Developing and Testing a COVID-19 Vaccination Acceptance Intervention

Study Overview
=================
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.

Official Title
-----------------
Developing and Testing a COVID-19 Vaccination Acceptance Intervention

Conditions
-----------------
COVID-19 Vaccination

Intervention / Treatment
-----------------
* Behavioral: Moving to COVID-19 Vaccine Acceptance Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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. | Behavioral: Moving to COVID-19 Vaccine Acceptance Intervention<br>* 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.<br>|
| No Intervention: Usual Care Arm<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 Vaccination Status | A greater proportion of previously unvaccinated Veterans in the intervention group will receive COVID-19 vaccination compared to usual care. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seasonal Influenza Vaccination Status | A greater proportion of Veterans in the intervention arm will receive the seasonal flu vaccination compared to usual care | 1 year | 
| Survey of Veterans from Intervention and Usual Care who did and did not receive COVID-19 vaccination | The survey will examine predictors of COVID-19 vaccine acceptance and are organized according to the World Health Organization Behavioral and Social Drivers of Vaccination (BeSD) framework. The survey includes questions from Centers for Disease Control and multiple VA surveys. | 18 months | 
| Qualitative Interview with purposive subset of Veterans from Intervention and Usual Care who did and did not receive COVID-19 vaccination | In purposive subset of Veterans, the investigators will conduct deeper-dive qualitative interviews to explore with Veterans' HCPs influence their decisions to accept COVID-19 vaccination and which factors (e.g., trust in VA HCPs, correct information about vaccines, prior experiences with VA healthcare, risk perception, perceived lack of time/access, and/or discrimination) are most influential in Veterans' decision-making regarding COVID-19 vaccination. | 18 months | 
| Qualitative Interviews with VA staff and Healthcare Providers | Conduct mid-trial and end-of-trial qualitative interviews with VISN 16 and 21 study stakeholders, (i.e., a purposive sample of VA staff and HCPs from sites with high and low vaccination rates) to learn which aspects of the Vaccine Acceptance Intervention and which implementation strategies were helpful (or not) in improving Veteran vaccine acceptance and access. | 18 months | 
| Secondary Analysis of VA National Data | The investigators will utilize the VA Corporate Data Warehouse (CDW) and other VA administrative data (e.g., VA Shared COVID-19 Data Resource), to assess other independent predictors of vaccine acceptance, including sociodemographic factors, clinical diagnoses, and health services utilization. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 Vaccine, Motivational Interviewing