Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547814
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
COVID-19 Vaccine Hesitancy Counseling Intervention for Pharmacists A Stepped-Wedge Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Addressing COVID-19 Vaccine Hesitancy in Rural Community Pharmacies Reducing Disparities Through an Implementation Science Approach
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to test if virtual facilitation eg video coaching increases rural pharmacists ability to implement COVID-19 vaccine hesitancy counseling when compared to a standard implementation approach eg 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
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
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 eg 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 eg 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 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
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 eg 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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None