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| Name | Class |
|---|---|
| Edith Nourse Rogers Memorial Veterans Hospital | FED |
| Central Arkansas Veterans Healthcare System | FED |
| Minneapolis Veterans Affairs Medical Center | FED |
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The COVID-19 pandemic has resulted in significant loss of life and suffering with total case and death counts increasing daily, particularly with the emergence of the delta variant. COVID-19 vaccines have proven highly effective in preventing severe illness, hospitalization, and death. Nevertheless, according to VA data sources, only 56% of all U.S. Veterans have been vaccinated to date, largely owing to vaccine hesitancy and lack of access to vaccination. Thus, there is a critical need for evidence-based interventions to increase COVID-19 vaccine acceptance and access among Veterans, many of whom are vulnerable to poor outcomes of COVID-19. The overall goal of this study is to increase COVID-19 vaccination in Veterans of VISNs 16 and 21 who remain unvaccinated either because of vaccine hesitancy or lack of access to COVID-19 vaccine. Specifically, the investigators will test a COVID-19 Vaccine Acceptance Intervention (Motivational Interviewing) plus Implementation Facilitation.
For Aim 1, the investigators will conduct a one-year cluster randomized controlled trial of a Vaccine Acceptance Intervention versus Usual Care with randomization at the level of VA Medical Center (VAMC). Usual Care will consist of all national and local initiatives to promote COVID-19 vaccine acceptance in Veterans such as vaccine mandates, mobile clinics, outreach calls, etc. The Implementation Facilitation team will include a VISN-level external facilitator, VAMC-level internal facilitators, and clinic-level site champions to support PACT staff, Coaches and Peers in implementing the Vaccine Acceptance Intervention with unvaccinated Veterans as well as in lowering barriers to vaccine access at intervention sites. For Aim 2, the investigators will identify a diverse sample of 450 Veterans across VAMCs in VISNs 16 and 21, who have had primary care visits at Intervention and Usual Care sites, and who have either recently received (N=360) or have not received (N=90) COVID-19 vaccination. The investigators will over sample recently vaccinated Veterans to describe the impact of the Vaccine Acceptance Intervention on Veterans' decisions to accept COVID-19 vaccination in addition to over-sampling women, ethnic/racial minorities, rural and younger Veterans, and those with mental health conditions. Follow-up qualitative interviews will be conducted in a subsample to better understand factors related to recent vaccine acceptance and persistent vaccine hesitancy. Finally, for Aim 3, the investigators will conduct process and summative interviews with VA staff and providers from VAMC sites in VISNs 16 and 21 with high and low vaccination rates) to learn which implementation strategies were most and least effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | The VAMC Internal Facilitator will partner with the trial External Facilitators (research team and designated External Facilitators in VISNS 16 and 21) to adapt and implement the study intervention to best meet the needs and preferences of their VAMC site. In addition, each CBOC and clinic affiliated with a VAMC in the Intervention arm will need to identify a Site Champion to provide clinic-specific information to facilitate implementation of the Vaccine Acceptance Intervention at their clinic or CBOC. In addition, for clinics and CBOCs assigned to the Vaccine Acceptance Intervention, VAMC, clinic and CBOC leadership will need to agree to release PACT staff for an initial two-hour Motivational Interviewing (MI) training, and at least one 60-minute post-training consultation session over the one-year trial period. There will be additional consultation sessions offered to intervention clinics and CBOC staff, but these will be optional. |
|
| Usual Care Arm | No Intervention | A VAMC assigned to Usual Care will have no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID-19 vaccine acceptance. At both Intervention and Usual Care sites, the study team will perform quarterly "environmental scans". The environmental scan survey will include questions about site specific barriers to COVID-19 vaccination (first dose and second dose if needed), current programs/initiatives in the clinic or local community that are improving or have had no impact on vaccination rates, and the perceived importance that the VAMC/CBOC clinic staff is placing on vaccination (Environmental Scan Survey, in preparation). At Usual Care sites, a point of contact will be chosen from each clinic and CBOC to complete the environmental scan, and at Intervention sites, the Site Champion (see below) will perform the quarterly scan. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moving to COVID-19 Vaccine Acceptance Intervention | Behavioral | The intervention utilizes a multi-pronged approach to increase Veteran vaccine acceptance. First, the research team will train Health Behavior Coordinators (HBCs) at VAI sites. HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans. Whole Health Coaches, Peer Specialists and other VA Staff will conduct outreach calls, using strategies, with unvaccinated Veterans. |
