Congratulations to Drs. Vincent Mor, Susan Mitchell, and Angelo Volandes and their team for the publication of their article in JAMA Internal Medicine reporting the primary results of the Pragmatic Trial of Video Education in Nursing Homes (PROVEN), an NIH Collaboratory Trial.

PROVEN was the first large-scale embedded pragmatic clinical trial conducted in nursing homes. The intervention was an advance care planning video, meant as an adjunct to first-person discussions with the clinical care provider to help people understand their options for end-of-life care, including life prolongation, limited care, and comfort care. PROVEN’s primary outcome was the number of transfers to the hospital from the nursing home over 12 months among long-stay residents with advanced illness. Secondary outcomes included hospital transfers, burdensome treatments, and hospice use among residents with or without advanced illness.

Although the video program was effective in previous small randomized trials, it was not effective in the PROVEN trial in reducing either the primary or secondary outcomes. The authors suggest that implementation error may explain the findings: intervention fidelity was low, only 1 in 5 targeted residents were shown the video, and implementation of the intervention was highly variable across facilities. The authors state that the results are “sobering,” that creative approaches are needed to change care in nursing homes, and that the perspectives of key stakeholders should be considered.

“For pragmatic trialists and implementation scientists focused on the nursing home setting, the highest level of health care system readiness and endorsement from senior and local leadership must be present before embarking on [pragmatic clinical trials]; otherwise, low implementation fidelity may compromise interpretation of its findings.” — Mitchell et al. 2020 JAMA Internal Med

Drs. Mitchell and Mor are also co–principal investigators of the National Institute on Aging (NIA) IMPACT Collaboratory (Imbedded Pragmatic Alzheimer’s Disease [AD] and AD-Related Dementias [AD/ADRD] Clinical Trials),  which is similar to the NIH Collaboratory in that it aims to build the nation’s capacity to conduct pragmatic clinical trials embedded within healthcare systems. The population of interest for the IMPACT Collaboratory is people living with dementia and their caregivers.

Data and resources from PROVEN will be posted on the NIH Collaboratory’s Data and Resource Sharing page in the coming months. As part of the program’s commitment to sharing, all NIH Collaboratory Trials are expected to share data and resources, such as protocols, consent documents, public use datasets, computable phenotypes, and analytic code.

See the June 12, 2020, Grand Rounds webinar for a presentation of the PROVEN results: A Cluster Randomized Pragmatic Trial of an Advance Care Planning Video Intervention in Long-Stay Nursing Home Residents: Main Findings from the PROVEN Trial (Susan Mitchell, MD, MPH).