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Transforming Dementia Care Through Pragmatic Clinical Trials Embedded in Learning Healthcare Systems
Authors:Leah Tuzzio MPH  Leah R. Hanson PhD  David B. Reuben MD  Rosa R. Baier MPHc  Jerry H. Gurwitz MD  Elizabeth A. Bayliss MD  MSPH  Jeff Williamson MD  James R. Fraser BA  Samantha J. Sherman BS  Eric B. Larson MD MPH
Affiliation:1. Kaiser Permanente Washington Health Research Institute, Kaiser Permanente Washington, Seattle, Washington, USA;2. HealthPartners Institute, Minneapolis, Minnesota, USA;3. David Geffen School of Medicine at UCLA, Los Angeles, California, USA;4. Center for Long-Term Care Quality & Innovation Department of Health Services, Policy & Practice, Brown University School of Public Health, Providence, Rhode Island, USA;5. Meyers Primary Care Institute, A Joint Endeavor of University of Massachusetts Medical School, Fallon Health, and Reliant Medical Group, Worcester, Massachusetts, USA;6. Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado, USA

Department of Family Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA;7. Wake Forest School of Medicine, Winston-Salem, North Carolina, USA

Abstract:The current evidence base for testing nonpharmacological interventions for people living with dementia (PLWD) and their caregivers is limited, especially within care settings such as ambulatory care, assisted living communities, nursing homes, hospitals, and hospices. There has been even less attention to translation of effective interventions for PLWD into delivery of care. Thus, there is an urgent need for researchers to partner with these care settings, especially those that follow a learning healthcare systems (LHSs) model, and vice versa to conduct embedded pragmatic clinical trials (ePCTs). These trials are conducted within sites that offer routine care and are designed to answer important, relevant clinical questions and leverage existing electronic health and administrative data. ePCTs set in LHSs create a unique opportunity for researchers, healthcare providers, and PLWD and their families to work and learn together as potentially effective interventions are studied and stress tested in real-world situations. Healthcare settings that embrace research or quality improvement as part of a culture of continuous learning are ideal settings for ePCTs. In this article, we summarize what we have learned from the National Institutes of Health's Health Care Systems Research Collaboratory–funded ePCTs, discuss challenges of ePCTs within settings that serve PLWD, and describe the work of the Health Care Systems Core within the National Institute on Aging's IMbedded Alzheimer's Disease and Related Dementias Clinical Trials Collaboratory that will occur over the next 5 years. J Am Geriatr Soc 68:S43–S48, 2020 .
Keywords:learning healthcare systems  embedded pragmatic clinical trials  dementia care
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