Vaccination Reaction Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 2000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 0 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Anna Taddio | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto | Public Health Agency of Canada (PHAC), Wholehealth Pharmacy Partners |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Experience with vaccination | Vaccine client self-reported experience with vaccination (better or not) | within 15 minutes after vaccination | |
Secondary | Fear | Vaccine client self-reported fear during vaccination (0-10) | within 15 minutes after vaccination | |
Secondary | Pain | Vaccine client self-reported pain during vaccination (0-10) | within 15 minutes after vaccination | |
Secondary | Dizziness | Vaccine client self-reported dizziness during vaccination (0-10) | within 15 minutes after vaccination | |
Secondary | Fainting | Fainting during/after vaccination (yes/no) | within 15 minutes after vaccination | |
Secondary | Utilization of coping strategies during vaccination | Use of individual coping strategies during vaccination (e.g., distraction, support person) (yes/no) | within 5 minutes of vaccination | |
Secondary | CARD satisfaction survey | 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 | |
Secondary | Implementation success of CARD | 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 | |
Secondary | Attitudes about vaccination | 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 | |
Secondary | Vaccination behaviours | 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 | |
Secondary | Vaccine interaction survey | 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 |
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