Trial Outcomes & Findings for Implementing a Skills-Based Caregiver Training Program (Caregivers FIRST): Function QUERI 2.0 (NCT NCT05319535)

NCT ID: NCT05319535

Last Updated: 2025-04-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

12 months (cumulative)

Results posted on

2025-04-16

Participant Flow

The Protocol Enrollment reflect the number of VA Facilities (sites) enrolled.

Unit of analysis: VA Facilities

Participant milestones

Participant milestones
Measure
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. 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.
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. 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.
Overall Study
STARTED
0 12
0 13
Overall Study
COMPLETED
0 12
0 13
Overall Study
NOT COMPLETED
0 0
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data was collected at the site level and these characteristics were not relevant and not collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Foundational REP
n=12 VA Facilities
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. 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.
Enhanced REP
n=13 VA Facilities
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. 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.
Total
n=25 VA Facilities
Total of all reporting groups
Sex: Female, Male
Female
NA VA Facilities
n=12 VA Facilities • Data was collected at the site level and these characteristics were not relevant and not collected.
NA VA Facilities
n=13 VA Facilities • Data was collected at the site level and these characteristics were not relevant and not collected.
NA VA Facilities
n=25 VA Facilities • Data was collected at the site level and these characteristics were not relevant and not collected.
Sex: Female, Male
Male
NA VA Facilities
n=12 VA Facilities • Data was collected at the site level and these characteristics were not relevant and not collected.
NA VA Facilities
n=13 VA Facilities • Data was collected at the site level and these characteristics were not relevant and not collected.
NA VA Facilities
n=25 VA Facilities • Data was collected at the site level and these characteristics were not relevant and not collected.
Race/Ethnicity, Customized
NA VA Facilities
n=12 VA Facilities
NA VA Facilities
n=13 VA Facilities
NA VA Facilities
n=25 VA Facilities
Region of Enrollment
United States
12 VA Facilities
n=12 VA Facilities
13 VA Facilities
n=13 VA Facilities
25 VA Facilities
n=25 VA Facilities
Sites with prior implementation of Caregivers FIRST
7 VA Facilities
n=12 VA Facilities
7 VA Facilities
n=13 VA Facilities
14 VA Facilities
n=25 VA Facilities
Low facility complexity
8 VA Facilities
n=12 VA Facilities
9 VA Facilities
n=13 VA Facilities
17 VA Facilities
n=25 VA Facilities

PRIMARY outcome

Timeframe: 12 months (cumulative)

Population: Unit of analysis for this study was VA Facilities (site level); therefore, the Overall Number of Participants Analyzed is not available.

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.

Outcome measures

Outcome measures
Measure
Foundational REP
n=12 VA Facilities
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. 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.
Enhanced REP
n=13 VA Facilities
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. 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.
Penetration 1
6.1 percentage of caregivers
Standard Deviation 4.5
8.3 percentage of caregivers
Standard Deviation 4.5

PRIMARY outcome

Timeframe: 12 months (cumulative)

Population: Unit of analysis for this study was VA Facilities (site level); therefore, the Overall Number of Participants Analyzed is not available.

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

Outcome measures

Outcome measures
Measure
Foundational REP
n=12 VA Facilities
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. 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.
Enhanced REP
n=13 VA Facilities
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. 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.
Penetration 2
5.5 number of classes
Standard Deviation 4.9
8.4 number of classes
Standard Deviation 5.6

SECONDARY outcome

Timeframe: 12 months (cumulative)

Population: Unit of analysis for this study was VA Facilities (site level); therefore, the Overall Number of Participants Analyzed is not available.

Fidelity will be measured by 1) the percentage of number of recommended classes delivered by site.

Outcome measures

Outcome measures
Measure
Foundational REP
n=12 VA Facilities
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. 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.
Enhanced REP
n=13 VA Facilities
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. 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.
Fidelity 1
68.8 percentage of classes
Standard Deviation 61.4
104.8 percentage of classes
Standard Deviation 70.3

SECONDARY outcome

Timeframe: 12 months (cumulative)

Population: Unit of analysis for this study was VA Facilities (site level); therefore, the Overall Number of Participants Analyzed is not available.

Fidelity will be measured by 2) number of caregivers attended at least one class by site.

Outcome measures

Outcome measures
Measure
Foundational REP
n=12 VA Facilities
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. 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.
Enhanced REP
n=13 VA Facilities
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. 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.
Fidelity 2
1.9 number of caregivers
Standard Deviation 1.0
2.4 number of caregivers
Standard Deviation 0.7

SECONDARY outcome

Timeframe: 12 months (cumulative)

Population: Unit of analysis for this study was VA Facilities (site level); therefore, the Overall Number of Participants Analyzed is not available.

Fidelity will be measured by 3) mean number of classes attended per caregiver.

Outcome measures

Outcome measures
Measure
Foundational REP
n=12 VA Facilities
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. 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.
Enhanced REP
n=13 VA Facilities
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. 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.
Fidelity 3
11.3 classes attended per caregiver
Standard Deviation 8.8
13.2 classes attended per caregiver
Standard Deviation 8.6

SECONDARY outcome

Timeframe: 12 months (cumulative)

Population: Unit of analysis for this study was VA Facilities (site level); therefore, the Overall Number of Participants Analyzed is not available.

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.

Outcome measures

Outcome measures
Measure
Foundational REP
n=12 VA Facilities
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. 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.
Enhanced REP
n=13 VA Facilities
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. 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.
Adoption
6 VA Facilities
10 VA Facilities

Adverse Events

Foundational REP

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Enhanced REP

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Courtney H Van Houtven, PhD

Durham VA Medical Center

Phone: 919-286-6936

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place