UH3 Project: Pragmatic Trial of Video Education in Nursing Homes (PROVEN)
Overview
Principal Investigators:
Sponsoring Institution: Brown University School of Public Health
NIH Institute Providing Oversight: National Institute on Aging (NIA)
Program Official: Marcel Salive, MD, MPH (NIA)
Project Scientist: Jeri Miller, PhD (National Institute of Nursing Research [NINR])
ClinicalTrials.gov Identifier: NCT02612688
Locations: Nursing homes in Genesis HealthCare and PruittHealth healthcare systems
Trial Status: Completed
Trial Summary
Study question and significance: Nursing homes are often charged with guiding patients through decisions about the direction of their treatment. Identifying effective approaches that nursing homes can use to better promote goal-directed care within existing resources is a research, public health, and clinical priority. Yet, evidenced-based approaches to advance care planning in nursing homes are lacking. The objective of PROVEN was to test the effect of an advance care planning video program on hospital transfers, burdensome treatments, and hospice enrollment among long-stay nursing home residents.
Design and setting: Cluster randomized trial with 197,692 residents in 360 nursing homes in 32 states owned by 2 for-profit corporations, of which 241 facilities were randomly assigned to the control group and 119 facilities were randomly assigned to the intervention.
Intervention and methods: The intervention involved 5 short advance care planning videos made available on tablet computers or online. Designated champions in the intervention facilities were instructed to offer residents or their proxies the opportunity to view a video on admission and every 6 months. Control facilities used usual advance care planning practices. The primary outcome was hospital transfers per 1000 person- days alive among residents with advanced illness. Secondary outcomes included the proportion of residents with or without advanced illness experiencing 1 or more hospital transfer, 1 or more burdensome treatment, and hospice enrollment. The analyses followed the intention-to-treat principle.
Findings: There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention vs control groups. Secondary outcomes did not significantly differ between groups among residents with and without advanced illness. Only 912 of 4171 residents with advanced illness viewed the advance care planning videos. Facility-level rates of showing the videos ranged from 0% to more than 40%.
Conclusions and relevance: The advance care planning video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay nursing home residents with or without advanced illness. The low level of intervention fidelity highlights the challenges of implementing new programs in nursing homes.
Data and Resource Sharing
- PROVEN Protocol
PROVEN Protocol
- PROVEN_MorMitchellVolandes_UH3_Follow-up
PROVEN ethics and regulatory documentation - UH3 project updates
- Mitchell-Mor-Volandes PROVEN Reg-Ethics Minutes Suppl Material
PROVEN UH2 ethics and regulatory documentation
Featured Interviews
Dr. Mitchell presents findings from the PROVEN Trial, an NIH Collaboratory Trial that studied the effect of showing advance care planning videos to long-stay nursing home residents.
News and Interviews
- News_Your Pragmatic Trial Has Ended Now What
January 22, 2024: Your Pragmatic Trial Has Ended. Now What?
