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Advancing Clinical Trials in Nursing Homes: A Proposed Roadmap to Success
Institution:1. Meyers Health Care Institute, Worcester, MA, USA;2. UMass Chan Medical School, Worcester, MA, USA;3. University of Maryland School of Medicine, Baltimore, MD, USA;4. Stanford University School of Medicine, Stanford, CA, USA;5. AGING Patient/Caregiver Advisory Council, Worcester, MA, USA;6. Institute for Healthcare Improvement, Boston, MA, USA;7. Johns Hopkins University School of Nursing, Baltimore, MD, USA;8. Kaiser Permanente Colorado, Denver, CO, USA;9. American Health Care Association, Washington, DC, USA;10. Hebrew SeniorLife Hinda and Arthur Marcus Institute for Aging Research, Boston, MA, USA;11. University of Michigan, Ann Arbor, MI, USA;12. University of Pittsburgh, Pittsburgh, PA, USA;13. Florida Atlantic University, Boca Raton, FL, USA;14. Genesis Healthcare, Kenneth Square, PA, USA;15. University of Maryland School of Nursing, Baltimore, MD, USA;p. UNC Chapel Hill, Chapel Hill, NC, USA
Abstract:An effective clinical research effort in nursing homes to address prevention and treatment of COVID-19 faced overwhelming challenges. Under the Health Care Systems Research Network-Older Americans Independence Centers AGING Initiative, a multidisciplinary Stakeholder Advisory Panel was convened to develop recommendations to improve the capability of the clinical research enterprise in US nursing homes. The Panel considered the nursing home as a setting for clinical trials, reviewed the current state of clinical trials in nursing homes, and ultimately developed recommendations for the establishment of a nursing home clinical trials research network that would be centrally supported and administered. This report summarizes the Panel’s recommendations, which were developed in alignment with the following core principles: build on available research infrastructure where appropriate; leverage existing productive partnerships of researchers with groups of nursing homes and nursing home corporations; encompass both efficacy and effectiveness clinical trials; be responsive to a broad range of stakeholders including nursing home residents and their care partners; be relevant to an expansive range of clinical and health care delivery research questions; be able to pivot as necessary to changing research priorities and circumstances; create a pathway for industry-sponsored research as appropriate; invest in strategies to increase diversity in study populations and the research workforce; and foster the development of the next generation of nursing home researchers.
Keywords:Nursing homes  long-term care  clinical trials  pandemic  COVID-19
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