Trial Outcomes & Findings for COVID-19 Vaccine Hesitancy Counseling Intervention for Pharmacists (NCT NCT05926544)

Last Updated: 2026-01-14

Results Overview

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 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.

Recruitment status

TERMINATED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

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

Results posted on

2026-01-14

Participant Flow

Pharmacies begin with the standard implementation interventions for 8-16 weeks and after completing the standard implementation, then complete the virtual facilitation intervention for 8-16 weeks, then move into follow-up period for 8 weeks.

Unit of analysis: Pharmacy

Participant milestones

Participant milestones
Measure	Sequence 1: Oct-Nov 23 8 Weeks Standard, Dec-Jan 8 Weeks Facilitation, Feb-Mar 24 8 Weeks Follow Up Pharmacies begin with the standard implementation intervention for 8 weeks. This involves a webinar and online training. The 1-hour webinar (either live or pre-recorded) includes 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. After completing the standard implementation, pharmacies then complete the virtual facilitation intervention for 8 weeks. This involves a 30-minute virtual facilitation site visit and 8 30-minute virtual facilitator coaching sessions. The virtual site visit over Zoom establishes the personnel and workflows at each pharmacy and allows the facilitator to establish rapport. Weekly Zoom calls allow the virtual facilitator to work with a pharmacy to review overall implementation challenges associated with approaching patients, delivering the intervention, and documenting results. After completing the virtual facilitation, pharmacies move into follow-up period for 8 weeks.	Sequence 2: Oct 23-Jan 24 16 Weeks Standard, Feb-Mar 8 Weeks Facilitation, Aug-Sep 8 Weeks Follow up Pharmacies begin with the standard implementation intervention for 16 weeks. This involves a webinar and online training. The 1-hour webinar (either live or pre-recorded) includes 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. After completing the standard implementation, pharmacies then complete the virtual facilitation intervention for 8 weeks. This involves a 30-minute virtual facilitation site visit and 8 30-minute virtual facilitator coaching sessions. The virtual site visit over Zoom establishes the personnel and workflows at each pharmacy and allows the facilitator to establish rapport. Weekly Zoom calls allow the virtual facilitator to work with a pharmacy to review overall implementation challenges associated with approaching patients, delivering the intervention, and documenting results. After completing the virtual facilitation, pharmacies move into follow-up period for 8 weeks.	Sequence 3: Oct-Nov 23 8 Weeks Standard, Dec-Mar 16 Weeks Facilitation, Aug-Sep 24 8 Weeks Follow up Pharmacies begin with the standard implementation intervention for 8 weeks. This involves a webinar and online training. The 1-hour webinar (either live or pre-recorded) includes 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. After completing the standard implementation, pharmacies then complete the virtual facilitation intervention for 16 weeks. This involves a 30-minute virtual facilitation site visit and 8 30-minute virtual facilitator coaching sessions. The virtual site visit over Zoom establishes the personnel and workflows at each pharmacy and allows the facilitator to establish rapport. Weekly Zoom calls allow the virtual facilitator to work with a pharmacy to review overall implementation challenges associated with approaching patients, delivering the intervention, and documenting results. After completing the virtual facilitation, pharmacies move into follow-up period for 8 weeks.
Oct-Nov 2023 STARTED	6 6	5 5	5 5
Oct-Nov 2023 COMPLETED	5 5	5 5	5 5
Oct-Nov 2023 NOT COMPLETED	1 1	0 0	0 0
Dec 2023-Jan 2024 STARTED	5 5	5 5	5 5
Dec 2023-Jan 2024 COMPLETED	5 5	4 4	5 5
Dec 2023-Jan 2024 NOT COMPLETED	0 0	1 1	0 0
Feb-Mar 2024 STARTED	5 5	4 4	5 5
Feb-Mar 2024 COMPLETED	1 1	4 4	5 5
Feb-Mar 2024 NOT COMPLETED	4 4	0 0	0 0
Aug-Sep 2024 STARTED	0 0	0 0	0 0
Aug-Sep 2024 COMPLETED	0 0	0 0	0 0
Aug-Sep 2024 NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

COVID-19 Vaccine Hesitancy Counseling Intervention for Pharmacists

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: From baseline through the end of the virtual facilitation periods, up to 24 weeks max.

Population: Pharmacists were unable to record actual conversations at the pharmacy and the approach was changed to a standardized patient audio recording. This change was made towards the end of the Standard implementation period thus only 1 pharmacy provided data using the viable method. Data successfully collected from 9 pharmacies in the Virtual facilitation period.

Outcome measures

Outcome measures
Measure	Standard Implementation (Stage 1) n=1 Pharmacies Pharmacies begin with the standard implementation interventions for 8-16 weeks, depending on random block assignment. 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.	Virtual Facilitation (Stage 2) n=9 Pharmacies After completing the standard implementation, participants then complete the virtual facilitation intervention for 8-16 weeks, depending on random block assignment. 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 pharmacy 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).
Mean Fidelity Score	20 score on a scale Standard Deviation 0	15.82 score on a scale Standard Deviation 2.06

SECONDARY outcome

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

Population: Not all pharmacists documented their conversations with COVID vaccine hesitant patients, resulting in missing data from both the standard implementation and virtual facilitation periods.

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.

Outcome measures

Outcome measures
Measure	Standard Implementation (Stage 1) n=85 Conversations documented Pharmacies begin with the standard implementation interventions for 8-16 weeks, depending on random block assignment. 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.	Virtual Facilitation (Stage 2) n=82 Conversations documented After completing the standard implementation, participants then complete the virtual facilitation intervention for 8-16 weeks, depending on random block assignment. 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 pharmacy 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).
Proportion of Individuals Receiving Vaccine Hesitancy Counseling Who Chose to Get the COVID-19 Vaccine	0.38 Proportion of patients vaccinated	0.20 Proportion of patients vaccinated

Additional Information

Abby Gamble, MA

University of North Carolina at Chapel Hill

Phone: 828-513-0636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place