Clinical trial NCT05319535: Implementing a Skills-Based Caregiver Training Program (Caregivers FIRST): Function QUERI 2.0
Official title: Implementing a Caregiver Skills Training Program (Caregivers FIRST): Function QUERI 2.0 (QUE 20-023)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Functional Status
Keywords: Caregivers
Veterans
Training Programs
Informal Care
Implementation Science
Functional Independence
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-04-08
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel cluster-randomized trial (parallel-CRT): used in pragmatic evaluations of health program or policy interventions, where half the clusters (in this case, VA medical centers) are randomly assigned to two interventions: Foundational REP (active comparator) vs. Enhanced REP (experimental).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Implementing a Skills-Based Caregiver Training (Caregivers FIRST): Function QUERI 2.0 aims to compare implementation strategies for large-scale spread of Caregivers FIRST, a group training for friend or family caregivers of Veterans. The goal is to use a type III effectiveness-implementation hybrid design framework to compare continuation of implementation strategies for 24 sites that do not meet implementation adoption benchmarks.

Detailed description: Background/Purpose. Over 5 million former or current military personnel receive informal care in the home from family members or friends. Unintended impacts on caregivers can include strain, burden, burnout, and depression. Additionally, half of caregivers of Veterans with functional/cognitive limitations report unmet needs for training.

Caregivers FIRST (Caregivers Finding Important Resources, Support, and Training) is an evidence-based skills training program for caregivers of Veterans with cognitive and/or functional limitations. Caregivers FIRST promotes Veteran function and independence through caregiver skill training and support in a series of 4 proactive group classes to help general caregivers build self-care and psychological coping, health system navigation, and hands-on clinical skills.

As part of Implementing a Skills-Based Caregiver Training (Caregivers FIRST), the investigators plan to implement the Caregivers FIRST clinical program nationally in partnership with the VA Caregiver Support Program (maximum 150 VA medical centers). The investigators then plan to use a type III effectiveness-implementation hybrid design framework with 24 sites that do not meet implementation adoption benchmarks. Those enrolled sites will be randomized to receive standard implementation support (foundational Replicating Effective Programs or REP) or a higher-intensity implementation support (enhanced REP including additional facilitation, self-organization, and team building support). The investigators will compare continuation of foundational REP versus addition of higher intensity strategies.

Key questions: What VA Central Office and regional (VISN) partnerships and activities will enhance national dissemination of Caregivers FIRST? How should Caregivers FIRST clinical program be adapted to leverage site-specific resources and optimize sustainability? Are there differences in implementation outcomes (penetration, fidelity) at 6, 12, or 18 months between arms? What is the impact on effectiveness outcomes/quality metrics (quality of VA General Caregiver Program, Veteran days in the community) at implementing sites? How do sites experience implementation strategies in each arm? The investigators also plan to conduct an explanatory sequential mixed method design that includes qualitative data collection and analysis that will not be reported here.

Methodology. To evaluate implementation, the investigators will randomize sites (n=24) 1:1 to either foundational REP or enhanced REP. The investigators will use generalized linear models to examine the effect of foundational vs. enhanced REP on implementation outcomes at 12 months.

Eligibility criteria: Inclusion Criteria:

* Site inclusion criteria includes sites not meeting benchmarks for adoption of Caregivers FIRST and submission of a signed participation agreement.
* Enrolled sites will all be exposed to Foundational REP.
* Half of sites will be randomized to receive higher-intensity implementation support (Enhanced REP).

Exclusion Criteria:

* The eight Caregivers FIRST (formerly called iHI-FIVES) sites that have previously participated in Function QUERI (ClinicalTrials.gov Identifier: NCT03474380) will be excluded from enrollment in this study.

Primary outcomes:
measure: Penetration 1
timeFrame: 12 months (cumulative)
measure: Penetration 2
timeFrame: 12 months (cumulative)
Secondary outcomes:
measure: Fidelity 1
timeFrame: 12 months (cumulative)
measure: Fidelity 2
timeFrame: 12 months (cumulative)
measure: Fidelity 3
timeFrame: 12 months (cumulative)
measure: Adoption
timeFrame: 12 months (cumulative)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Courtney H Van Houtven, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Durham VA Medical Center, Durham, NC
name: Kelli D. Allen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Durham VA Medical Center, Durham, NC
name: Susan N. Hastings, MD MHSc
role: PRINCIPAL_INVESTIGATOR
References: