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

University of North Carolina (UNC)

Status: Invitation-only

Conditions: COVID-19

Treatments: Behavioral: Virtual facilitation; Behavioral: Standard implementation webinar and online training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06547814

1R01MD018085 (U.S. NIH Grant/Contract)

22-2602b

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Standard implementation (Stage 1)

Experimental group

Description:

Participants begin with the standard implementation interventions for 8-16 weeks, depending on random block assignment.

Treatment:

Behavioral: Standard implementation webinar and online training

Virtual facilitation (Stage 2)

Experimental group

Description:

After completing the standard implementation, participants then complete the virtual facilitation intervention for 8-16 weeks, depending on random block assignment.

Treatment:

Behavioral: Virtual facilitation