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Completed

NCT Number: NCT06547814

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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 cross over 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard implementation webinar and online training

Behavioral

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.

Virtual facilitation

Behavioral

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).

Primary outcomes

  1. Mean Fidelity Score

    Time frame: 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 with values ranging from 1 to 3) 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. The overall composite competency score is the sum of the 7 items with scores ranging from 7 to 21, with higher scores reflecting greater competency in the 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 outcomes

  1. Proportion of Individuals Receiving Vaccine Hesitancy Counseling Who Chose to Get the COVID-19 Vaccine

    Time frame: From baseline through the end of the virtual facilitation periods, up to 24 weeks maximum.

    Effectiveness will be calculated as the proportion of patients who received the vaccine hesitancy counseling intervention who chose to get the COVID-19 vaccine. Pharmacists at each pharmacy were asked to document 30 conversations (10 per 8-week period). Pharmacists documented whether each of the patients elected to get the COVID-19 vaccine after their conversation.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • University of Arkansas
  • University of South Carolina

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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