CARD for Community Pharmacy Vaccinations - Phase 2

University of Toronto

Status: Not yet enrolling

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

Treatments: Behavioral: Sustained CARD; Behavioral: First-time CARD

Study type: Interventional

Funder types: Other

Identifiers

NCT06666868

43097-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• able to speak and write in English

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Sustained CARD

Experimental group

Description:

CARD is being used for the 2nd year in a row as the vaccination delivery framework in participating pharmacies (It was used in the 2023-2024 fall/winter vaccination season and is now being sustained in the 2024-2025 fall/winter season). CARD comprises of education, environment, engagement and evaluation components.

Treatment:

Behavioral: Sustained CARD

First-time CARD

Active Comparator group

Description:

CARD is being used for the 1st time as the vaccination delivery framework in participating pharmacies (2024-2025 fall/winter vaccinations only). CARD comprises of education, environment, engagement and evaluation components.

Treatment:

Behavioral: First-time CARD