CARD for Community Pharmacy Vaccinations

October 23, 2023 updated by: Anna Taddio, University of Toronto

CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 3M2
        • Anna Taddio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Behavioral: CARD (Comfort Ask Relax Distract)
CARD is a vaccine delivery framework/protocol to plan and deliver vaccinations
No Intervention: Control (standard care)
There are no specific procedures being undertaken to plan or execute vaccine clinics. Usual practices will be instituted by participating pharmacies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experience with vaccination
Time Frame: within 15 minutes after vaccination
Vaccine client self-reported experience with vaccination (better or not)
within 15 minutes after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear
Time Frame: within 15 minutes after vaccination
Vaccine client self-reported fear during vaccination (0-10)
within 15 minutes after vaccination
Pain
Time Frame: within 15 minutes after vaccination
Vaccine client self-reported pain during vaccination (0-10)
within 15 minutes after vaccination
Dizziness
Time Frame: within 15 minutes after vaccination
Vaccine client self-reported dizziness during vaccination (0-10)
within 15 minutes after vaccination
Fainting
Time Frame: within 15 minutes after vaccination
Fainting during/after vaccination (yes/no)
within 15 minutes after vaccination
Utilization of coping strategies during vaccination
Time Frame: within 5 minutes of vaccination
Use of individual coping strategies during vaccination (e.g., distraction, support person) (yes/no)
within 5 minutes of vaccination
CARD satisfaction survey
Time Frame: within 15 minutes of vaccination
Vaccine client self-reported satisfaction with CARD (e.g., helpfulness, willingness to use again, willingness to return for next vaccination, vaccination decision-making, as applicable), responses reported for individual items
within 15 minutes of vaccination
Implementation success of CARD
Time Frame: within 3 months of vaccination clinics
Perceptions of implementation success of CARD program delivery as reported by CARD implementers (primary targets) using CARD Global Impression Checklist, individual questions (5-point Likert Scale higher number represents better outcome); responses reported for individual items. This information is supplemented with focus group information and study notes.
within 3 months of vaccination clinics
Attitudes about vaccination
Time Frame: within 3 months of vaccination clinics
Perceptions of CARD and non-CARD implementers using CARD Attitudes survey, individual questions (5-point Likert Scale higher number represents better outcome); responses reported for individual items. This information is supplemented with focus group information and study notes.
within 3 months of vaccination clinics
Vaccination behaviours
Time Frame: within 3 months of vaccination clinics
Self-reported vaccine behaviours of immunizers using CARD Behaviour Survey, individual questions (rank as whether behaviours are done or not); responses reported for individual items. Includes CARD and non-CARD implementers.
within 3 months of vaccination clinics
Vaccine interaction survey
Time Frame: within 5 minutes of vaccination
Perceptions of CARD and non-CARD immunizers about vaccination interaction [duration, satisfaction, CARD usefulness (intervention group only)]; responses reported for individual items.
within 5 minutes of vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

Public Health Agency of Canada (PHAC)
Wholehealth Pharmacy Partners

Investigators

  • Principal Investigator: Anna Taddio, PhD, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 19, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 43097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not have permission to share this information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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