Trial Outcomes & Findings for COVID-19 Vaccine Hesitancy Counseling Intervention for Pharmacists: A Stepped-Wedge Trial (NCT NCT06547814)

Last Updated: 2026-01-21

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 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

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

Results posted on

2026-01-21

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.

Unit of analysis: Pharmacy

Participant milestones

Participant milestones
Measure	Sequence 1: First 8 Weeks Standard, Next 8 Weeks Facilitation 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, 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. 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.	Sequence 2: First 16 Weeks Standard, Next 8 Weeks Facilitation 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, 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. 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.	Sequence 3: First 8 Weeks Standard, Next 16 Weeks Facilitation 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, 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. 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.
Early Fall 2024 STARTED	6 5	7 5	7 7
Early Fall 2024 COMPLETED	6 5	7 5	7 7
Early Fall 2024 NOT COMPLETED	0 0	0 0	0 0
Late Fall 2024 STARTED	6 5	7 5	7 7
Late Fall 2024 COMPLETED	6 5	7 5	7 7
Late Fall 2024 NOT COMPLETED	0 0	0 0	0 0
Winter 2024-2025 STARTED	6 5	7 5	7 7
Winter 2024-2025 COMPLETED	6 5	7 5	7 7
Winter 2024-2025 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: A Stepped-Wedge Trial

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 maximum.

Outcome measures

Outcome measures
Measure	Standard Implementation (Stage 1) n=180 Standardized patient interaction 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, 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 (Stage 2) n=138 Standardized patient interaction After completing the standard implementation, pharmacies 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 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 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	18.1 score on a scale Standard Deviation 1.7	18.4 score on a scale Standard Deviation 1.5

SECONDARY outcome

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

Population: One pharmacy did not document any conversations during either the standard implementation or 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.