Clinical trial NCT02612688: Pragmatic Trial of Video Education in Nursing Homes
Official title: PROVEN: Pragmatic Trial of Video Education in Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Heart Failure
Pulmonary Disease, Chronic Obstructive
Keywords: 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
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Hebrew SeniorLife
name: Massachusetts General Hospital
name: Genesis HealthCare
name: PruittHealth
First posted: 2015-11-24
Enrollment: 197692
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Hospital Transfer Rate in Target Cohort
timeFrame: 12-month observation period
Secondary outcomes:
measure: Hospital Transfer Rate Among Long-stay Residents Without Advanced Illness
timeFrame: 12-month observation period
measure: Hospital Transfer Rate Among Short-stay Residents With Advanced Illness
timeFrame: 100-day observation period
measure: Hospital Transfer Rate Among Short-stay Residents Without Advanced Illness
timeFrame: 100-day observation period
measure: Proportion of Target Cohort With Last Observed Advance Directive Status
timeFrame: 12-month observation period
measure: Proportion of Long-stay Residents Without Advanced Illness With Last Observed Advance Directive Status
timeFrame: 12-month observation period
measure: Proportion of Short-stay Residents With Advanced Illness With Last Observed Advance Directive Status
timeFrame: 100-day observation period
measure: Proportion of Short-stay Residents Without Advanced Illness With Last Observed Advance Directive Status
timeFrame: 100-day observation period
measure: Proportion of Target Cohort Receiving Any Burdensome Treatment
timeFrame: 12-month observation period
measure: Proportion of Long-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment
timeFrame: 12-month observation period
measure: Proportion of Short-stay Residents With Advanced Illness Receiving Any Burdensome Treatment
timeFrame: 100-day observation period
measure: Proportion of Short-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment
timeFrame: 100-day observation period
measure: Proportion of Target Cohort With Any Hospice Enrollment
timeFrame: 12-month observation period
measure: Proportion of Long-stay Residents Without Advanced Illness With Any Hospice Enrollment
timeFrame: 12-month observation period
measure: Proportion of Short-stay Residents With Advanced Illness With Any Hospice Enrollment
timeFrame: 100-day observation period
measure: Proportion of Short-stay Residents Without Advanced Illness With Any Hospice Enrollment
timeFrame: 100-day observation period
measure: Proportion of Target Cohort That Has Medicare ACP Billing Codes
timeFrame: 12-month observation period
measure: Proportion of Long-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes
timeFrame: 12-month observation period
measure: Proportion of Short-stay Residents With Advanced Illness That Has Medicare ACP Billing Codes
timeFrame: 100-day observation period
measure: Proportion of Short-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes
timeFrame: 100-day observation period
Other outcomes:
Locations:
city: Norcross
country: United States
facility: PruittHealth
state: Georgia
city: Kennett Square
country: United States
facility: Genesis HealthCare
state: Pennsylvania
Study officials:
affiliation: Brown University
name: Vincent Mor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebrew SeniorLife
name: Susan Mitchell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Angelo Volandes, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.