NCT06666868

CARD for Community Pharmacy Vaccinations - Phase 2

CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations - Phase 2

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Vaccination
• Vaccination Pain
• Vaccination Reaction
• Vaccination Pharmacy

Interventions

Type	Name	Description
BEHAVIORAL	Sustained CARD	This group is using CARD for the 2nd year in a row in participating pharmacies as the vaccination delivery framework (It was used in the 2023-2024 fall/winter vaccination season and is now being sustained in the 2024-2025 fall/winter vaccination season).
BEHAVIORAL	First-time CARD	CARD is being used for the 1st time in participating pharmacies as the vaccination delivery framework (2024-2025 fall/winter vaccination season).

Timeline

• Start date: 2024-11-05
• Primary completion: 2025-03-31
• Completion: 2025-08-31
• First posted: 2024-10-31
• Last updated: 2024-10-31

Locations

1 site across 1 country: Canada