Developing and Testing a COVID-19 Vaccination Acceptance Intervention

NCT05027464 | Completed Results DMC

• 1 other identifier: SDR 21-141
• Study Type: interventional
• Target: 338,718
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19 Vaccination

Keywords

COVID-19 Vaccine; Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Primary Series Completion of COVID-19 Vaccination

  1 year

Other Outcomes (2)

• COVID-19 Booster Vaccination

  1 Year

• Receipt of Flu Vaccine

  1 Year

Study Arms (2)

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.

Behavioral: Moving to COVID-19 Vaccine Acceptance Intervention

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.

Interventions

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Edith Nourse Rogers Memorial Veterans Hospital: collaborator
• Central Arkansas Veterans Healthcare System: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator

Study Sites (2)

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

North Little Rock, Arkansas, 72114-1706, United States

Location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

Location

Related Publications (2)

• 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.

  PMID: 37652356 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.

  PMID: 35852805 RESULT

Limitations and Caveats

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.

Results Point of Contact

• Title: Nicole McCamish
• Organization: Veterans Affairs San Francisco HCS

nicole.mccamish@va.gov

415-221-4810

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: August 30, 2021
• Study Start: April 5, 2022
• Primary Completion: August 30, 2023
• Study Completion: September 30, 2024
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)