| Measure | Description | Time Frame |
|---|---|---|
| Receipt of Any Dose COVID-19 Vaccination | A greater proportion of Veterans in the intervention group will receive any dose of COVID-19 vaccination compared to usual care. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Series Completion of COVID-19 Vaccination | A greater proportion of previously unvaccinated Veterans in the intervention arm will complete the primary series for COVID-19 vaccination compared to usual care | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 Booster Vaccination | Receipt of booster requires the Veteran needs to have completed the primary series of the COVID-19 vaccination. | 1 Year |
| Receipt of Flu Vaccine | Receipt of Flu Vaccine during study period. |
Inclusion Criteria:
Inclusion Criteria by Aim:
Aim 1: Primary care clinic visit in VISN 16 or 21
Aim 2: =1 visit(s) at a participating VISN 16 or 21 primary care clinic or CBOC after the start of the trial at their site, and at the time of recruitment, COVID-19 vaccination status is verified as one of the following:
Aim 3: Implementation-focused Interviews with VISN 16 and 21 Staff and HCPs
Exclusion Criteria:
Exclusion Criteria by Aim:
Aim 1: Per VISN or VAMC leadership, the clinic or CBOC has extreme staffing shortages such that it would not be feasible or in the best interests of patient care to allow clinic or CBOC staff release time to participate in trainings or other meetings related to the trial
Aim 2: Has initiated COVID-19 vaccination with one of the mRNA vaccines and is within the window to complete the second dose on schedule (< 42 days since dose 1)
Aim 3: Staff or HCPs declines invitation to participate in the interview
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| Name | Affiliation | Role |
|---|---|---|
| Karen H Seal, MD MPH | San Francisco VA Medical Center, San Francisco, CA | Principal Investigator |
| Jeffrey M Pyne, MD | Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR | Principal Investigator |
| Jennifer K Manuel, PhD | San Francisco VA Medical Center, San Francisco, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR | North Little Rock | Arkansas | 72114-1706 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37652356 | Result | Pyne JM, Seal KH, Manuel JK, DeRonne B, Oliver KA, Bertenthal D, Esserman D, Purcell N, Petrakis BA, Elwy AR. Developing and testing a COVID-19 vaccination acceptance intervention: A pragmatic trial comparing vaccine acceptance intervention vs usual care - Rationale, methods, and implementation. Contemp Clin Trials. 2023 Oct;133:107325. doi: 10.1016/j.cct.2023.107325. Epub 2023 Aug 29. | |
| 35852805 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | The VAHCS Internal Facilitator will partner with the trial External Facilitators (research team and designated External Facilitators in VISNS 16 and 21) to adapt and implement the study intervention to best meet the needs and preferences of their VAHCS site. In addition, each CBOC and clinic affiliated with a VAHCS in the Intervention arm will need to identify a Site Champion to provide clinic-specific information to facilitate implementation of the Vaccine Acceptance Intervention at their clinic or CBOC. In addition, for clinics and CBOCs assigned to the Vaccine Acceptance Intervention, VAHCS, clinic and CBOC leadership will need to agree to release PACT staff for an initial two-hour Motivational Interviewing (MI) training, and at least one 60-minute post-training consultation session over the one-year trial period. There will be additional consultation sessions offered to intervention clinics and CBOC staff, but these will be optional. Moving to COVID-19 Vaccine Acceptance Intervention: The intervention utilizes a multi-pronged approach to increase Veteran vaccine acceptance. First, the research team will train Health Behavior Coordinators (HBCs) at VAI sites. HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans. Whole Health Coaches, Peer Specialists and other VA Staff will conduct outreach calls, using strategies, with unvaccinated Veterans. |
