Implementing a Skills-Based Caregiver Training Program (Caregivers FIRST): Function QUERI 2.0

NCT05319535 | Completed Results

• 1 other identifier: QUX 21-002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Function; Functional Status

Keywords

Caregivers; Veterans; Training Programs; Informal Care; Implementation Science; Functional Independence

Outcome Measures

Primary Outcomes (2)

• Penetration 1

  Penetration is defined as the 1) percentage of caregivers who received consults for VA caregiver education and training services who attended at least one class.

  12 months (cumulative)

• Penetration 2

  Penetration is defined as the 2) number of classes delivered by site.

  12 months (cumulative)

Secondary Outcomes (4)

• Fidelity 1

  12 months (cumulative)

• Fidelity 2

  12 months (cumulative)

• Fidelity 3

  12 months (cumulative)

• Adoption

  12 months (cumulative)

Study Arms (2)

Foundational REP

ACTIVE COMPARATOR

Foundational REP uses the Replicating Effective Program implementation strategy and includes 5 elements that were developed and tested in the investigators' prior Function QUERI work: Stakeholder engagement; Toolkit; SharePoint access for clinical program training materials; Data dashboard to assist sites with tracking their own data; and Diffusion Networks to promote peer-to-peer sharing and implementation support.

Other: Implementation Strategy: Foundational REP

Enhanced REP

EXPERIMENTAL

Enhanced REP begins with the same activities as Foundational REP. Sites randomized to receive Enhanced REP will continue with Foundational REP and also receive higher intensity support for a period of approximately 4 months. The higher intensity support will consist of facilitation, a process of interactive problem solving and support that occurs in a context of a supportive interpersonal relationship and CONNECT, a complexity science-based bundle of interaction-oriented activities designed to supplement implementation efforts by promoting team function and readiness for change. Facilitation will be provided by Function QUERI team members.

Other: Implementation Strategy: Enhanced REP

Interventions

Implementation Strategy: Foundational REP OTHER

Among Caregivers FIRST sites that do not meet implementation adoption benchmarks, the goal is to test implementation intensification approaches, specifically Foundational REP vs. Enhanced REP. The investigators propose that low intensity implementation support that promotes adapting Caregivers FIRST for context and provides tools for ongoing Caregivers FIRST evaluation (defined as foundational REP), will be sufficient for some but not all sites to successfully incorporate Caregivers FIRST into routine practice.

Foundational REP

Implementation Strategy: Enhanced REP OTHER

Among Caregivers FIRST sites that do not meet implementation adoption benchmarks, the goal is to test implementation intensification approaches, specifically Foundational REP vs. Enhanced REP. The investigators posit that higher intensity strategies (defined as Enhanced REP) that directly influence teams' capacity and skills to effectively self-organize and problem-solve will lead to higher implementation adoption, penetration, fidelity, and value.

Enhanced REP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled sites will all be exposed to Foundational REP.
• Half of sites will be randomized to receive higher-intensity implementation support (Enhanced REP).

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Related Publications (3)

• Hughes JM, Makaroun LK, Decosimo K, Tucker M, Dadolf J, Drake C, Zullig LL, Coffman CJ, Kota S, Sperber NR, Christensen L, Chadduck T, Allen KD, Hastings SN, Van Houtven CH. Development and Delivery of Enhanced Implementation Support to Disseminate a National Caregiver Skills Training Program. Innov Aging. 2024 Dec 17;9(1):igae107. doi: 10.1093/geroni/igae107. eCollection 2025.

  PMID: 39872410 DERIVED

• Decosimo K, Drake C, Coffman CJ, Sperber NR, Tucker M, Hughes JM, Zullig LL, Chadduck T, Christensen L, Kaufman B, Allen KD, Hastings SN, Van Houtven CH. Implementation intensification to disseminate a skills-based caregiver training program: protocol for a type III effectiveness-implementation hybrid trial. Implement Sci Commun. 2023 Aug 16;4(1):97. doi: 10.1186/s43058-023-00475-7.

  PMID: 37587517 DERIVED

• Hughes JM, Zullig LL, Choate AL, Decosimo KP, Wang V, Van Houtven CH, Allen KD, Nicole Hastings S. Intensification of Implementation Strategies: Developing a Model of Foundational and Enhanced Implementation Approaches to Support National Adoption and Scale-up. Gerontologist. 2023 Mar 21;63(3):604-613. doi: 10.1093/geront/gnac130.

  PMID: 36029028 DERIVED

Results Point of Contact

• Title: Courtney H Van Houtven, PhD
• Organization: Durham VA Medical Center

courtney.vanhoutven@va.gov

919-286-6936

Study Officials

• Courtney H Van Houtven, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

• Kelli D. Allen, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

• Susan N. Hastings, MD MHSc

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 8, 2022
• Study Start: April 25, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Available upon request.
• Access Criteria: Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re- identify any individual whose data are included in the dataset.

Locations

US (1)