CARD for Community Pharmacy Vaccinations

NCT ID: NCT06098703

Last Updated: 2023-10-25

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-12-31

Brief Summary

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To integrate CARD in community pharmacy-led vaccinations and document impact on vaccine clients and pharmacy staff.

Detailed Description

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It is estimated that 1 out of 5 children and adults are not vaccinated because of concerns about pain and fear. The CARD (Comfort Ask Relax Distract) system is a new vaccine delivery system proven to reduce pain, fear and immunization stress-related responses. Improving the vaccination experiences of patients can improve attitudes about vaccination and increase vaccine acceptance.

The objective of this cluster randomized trial is to evaluate scaling of CARD across community pharmacies on patients vaccination symptoms, beliefs and attitudes and pharmacy staff beliefs and attitudes.

Conditions

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Vaccination Reaction Vaccination Pain Community Pharmacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster trial involving at least 24 community pharmacies allocated to CARD or control (standard care) in a 1:1 ratio. Eligible pharmacies belonging to Wholehealth Pharmacy Partners from across Ontario, Canada, will be included.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Vaccine recipients will not be aware of whether they are in the intervention or control group or the objective of the trial. Care providers who are trained in the intervention are aware of the group allocation. They will not communicate with care providers not trained in the intervention. Care providers that are in the intervention pharmacies will not deliver care to participants in the control pharmacies and care providers in the control pharmacies will not deliver care in the intervention pharmacies. Vaccine recipients are rating the primary outcome.

Study Groups

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CARD (multi-faceted intervention)

CARD will be integrated in the pharmacy vaccination process. This includes education, environment (e.g., clinic spaces), engagement (interactions), and evaluation (surveys/feedback).

Group Type EXPERIMENTAL

CARD (Comfort Ask Relax Distract)

Intervention Type BEHAVIORAL

CARD is a vaccine delivery framework/protocol to plan and deliver vaccinations

Control (standard care)

There are no specific procedures being undertaken to plan or execute vaccine clinics. Usual practices will be instituted by participating pharmacies.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CARD (Comfort Ask Relax Distract)

CARD is a vaccine delivery framework/protocol to plan and deliver vaccinations

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* vaccine clients being vaccinated in community pharmacies participating in the project
* pharmacy staff in community pharmacies participating in the project

Exclusion Criteria

* unable to understand and read English
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Public Health Agency of Canada (PHAC)

OTHER_GOV

Sponsor Role collaborator

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

University of Toronto

Locations

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Anna Taddio

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

References

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Taddio A, Morrison J, Logeman C, Gudzak V, Bucci LM, McMurtry CM, Yang M, Folinas M, Moineddin R, MacDonald NE. CARD (Comfort Ask Relax Distract) and community pharmacy vaccinations: Evaluation of effectiveness outcomes from a cluster randomized trial. Hum Vaccin Immunother. 2025 Dec;21(1):2488064. doi: 10.1080/21645515.2025.2488064. Epub 2025 Aug 6.

Reference Type DERIVED
PMID: 40768541 (View on PubMed)

Taddio A, Morrison J, Logeman C, Gudzak V, Bucci LM, McMurtry CM, Yang M, Folinas M, Moineddin R, MacDonald NE. CARD (Comfort Ask Relax Distract) and community pharmacy vaccinations: Evaluation of implementation outcomes from a cluster randomized trial. Hum Vaccin Immunother. 2025 Dec;21(1):2503524. doi: 10.1080/21645515.2025.2503524. Epub 2025 May 15.

Reference Type DERIVED
PMID: 40371950 (View on PubMed)

Other Identifiers

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43097

Identifier Type: -

Identifier Source: org_study_id

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