and Conduct of Embedded Pragmatic Clinical Trials for Alzheimer’s Disease and Alzheimer’s Disease–Related Dementias
- Statistical Considerations for Embedded Pragmatic Clinical Trials in People Living with Dementia
Goldfeld Blog Post: Consider a permutation test for a small pilot study
Check out the latest blog post from Keith Goldfeld, DrPH, MS, MPA, executive committee member of the IMPACT Design and Statistics Core. Goldfeld considers the use of a permutation test for a small pilot study.
Link: https://www.rdatagen.net/post/permutation-test-for-a-covid-19-pilot-nursing-home-study/
Finding Pragmatic and Relevant Outcomes for AD/ADRD ePCTs
June 2020 – Grand Rounds 7, members of IMPACT's Patient Caregiver Relevant Outcomes Core describe person and caregiver-centered outcome measurement in AD/ADRD ePCTs, give an overview of how outcomes are mapped to care domains, and highlight the methodological challenges present in AD/ADRD and pragmatic research.
Speakers
Laura C. Hanson, MD, MPH
Core Leader, Patient/Caregiver Relevant Outcomes Core
Member, Steering Committee
Professor, Division of Geriatric Medicine
Director, UNC Palliative Care Program
University of North Carolina School of Medicine
Sheryl Zimmerman, PhD
Executive Committee, Patient/Caregiver Relevant Outcomes (PCRO) Core
University Distinguished Professor and Co-Director, Program on Aging, Disability, and Long-Term Care, Cecil G. Sheps Center for Health Services Research
University of North Carolina at Chapel Hill
Learning Objectives
- Describe outcomes relevant for people living with dementia and their caregivers
- Describe the application of the Alzheimer’s Association conceptual framework to link care interventions to outcomes
- Describe considerations for selecting outcome measures for AD/ADRD ePCTs
IMPACT Collaboratory funds two pilot study awards
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 the recipients of its inaugural cycle of the IMPACT Pilot Grant award program. Recipients were selected from an impressive group of competitive applications.
IMPACT Pilot Grant Award Recipients (RFA 2019)
Brent Forester, MD, MSc, Mass General Brigham
Implementation of the Care Ecosystem training model for individuals with dementia in a high risk, integrated care management program
Ula Hwang, MD, MPH, Icahn School of Medicine at Mount Sinai
Pathway to Detection & Differentiation of Delirium & Dementia in the Emergency Department
About IMPACT Collaboratory
The IMPACT Collaboratory was established in 2019 to meet the urgent public health need to deliver high quality, evidence-based care to people living with dementia (PLWD) and their care partners within the healthcare systems (HCS) that serve them. The IMPACT Collaboratory accomplishes this mission by building the nation’s capacity to conduct embedded pragmatic clinical trials (ePCTs) among people living with dementia and their care partners through building investigator capacity, funding and supporting the design and conduct of ePCTs, and ensuring the research includes culturally-tailored interventions and people from diverse and under-represented backgrounds.
The IMPACT Collaboratory brings together multidisciplinary experts from across the nation organized into 10 Working Cores Groups and Teams. The cores and teams partner with health care system leaders and key stakeholders to support the IMPACT mission. The IMPACT Collaboratory hosts monthly Grand Rounds and podcasts open to everyone to provide insight into conducting ePCTs for PLWD and their care partners. Learn more on our website, Twitter and LinkedIn.
About IMPACT Collaboratory’s 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. The IMPACT Collaboratory encourages applications that address dementia care for people of all backgrounds and promote health equity.
Currently Accepting Applications for 2020 IMPACT Pilot Grant Program
Award applications for the current awards cycle opened April 28, 2020. The application process is a 2-step competitive process. The first step, a mandatory LOI, is due no later than May 29, 2020. Selected investigators will be invited to submit a full application.
In response to the coronavirus disease (COVID-2019) outbreak, in this award cycle, the IMPACT Collaboratory will prioritize applications proposing pilot ePCTs of telemedicine, telehealth, and remote technologies interventions aimed at improving the health care, unmet needs, quality of life and/or health outcomes for people living with AD/ADRD and their care partners. Applications for pilot ePCTs testing other types of non-pharmacological interventions in this population will also be considered.
Please join our mailing list to receive news and invitations to events and Grand Rounds.
NIH Collaboratory Grand Rounds – EHR Workshop Series
The NIH Health Care Systems Research Collaboratory is launching a special workshop series on its popular Grand Rounds program to explore challenges and opportunities in using electronic health records (EHRs) in pragmatic clinical trials. The series will highlight advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic trials.
The webinar series will kick off on Friday, May 1 at 1 p.m. ET with a keynote presentation by Dr. Robert Califf, head of strategy and policy for Verily Life Sciences and Google Health.
The series will include four moderated webinar discussions with panels of experts, wrapping up with a podcast discussion in July. Download the EHR workshop series flyer and see the full schedule below. All sessions are free and open to the public; no registration required. Recordings will be archived on the Grand Rounds website.
We hope you can tune in!
