CARD for Community Pharmacy Vaccinations - Phase 2

Not Applicable

Not yet recruiting

• Conditions: Vaccination; Vaccination Pain; Vaccination Reaction; Vaccination Pharmacy

• Registration Number: NCT06666868
• Lead Sponsor: University of Toronto

Brief Summary

This study is phase 2 of a cluster trial integrating the CARD (Comfort Ask Relax System) in community pharmacies affiliated with Wholehealth Pharmacy Partners. It involves continuing CARD in pharmacies randomized to CARD in phase 1 of the trial (2023-2024 fall/winter vaccination season), and initiating CARD in pharmacies randomized to Control (usual care) in phase 1 of the trial. Both groups will use CARD for delivery of vaccinations during the 2024-2025 fall/winter vaccination season.

Detailed Description

This study is a continuation of a previous cluster trial. Pharmacies that participated in the original trial will be asked if they want to volunteer for the present study. They will all use the CARD system as the vaccination delivery system for their community pharmacies during the 2024-2025 fall/winter vaccination season. They will collect feedback from vaccine clients using a paper survey that tracks experiences, including symptoms, during vaccination. The responses will be compared between groups.

The sample size is limited by the number of pharmacies that volunteer. We expect 8 pharmacies will participate in a 1:1 ratio (about 1/3 of all pharmacies in original cluster trial), with a total of at least 500 vaccination clients. We will collect data for all vaccinations that are conducted and for which client feedback data are available. Thus, the sample size is expected to deviate from the estimated sample size of 500.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Study First Posted: 2024-10-31
• Last Update Posted: 2024-10-31
• Study Start: 2024-11-05
• Primary Completion: 2025-03-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• clients undergoing vaccination in participating pharmacies and providers working in participating pharmacies

Exclusion Criteria

• able to speak and write in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Experience with vaccination	Within 15 minutes of vaccination	Self-reported experience about how much CARD helped (4-point Likert scale and dichotomized)

Secondary Outcome Measures

Name	Time	Method
Implementation outcomes	Within 3 months of vaccination season ending	Provider quantitative and qualitative feedback on surveys and interviews (assessing implementation outcomes)
Pain	Within 15 minutes of vaccination	Self-reported pain during vaccination (0-10)
Fear	Within 15 minutes of vaccination	Self-reported fear during vaccination (0-10)
Dizziness	Within 15 minutes of vaccination	Self-reported dizziness during vaccination (0-10)
Fainting	Within 15 minutes of vaccination	Self-reported fainting during vaccination (yes/no) confirmed by provider
Overall experience	Within 15 minutes of vaccination	Self-reported overall experience (5-point Likert scale, and dichotomized)
Vaccination decision-making	Within 15 minutes of vaccination	Self-reported vaccination decision-making (5-point Likert scale, and dichotomized)

Trial Locations

Locations (1)

Leslie Dan Faculty of Pharmacy, University of Toronto; 🇨🇦 Toronto, Ontario, Canada