- News_Wealth of New Insights From the NIH Pragmatic Trials Collaboratory
December 13, 2022: In Our Tenth Year, a Wealth of New Insights From the NIH Pragmatic Trials Collaboratory
- News_A Year of New Insights From the NIH Collaboratory
December 14, 2021: A Year of New Insights From the NIH Collaboratory
- News_Mor
September 20, 2021: Vince Mor to Present on Challenges to Implementing Innovative Programs in Long-Term Care
- News_Mor receives Rosenberger Medal
May 17, 2021: Dr. Vince Mor Receives Rosenberger Medal, Brown’s Highest Faculty Honor
- News_A Year of Results and New Insights From the NIH Collaboratory
December 15, 2020: A Year of Results and New Insights From the NIH Collaboratory
- Designing With Implementation in Mind
Designing With Implementation in Mind (Living Textbook Video Module)
- News_PIs of Completed NIH Collaboratory Demonstration Projects Share Accomplishments
July 14, 2020: PIs of Completed NIH Collaboratory Trials Share Accomplishments
- News_ EHR Workshop Grand Rounds Series Continues With Experiences From the Collaboratory PCTs
May 27, 2020: EHR Workshop Grand Rounds Series Continues With Experiences From the Collaboratory PCTs
- News_PROVEN Primary Results Published
July 7, 2020: PROVEN Primary Results Published
Publications
- McCreedy et al BMC Geriatr 2022
Effect of advance care planning video on do-not-hospitalize orders for nursing home residents with advanced illness
- Moyo et al J Am Med Dir Assoc 2022
Effect of a video-assisted advance care planning intervention on end-of-life health care transitions among long-stay nursing home residents
- Zhai and Gutman J Stat Comput Simul 2021
Using the potential outcome framework to estimate optimal sample size for cluster randomized trials: a simulation-based algorithm
- Richesson et al J Am Med Inform Assoc 2021
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
- Loomer et al J Am Geriatr Soc 2020
Impact of an advance care planning video intervention on care of short-stay nursing home patients
- PROVEN Snapshot
PROVEN Study Snapshot
- Mitchell et al JAMA Intern Med 2020
PROVEN Main Outcome Paper
- Living Textbook Chapter_Which PCTs Should Have a DMC
Living Textbook Chapter: Which PCTs Should Have a DMC?
- Living Textbook_The Embedded Pragmatic Trials Ecosystem
Living Textbook: The Embedded Pragmatic Clinical Trial Ecosystem
- Living Textbook Chapter_Monitoring Intervention and Fidelity Adaptions
Living Textbook Chapter: Monitoring Intervention and Fidelity Adaptions: Intervention Adaptation Strategies and Examples
- McCarthy et al JAMA Intern Med 2019
Hospital transfer rates among US nursing home residents with advanced illness before and after initiatives to reduce hospitalizations
- Palmer et al Trials 2019
Understanding implementation fidelity in a pragmatic randomized clinical trial in the nursing home setting: a mixed-methods examination
- Loomer et al J Am Geriatr Soc 2019
Black nursing home residents more likely to watch advance care planning video
- Loomer et al J Am Med Dir Assoc 2019a
Proxies viewing decision support video in nursing home report higher advance care planning engagement
- Palmer et al BMC Health Serv Res 2019
Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting
- Loomer et al J Am Med Dir Assoc 2019
Nursing home characteristics associated with implementation of an advance care planning video intervention
- Living Textbook Chapter_Data Sharing Concerns
Living Textbook: Data Sharing Concerns
- Living Textbook Chapter_Data Sharing and Embedded Research
Living Textbook Chapter: Data Sharing Solutions for Embedded Research
- Palmer et al Trials 2018
A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems
- Baier et al J Am Med Dir Assoc 2018
Identifying and supporting nonpharmacological dementia interventions ready for pragmatic trials: results from an expert workshop
- McCreedy et al J AmMed Dir Assoc 2018
Representation in the care planning process for nursing home residents with dementia
- PROVEN 2017-Snapshot
PROVEN Study Snapshot
- Living Textbook Chapter_Identifying the Study Population
Living Textbook Chapter: Using EHR Data in PCTs - Identifying the Study Population
