NCT06666868

Brief Summary

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.

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
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 29, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

November 5, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

October 29, 2024

Last Update Submit

October 29, 2024

Conditions

VaccinationVaccination PainVaccination ReactionVaccination Pharmacy

Keywords

vaccination reactionvaccination experience

Outcome Measures

Primary Outcomes (1)

  • Experience with vaccination

    Self-reported experience about how much CARD helped (4-point Likert scale and dichotomized)

    Within 15 minutes of vaccination

Secondary Outcomes (7)

  • Pain

    Within 15 minutes of vaccination

  • Fear

    Within 15 minutes of vaccination

  • Dizziness

    Within 15 minutes of vaccination

  • Fainting

    Within 15 minutes of vaccination

  • Overall experience

    Within 15 minutes of vaccination

  • +2 more secondary outcomes

Study Arms (2)

Sustained CARD

EXPERIMENTAL

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.

Behavioral: Sustained CARD

First-time CARD

ACTIVE COMPARATOR

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.

Behavioral: First-time CARD

Interventions

Sustained CARDBEHAVIORAL

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).

Also known as: Sustained CARD use
Sustained CARD
First-time CARDBEHAVIORAL

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

Also known as: First-time CARD use
First-time CARD

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • able to speak and write in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leslie Dan Faculty of Pharmacy, University of Toronto

Toronto, Ontario, M5S 3M2, Canada

Location

Study Officials

  • Anna Taddio, PhD

    Leslie Dan Faculty Of Pharmacy, 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 clients are blinded to the hypothesis. Providers are aware of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 29, 2024

First Posted

October 31, 2024

Study Start

November 5, 2024

Primary Completion

March 31, 2025

Study Completion

August 31, 2025

Last Updated

October 31, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

We do not have permission to share individual participant data.

Locations

CA(1)