- May 1, 2020, 1 p.m. ET: Keynote: Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem? (Robert Califf, MD, MACC)
- May 8, 2020, 1 p.m. ET: Real World Evidence: Contemporary Experience and Future Directions (Jacqueline Corrigan-Curay, JD, MD; Joshua C. Denny, MD, MS, FACMI; Moderator: Patrick J. Heagerty, PhD)
- May 29, 2020, 1 p.m. ET: Experiences From the Collaboratory PCTs (Jeffrey [Jerry] G. Jarvik, MD, MPH; Lynn DeBar, PhD; Doug Zatzick, MD; Vince Mor, PhD; Moderator: Wendy Weber, ND, PhD, MPH)
- June 26, 2020, 1 p.m. ET: Keys to Success in the Evolving EHRs Environment (Teresa Zayas-Cabán, PhD; George [Holt] Oliver, MD, PhD; Christopher A. Longhurst, MD, MS; Rachel Richesson, PhD, MPH; Moderator: Keith Marsolo, PhD)
- Recording June 30, Available July 7, 2020: Podcast: Summary Expert Panel Discussion (Patrick J. Heagerty, PhD; Keith Marsolo, PhD; Wendy Weber, ND, PhD, MPH; Moderator: Lesley H. Curtis, PhD)
Two new IMPACT Collaboratory funding opportunities: Request for Applications for Pilot Grant Award and Career Development Award Programs
The National Institute on Aging (NIA) IMbedded Pragmatic Alzheimer’s disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory has released two new funding opportunities available for investigators interested in developing embedded pragmatic clinical trials in dementia research. In support of our mission, the IMPACT Collaboratory is requesting applications for the Pilot Grant Award and Career Development Award (CDA) Programs.
Pilot Grant Awards are 1-year non-renewable awards to generate the preliminary data necessary to design and conduct future full-scale embedded pragmatic clinical trials (ePCTs) of non-pharmacological interventions in healthcare systems for people living with AD/ADRD and/or their care partners.
Career Development Awards are 2-year mentored research awards to support the development of early-stage MD, PhD, or equivalent researchers who seek careers conducting ePCTs for people living with AD/ADRD and/or their care partners.
The IMPACT Collaboratory will hold informational webinars for each grant program in the coming weeks. Detailed information about these programs as well as timelines, eligibility, and other requirements are provided below and in the request for applications (RFAs). Updates will be posted to impactcollaboratory.org.
The IMPACT Collaboratory will fund up to five 1-year non-renewable pilot grant awards for up to $175,000 in direct costs. Letters of intent are required and due May 29, 2020. Full proposal applications are by invitation only and will be due September 4, 2020. For further details, please see the on the IMPACT Pilot Grant Program webpage.
In response to the coronavirus disease (COVID-2019) outbreak, the IMPACT Collaboratory will prioritize applications proposing pilot ePCTs of telemedicine, telehealth, and remote technologies interventions aimed at improving health care, unmet needs, quality of life and/or health outcomes for people living with dementia and/or their care partners for this award cycle. Applications for pilot ePCTs testing other types of non-pharmacological interventions in this population will also be considered.
Two optional informational webinars will be held to provide additional information and answer questions from potential applicants. Registration is required and can be completed through the links below:
- Informational Webinar #1 for IMPACT Pilot Grant RFA
April 28, 2020 01:30 PM Eastern Time. Watch webinar here. - Informational Webinar #2 for IMPACT Pilot Grant RFA
May 6, 2020 04:00 PM Eastern Time. Registration closed.
Registrants will receive a confirmation email containing information to join the webinar.
Career Development Award (CDA) RFA
The IMPACT Collaboratory will fund two to three, 2-year Career Development Awards (CDAs) to support the development of early-stage MD, PhD, or equivalent researchers who seek careers conducting embedded pragmatic clinical trials (ePCTs) for people living with dementia and their care partners. CDAs provide support for up to $100,000 per year in direct costs and candidates are required to devote a minimum of 75% effort toward the goals of the CDA. The IMPACT Collaboratory will prioritize applications that address dementia care for people of all backgrounds and promote health equity.
Full Applications are due July 15, 2020. There is no letter of intent. For further details, go to the IMPACT CDA Program webpage.
Two optional informational webinars will be held to provide additional information and answer questions from potential applicants. Registration is required and can be completed through the links below:
- Informational Webinar #1 for IMPACT CDA
April 29, 2020 03:00 PM Eastern Time. Registration closed. - Informational Webinar #2 for IMPACT CDA
May 20, 2020 01:00 PM Eastern Time. Registration closed.
Registrants will receive a confirmation email containing information to join the webinar.
The IMPACT Collaboratory encourages all eligible researchers to take advantage these important funding opportunities, which have the potential to advance care for people living with dementia and/or their care partners in real-world settings. For more information about the IMPACT Collaboratory, please visit impactcollaboratory.org.
The NIA IMPACT Collaboratory is supported through funding from the National Institute on Aging (U54AG063546).
Update from IMPACT Collaboratory: Stakeholder Engagement Report on Research Priorities
We are pleased to share a new report from the IMPACT Stakeholder Engagement Team, led by Gary Epstein-Lubow, MD and Katie Maslow, MSW, regarding stakeholder research priorities.
This report is a compilation of work beginning with input from the NIA IMPACT Collaboratory’s Stakeholder Advisory Committee and then finalized after additional Stakeholder Engagement Team discussion during and following the NIA IMPACT Collaboratory in-person meeting January 28 & 29, 2020.
The IMPACT Collaboratory’s Stakeholder Engagement Team (SET) conducted a one-day in-person meeting on December 3, 2019 including members of the Stakeholder Advisory Committee (SAC) and additional participants relevant to the IMPACT Collaboratory’s efforts regarding stakeholder engagement.
Unroe co-created a video for advance care planning for nursing home residents during COVID-19
Kathleen Unroe, MD, MHA, Associate Core Leader of the IMPACT Pilot Studies Core co-created with Susan Hickman, PhD, a video for advance care planning for nursing home residents during the COVID-19 pandemic. This is an excellent resource from the Indiana University Center for Aging Research, Regenstrief Institute for people living with dementia (PLWD) and their caregivers in this setting during the COVID-19 crisis, and a reminder about the importance of advance care planning.
Find link to video here: https://youtu.be/F_cS89aa0DE