COVID-19 Vaccination
Conditions
Keywords
COVID-19 Vaccine, Motivational Interviewing
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMoving 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.
Sponsors
Edith Nourse Rogers Memorial Veterans Hospital
Central Arkansas Veterans Healthcare System
Minneapolis Veterans Affairs Medical Center
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * has not initiated COVID-19 vaccination * has initiated one of the two mRNA vaccines and is outside the window for the second dose * recently completed COVID-19 vaccination (has completed two doses of mRNA vaccination or has completed the single-dose Janssen/Johnson & Johnson vaccine within the past 60 days) * Aim 3: Implementation-focused Interviews with VISN 16 and 21 Staff and HCPs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of Any Dose COVID-19 Vaccination | 1 year | A greater proportion of Veterans in the intervention group will receive any dose of COVID-19 vaccination compared to usual care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Series Completion of COVID-19 Vaccination | 1 year | A greater proportion of previously unvaccinated Veterans in the intervention arm will complete the primary series for COVID-19 vaccination compared to usual care |
Other
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 Booster Vaccination | 1 Year | Receipt of booster requires the Veteran needs to have completed the primary series of the COVID-19 vaccination. |
| Receipt of Flu Vaccine | 1 Year | Receipt of Flu Vaccine during study period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 148,291 |
| 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. | 5 |
| 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. | 190,427 |
| 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. | 5 |
| Total | 338,728 |
Baseline characteristics
| Characteristic | Intervention Arm | Usual Care Arm | Total |
|---|---|---|---|
| Age, Continuous | 63.3 Years STANDARD_DEVIATION 15.1 | 62.9 Years STANDARD_DEVIATION 16 | 63.1 Years STANDARD_DEVIATION 15.6 |
| Baseline Primary Series Rate (Randomization Unit Level) | 61.8 Percent of Participants STANDARD_DEVIATION 6.3 | 64.2 Percent of Participants STANDARD_DEVIATION 6.6 | 63.0 Percent of Participants STANDARD_DEVIATION 5.89 |
| Care Assessment Needs (CAN) Score 1 Year Event Probability | 0.181 Probability STANDARD_DEVIATION 0.175 | 0.179 Probability STANDARD_DEVIATION 0.174 | 0.180 Probability STANDARD_DEVIATION 0.174 |
| Marriage Status Divorced/Separated | 38165 Participants | 49476 Participants | 87641 Participants |
| Marriage Status Married/Common Law | 80240 Participants | 105951 Participants | 186191 Participants |
| Marriage Status Single/Never Married | 22233 Participants | 25002 Participants | 47235 Participants |
| Marriage Status Unknown | 2786 Participants | 2514 Participants | 5300 Participants |
| Marriage Status Widow/Widower | 4867 Participants | 7484 Participants | 12351 Participants |
| Race/Ethnicity, Customized Ethnicity Declined to Answer | 1717 Participants | 2655 Participants | 4372 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 9005 Participants | 17336 Participants | 26341 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 129305 Participants | 161567 Participants | 290872 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown | 8264 Participants | 8869 Participants | 17133 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1081 Participants | 1810 Participants | 2891 Participants |
| Race/Ethnicity, Customized Race Asian | 8451 Participants | 3918 Participants | 12369 Participants |
| Race/Ethnicity, Customized Race Black or African American | 32918 Participants | 32313 Participants | 65231 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 6192 Participants | 2050 Participants | 8242 Participants |
| Race/Ethnicity, Customized Race Unknown | 15245 Participants | 19366 Participants | 34611 Participants |
| Race/Ethnicity, Customized Race White | 84404 Participants | 130970 Participants | 215374 Participants |
| Region of Enrollment United States | 148291 participants | 190427 participants | 338718 participants |
| Rurality Highly Rural | 1399 Participants | 1514 Participants | 2913 Participants |
| Rurality Rural | 40958 Participants | 59849 Participants | 100807 Participants |
| Rurality Unknown | 2709 Participants | 28 Participants | 2737 Participants |
| Rurality Urban | 103225 Participants | 129036 Participants | 232261 Participants |
| Sex/Gender, Customized Female | 14406 Participants | 18094 Participants | 32500 Participants |
| Sex/Gender, Customized Male | 131215 Participants | 168777 Participants | 299992 Participants |
| Sex/Gender, Customized Unknown | 2670 Participants | 3556 Participants | 6226 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 148,291 | 0 / 190,427 |
| other Total, other adverse events | 0 / 148,291 | 0 / 190,427 |
| serious Total, serious adverse events | 0 / 148,291 | 0 / 190,427 |
Outcome results
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.
