Pragmatic Trial of Video Education in Nursing Homes (PROVEN)

• ClinicalTrials.gov Identifier: NCT02612688
• Recruitment Status: Completed
• First Posted: November 24, 2015
• Results First Posted: June 18, 2020
• Last Update Posted: October 12, 2020
• Sponsor: Brown University
• Collaborators: National Institute on Aging (NIA); Hebrew SeniorLife; Massachusetts General Hospital; Genesis HealthCare; PruittHealth
• Information provided by (Responsible Party): Vincent Mor, Brown University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease; Dementia; Heart Failure; Pulmonary Disease, Chronic Obstructive	Behavioral: ACP Video Program	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 197692 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: PROVEN: Pragmatic Trial of Video Education in Nursing Homes
• Actual Study Start Date: March 1, 2016
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: May 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Hospital Transfer Rate in Target Cohort [ Time Frame: 12-month observation period ]
   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

Secondary Outcome Measures :

1. Hospital Transfer Rate Among Long-stay Residents Without Advanced Illness [ Time Frame: 12-month observation period ]
   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
2. Hospital Transfer Rate Among Short-stay Residents With Advanced Illness [ Time Frame: 100-day observation period ]
   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
3. Hospital Transfer Rate Among Short-stay Residents Without Advanced Illness [ Time Frame: 100-day observation period ]
   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
4. Proportion of Target Cohort With Last Observed Advance Directive Status [ Time Frame: 12-month observation period ]
   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.
5. Proportion of Long-stay Residents Without Advanced Illness With Last Observed Advance Directive Status [ Time Frame: 12-month observation period ]
   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.
6. Proportion of Short-stay Residents With Advanced Illness With Last Observed Advance Directive Status [ Time Frame: 100-day observation period ]
   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.
7. Proportion of Short-stay Residents Without Advanced Illness With Last Observed Advance Directive Status [ Time Frame: 100-day observation period ]
   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.
8. Proportion of Target Cohort Receiving Any Burdensome Treatment [ Time Frame: 12-month observation period ]
   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
9. Proportion of Long-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment [ Time Frame: 12-month observation period ]
   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
10. Proportion of Short-stay Residents With Advanced Illness Receiving Any Burdensome Treatment [ Time Frame: 100-day observation period ]
    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
11. Proportion of Short-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment [ Time Frame: 100-day observation period ]
    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
12. Proportion of Target Cohort With Any Hospice Enrollment [ Time Frame: 12-month observation period ]
    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
13. Proportion of Long-stay Residents Without Advanced Illness With Any Hospice Enrollment [ Time Frame: 12-month observation period ]
    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
14. Proportion of Short-stay Residents With Advanced Illness With Any Hospice Enrollment [ Time Frame: 100-day observation period ]
    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
15. Proportion of Short-stay Residents Without Advanced Illness With Any Hospice Enrollment [ Time Frame: 100-day observation period ]
    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
16. Proportion of Target Cohort That Has Medicare ACP Billing Codes [ Time Frame: 12-month observation period ]
    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
17. Proportion of Long-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes [ Time Frame: 12-month observation period ]
    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
18. Proportion of Short-stay Residents With Advanced Illness That Has Medicare ACP Billing Codes [ Time Frame: 100-day observation period ]
    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
19. Proportion of Short-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes [ Time Frame: 100-day observation period ]
    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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Georgia

PruittHealth

Norcross, Georgia, United States, 30093

United States, Pennsylvania

Genesis HealthCare

Kennett Square, Pennsylvania, United States, 19348

Sponsors and Collaborators

Brown University

National Institute on Aging (NIA)

Hebrew SeniorLife

Massachusetts General Hospital

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

  Study Documents (Full-Text)

Documents provided by Vincent Mor, Brown University:

Study Protocol and Statistical Analysis Plan  [PDF] April 17, 2018

More Information

Additional Information:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Vincent Mor, Professor of Medical Science, Florence Pirce Grant University Professor, Health Services, Policy & Practice, Brown University
• ClinicalTrials.gov Identifier: NCT02612688
• Other Study ID Numbers: 4UH3AG049619-02 ( U.S. NIH Grant/Contract ); 4UH3AG049619-02 ( U.S. NIH Grant/Contract )
• First Posted: November 24, 2015
• Results First Posted: June 18, 2020
• Last Update Posted: October 12, 2020
• Last Verified: September 2020

Keywords provided by Vincent Mor, Brown University:

Advance Care Planning; Advance Directives; Alzheimer Disease; Dementia; Do-Not-Resuscitate Orders; Enteral Nutrition; Heart Failure; Hospices; Hospitalization; Instructional Films and Videos; Intubation; Nursing Homes; Parenteral Nutrition; Pragmatic Clinical Trials; Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trials; Resuscitation Orders; Skilled Nursing Facilities

Additional relevant MeSH terms:

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Alzheimer Disease; Dementia; Heart Failure; Chronic Disease; Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Lung Diseases, Obstructive