COVID-19
Conditions
Keywords
vaccine hesitancy, fidelity, vaccination
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).
Interventions
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.
BEHAVIORALVirtual 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).
Sponsors
University of Arkansas
University of South Carolina
National Institute on Minority Health and Health Disparities (NIMHD)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
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.
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Fidelity Score | 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 (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Block 1 Standard Implementation Pharmacies begin with the standard implementation interventions for 8-16 weeks. | 0 |
| Block 1 Standard Implementation Pharmacies begin with the standard implementation interventions for 8-16 weeks. | 0 |
| Block 2 Standard Implementation Pharmacies begin with the standard implementation interventions for 8-16 weeks. | 0 |
| Block 2 Standard Implementation Pharmacies begin with the standard implementation interventions for 8-16 weeks. | 0 |
| Block 3 Standard Implementation Pharmacies begin with the standard implementation interventions for 8-16 weeks. | 0 |
| Block 3 Standard Implementation Pharmacies begin with the standard implementation interventions for 8-16 weeks. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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 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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Implementation (Stage 1) | Mean Fidelity Score | 20 score on a scale | Standard Deviation 0 |
| Virtual Facilitation (Stage 2) | Mean Fidelity Score | 15.82 score on a scale | Standard Deviation 2.06 |
Secondary
Proportion of Individuals Receiving Vaccine Hesitancy Counseling Who Chose to Get the COVID-19 Vaccine
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Implementation (Stage 1) | Proportion of Individuals Receiving Vaccine Hesitancy Counseling Who Chose to Get the COVID-19 Vaccine | 0.38 Proportion of patients vaccinated |
| Virtual Facilitation (Stage 2) | Proportion of Individuals Receiving Vaccine Hesitancy Counseling Who Chose to Get the COVID-19 Vaccine | 0.20 Proportion of patients vaccinated |
95% CI: [0.18, 1.16]