June 8, 2018: Implementation in the PROVEN Trial: Challenges of Conducting PCTs in Nursing Home Health Care Systems (Susan Mitchell, MD, MPH; Angelo Volandes, MD, MPH)


Susan Mitchell, MD, MPH
Senior Scientist, Institute for Aging Research, Hebrew Senior Life
Professor of Medicine, Harvard Medical School

Angelo Volandes, MD, MPH
Associate Professor of Medicine, Harvard Medical School
Division of General Internal Medicine, Massachusetts General Hospital


Implementation in the PROVEN Trial: Challenges of Conducting PCTs in Nursing Home Health Care Systems


Clinical research; Clinical decision making; Healthcare; Medical systems; Patient experience; Clinical data; Pragmatic cluster trial; Randomized clinical trial; Advance care planning; Nursing homes; Quality assurance

Key Points

  • The objective of the PROVEN trial is to conduct a pragmatic cluster-randomized clinical trial of an advance care planning video shown to nursing home patients with advanced conditions in 2 nursing home healthcare systems.
  • Distribution of the nursing home sites for the PROVEN trial involves intervention and control centers and is far-reaching across the United States.
  • A primary challenge of the PROVEN trial is defining compliance and triaging long-stay patients.
  • Implementing interventions into nursing home healthcare systems in pragmatic clinical trials requires a mandate from senior management and endorsement in standard operating procedures.

Discussion Themes

The PROVEN trial is a first of its kind. Much has been discovered and additional lessons will be learned over time.

Reducing hospitalization served as an incentive for many of the PROVEN partnering organizations. However, the same incentive is used elsewhere in the market, so the potential of including some sort of financial incentive is something that has been discussed.

The advance care planning videos are intended to serve as a catalyst for better care. Patient and caretaker engagement is the ultimate goal. The videos help provide a more engaged and collaborative environment for patients and can better inform the medical team on why decisions are made by patients and their families.

Currently, there is a lack of the sites in the Midwest region due to the nature of the market.



@AngeloVolandes, #randomizedclinicaltrial, #nursinghome, #healthcaresystems, #pragmaticclinicaltrial, #pctGR, @Collaboratory1

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