CARD for Community Pharmacy Vaccinations - Phase 2

NCT ID: NCT06666868

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-05

Study Completion Date

2025-08-31

Brief Summary

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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

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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

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Vaccination Vaccination Pain Vaccination Reaction Vaccination Pharmacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster trial involving at least 8 community pharmacies allocated in a 1:1 ratio to: 1) repeat use or 2) first-time use of the CARD system for vaccination delivery in 2024-2025 fall/winter vaccination season.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Vaccine clients are blinded to the hypothesis. Providers are aware of the intervention.

Study Groups

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Sustained CARD

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.

Group Type EXPERIMENTAL

Sustained CARD

Intervention Type BEHAVIORAL

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).

First-time CARD

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.

Group Type ACTIVE_COMPARATOR

First-time CARD

Intervention Type BEHAVIORAL

CARD is being used for the 1st time in participating pharmacies as the vaccination delivery framework (2024-2025 fall/winter vaccination season).

Interventions

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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).

Intervention Type 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).

Intervention Type BEHAVIORAL

Other Intervention Names

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Sustained CARD use First-time CARD use

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* able to speak and write in English
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wholehealth Pharmacy Partners

UNKNOWN

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Anna Taddio

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Taddio, PhD

Role: PRINCIPAL_INVESTIGATOR

Leslie Dan Faculty Of Pharmacy, University Of Toronto

Locations

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Leslie Dan Faculty of Pharmacy, University of Toronto

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Charlotte Logeman, MPH

Role: CONTACT

416-978-2889

Victoria Gudzak, MSc

Role: CONTACT

416-978-2889

Facility Contacts

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Anna Taddio, PhD

Role: primary

416-978-2889

Anna Taddio, PhD

Role: backup

Other Identifiers

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43097-2024

Identifier Type: -

Identifier Source: org_study_id

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