Pragmatic Trial of Video Education in Nursing Homes (PROVEN)

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Brown University

Status

Completed

Conditions

Alzheimer Disease
Pulmonary Disease, Chronic Obstructive
Heart Failure
Dementia

Treatments

Behavioral: ACP Video Program

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02612688
4UH3AG049619-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

197,692 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

197,692 participants in 2 patient groups

ACP Video Program
Experimental group
Description:
Facility asked to implement ACP Video Program
Treatment:
Behavioral: ACP Video Program
Usual ACP procedures
No Intervention group
Description:
Facility follows usual ACP procedures

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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