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

Implementing a Caregiver Skills Training Program (Caregivers FIRST): Function QUERI 2.0 (QUE 20-023)

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function; Functional Status
• Intervention / Treatment: Other: Implementation Strategy: Foundational REP; Other: Implementation Strategy: Enhanced REP

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705-3875
      • Durham VA Medical Center, Durham, NC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Foundational REP; 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; 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.
Experimental: Enhanced REP; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity 1	Fidelity will be measured by 1) the percentage of number of recommended classes delivered by site.	12 months (cumulative)
Fidelity 2	Fidelity will be measured by 2) number of caregivers attended at least one class by site.	12 months (cumulative)
Fidelity 3	Fidelity will be measured by 3) mean number of classes attended per caregiver.	12 months (cumulative)
Adoption	Adoption is defined as the number of VA Facilities meeting a threshold of four or more training classes delivered to a minimum of five caregivers.	12 months (cumulative)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Courtney H Van Houtven, PhD, Durham VA Medical Center, Durham, NC; Principal Investigator: Susan N. Hastings, MD MHSc, Durham VA Medical Center, Durham, NC; Principal Investigator: Kelli D. Allen, PhD, Durham VA Medical Center, Durham, NC

Publications and helpful links

Helpful Links

• Durham VA Optimizing Function & Independence QUERI

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Veterans; Caregivers; Implementation Science; Functional Independence; Training Programs; Informal Care
• Other Study ID Numbers: QUX 21-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

A de-identified, anonymized dataset may be created upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format.

Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication.

No data or statistical code that could lead to re-identification of individuals will be released.

Data will be stored & maintained in an approved, secured location as described in the VA Research Data Inventory Form.

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.

• IPD Sharing Time Frame: Available upon request.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No