Developing and Testing a COVID-19 Vaccination Acceptance Intervention
Purpose
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.
Condition
- COVID-19 Vaccination
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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
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) - Serious allergic reaction or other contraindication to COVID-19 vaccination or other vaccines (e.g., flu vaccine) - Currently in hospice care or < 6 months to live - No consistent ability to be contacted by phone - Participating in another COVID-19 trial or study (research study flag) - Moderate to severe dementia as documented in the patient's VA medical record - Increased suicide risk as indicated by behavioral health flag - Aim 3: Staff or HCPs declines invitation to participate in the interview
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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.
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention Arm |
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. |
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No Intervention Usual Care Arm |
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. |
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Recruiting Locations
More Details
- NCT ID
- NCT05027464
- Status
- Active, not recruiting
- Sponsor
- VA Office of Research and Development
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.