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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD018085 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Arkansas | OTHER |
| University of South Carolina | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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 cross over 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. Based on a proposed Fall 2024 vaccine administration schedule by the Federal Drug Administration, the investigators anticipate implementing the study over two vaccination seasons (Fall 2024 and Fall 2025).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard implementation (Stage 1) | Experimental | Participants begin with the standard implementation interventions for 8-16 weeks, depending on random block assignment. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Delesha M Carpenter, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Geoffrey Curran, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28619650 | Background | 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. | |
| 30821830 | 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. |
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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.
Beginning 9 and continuing for 36 months following publication
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Early Fall 2024 |
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| Late Fall 2024 |
| |||||||||||||
| Winter 2024-2025 |
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The unit of analysis is pharmacy and no baseline characteristics were collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Block 1 Standard Implementation | Pharmacies begin with the standard implementation interventions for 8-16 weeks. |
| BG001 | Block 2 Standard Implementation | Pharmacies begin with the standard implementation interventions for 8-16 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age data were not collected. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 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. | Posted | Mean | Standard Deviation | score on a scale | From baseline through the end of the virtual facilitation periods, up to 24 weeks maximum. | Standardized patient interaction | Standardized patient interaction |
|
This study did not monitor for untoward medical occurrences/adverse events.
Per the study protocol, participating pharmacists were not considered to be at risk for medically-related adverse events. An example of a relevant "adverse event" would be a data breach which although study-related is not a medical event. Therefore, adverse events data collection was not a part of this protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Block 1 Standard Implementation | Pharmacies begin with the standard implementation interventions for 8-16 weeks. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abby Shackley, MA | University of North Carolina at Chapel Hill | 828-407-2107 | abigail_gamble@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2025 | Nov 21, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 30, 2024 | Nov 21, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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).
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Study staff who are rating fidelity will be blinded to whether the observation is from the standard implementation or virtual facilitation condition.
|
| 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). |
|
| From baseline through the end of the virtual facilitation periods, up to 24 weeks maximum. |
| 18353186 | 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. |
| 23965255 | 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. |
| Background | Knox L. Module 2: Practice Facilitation as a Resource for Practice Improvement. In: Quality AfHRa, ed. pcmh.ahrq.gov: AHRQ; 2015. |
| 41192509 | 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. |
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| NOT COMPLETED |
|
| BG002 | Block 3 Standard Implementation | Pharmacies begin with the standard implementation interventions for 8-16 weeks. |
| BG003 | Total | Total of all reporting groups |
|
| Sex: Female, Male | Sex data were not collected. |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| OG000 |
| Standard Implementation (Stage 1) |
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. |
| OG001 | Virtual Facilitation (Stage 2) | 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). |
|
|
| 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. | One pharmacy did not document any conversations during either the standard implementation or virtual facilitation periods. | Posted | Number | Proportion of patients vaccinated | From baseline through the end of the virtual facilitation periods, up to 24 weeks maximum. | Conversations documented | Conversations documented |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Block 1 Virtual Facilitation | After completing the standard implementation, pharmacies then complete the virtual facilitation intervention for 8-16 weeks. 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). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Block 2 Standard Implementation | Pharmacies begin with the standard implementation interventions for 8-16 weeks. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Block 2 Virtual Facilitation | After completing the standard implementation, pharmacies then complete the virtual facilitation intervention for 8-16 weeks. 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). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Block 3 Standard Implementation | Pharmacies begin with the standard implementation interventions for 8-16 weeks. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Block 3 Virtual Facilitation | After completing the standard implementation, pharmacies then complete the virtual facilitation intervention for 8-16 weeks. 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). | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |