Clinical trial NCT05027464: Developing and Testing a COVID-19 Vaccination Acceptance Intervention
Official title: Developing and Testing a COVID-19 Vaccination Acceptance Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Vaccination
Keywords: COVID-19 Vaccine
Motivational Interviewing
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Edith Nourse Rogers Memorial Veterans Hospital
name: Central Arkansas Veterans Healthcare System
name: Minneapolis Veterans Affairs Medical Center
First posted: 2021-08-30
Enrollment: 338718
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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

Primary outcomes:
measure: Receipt of Any Dose COVID-19 Vaccination
timeFrame: 1 year
Secondary outcomes:
measure: Primary Series Completion of COVID-19 Vaccination
timeFrame: 1 year
Other outcomes:
measure: COVID-19 Booster Vaccination
timeFrame: 1 Year
measure: Receipt of Flu Vaccine
timeFrame: 1 Year
Locations:
city: North Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
state: Arkansas
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Karen H Seal, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
name: Jeffrey M Pyne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Jennifer K Manuel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.