An interventional study of CARD (Comfort Ask Relax Distract) in Vaccination Reaction, Vaccination Pain and Community Pharmacy, sponsored by University of Toronto. Not yet recruiting at 1 site in Canada. Open to participants aged 0 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by University of Toronto · Not applicable, Interventional, and Treatment
To integrate CARD in community pharmacy-led vaccinations and document impact on vaccine clients and pharmacy staff.
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.
University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CARD will be integrated in the pharmacy vaccination process. This includes education, environment (e.g., clinic spaces), engagement (interactions), and evaluation (surveys/feedback).
Behavioral: CARD (Comfort Ask Relax Distract)
There are no specific procedures being undertaken to plan or execute vaccine clinics. Usual practices will be instituted by participating pharmacies.
CARD is a vaccine delivery framework/protocol to plan and deliver vaccinations
Experience with vaccination
Vaccine client self-reported experience with vaccination (better or not)
Time frame: within 15 minutes after vaccination
Fear
Vaccine client self-reported fear during vaccination (0-10)
Time frame: within 15 minutes after vaccination
Pain
Vaccine client self-reported pain during vaccination (0-10)
Time frame: within 15 minutes after vaccination
Dizziness
Vaccine client self-reported dizziness during vaccination (0-10)
Time frame: within 15 minutes after vaccination
Fainting
Fainting during/after vaccination (yes/no)
Time frame: within 15 minutes after vaccination
Utilization of coping strategies during vaccination
Use of individual coping strategies during vaccination (e.g., distraction, support person) (yes/no)
Time frame: within 5 minutes of vaccination
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
Time frame: within 15 minutes of vaccination
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.
Time frame: within 3 months of vaccination clinics
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.
Time frame: within 3 months of vaccination clinics
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.
Time frame: within 3 months of vaccination clinics
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.
Time frame: within 5 minutes of vaccination
Plan to share: No — We do not have permission to share this information.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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