- Living Textbook_Analysis Plan_Unanticipated Changes
Living Textbook Chapter: Analysis Plan: Unanticipated Changes
- Mor et al Clin Trials 2017
PROVEN Study Design Paper
Presentations
- 2023 NIH Workshop_Panel 1_Mor
2023 NIH Workshop Panel 1: Mor
- SC-Mtg-2023-Day1-Mor
PROVEN Presentation at 2023 Steering Committee Meeting
- 2022 NIH Workshop_Mor
2022 NIH Workshop PROVEN Presentation
- PROVEN Primary Results Presentation (PruittHealth 2020)
PROVEN Primary Results Presentation (PruittHealth 2020)
- GR-Video-06-12-20
A Cluster Randomized Pragmatic Trial of an Advance Care Planning Video Intervention in Long-Stay Nursing Home Residents: Main Findings from the PROVEN Trial (GR Video 2020)
- GR-Slides-06-12-20
A Cluster Randomized Pragmatic Trial of an Advance Care Planning Video Intervention in Long-Stay Nursing Home Residents: Main Findings from the PROVEN Trial (GR Slides 2020)
- GR-Video-05-29-20
EHR Core Workshop: Experiences from the Collaboratory PCTs (GR Video 2020)
- GR-Slides-05-29-20
EHR Core Workshop: Experiences from the Collaboratory PCTs (GR Slides 2020)
- Presentations at the April 2020 SC Meeting
Presentations at the April 2020 SC Meeting
- Presentation_PROVEN_GSA_2019_c
Relationship Between Family Involvement in Care Planning and Establishing an Advance Directive (GSA 2019)
- Presentation_PROVEN_JCHC_2019_c
Big Data as a Catalyst for Policy Research, Pharmaco-Epidemiology and Cluster Randomized Clinical Trials (JCHP 2019)
- Presentation_PROVEN_NRSA_2018_c
Using Electronic Orders, a Presentation from PROVEN
- Presentation_PROVEN_ARM_2019_c
Characterizing Implementation in High Versus Low Fidelity Nursing Homes Within a Large Pragmatic Trial (AcademyHealth 2019)
- SC-2019-Barriers-PROVEN
Barriers and Challenges-PROVEN
- Presentation_ABATE_TiME_PROVEN_ARM_2019_c
Pragmatic Trial Design Panel (AcademyHealth 2019)
- Poster_PROVEN_ARM_2019_c
Family Participation in Routine Care Planning Assessments and Documentation of Advance Directives for Nursing Home Residents Admitted as “Full Code” (AcademyHealth 2019)
- Presentation_PROVEN_NYGR_2019_c
Designing and Disseminating the Next Generation of Interventions for Persons with Dementia (2019)
- Workshop Design and Analysis of PCT_Panel 1_Measurement and Data_Outcomes, Exposures, and Subgroups Based on EHR Data
Workshop Design and Analysis of PCT_Panel 1_Measurement and Data_Outcomes, Exposures, and Subgroups Based on EHR Data
- Presentation_PROVEN_MN_2019_c
Keynote: Quality Long-Term Care: How Research and Innovation Lead to Better Outcomes (or Not) (MGS 2019)
- Presentation_PROVEN_MN_2019_2_c
The Science of Changing Health Systems Behavior: The Kane Legacy (MGS 2019)
- Presentation_PROVEN_Hartford_2018_c
Designing and Disseminating the Next Generation of Interventions for Persons with Dementia (NHCGNE 2018)
- Presentation_PROVEN_GSA_2018_c
Establishing Rate of Conversion from Full Code to Do Not Resuscitate Status among Long-Stay Nursing Home Residents (GSA 2018)
- Poster_PROVEN_JSM_2018_c
Optimal Sample Size for Cluster Randomized Trials Based on Simulation and Randomization Distribution (JSM 2018)
- Poster_PROVEN_AAIC_2018_c
Advance Care Planning for Cognitively Impaired Within the Nursing Home Setting (AAIC 2018)
- Presentation_PROVEN_ARM_2018_c
Embedding PCTs in Health Care Systems: Trials and Tribulations (PROVEN) (AcademyHealth 2018)
- Poster_PROVEN_ARM_2018_c
Establishing Rate of Conversion from Full Code to Do Not Resuscitate Status Among Long-Stay Nursing Home Residents (AcademyHealth 2018)
- Poster_PROVEN_ARM_2018_3_c
Barriers and Facilitators to Implementing a Pragmatic Trial to Improve Advance Care Planning in Two Large Nursing Home Systems (AcademyHealth 2018)
- Poster_PROVEN_ARM_2018_2_c
Facility Characteristics Associated With Implementation of an Advance Care Planning Video Intervention Within the Nursing Home Setting (AcademyHealth 2018)
- GR-Slides-06-08-18
Implementation in the PROVEN Trial: Challenges of Conducting PCTs in Nursing Home Health Care Systems (GR Slides 2018)
- GR-Video-06-08-18
Implementation in the PROVEN Trial: Challenges of Conducting PCTs in Nursing Home Health Care Systems (GR Video 2018)