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NCT Number: NCT06666868

CARD for Community Pharmacy Vaccinations - Phase 2

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.

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Key information

Conditions

Vaccination Vaccination Pain Vaccination Pharmacy Vaccination Reaction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leslie Dan Faculty of Pharmacy, University of Toronto

Toronto, Ontario, M5S 3M2, Canada

Location contact

Anna Taddio, PhD

CONTACT

[email protected]

416-978-2889

Anna Taddio, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • able to speak and write in English

Treatment and study plan

Sustained CARD

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).

Other names: Sustained CARD use

First-time CARD

Behavioral

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

Other names: First-time CARD use

Primary outcomes

  1. Experience with vaccination

    Time frame: Within 15 minutes of vaccination

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

Secondary outcomes

  1. Pain

    Time frame: Within 15 minutes of vaccination

    Self-reported pain during vaccination (0-10)

  2. Fear

    Time frame: Within 15 minutes of vaccination

    Self-reported fear during vaccination (0-10)

  3. Dizziness

    Time frame: Within 15 minutes of vaccination

    Self-reported dizziness during vaccination (0-10)

  4. Fainting

    Time frame: Within 15 minutes of vaccination

    Self-reported fainting during vaccination (yes/no) confirmed by provider

  5. Overall experience

    Time frame: Within 15 minutes of vaccination

    Self-reported overall experience (5-point Likert scale, and dichotomized)

  6. Vaccination decision-making

    Time frame: Within 15 minutes of vaccination

    Self-reported vaccination decision-making (5-point Likert scale, and dichotomized)

  7. Implementation outcomes

    Time frame: Within 3 months of vaccination season ending

    Provider quantitative and qualitative feedback on surveys and interviews (assessing implementation outcomes)

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Logeman, MPH

CONTACT

[email protected]

416-978-2889

Victoria Gudzak, MSc

CONTACT

[email protected]

416-978-2889

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Wholehealth Pharmacy Partners

Registry information

Official study title

CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations - Phase 2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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