June 26, 2020
Authors: Julie P.W. Bynum, MD, MPH, David A. Dorr, MD, Julie Lima, MPH, Ellen P. McCarthy, PhD, Ellen McCreedy, PhD, Richard Platt, MD, and V.G. Vinod Vydiswaran, PhD
Core/Team: Technical Data Core
Abstract: Embedded pragmatic clinical trials (ePCTs) are embedded in healthcare systems as well as their data environments. For people living with dementia (PLWD), settings of care can be different from the general population and involve additional people whose information is also important. The ePCT designs have the opportunity to leverage data that becomes available through the normal delivery of care. They may be particularly valuable in Alzheimer’s disease and Alzheimer’s disease-related dementia (AD/ADRD), given the complexity of case identification and the diversity of care settings. Grounded in the objectives of the Data and Technical Core of the newly established National Institute on Aging Imbedded Pragmatic Alzheimer’s Disease and AD-Related Dementias Clinical Trials Collaboratory (IMPACT Collaboratory), this article summarizes the state of the art in using existing data sources (eg, Medicare claims, electronic health records) in AD/ADRD ePCTs and approaches to integrating them in real-world settings. J Am Geriatr Soc 68:S49-S54, 2020.
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Keywords: pragmatic trial; dementia; measurement; Alzheimer’s disease
About this 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 and Vincent Mor, PhD, as well as the two executive directors, Ellen McCarthy, PhD, MPH, and Jill Harrison, PhD.