Cognitive Function, Functional Status
Conditions
Keywords
Caregivers, Veterans, Training Programs, Informal Care, Implementation Science, Functional Independence
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.
Interventions
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.
OTHERImplementation 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Penetration 1 | 12 months (cumulative) | 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. |
| Penetration 2 | 12 months (cumulative) | Penetration is defined as the 2) number of classes delivered by site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity 1 | 12 months (cumulative) | Fidelity will be measured by 1) the percentage of number of recommended classes delivered by site. |
| Fidelity 2 | 12 months (cumulative) | Fidelity will be measured by 2) number of caregivers attended at least one class by site. |
| Fidelity 3 | 12 months (cumulative) | Fidelity will be measured by 3) mean number of classes attended per caregiver. |
| Adoption | 12 months (cumulative) | 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. |
Countries
United States
Participant flow
Pre-assignment details
The Protocol Enrollment reflect the number of VA Facilities (sites) enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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. | 12 |
| 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. | 0 |
| 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. | 13 |
| Total | 25 |
Baseline characteristics
| Characteristic | Total | Enhanced REP | Foundational REP |
|---|---|---|---|
| Low facility complexity | 17 VA Facilities | 9 VA Facilities | 8 VA Facilities |
| Race/Ethnicity, Customized | NA VA Facilities | NA VA Facilities | NA VA Facilities |
| Region of Enrollment United States | 25 VA Facilities | 13 VA Facilities | 12 VA Facilities |
| Sex: Female, Male Female | NA VA Facilities | NA VA Facilities | NA VA Facilities |
| Sex: Female, Male Male | NA VA Facilities | NA VA Facilities | NA VA Facilities |
| Sites with prior implementation of Caregivers FIRST | 14 VA Facilities | 7 VA Facilities | 7 VA Facilities |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foundational REP | Penetration 1 | 6.1 percentage of caregivers | Standard Deviation 4.5 |
| Enhanced REP | Penetration 1 | 8.3 percentage of caregivers | Standard Deviation 4.5 |
Comparison: Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).p-value: 0.2695% CI: [-1.8, 6.1]Regression, Linear
Primary
Penetration 2
Penetration is defined as the 2) number of classes delivered by site.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foundational REP | Penetration 2 | 5.5 number of classes | Standard Deviation 4.9 |
| Enhanced REP | Penetration 2 | 8.4 number of classes | Standard Deviation 5.6 |
Comparison: Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).p-value: 0.1195% CI: [0.9, 3.4]negative binomial regression
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Foundational REP | Adoption | 6 VA Facilities |
| Enhanced REP | Adoption | 10 VA Facilities |
Comparison: Model included the arm indicator variable.p-value: 0.1795% CI: [0.6, 18.5]Regression, Logistic
Secondary
Fidelity 1
Fidelity will be measured by 1) the percentage of number of recommended classes delivered by site.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foundational REP | Fidelity 1 | 68.8 percentage of classes | Standard Deviation 61.4 |
| Enhanced REP | Fidelity 1 | 104.8 percentage of classes | Standard Deviation 70.3 |
Comparison: Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).p-value: 0.1795% CI: [-18.1, 93.3]Regression, Linear
Secondary
Fidelity 2
Fidelity will be measured by 2) number of caregivers attended at least one class by site.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foundational REP | Fidelity 2 | 1.9 number of caregivers | Standard Deviation 1 |
| Enhanced REP | Fidelity 2 | 2.4 number of caregivers | Standard Deviation 0.7 |
Comparison: Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).p-value: 0.195% CI: [-0.1, 1.4]Regression, Linear
Secondary
Fidelity 3
Fidelity will be measured by 3) mean number of classes attended per caregiver.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foundational REP | Fidelity 3 | 11.3 classes attended per caregiver | Standard Deviation 8.8 |
| Enhanced REP | Fidelity 3 | 13.2 classes attended per caregiver | Standard Deviation 8.6 |
Comparison: Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).p-value: 0.3695% CI: [0.7, 2.3]negative binomial regression