| FG001 | Usual Care Arm | A VAHCS assigned to Usual Care will have no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID-19 vaccine acceptance. At both Intervention and Usual Care sites, the study team will perform quarterly "environmental scans". The environmental scan survey will include questions about site specific barriers to COVID-19 vaccination (first dose and second dose if needed), current programs/initiatives in the clinic or local community that are improving or have had no impact on vaccination rates, and the perceived importance that the VAMC/CBOC clinic staff is placing on vaccination (Environmental Scan Survey, in preparation). At Usual Care sites, a point of contact will be chosen from each clinic and CBOC to complete the environmental scan, and at Intervention sites, the Site Champion (see below) will perform the quarterly scan. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Veterans who had at least one primary care visit during the study period
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | The VAHCS Internal Facilitator will partner with the trial External Facilitators (research team and designated External Facilitators in VISNS 16 and 21) to adapt and implement the study intervention to best meet the needs and preferences of their VAHCS site. In addition, each CBOC and clinic affiliated with a VAHCS in the Intervention arm will need to identify a Site Champion to provide clinic-specific information to facilitate implementation of the Vaccine Acceptance Intervention at their clinic or CBOC. In addition, for clinics and CBOCs assigned to the Vaccine Acceptance Intervention, VAHCS, clinic and CBOC leadership will need to agree to release PACT staff for an initial two-hour Motivational Interviewing (MI) training, and at least one 60-minute post-training consultation session over the one-year trial period. There will be additional consultation sessions offered to intervention clinics and CBOC staff, but these will be optional. Moving to COVID-19 Vaccine Acceptance Intervention: The intervention utilizes a multi-pronged approach to increase Veteran vaccine acceptance. First, the research team will train Health Behavior Coordinators (HBCs) at VAI sites. HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans. Whole Health Coaches, Peer Specialists and other VA Staff will conduct outreach calls, using strategies, with unvaccinated Veterans. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Receipt of Any Dose COVID-19 Vaccination | A greater proportion of Veterans in the intervention group will receive any dose of COVID-19 vaccination compared to usual care. | Veterans with at least one primary care visit during the study period. | Posted | Count of Participants | Participants | 1 year |
|
1 Year of follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | The VAHCS Internal Facilitator will partner with the trial External Facilitators (research team and designated External Facilitators in VISNS 16 and 21) to adapt and implement the study intervention to best meet the needs and preferences of their VAHCS site. In addition, each CBOC and clinic affiliated with a VAHCS in the Intervention arm will need to identify a Site Champion to provide clinic-specific information to facilitate implementation of the Vaccine Acceptance Intervention at their clinic or CBOC. In addition, for clinics and CBOCs assigned to the Vaccine Acceptance Intervention, VAHCS, clinic and CBOC leadership will need to agree to release PACT staff for an initial two-hour Motivational Interviewing (MI) training, and at least one 60-minute post-training consultation session over the one-year trial period. There will be additional consultation sessions offered to intervention clinics and CBOC staff, but these will be optional. Moving to COVID-19 Vaccine Acceptance Intervention: The intervention utilizes a multi-pronged approach to increase Veteran vaccine acceptance. First, the research team will train Health Behavior Coordinators (HBCs) at VAI sites. HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans. Whole Health Coaches, Peer Specialists and other VA Staff will conduct outreach calls, using strategies, with unvaccinated Veterans. |
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Primary limitations were immunization ascertainment outside VHA. We supplemented using Medicare claims and state immunization registries, though neither covered the full period. VHA began querying state registries shortly before final data lock, with possible bias toward Veterans receiving more services. See SAP for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole McCamish | Veterans Affairs San Francisco HCS | 415-221-4810 | 24284 | nicole.mccamish@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2023 | Aug 20, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 11, 2023 | Aug 20, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 16, 2023 | Oct 4, 2023 | ICF_000.pdf |
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One-year cluster randomized parallel group trial, stratified by VISN, using covariate constrained randomization (e.g., rural/urban clinics, facility size). Specifically, the investigators will compare a Vaccine Acceptance Intervention versus Usual Care with randomization at the level of VA Medical Center (VAMC), with the intervention directed at VAMC clinic and CBOC PACT staff members.
