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Developing and Testing a COVID-19 Vaccination Acceptance Intervention (CoVAcS)

Primary Purpose

COVID-19 Vaccination

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Moving to COVID-19 Vaccine Acceptance Intervention

About this trial

This is an interventional health services research trial for COVID-19 Vaccination focused on measuring COVID-19 Vaccine, Motivational Interviewing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
San Francisco VA Medical Center, San Francisco, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Usual Care Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

COVID-19 Vaccination Status

A greater proportion of previously unvaccinated Veterans in the intervention group will receive COVID-19 vaccination compared to usual care.

Secondary Outcome Measures

Seasonal Influenza Vaccination Status

A greater proportion of Veterans in the intervention arm will receive the seasonal flu vaccination compared to usual care

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.

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.

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.

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.

Full Information

NCT ID

NCT05027464

First Posted

August 26, 2021

Last Updated

October 4, 2023

Sponsor

VA Office of Research and Development

Collaborators

Edith Nourse Rogers Memorial Veterans Hospital, Central Arkansas Veterans Healthcare System, Minneapolis Veterans Affairs Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05027464

Brief Title

Developing and Testing a COVID-19 Vaccination Acceptance Intervention

Acronym

CoVAcS

Official Title

Developing and Testing a COVID-19 Vaccination Acceptance Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 5, 2022 (Actual)

Primary Completion Date

August 30, 2023 (Actual)

Study Completion Date

October 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

Collaborators

Edith Nourse Rogers Memorial Veterans Hospital, Central Arkansas Veterans Healthcare System, Minneapolis Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Vaccination

Keywords

COVID-19 Vaccine, Motivational Interviewing

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantOutcomes 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.

Allocation

Randomized

Enrollment

230 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Arm

Arm Type

Experimental

Arm Description

Arm Title

Usual Care Arm

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Moving to COVID-19 Vaccine Acceptance Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

COVID-19 Vaccination Status

Description

A greater proportion of previously unvaccinated Veterans in the intervention group will receive COVID-19 vaccination compared to usual care.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Seasonal Influenza Vaccination Status

Description

A greater proportion of Veterans in the intervention arm will receive the seasonal flu vaccination compared to usual care

Time Frame

1 year

Title

Survey of Veterans from Intervention and Usual Care who did and did not receive COVID-19 vaccination

Description

Time Frame

18 months

Title

Qualitative Interview with purposive subset of Veterans from Intervention and Usual Care who did and did not receive COVID-19 vaccination

Description

Time Frame

18 months

Title

Qualitative Interviews with VA staff and Healthcare Providers

Description

Time Frame

18 months

Title

Secondary Analysis of VA National Data

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen H Seal, MD MPH

Organizational Affiliation

San Francisco VA Medical Center, San Francisco, CA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jeffrey M Pyne, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

North Little Rock

State/Province

Arkansas

ZIP/Postal Code

72114-1706

Country

United States

Facility Name

San Francisco VA Medical Center, San Francisco, CA

City

San Francisco

State/Province

California

ZIP/Postal Code

94121-1563

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Developing and Testing a COVID-19 Vaccination Acceptance Intervention

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