NCT06098703

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 19, 2023

Last Update Submit

October 23, 2023

Conditions

Vaccination ReactionVaccination PainCommunity Pharmacy

Keywords

Vaccination reactionVaccination experience

Outcome Measures

Primary Outcomes (1)

  • Experience with vaccination

    Vaccine client self-reported experience with vaccination (better or not)

    within 15 minutes after vaccination

Secondary Outcomes (10)

  • Fear

    within 15 minutes after vaccination

  • Pain

    within 15 minutes after vaccination

  • Dizziness

    within 15 minutes after vaccination

  • Fainting

    within 15 minutes after vaccination

  • Utilization of coping strategies during vaccination

    within 5 minutes of vaccination

  • +5 more secondary outcomes

Study Arms (2)

CARD (multi-faceted intervention)

EXPERIMENTAL

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

Behavioral: CARD (Comfort Ask Relax Distract)

Control (standard care)

NO INTERVENTION

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

Interventions

CARD (Comfort Ask Relax Distract)BEHAVIORAL

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

CARD (multi-faceted intervention)

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • unable to understand and read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anna Taddio

Toronto, Ontario, M5S 3M2, Canada

Location

Related Publications (2)

  • 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.

    PMID: 40768541DERIVED

  • 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.

    PMID: 40371950DERIVED

Study Officials

  • Anna Taddio, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Logeman, MPH

CONTACT

416-978-2889charlotte.logeman@utoronto.ca

Victoria Gudzak, MSc

CONTACT

416-978-2889victoria.gudzak@mail.utoronto.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 24, 2023

Study Start

November 1, 2023

Primary Completion

January 31, 2024

Study Completion

December 31, 2024

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

We do not have permission to share this information.

Locations

CA(1)