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The study PIs and co-investigators, other research staff (except for the study statistician, see below), qualitative interviewers and participating VA staff will be unblinded because they are involved in delivering the intervention or, in the case of the qualitative researchers, will be tasked with interviewing study stakeholders about the intervention or implementation strategies. In contrast, the study evaluators, study statistician, and Veterans will be blinded to study arm assignment. Evaluators will conduct the study survey in Veterans, and while they will be aware of COVID-19 vaccination status, they will not be apprised of study arm. In addition, unless Veterans are unintentionally informed, Veterans will not know to which arm their VAMC has been randomized. Blinding of the study statistician conducting the outcomes analyses, survey evaluators, and the Veteran participants is important to protect the internal validity of study findings.
|
| 1 Year |
| San Francisco VA Medical Center, San Francisco, CA | San Francisco | California | 94121-1563 | United States |
| Result |
| Seal KH, Bertenthal D, Manuel JK, Pyne JM. Association of Demographic, Clinical, and Social Determinants of Health With COVID-19 Vaccination Booster Dose Completion Among US Veterans. JAMA Netw Open. 2022 Jul 1;5(7):e2222635. doi: 10.1001/jamanetworkopen.2022.22635. |
| 41680545 | Derived | Seal KH, Kaplan A, Manuel JK, Bertenthal D, Purcell N, DeRonne BM, Oliver KA, Esserman D, McCamish N, Mesidor M, Griffin B, Borsari B, Woodruff NA, Usman H, Pyne JM. A Cluster Randomized Trial of a Vaccination Communication Educational Intervention: Impact on COVID-19 Vaccine Uptake in Veterans. J Gen Intern Med. 2026 Jun;41(8):2217-2226. doi: 10.1007/s11606-026-10209-9. Epub 2026 Feb 12. |
| 41413473 | Derived | Pyne JM, Seal KH, Manuel JK, Kaplan AN, Purcell N, Bertenthal D, Esserman D, Mesidor M, DeRonne BM, Oliver KA, Griffin BJ, Simpson H, Woodruff N, Borsari B, Tobey-Moore L, Usman H. Factors contributing to COVID-19 vaccine hesitancy in Veterans later in the pandemic. BMC Public Health. 2025 Dec 19;26(1):295. doi: 10.1186/s12889-025-25716-3. |
| BG001 | Usual Care Arm | A VAHCS assigned to Usual Care will have no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID-19 vaccine acceptance. At both Intervention and Usual Care sites, the study team will perform quarterly "environmental scans". The environmental scan survey will include questions about site specific barriers to COVID-19 vaccination (first dose and second dose if needed), current programs/initiatives in the clinic or local community that are improving or have had no impact on vaccination rates, and the perceived importance that the VAMC/CBOC clinic staff is placing on vaccination (Environmental Scan Survey, in preparation). At Usual Care sites, a point of contact will be chosen from each clinic and CBOC to complete the environmental scan, and at Intervention sites, the Site Champion (see below) will perform the quarterly scan. |
| BG002 | Total | Total of all reporting groups |
| VAHCS |
|
| Years |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Baseline Primary Series Rate (Randomization Unit Level) | This baseline measure was the percent of the randomization unit's participants that completed the COVID-19 vaccine primary series at the time of randomization and was used during covariate-constrained randomization to balance study arms by higher and lower vaccination rates. | The number of units for this baseline measure are the number of randomization units assigned to each arm (i.e., 5 and 5). This measure is percentage of participants in each randomization unit who completed primary series at the time of randomization | Mean | Standard Deviation | Percent of Participants | VAHCS |
|
| Marriage Status | Count of Participants | Participants | Participants |
|
| Rurality | Count of Participants | Participants | Participants |
|
| Care Assessment Needs (CAN) Score 1 Year Event Probability | The CAN score is a comorbidity index defined as a probability of being hospitalized or of mortality within a year. The CAN score was determined at baseline in this study and is used as a covariate in primary analyses. | Mean | Standard Deviation | Probability | Participants |