Time frame: 1 year
Population: Veterans with at least one primary care visit during the study period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Receipt of Any Dose COVID-19 Vaccination | 57621 Participants |
| Usual Care Arm | Receipt of Any Dose COVID-19 Vaccination | 65407 Participants |
Comparison: Generalized linear mixed model to account for patient demographics and hierarchical levels for clinics nested within VAHCS. Null hypothesis is that both arms perform equivalently in vaccine uptake after a year. Power was based on recruited VAHCSs and at least 1,000 Veterans per clinic. Using two-sided 0.05 type I error rate, 5-20% outcome rate in UC, we have 90% power to detect between a 9.6% and 14.6% difference with a total sample size of 90,000 to 100,000.p-value: 0.20295% CI: [0.888, 1.759]Regression, Logistic
Comparison: 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 visitp-value: 0.24795% CI: [0.867, 1.738]Regression, Logistic
Comparison: Sensitivity analysis; same model and null hypothesis but reassigning small clinics to their parent VAHCS facility, small meaning \< 100 participants. This data set uses the primary analysis data set with the primary visit constraint.p-value: 0.45595% CI: [0.684, 2.334]Regression, Logistic
Comparison: 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.p-value: 0.36495% CI: [0.765, 2.075]Regression, Logistic
Comparison: 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.p-value: 0.16895% CI: [0.904, 1.778]Regression, Logistic
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
Time frame: 1 year
Population: Veterans without any COVID-19 vaccination prior to study start who also had at least one primary care visit during the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Primary Series Completion of COVID-19 Vaccination | 378 Participants |
| Usual Care Arm | Primary Series Completion of COVID-19 Vaccination | 533 Participants |
Comparison: Power calculation is similar to the calculation for the primary outcome. Null hypothesis is described in the outcome comparison related to this statistical analysis plan.p-value: 0.97695% CI: [0.643, 1.535]Regression, Logistic
Comparison: 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 visitp-value: 0.89395% CI: [0.702, 1.361]Regression, Logistic
Comparison: 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.p-value: 0.86395% CI: [0.613, 1.507]Regression, Logistic
Comparison: 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.p-value: 0.96395% CI: [0.636, 1.607]Regression, Logistic
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.
Time frame: 1 Year
Population: Veterans with at least one primary care visit and have completed the primary series either before or with enough time in the study period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | COVID-19 Booster Vaccination | 56408 Participants |
| Usual Care Arm | COVID-19 Booster Vaccination | 63909 Participants |
Comparison: No power calculation for this exploratory outcome. Null hypothesis is that both arms will have equal uptake rates of the COVID-19 Booster vaccination during the study period.p-value: 0.39595% CI: [0.796, 1.781]Regression, Logistic
Other Pre-specified
Receipt of Flu Vaccine
Receipt of Flu Vaccine during study period.
Time frame: 1 Year
Population: Veteran had to have at least one primary care visit during the study for primary analysis of this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Receipt of Flu Vaccine | 76295 Participants |
| Usual Care Arm | Receipt of Flu Vaccine | 96561 Participants |
Comparison: Null hypothesis is that both study arms will have equal rates of flu vaccination uptake during the study period. No power calculation since this outcome is exploratory.p-value: 0.11995% CI: [0.97, 1.311]Regression, Logistic