A special Grand Rounds with three experts in dementia care and pragmatic clinical trials to provide an update on how COVID-19 is impacting nursing homes and to share preliminary data for research related to COVID-19.
May 7, 2020
David C. Grabowski, PhD
- Learn about impact of COVID-19 in U.S nursing homes
- Gain knowledge about rapid pragmatic research approaches in response to the crisis in health care systems
• Hebrew SeniorLife
• Genesis Health Care
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The NIH Health Care Systems Research Collaboratory recently released a summary of a 2019 comprehensive workshop to explore and discuss statistical issues encountered with embedded pragmatic clinical trials (ePCTs). The new Workshop Summary describes panel discussions with the principal investigators and statisticians of NIH Collaboratory Demonstration Projects and the challenges and solutions encountered during the design and analysis of their trials.
Read more about the workshop and access the full summary on the NIH Collaboratory website.
Pragmatic clinical trials (ePCTs) advance research on Alzheimer’s disease and related dementias (AD/ADRD) in real world contexts; however, health equity issues have not yet been fully considered, assessed, or integrated into ePCT designs. Health disparities populations may not be well represented in ePCTs without special efforts to identify and successfully recruit sites of care that serve larger numbers of these populations. The National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer’s disease (AD) and AD Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory’s Health Equity Team (HET) will contribute to the overall mission of the NIA IMPACT Collaboratory by developing and implementing strategies to address health equity in the conduct of ePCTs to ensure that the Collaboratory is a national resource for all Americans with dementia. As a first step toward meeting these goals, this talk highlights unique challenges related to health equity in the conduct of ePCTs.
April 16, 2020
- Understand the role and objectives of the Health Equity Team in the IMPACT Collaboratory.
- Describe the conceptualization of health equity as it relates to ePCTs design.
- Understand and describe important health equity considerations in the design of ePCTs.
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AcademyHealth has developed a report focused on information needs of the health care and community organizations engaged in the COVID-19 response. The report is intended to inform decision-making of federal and foundation funders of health services research to guide investments in responsive research.
Read the full report and background information on the AcademyHealth website.
On April 15 2020, the National Academies’ Committee on Care Interventions for Individuals with Dementia and Their Caregivers hosted a virtual public workshop. This workshop brought together key stakeholders and experts to provide input to the committee on a draft Agency for Healthcare Research and Quality (AHRQ) systematic review that examines existing evidence on care interventions that support individuals with dementia and their caregivers. This AHRQ systematic review will form the predominant basis of the National Academies committee’s report on which care interventions can be considered ready for broad implementation and dissemination.
IMPACT Collaboratory members Eric Larson, MD, MPH, Chris Callahan, MD, MACP, Jason Karlawish, MD, Maria Aranda, PhD, Laura Gitlin, PhD, FGSA, FAAN, and Joe Gaugler, PhD all participated in the workshop to provide input on the systematic review.
Read the full workshop agenda and participants on the workshop summary website.
In this Grand Rounds, Jason Karlawish, MD, discusses waivers and alterations of written informed consent in pragmatic clinical trials. He provides two case studies of pragmatic clinical trials to determine whether or not it is appropriate to permit a modification or a waiver of research informed consent. Focusing on regulatory criteria addressing acceptable levels of research risk, the practicability of conducting the research with informed consent, and efforts to respect the rights and welfare of PLWD.
February 20, 2020
- Identify how consideration of ethical and regulatory issues in the design phase of an ePCT with PLWD can help make the study more pragmatic.
- Review the regulatory requirements for a waiver or alteration of informed consent and discuss related ethical considerations.
- Apply what we’ve covered to two case studies.
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Download the slides: IMPACT Grand Rounds February 20 2020.
- 45 CFR 46 – Protection of Human Subjects
- Scott Kim and Frank Miller. “Waivers and alterations to consent in pragmatic clinical trials: Respecting the principle of respect for persons.” IRB: Ethics and Human Research. January-February 2016, Vol 38, issue 1.
- January 31, 2008 SACHRP letter to HHS Secretary: Recommendations related to waiver of informed consent and interpretation of “minimal risk,” available at https://hhs.gov/ohrp/sachrp-committee/recommendations/2008-january-31-letter/index.html
The latest blog post from Keith Goldfeld, DrPH, MS, MPA, member of the executive committee of the IMPACT Collaboratory Design and Statistics Core, discusses how the design effect could provide additional insight into cluster randomized trials in his most recent blog post. The ideas in this blog post were motivated in part by Goldfeld’s work with the IMPACT Collaboratory.
The Tailored Activity Plan (TAP), a home-based occupational therapy intervention shown to reduce behavioral symptoms in people living with dementia and caregiver burden, was recently included in an article in the Wall Street Journal. The TAP program was developed by Laura Gitlin, PhD, FGSA, FAAN, Dean and distinguished professor at College of Nursing and Health Professions, at Drexel University and leader of the IMPACT Collaboratory Dissemination and Implementation Core and her colleagues. Read the full article at the Wall Street Journal at this link.
Richard J. Hodes, MD, Director of the National Institute of Aging and Partha Bhattacharyya, PhD, the IMPACT Collaboratory Project Officer and Program Director in the Division of Behavioral and Social Research, share their thoughts on the need for the IMPACT Collaboratory and the project goals.