IMPACT’s Multiple Principal Investigators Susan Mitchell, MD, MPH and Vincent Mor, PhD, together with Angelo Volandes, MD, recently published results of The Pragmatic Trial of Video Education in Nursing Homes (PROVEN) trial, a demonstration project under the NIH Health Care Systems Collaboratory.
PROVEN was among the first large-scale embedded pragmatic clinical trials conducted in nursing homes. The trial was conducted between February 1, 2016 and May 31, 2019 in 360 nursing homes (119 intervention and 241 control) owned by two for-profit corporations in 32 states. PROVEN tested the effectiveness of an advance care planning (ACP) video intervention, intended to help nursing home residents understand and chose their preferred goal of care. A suite of 5 different ACP videos were made available on tablet devices and online and offered to residents and their proxies at time of admission to the nursing home and then again every 6 months. Control nursing homes used usual advance care planning practices. The primary outcome was hospital transfers among long-stay (> 100 days) residents with advanced illness. Secondary outcomes included the proportion of those residents experiencing one or more hospital transfers, burdensome treatments, and hospice enrollment. Twelve month outcomes were measured for each resident. Data sources included Centers for Medicare & Medicaid Services Medicare claims and nursing homes’ electronic health records.
In this pragmatic cluster randomized trial, the PROVEN video intervention did not significantly reduce hospital transfers and burdensome treatments or increase hospice enrollment over 12 months among residents with advanced illness.
Overall intervention fidelity was low and highly variable across nursing homes, which may be one explanation of the negative findings. The low fidelity to the intervention highlights the challenge of implementing interventions in the nursing home environment and the need to ensure the highest level of engagement from key stakeholders, including front-line providers, when conducting pragmatic trials in this setting.
See the NIH HCS Collaboratory’s 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).