Study Results
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View full resultsBasic Information
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COMPLETED
NA
197692 participants
INTERVENTIONAL
2016-03-01
2019-05-31
Brief Summary
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Detailed Description
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Advance care planning is the most consistent modifiable factor associated with better palliative care outcomes. Traditional ACP relies on verbal descriptions of hypothetical health states and treatments. This approach is limited because complex scenarios are difficult to envision, counseling is inconsistent, and verbal explanations are hindered by literacy and language barriers.
To address these shortcomings, the PROVEN project has developed video-assisted ACP decision-support tools that have shown efficacy in small randomized controlled trials. While several large health care systems have begun to adopt the videos, efforts have not rigorously evaluated outcomes-a critical step prior to widespread implementation.
The goal of PROVEN is to conduct a pragmatic cluster-randomized trial to evaluate the effectiveness of the ACP Video Program in the NH setting by partnering with 2 large health care systems that operate 456 nursing homes nationwide. This work has the potential to improve the care provided to millions of older Americans in nursing homes and enable future pragmatic trials in this setting.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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ACP Video Program
Facility asked to implement ACP Video Program
ACP Video Program
The ACP Video Program consists of five videos that address ACP decisions: (1) General Goals of Care, (2) Goals of Care for Advanced Dementia, (3) Hospice, (4) Hospitalization, and (5) ACP for Healthy Patients. NH staff will offer videos to patients at these clinical triggers: (1) Within 7 days of admission or readmission; (2) Every 6 months for long-stay patients; (3) When there is a significant change in clinical status; (4) When a treatment decision arises for which there is a specific video; and (5) Special circumstances when goals of care are being considered (e.g., family visiting).
Usual ACP procedures
Facility follows usual ACP procedures
No interventions assigned to this group
Interventions
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ACP Video Program
The ACP Video Program consists of five videos that address ACP decisions: (1) General Goals of Care, (2) Goals of Care for Advanced Dementia, (3) Hospice, (4) Hospitalization, and (5) ACP for Healthy Patients. NH staff will offer videos to patients at these clinical triggers: (1) Within 7 days of admission or readmission; (2) Every 6 months for long-stay patients; (3) When there is a significant change in clinical status; (4) When a treatment decision arises for which there is a specific video; and (5) Special circumstances when goals of care are being considered (e.g., family visiting).
Eligibility Criteria
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Inclusion Criteria
* Facilities have facility identifiers that indicate that they are Medicare/Medicaid-certified nursing facilities in the U.S.
* Facilities serve both short and long-stay patients
* Facilities have \>50 beds
* Facilities have an electronic medical records system
* Facilities had at least 20 admissions and 20 annual Minimum Data Set (MDS) assessments (regardless of whether they were discharged alive) in 2013
Exclusion Criteria
* Facilities excluded per corporate leaders in health care system because of recent bad state or federal quality assurance survey (e.g. restriction on admissions, levied large civil monetary penalty, etc.)
* Facilities excluded per corporate leaders in health care system because of current new initiatives/competing demands
65 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Hebrew SeniorLife
OTHER
Massachusetts General Hospital
OTHER
Genesis HealthCare
OTHER
PruittHealth
OTHER
Brown University
OTHER
Responsible Party
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Vincent Mor
Professor of Medical Science, Florence Pirce Grant University Professor, Health Services, Policy & Practice
Principal Investigators
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Vincent Mor, PhD
Role: PRINCIPAL_INVESTIGATOR
Brown University
Susan Mitchell, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Hebrew SeniorLife
Angelo Volandes, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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PruittHealth
Norcross, Georgia, United States
Genesis HealthCare
Kennett Square, Pennsylvania, United States
Countries
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References
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McCreedy EM, Yang X, Mitchell SL, Gutman R, Teno J, Loomer L, Moyo P, Volandes A, Gozalo PL, Belanger E, Ogarek J, Mor V. Effect of advance care planning video on do-not-hospitalize orders for nursing home residents with advanced illness. BMC Geriatr. 2022 Apr 8;22(1):298. doi: 10.1186/s12877-022-02970-3.
Mitchell SL, Volandes AE, Gutman R, Gozalo PL, Ogarek JA, Loomer L, McCreedy EM, Zhai R, Mor V. Advance Care Planning Video Intervention Among Long-Stay Nursing Home Residents: A Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2020 Aug 1;180(8):1070-1078. doi: 10.1001/jamainternmed.2020.2366.
Palmer JA, Parker VA, Barre LR, Mor V, Volandes AE, Belanger E, Loomer L, McCreedy E, Mitchell SL. Understanding implementation fidelity in a pragmatic randomized clinical trial in the nursing home setting:a mixed-methods examination. Trials. 2019 Nov 28;20(1):656. doi: 10.1186/s13063-019-3725-5.
Palmer JA, Parker VA, Mor V, Volandes AE, Barre LR, Belanger E, Carter P, Loomer L, McCreedy E, Mitchell SL. Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting. BMC Health Serv Res. 2019 Jul 29;19(1):527. doi: 10.1186/s12913-019-4309-5.
Loomer L, McCreedy E, Belanger E, Palmer JA, Mitchell SL, Volandes AE, Mor V. Nursing Home Characteristics Associated With Implementation of an Advance Care Planning Video Intervention. J Am Med Dir Assoc. 2019 Jul;20(7):804-809.e1. doi: 10.1016/j.jamda.2019.01.133. Epub 2019 Mar 7.
Palmer JA, Mor V, Volandes AE, McCreedy E, Loomer L, Carter P, Dvorchak F, Mitchell SL. A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems. Trials. 2018 Aug 22;19(1):453. doi: 10.1186/s13063-018-2817-y.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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NIH Collaboratory website for UH3 Project: Pragmatic Trial of Video Education in Nursing Homes (PROVEN)
Other Identifiers
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