Clinical trial NCT06666868: CARD for Community Pharmacy Vaccinations - Phase 2
Official title: CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations - Phase 2
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vaccination
Vaccination Pain
Vaccination Reaction
Vaccination Pharmacy
Keywords: vaccination reaction
vaccination experience
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Wholehealth Pharmacy Partners
First posted: 2024-10-31
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* able to speak and write in English

Primary outcomes:
measure: Experience with vaccination
timeFrame: Within 15 minutes of vaccination
Secondary outcomes:
measure: Pain
timeFrame: Within 15 minutes of vaccination
measure: Fear
timeFrame: Within 15 minutes of vaccination
measure: Dizziness
timeFrame: Within 15 minutes of vaccination
measure: Fainting
timeFrame: Within 15 minutes of vaccination
measure: Overall experience
timeFrame: Within 15 minutes of vaccination
measure: Vaccination decision-making
timeFrame: Within 15 minutes of vaccination
measure: Implementation outcomes
timeFrame: Within 3 months of vaccination season ending
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Leslie Dan Faculty of Pharmacy, University of Toronto
state: Ontario
Study officials:
affiliation: Leslie Dan Faculty Of Pharmacy, University Of Toronto
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References: