CARD for Community Pharmacy Vaccinations
- Conditions
- Vaccination PainVaccination ReactionCommunity Pharmacy
- Interventions
- Behavioral: CARD (Comfort Ask Relax Distract)
- Registration Number
- NCT06098703
- Lead Sponsor
- University of Toronto
- Brief Summary
To integrate CARD in community pharmacy-led vaccinations and document impact on vaccine clients and pharmacy staff.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- vaccine clients being vaccinated in community pharmacies participating in the project
- pharmacy staff in community pharmacies participating in the project
- unable to understand and read English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CARD (multi-faceted intervention) CARD (Comfort Ask Relax Distract) CARD will be integrated in the pharmacy vaccination process. This includes education, environment (e.g., clinic spaces), engagement (interactions), and evaluation (surveys/feedback).
- Primary Outcome Measures
Name Time Method Experience with vaccination within 15 minutes after vaccination Vaccine client self-reported experience with vaccination (better or not)
- Secondary Outcome Measures
Name Time Method Fainting within 15 minutes after vaccination Fainting during/after vaccination (yes/no)
Attitudes about vaccination 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.
Fear within 15 minutes after vaccination Vaccine client self-reported fear during vaccination (0-10)
Pain within 15 minutes after vaccination Vaccine client self-reported pain during vaccination (0-10)
Dizziness within 15 minutes after vaccination Vaccine client self-reported dizziness during vaccination (0-10)
Utilization of coping strategies during vaccination within 5 minutes of vaccination Use of individual coping strategies during vaccination (e.g., distraction, support person) (yes/no)
CARD satisfaction survey 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
Implementation success of CARD 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.
Vaccination behaviours 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.
Vaccine interaction survey 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.
Trial Locations
- Locations (1)
Anna Taddio
🇨🇦Toronto, Ontario, Canada