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

NCT06547814 | Completed Results

• 2 other identifiers: 22-2602b1R01MD018085
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

vaccine hesitancy; fidelity; vaccination; pharmacy

Outcome Measures

Primary Outcomes (1)

• Mean Fidelity Score

  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.

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

Secondary Outcomes (1)

• 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.

Study Arms (2)

Standard implementation (Stage 1)

EXPERIMENTAL

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

Behavioral: Standard implementation webinar and online training

Virtual facilitation (Stage 2)

EXPERIMENTAL

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

Behavioral: Virtual facilitation

Interventions

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.

Standard implementation (Stage 1)

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).

Virtual facilitation (Stage 2)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Arkansas: collaborator
• University of South Carolina: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (6)

• Curran GM, Shoemaker SJ. Advancing pharmacy practice through implementation science. Res Social Adm Pharm. 2017 Sep-Oct;13(5):889-891. doi: 10.1016/j.sapharm.2017.05.018. Epub 2017 Jun 1. No abstract available.

  PMID: 28619650 BACKGROUND

• Bauer MS, Miller CJ, Kim B, Lew R, Stolzmann K, Sullivan J, Riendeau R, Pitcock J, Williamson A, Connolly S, Elwy AR, Weaver K. Effectiveness of Implementing a Collaborative Chronic Care Model for Clinician Teams on Patient Outcomes and Health Status in Mental Health: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190230. doi: 10.1001/jamanetworkopen.2019.0230.

  PMID: 30821830 BACKGROUND

• Curran GM, Mukherjee S, Allee E, Owen RR. A process for developing an implementation intervention: QUERI Series. Implement Sci. 2008 Mar 19;3:17. doi: 10.1186/1748-5908-3-17.

  PMID: 18353186 BACKGROUND

• Parchman ML, Noel PH, Culler SD, Lanham HJ, Leykum LK, Romero RL, Palmer RF. A randomized trial of practice facilitation to improve the delivery of chronic illness care in primary care: initial and sustained effects. Implement Sci. 2013 Aug 22;8:93. doi: 10.1186/1748-5908-8-93.

  PMID: 23965255 BACKGROUND

• Knox L. Module 2: Practice Facilitation as a Resource for Practice Improvement. In: Quality AfHRa, ed. pcmh.ahrq.gov: AHRQ; 2015.

  BACKGROUND

• Shackley AG, Carpenter DM, Charton H, Teeter BS, Smith M, Hastings TJ, Hughes T, Curran G. Lessons learned in optimizing recruitment and data collection for a pharmacy-based implementation trial. J Am Pharm Assoc (2003). 2026 Jan-Feb;66(1):102972. doi: 10.1016/j.japh.2025.102972. Epub 2025 Nov 3.

  PMID: 41192509 BACKGROUND

MeSH Terms

Conditions

COVID-19; Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Abby Shackley, MA
• Organization: University of North Carolina at Chapel Hill

abigail_gamble@email.unc.edu

828-407-2107

Study Officials

• Delesha M Carpenter, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Geoffrey Curran, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study staff who are rating fidelity will be blinded to whether the observation is from the standard implementation or virtual facilitation condition.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: August 5, 2024
• Primary Completion: March 7, 2025
• Study Completion: April 1, 2025
• Last Updated: January 21, 2026
• Results First Posted: January 12, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)