Cognitive FunctionNCT05319535
Implementing a Skills-Based Caregiver Training Program (Caregivers FIRST): Function QUERI 2.0
A study testing Implementation Strategy: Foundational REP and Implementation Strategy: Enhanced REP in people with Cognitive Function and Functional Status, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cognitive Function, Functional Status
- What is being tested?
- Implementation Strategy: Foundational REP and Implementation Strategy: Enhanced REP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Function, Functional Status
- Being tested
- Implementation Strategy: Foundational REP, Implementation Strategy: Enhanced REP
- Keywords
- Caregivers, Veterans, Training Programs, Informal Care, Implementation Science, Functional Independence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation Strategy: Foundational REPOther
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.
Implementation Strategy: Enhanced REPOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Implementation Strategy: Enhanced REP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months (cumulative)
Penetration 2
Penetration is defined as the 2) number of classes delivered by site.
Measured: 12 months (cumulative)
Secondary outcomes (4)
Fidelity 1
Fidelity will be measured by 1) the percentage of number of recommended classes delivered by site.
Measured: 12 months (cumulative)
Fidelity 2
Fidelity will be measured by 2) number of caregivers attended at least one class by site.
Measured: 12 months (cumulative)
Fidelity 3
Fidelity will be measured by 3) mean number of classes attended per caregiver.
Measured: 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.
Measured: 12 months (cumulative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start25 Apr 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Courtney H Van Houtven, PhD, Principal investigator, Durham VA Medical Center, Durham, NCKelli D. Allen, PhD, Principal investigator, Durham VA Medical Center, Durham, NCSusan N. Hastings, MD MHSc, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319535
- Sponsor's protocol ID
- QUX 21-002
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2022
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Van Houtven CH, Decosimo K, Coffman CJ, Kota S, Drake C, Sperber NR, Hughes JM, Zullig LL, Tucker M, Webster A, Franzosa E, Blok A, Chadduck T, Christensen L, Kaufman BG, Shepherd-Banigan M, Allen KD, Hastings SN. Evaluating two implementation approaches to support a nationally mandated caregiver skills training in veterans affairs: a type III hybrid implementation-effectiveness randomized controlled trial. Implement Sci Commun. 2026 Jun 11. doi: 10.1186/s43058-026-00960-9. Online ahead of print.
PubMed 42277972Hughes 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.
PubMed 39872410Decosimo 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.
PubMed 37587517Hughes 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.
PubMed 36029028
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Caregiver Skills Training Program (Caregivers FIRST): Function QUERI 2.0 (QUE 20-023)
- ClinicalTrials.gov ID
- NCT05319535
- Acronym / sponsor ID
- QUX 21-002
- Conditions
- Cognitive Function, Functional Status
- Keywords
- Caregivers, Veterans, Training Programs, Informal Care, Implementation Science, Functional Independence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Foundational REP | Active comparator | Other: Implementation Strategy: Foundational REPFoundational 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. |
| Enhanced REP | Experimental | Other: Implementation Strategy: Enhanced REPEnhanced 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation Strategy: Foundational REPAmong 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. | Other | Foundational REP |
| Implementation Strategy: Enhanced REPAmong 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. | Other | Enhanced REP |
Primary outcome
Penetration 1
Time frame: 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
Time frame: 12 months (cumulative)
Penetration is defined as the 2) number of classes delivered by site.
4 secondary outcomes
Fidelity 1
Time frame: 12 months (cumulative)
Fidelity 2
Time frame: 12 months (cumulative)
Fidelity 3
Time frame: 12 months (cumulative)
Adoption
Time frame: 12 months (cumulative)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42277972Van Houtven CH, Decosimo K, Coffman CJ, Kota S, Drake C, Sperber NR, Hughes JM, Zullig LL, Tucker M, Webster A, Franzosa E, Blok A, Chadduck T, Christensen L, Kaufman BG, Shepherd-Banigan M, Allen KD, Hastings SN. Evaluating two implementation approaches to support a nationally mandated caregiver skills training in veterans affairs: a type III hybrid implementation-effectiveness randomized controlled trial. Implement Sci Commun. 2026 Jun 11. doi: 10.1186/s43058-026-00960-9. Online ahead of print.
- Derived from this study: PubMed 39872410Hughes 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.
- Derived from this study: PubMed 37587517Decosimo 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.
- Derived from this study: PubMed 36029028Hughes 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney H Van Houtven, PhD principal investigator
Durham VA Medical Center, Durham, NC
Kelli D. Allen, PhD principal investigator
Durham VA Medical Center, Durham, NC
Susan N. Hastings, MD MHSc principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Strategy: Foundational REP and Implementation Strategy: Enhanced REP in people with Cognitive Function and Functional Status, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration 1 (time frame: 12 months (cumulative)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05319535, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.