COVID-19 Vaccine Hesitancy Counseling Intervention for Pharmacists: A Stepped-Wedge Trial

Not Applicable

• Conditions: COVID-19
• Interventions: Behavioral: Virtual facilitation; Behavioral: Standard implementation webinar and online training

• Registration Number: NCT06547814
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

Because COVID-19 vaccination conversations are sensitive and often politically charged, pharmacists need implementation support, including training and ongoing guidance to deliver evidence-based vaccine hesitancy counseling interventions. Implementation facilitation, in which trained facilitators coach and troubleshoot problems with professionals as they implement new practices, increases adoption of practices with fidelity. However, implementation facilitation generally, and virtual facilitation (e.g., video coaching) in particular, has not been systematically studied in community pharmacy settings.

The goal of this study is to test if virtual facilitation 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). Using a rural pharmacy practice-based research network (PBRN) that spans 7 southeastern states, the investigators will conduct a stepped-wedge trial with 30 rural pharmacies to test whether virtual facilitation outperforms the standard approach in increasing the fidelity with which pharmacists implement the vaccine hesitancy counseling intervention. Using a project-sponsored data collection system, the investigators will gather data on implementation outcomes, including fidelity and effectiveness.

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 the standard implementation period, they will crossover 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. Based on a proposed Fall 2024 vaccine administration schedule by the Federal Drug Administration, the investigators anticipate implementing the study over two vaccination seasons (Fall 2024 and Fall 2025).

Study Timeline

• Study Start: 2024-08-05
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-07
• Study First Posted: 2024-08-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• The pharmacy must be a member of the Rural Research Alliance for Community Pharmacies (RURAL-CP).
• The pharmacy must be located in a county that has an African American population of at least 25% or had at least 51% of the population vote for a Republican president in 2020.

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Exclusion Criteria

• The pharmacy will be excluded if it does not offer COVID-19 vaccines.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Virtual facilitation (Stage 2)	Virtual facilitation	After completing the standard implementation, participants then complete the virtual facilitation intervention for 8-16 weeks, depending on random block assignment.
Standard implementation (Stage 1)	Standard implementation webinar and online training	Participants begin with the standard implementation interventions for 8-16 weeks, depending on random block assignment.

Primary Outcome Measures

Name	Time	Method
Mean Fidelity Score	From baseline through the end of the virtual facilitation periods, up to 24 weeks maximum.	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Individuals Receiving Vaccine Hesitancy Counseling Who Chose to Get the COVID-19 Vaccine	From baseline through the end of the virtual facilitation periods, up to 24 weeks maximum.	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.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States