CARD for Community Pharmacy Vaccinations

Vaccination Reaction Clinical Trial

Official title:

CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06098703
• Other study ID #: 43097
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: University of Toronto
• Contact: Charlotte Logeman, MPH
• Phone: 416-978-2889
• Email: charlotte.logeman[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To integrate CARD in community pharmacy-led vaccinations and document impact on vaccine clients and pharmacy staff.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Vaccination Reaction

Intervention

Behavioral:
• CARD (Comfort Ask Relax Distract)
CARD is a vaccine delivery framework/protocol to plan and deliver vaccinations

Locations

Country	Name	City	State
Canada	Anna Taddio	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	Public Health Agency of Canada (PHAC), Wholehealth Pharmacy Partners

Country where clinical trial is conducted

Canada, 

Outcome

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