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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
500
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).
CARD is being used for the 1st time in participating pharmacies as the vaccination delivery framework (2024-2025 fall/winter vaccination season).
Leslie Dan Faculty of Pharmacy, University of Toronto
Toronto, Ontario, Canada
Experience with vaccination
Self-reported experience about how much CARD helped (4-point Likert scale and dichotomized)
Time frame: Within 15 minutes of vaccination
Pain
Self-reported pain during vaccination (0-10)
Time frame: Within 15 minutes of vaccination
Fear
Self-reported fear during vaccination (0-10)
Time frame: Within 15 minutes of vaccination
Dizziness
Self-reported dizziness during vaccination (0-10)
Time frame: Within 15 minutes of vaccination
Fainting
Self-reported fainting during vaccination (yes/no) confirmed by provider
Time frame: Within 15 minutes of vaccination
Overall experience
Self-reported overall experience (5-point Likert scale, and dichotomized)
Time frame: Within 15 minutes of vaccination
Vaccination decision-making
Self-reported vaccination decision-making (5-point Likert scale, and dichotomized)
Time frame: Within 15 minutes of vaccination
Implementation outcomes
Provider quantitative and qualitative feedback on surveys and interviews (assessing implementation outcomes)
Time frame: Within 3 months of vaccination season ending
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