Advancing Clinical Trials in Nursing Homes: A Proposed Roadmap to Success

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 See related editorial by Zimmerman et al. and Special Articles by Levy et al. and Resnick et al. in this issue.

Stakeholders' views on priorities essential for establishing a supportive environment for clinical trials in nursing homes

“…Gurwitz et al offer recommendations for the creation of such a network, making detailed recommendations related to the coordination, leadership, stakeholders, regulations, and funding for a national nursing home clinical trials network, and outline 10 core principles to guide the establishment of such a network. 12 The findings reported here, reflecting the views and expertise of diverse stakeholders with direct experience of nursing home research, could further inform decisions about such a network by delineating the characteristics of facilities that would need to be involved, the stakeholder relationships and communications necessary to sustain long-term partnerships, and the researcher qualities and contributions essential to meaningfully engaging multiple sites with varying priorities and needs.…”

“…The Steering Committee had been assembled to provide expertise and guidance on the development of a roadmap to inform a nursing home clinical trials research network. 12 Key informants and Steering Committee members included national experts in nursing home research, operations, policy, clinical research, and caregivers and resident advocates. The research team, comprised of the authors, drafted the items.…”

“…11 While funding was available for COVID-19 related research, the lack of a clinical research infrastructure in nursing homes and the limited number of experienced investigators prepared to navigate these challenges has posed significant challenges. 12 While the present study was motivated by the devastating impact of COVID-19 on nursing home residents, our goal was to obtain information that would inform clinical research in nursing homes broadly. Pandemicrelated obstacles posed specific challenges to conducting research (e.g., lack of full information about the COVID-19 virus and transmissibility, limited access to personal protective equipment), but the nursing home research enterprise was inefficient and siloed prior to the pandemic.…”

“…With some exceptions, 6–10 researchers have been challenged in mounting clinical trials in nursing homes to address urgent questions relevant to the prevention and treatment of COVID‐19 since the onset of the pandemic 11 . While funding was available for COVID‐19 related research, the lack of a clinical research infrastructure in nursing homes and the limited number of experienced investigators prepared to navigate these challenges has posed significant challenges 12 …”

Pragmatic Trials and Improving Long-Term Care: Recommendations From a National Institutes of Health Conference

“…8e15 Recognition of these challenges catalyzed a recent initiative to develop recommendations for a nursing home clinical trials network. 16 A key limitation of all such trials, however, is the extent to which they ultimately change practice and policy and improve care and outcomes, especially for persons living with dementia; for that purpose, pragmatic trials are recommended. First articulated more than 50 years ago, a pragmatic approach determines an intervention's effectiveness in routine clinical practice.…”