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.
COMPLETED
NA
25 participants
12 months (cumulative)
2025-04-16
Participant Flow
The Protocol Enrollment reflect the number of VA Facilities (sites) enrolled.
Unit of analysis: VA Facilities
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.
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|---|---|---|
|
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
| 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
|
|---|---|---|---|
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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
| 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
| 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
| 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
| 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
| 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
| 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
Enhanced REP
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place