CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Toronto
- Enrollment
- 2,000
- Locations
- 2
- Primary Endpoint
- Experience with vaccination
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Vaccine recipients will not be aware of whether they are in the intervention or control group or the objective of the trial. Care providers who are trained in the intervention are aware of the group allocation. They will not communicate with care providers not trained in the intervention. Care providers that are in the intervention pharmacies will not deliver care to participants in the control pharmacies and care providers in the control pharmacies will not deliver care in the intervention pharmacies. Vaccine recipients are rating the primary outcome.
Eligibility Criteria
- Ages
- 0 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Experience with vaccination
Time Frame: within 15 minutes after vaccination
Vaccine client self-reported experience with vaccination (better or not)
Secondary Outcomes
- Attitudes about vaccination(within 3 months of vaccination clinics)
- Fear(within 15 minutes after vaccination)
- Pain(within 15 minutes after vaccination)
- Dizziness(within 15 minutes after vaccination)
- Fainting(within 15 minutes after vaccination)
- Utilization of coping strategies during vaccination(within 5 minutes of vaccination)
- CARD satisfaction survey(within 15 minutes of vaccination)
- Implementation success of CARD(within 3 months of vaccination clinics)
- Vaccination behaviours(within 3 months of vaccination clinics)
- Vaccine interaction survey(within 5 minutes of vaccination)
Investigators
Anna Taddio
Professor
University of Toronto