COVID-19 Vaccine Hesitancy Counseling Intervention for Pharmacists: A Stepped-Wedge Trial
NCT Number: NCT06547814
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: COVID-19
Interventions: BEHAVIORAL: Standard implementation webinar and online training|BEHAVIORAL: Virtual facilitation
Sponsor: University of North Carolina, Chapel Hill
Collaborators: University of Arkansas|University of South Carolina|National Institute on Minority Health and Health Disparities (NIMHD)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-14
Completion Date: 2026-03-01
Locations: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States

Summary:
The goal of this clinical trial is to test if virtual facilitation (e.g., video coaching) increases rural pharmacists' ability to implement COVID-19 vaccine hesitancy counseling when compared to a "standard" implementation approach (e.g., training and dissemination of implementation support tools) in rural pharmacies. The main question it aims to answer is if virtual facilitation improves fidelity to a newly developed vaccine hesitancy counseling intervention when compared to standard implementation.

All participants will begin in the standard implementation condition, where they will complete a webinar on COVID-19 vaccinations and a 30-minute online training on vaccine hesitancy communication. After standard implementation, they will switch to the virtual facilitation condition where they will be assigned a virtual coach to help them with implementing the intervention. There will be six fidelity observations per each 8-week intervention period to determine whether pharmacists are implementing the intervention as intended. Researchers will compare fidelity between the standard and virtual facilitation conditions.

Primary Outcome Measures: Mean Fidelity Score, The fidelity measure focuses on the competence and skill of the pharmacist (7 items) in their delivery of the vaccine hesitancy counseling intervention. Each competence item will be assessed on a scale from 0 to 2, with 0=skill not demonstrated, 1=skill needs development, and 2=skill demonstrated with competence. Competence scale scores will range from 0 to 14, with higher scores reflecting greater competency in delivery of the vaccine hesitancy intervention. Fidelity will be measured for each pharmacist six times per each 8-week intervention period under the standard implementation approach and the virtual facilitation approach. In pharmacies with more than one pharmacist, fidelity ratings will be averaged to achieve a pharmacy-level measure., From baseline through the end of the virtual facilitation periods, up to 24 weeks maximum.
Secondary Outcome Measures: Proportion of Individuals Receiving Vaccine Hesitancy Counseling Who Chose to Get the COVID-19 Vaccine, Effectiveness will be calculated as the proportion of individuals who received the vaccine hesitancy counseling intervention who chose to get the COVID-19 vaccine. Effectiveness scores will range from 0 to 1, with higher scores reflecting a greater proportion of vaccine hesitant individuals who received the vaccine., From baseline through the end of the virtual facilitation periods, up to 24 weeks maximum.