Pragmatic Trial of Video Education in Nursing Homes (PROVEN)

PROVEN: Pragmatic Trial of Video Education in Nursing Homes

This is a pragmatic cluster-randomized control trial (RCT) of an Advance Care Planning (ACP) Video Program for nursing home (NH) patients ≥ 65 years old who are cared for in 360 NH facilities (intervention arm n=119; control arm n=241) within two NH health care systems: Genesis HealthCare and PruittHealth. The intervention NH facilities will implement the ACP Video Program, while the control NH facilities will follow their usual ACP procedures. The trial will evaluate the effectiveness of the ACP Video Program by comparing hospitalizations, advance directives, and hospice use in the intervention vs. control NHs.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Pulmonary Disease, Chronic Obstructive; Dementia; Alzheimer Disease
• Intervention / Treatment: Behavioral: ACP Video Program

Detailed Description

Nursing homes are complex health care systems that serve increasingly sick patients who have advanced comorbid conditions. NHs are often charged with guiding patients through decisions about the direction of their treatment. Patients at NHs commonly get aggressive care that may be inconsistent with their preferences and of little clinical benefit. Identifying effective approaches that NHs can use to better promote goal-directed care and optimize resources is a research, public health, and clinical priority.

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.

• Study Type: Interventional
• Enrollment (Actual): 197692
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Norcross, Georgia, United States, 30093
      • PruittHealth
  • Pennsylvania
    • Kennett Square, Pennsylvania, United States, 19348
      • Genesis Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Facilities are within Genesis HealthCare or PruittHealth health care systems
• 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 turnover in NH administrator or Director of Nursing
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACP Video Program; Facility asked to implement ACP Video Program	Behavioral: 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).
No Intervention: Usual ACP procedures; Facility follows usual ACP procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Transfer Rate in Target Cohort	Number of hospital transfers (number of transfers/person-days alive) over a 12-month observation period among Medicare fee-for-service long-stay residents (in a NH >=90 days) who are >=65 years old and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease	12-month observation period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Transfer Rate Among Long-stay Residents Without Advanced Illness	Number of hospital transfers (number of transfers/person-days alive) over a 12-month observation period among Medicare fee-for-service long-stay residents (in a NH >=90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease	12-month observation period
Hospital Transfer Rate Among Short-stay Residents With Advanced Illness	Number of hospital transfers (number of transfers/person-days alive) over a 100-day observation period among Medicare fee-for-service short-stay residents (in a NH <90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease	100-day observation period
Hospital Transfer Rate Among Short-stay Residents Without Advanced Illness	Number of hospital transfers (number of transfers/person-days alive) over a 100-day observation period among Medicare fee-for-service short-stay residents (in a NH <90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease	100-day observation period
Proportion of Target Cohort With Last Observed Advance Directive Status	Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease whose last observed advance directive status during their 12-month observation period was: Full Code, Do Not Resuscitate (NOT Do Not Hospitalize), or Do Not Hospitalize. A resident whose last observed status was both Do Not Resuscitate and Do Not Hospitalize is categorized as Do Not Hospitalize only. Analyses will be limited to Genesis HealthCare facilities in which >75% of residents have any advance directive because the remaining Genesis HealthCare and PruittHealth facilities do not have reliable sources for these data.	12-month observation period
Proportion of Long-stay Residents Without Advanced Illness With Last Observed Advance Directive Status	Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who do have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease whose last observed advance directive status during their 12-month observation period was: Full Code, Do Not Resuscitate (NOT Do Not Hospitalize), or Do Not Hospitalize. A resident whose last observed status was both Do Not Resuscitate and Do Not Hospitalize is categorized as Do Not Hospitalize only. Analyses will be limited to Genesis HealthCare facilities in which >75% of residents have any advance directive because the remaining Genesis HealthCare and PruittHealth facilities do not have reliable sources for these data.	12-month observation period
Proportion of Short-stay Residents With Advanced Illness With Last Observed Advance Directive Status	Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease whose last observed advance directive status during their 100-day observation period was: Full Code, Do Not Resuscitate (NOT Do Not Hospitalize), or Do Not Hospitalize. A resident whose last observed status was both Do Not Resuscitate and Do Not Hospitalize is categorized as Do Not Hospitalize only. Analyses will be limited to Genesis HealthCare facilities in which >75% of residents have any advance directive because the remaining Genesis HealthCare and PruittHealth facilities do not have reliable sources for these data.	100-day observation period
Proportion of Short-stay Residents Without Advanced Illness With Last Observed Advance Directive Status	Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease whose last observed advance directive status during their 100-day observation period was: Full Code, Do Not Resuscitate (NOT Do Not Hospitalize), or Do Not Hospitalize. A resident whose last observed status was both Do Not Resuscitate and Do Not Hospitalize is categorized as Do Not Hospitalize only. Analyses will be limited to Genesis HealthCare facilities in which >75% of residents have any advance directive because the remaining Genesis HealthCare and PruittHealth facilities do not have reliable sources for these data.	100-day observation period
Proportion of Target Cohort Receiving Any Burdensome Treatment	Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease who receive any burdensome treatment (new feeding tube insertions, parenteral therapy, intubation, ICU care) during a 12-month observation period	12-month observation period
Proportion of Long-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment	Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease who receive any burdensome treatment (new feeding tube insertions, parenteral therapy, intubation, ICU care) during a 12-month observation period	12-month observation period
Proportion of Short-stay Residents With Advanced Illness Receiving Any Burdensome Treatment	Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease who receive any burdensome treatment (new feeding tube insertions, parenteral therapy, intubation, ICU care) during a 100-day observation period among	100-day observation period
Proportion of Short-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment	Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease who receive any burdensome treatment (new feeding tube insertions, parenteral therapy, intubation, ICU care) during a 100-day observation period	100-day observation period
Proportion of Target Cohort With Any Hospice Enrollment	Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease with any hospice enrollment during a 12-month observation period	12-month observation period
Proportion of Long-stay Residents Without Advanced Illness With Any Hospice Enrollment	Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease with any hospice enrollment during a 12-month observation period	12-month observation period
Proportion of Short-stay Residents With Advanced Illness With Any Hospice Enrollment	Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease with any hospice enrollment during a 100-day observation period	100-day observation period
Proportion of Short-stay Residents Without Advanced Illness With Any Hospice Enrollment	Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease with any hospice enrollment during a 100-day observation period	100-day observation period
Proportion of Target Cohort That Has Medicare ACP Billing Codes	Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease who have any Medicare ACP billing code during their 12-month observation period	12-month observation period
Proportion of Long-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes	Proportion of long-stay residents (in a NH >=90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease who have any Medicare ACP billing code during their 12-month observation period	12-month observation period
Proportion of Short-stay Residents With Advanced Illness That Has Medicare ACP Billing Codes	Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have EITHER advanced dementia OR advanced congestive heart failure/chronic obstructive lung disease who have any Medicare ACP billing code during their 100-day observation period	100-day observation period
Proportion of Short-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes	Proportion of short-stay residents (in a NH <90 days) who are >=65 years old and who have NEITHER advanced dementia NOR advanced congestive heart failure/chronic obstructive lung disease who have any Medicare ACP billing code during their 100-day observation period	100-day observation period

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: Massachusetts General Hospital; National Institute on Aging (NIA); Hebrew SeniorLife; Genesis HealthCare; PruittHealth
• Investigators: Principal Investigator: Vincent Mor, PhD, Brown University; Principal Investigator: Susan Mitchell, MD, MPH, Hebrew SeniorLife; Principal Investigator: Angelo Volandes, MD, MPH, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• NIH Collaboratory website for UH3 Project: Pragmatic Trial of Video Education in Nursing Homes (PROVEN)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: November 20, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Heart Failure; Dementia; Randomized Controlled Trials; Alzheimer Disease; Enteral Nutrition; Intubation; Pulmonary Disease, Chronic Obstructive; Hospitalization; Parenteral Nutrition; Advance Care Planning; Pragmatic Clinical Trials; Nursing Homes; Advance Directives; Skilled Nursing Facilities; Resuscitation Orders; Instructional Films and Videos; Do-Not-Resuscitate Orders; Hospices
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neurocognitive Disorders; Disease Attributes; Neurodegenerative Diseases; Lung Diseases, Obstructive; Tauopathies; Heart Failure; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Dementia; Alzheimer Disease; Chronic Disease
• Other Study ID Numbers: 4UH3AG049619-02 (U.S. NIH Grant/Contract)