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Advancing Clinical Trials in Nursing Homes: A Proposed Roadmap to Success |
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| Authors: | Jerry H. Gurwitz MD Charlene C. Quinn RN PhD Ivan H. Abi-Elias BS Alyce S. Adams PhD Rosie Bartel MS Alice Bonner PhD RN Rebecca Boxer MD MS Christopher Delude MPH David Gifford MD MPH Bruce Hanson Mdiv Kouta Ito MD MS Paavani Jain MBBS MPH Jay S. Magaziner PhD MSHyg Kathleen M. Mazor EdD Susan L. Mitchell MD MPH Lona Mody MD MSc David Nace MD MPH Joseph Ouslander MD Jo Anne Reifsnyder PhD MSN MBA Barbara Resnick PhD RN Sheryl Zimmerman PhD MSW |
| Affiliation: | 1. Meyers Health Care Institute, Worcester, MA, USA;2. University of Maryland School of Medicine, Baltimore, MD, USA;3. Stanford University School of Medicine, Stanford, CA, USA;4. AGING Patient/Caregiver Advisory Council, Worcester, MA, USA;5. Institute for Healthcare Improvement, Boston, MA, USA Johns Hopkins University School of Nursing, Baltimore, MD, USA;6. Kaiser Permanente Colorado, Denver, CO, USA;7. American Health Care Association, Washington, DC, USA;8. Meyers Health Care Institute, Worcester, MA, USA UMass Chan Medical School, Worcester, MA, USA;9. Hebrew SeniorLife Hinda and Arthur Marcus Institute for Aging Research, Boston, MA, USA;10. University of Michigan, Ann Arbor, MI, USA;11. University of Pittsburgh, Pittsburgh, PA, USA;12. Florida Atlantic University, Boca Raton, FL, USA;13. Genesis Healthcare, Kenneth Square, PA, USA;14. University of Maryland School of Nursing, Baltimore, MD, USA;15. 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: | clinical trials COVID-19 long-term care nursing homes pandemic |