COVID-19 Vaccine Hesitancy Counseling Intervention for Pharmacists

• ClinicalTrials.gov Identifier: NCT05926544
• Recruitment Status: Enrolling by invitation
• First Posted: July 3, 2023
• Last Update Posted: October 5, 2023
• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: University of Arkansas; University of South Carolina; National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Tracking Information

• First Submitted Date: June 28, 2023
• First Posted Date: July 3, 2023
• Last Update Posted Date: October 5, 2023
• Actual Study Start Date: October 4, 2023
• Estimated Primary Completion Date: February 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 28, 2023)

Mean Fidelity Score [ Time Frame: From baseline through the end of the virtual facilitation periods, up to 24 weeks max. ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 28, 2023)

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 max. ]

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: COVID-19 Vaccine Hesitancy Counseling Intervention for Pharmacists
• Official Title: Addressing COVID-19 Vaccine Hesitancy in Rural Community Pharmacies Reducing Disparities Through an Implementation Science Approach

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 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

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).

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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).

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.

Primary Purpose: Health Services Research

• Condition: COVID-19

Intervention

• 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, 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.

• Behavioral: Virtual facilitation
  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).

Study Arms

• Experimental: Standard implementation (Stage 1)
  Participants begin with the standard implementation interventions for 8-16 weeks, depending on random block assignment.
  Intervention: Behavioral: Standard implementation webinar and online training
• 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.
  Intervention: Behavioral: Virtual facilitation

Publications *

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

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: June 28, 2023): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 1, 2025
• Estimated Primary Completion Date: February 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05926544
• Other Study ID Numbers: 22-2602; 1R01MD018085 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• Supporting Materials: 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.

• Current Responsible Party: University of North Carolina, Chapel Hill
• Original Responsible Party: Same as current
• Current Study Sponsor: University of North Carolina, Chapel Hill
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Principal Investigator: Delesha M Carpenter, PhD; University of North Carolina, Chapel Hill
• Principal Investigator: Geoffrey Curran, PhD; University of Arkansas

• PRS Account: University of North Carolina, Chapel Hill
• Verification Date: October 2023