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

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
The investigators will use an incomplete stepped wedge cluster randomized design, where units (pharmacies) begin in one condition (standard implementation approach) and "crossover" to the other condition (virtual facilitation).
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)
Masking Description
Study staff who are rating fidelity will be blinded to whether the observation is from the standard implementation or virtual facilitation condition.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Standard implementation (Stage 1) 		Participants begin with the standard implementation interventions for 8-16 weeks, depending on random block assignment.
  • Behavioral: Standard implementation webinar and online training
    The one-hour webinar (either live or pre-recorded) will include updated information about the COVID-19 virus, variant nomenclature, vaccine eligibility, mechanisms of action, and outcomes. The 30-minute online training addresses how to communicate about COVID-19 vaccinations, presents a 5-step process for initiating conversations, includes example verbiage about how to address specific concerns, and has example videos that show how to implement the 5-step process with vaccine hesitant patients.
Experimental
Virtual facilitation (Stage 2) 		After completing the standard implementation, participants then complete the virtual facilitation intervention for 8-16 weeks, depending on random block assignment.
  • Behavioral: Virtual facilitation
    This intervention involves a 30-minute virtual facilitation site visit and at least 8, 30-minute virtual facilitator coaching sessions. The virtual site visit over Zoom will establish the personnel and workflows at each pharmacy and allow the facilitator to establish rapport. Weekly Zoom calls will allow the virtual facilitator to work with a participant to review overall implementation challenges associated with approaching patients, delivering the intervention, and documenting results. Lastly, either the facilitator or the participant can request and schedule a Zoom call to go over any pressing implementation issue in need of rapid attention (e.g., technical difficulties with the website).

Recruiting Locations

More Details

NCT ID
NCT06547814
Status
Enrolling by invitation
Sponsor
University of North Carolina, Chapel Hill

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).