|
| OG001 | Usual Care Arm | A VAHCS assigned to Usual Care will have no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID-19 vaccine acceptance. At both Intervention and Usual Care sites, the study team will perform quarterly "environmental scans". The environmental scan survey will include questions about site specific barriers to COVID-19 vaccination (first dose and second dose if needed), current programs/initiatives in the clinic or local community that are improving or have had no impact on vaccination rates, and the perceived importance that the VAMC/CBOC clinic staff is placing on vaccination (Environmental Scan Survey, in preparation). At Usual Care sites, a point of contact will be chosen from each clinic and CBOC to complete the environmental scan, and at Intervention sites, the Site Champion (see below) will perform the quarterly scan. |
|
|
|
| Secondary | Primary Series Completion of COVID-19 Vaccination | A greater proportion of previously unvaccinated Veterans in the intervention arm will complete the primary series for COVID-19 vaccination compared to usual care | Veterans without any COVID-19 vaccination prior to study start who also had at least one primary care visit during the study. | Posted | Count of Participants | Participants | 1 year |
|
|
|
|
| Other Pre-specified | COVID-19 Booster Vaccination | Receipt of booster requires the Veteran needs to have completed the primary series of the COVID-19 vaccination. | Veterans with at least one primary care visit and have completed the primary series either before or with enough time in the study period. | Posted | Count of Participants | Participants | 1 Year |
|
|
|
|
| Other Pre-specified | Receipt of Flu Vaccine | Receipt of Flu Vaccine during study period. | Veteran had to have at least one primary care visit during the study for primary analysis of this outcome. | Posted | Count of Participants | Participants | 1 Year |
|
|
|
|
| 0 |
| 148,291 |
| 0 |
| 148,291 |
| 0 |
| 148,291 |
| EG001 | Usual Care Arm | A VAHCS assigned to Usual Care will have no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID-19 vaccine acceptance. At both Intervention and Usual Care sites, the study team will perform quarterly "environmental scans". The environmental scan survey will include questions about site specific barriers to COVID-19 vaccination (first dose and second dose if needed), current programs/initiatives in the clinic or local community that are improving or have had no impact on vaccination rates, and the perceived importance that the VAMC/CBOC clinic staff is placing on vaccination (Environmental Scan Survey, in preparation). At Usual Care sites, a point of contact will be chosen from each clinic and CBOC to complete the environmental scan, and at Intervention sites, the Site Champion (see below) will perform the quarterly scan. | 0 | 190,427 | 0 | 190,427 | 0 | 190,427 |
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| Sensitivity analysis, same null hypothesis and model as primary analysis but different pool of patients: Not constrained to Veterans with at least one primary care visit | Regression, Logistic | GLMM | 0.893 | Odds Ratio (OR) | 0.978 | 2-Sided | 95 | 0.702 | 1.361 | Superiority |
| Sensitivity Analysis: same model and null hypothesis as primary outcome but the source of vaccination records omits Medicare claims data. The primary data source had included Medicare claims data on vaccination records as a supplement to the VA data. | Regression, Logistic | GLMM | 0.863 | Odds Ratio (OR) | 0.961 | 2-Sided | 95 | 0.613 | 1.507 | Superiority |
| Sensitivity Analysis: same model and null hypothesis as primary analysis model but the source of data is supplemented by state level registries, named "IZ Gateway", which was deployed summer of 2023 where Veteran records of vaccination could be updated at the VA from external vaccination facilities if the Veteran entered the VA in the same state as that vaccination facility. The primary analysis data contains Medicare claims data in this analysis, too. | Regression, Logistic | GLMM | 0.963 | Odds Ratio (OR) | 1.011 | 2-Sided | 95 | 0.636 | 1.607 | Superiority |
| Superiority |