COVID-19 Vaccine Hesitancy Counseling Intervention for Pharmacists

Study Overview
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Brief Summary
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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 four 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
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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 four 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 2023 vaccine administration schedule by the Federal Drug Administration, we anticipate implementing the study over two vaccination seasons (Fall 2023 and Fall 2024).

Official Title
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Addressing COVID-19 Vaccine Hesitancy in Rural Community Pharmacies Reducing Disparities Through an Implementation Science Approach

Conditions
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COVID-19

Intervention / Treatment
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* Behavioral: Standard implementation webinar and online training
* Behavioral: Virtual facilitation


Participation Criteria
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Eligibility Criteria
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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 32.9% or had at least 58% of the population vote for a Republican president in 2020. Exclusion Criteria: The pharmacy will be excluded if it does not offer COVID-19 primary series or booster vaccines.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard implementation (Stage 1)<br>Participants begin with the standard implementation interventions for 8-16 weeks, depending on random block assignment. | Behavioral: Standard implementation webinar and online training<br>* The one-hour webinar (either live or pre-recorded) will include updated information about the COVID-19 virus, variant nomenclature, booster 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.<br>|
| Experimental: Virtual facilitation (Stage 2)<br>After completing the standard implementation, participants then complete the virtual facilitation intervention for 8-16 weeks, depending on random block assignment. | Behavioral: Virtual facilitation<br>* This intervention involves a 30-minute virtual facilitation site visit and 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Fidelity Score | The fidelity measure focuses on the competence and skill of the pharmacist (6 items) in their delivery of the vaccine hesitancy counseling intervention. Items assess whether they expressed empathy, used non-confrontational manner, spoke confidently without using jargon, emphasized patient autonomy, reflected back patient's statements accurately, and used a respectful demeanor. 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 12, with higher scores reflecting greater competency in delivery of the vaccine hesitancy intervention. Fidelity will be measured for each pharmacist four 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 max. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 percentage of vaccine hesitant individuals who received the vaccine. | From baseline through the end of the virtual facilitation periods, up to 24 weeks max. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine hesitancy, fidelity, vaccination