Effectiveness of a Multi-faceted Knowledge Translation Intervention (The CARD System) for School Based Immunizations: a Cluster Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vaccination; Complications
- Sponsor
- University of Toronto
- Enrollment
- 8839
- Locations
- 1
- Primary Endpoint
- Student fear
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Vaccination is estimated to have saved more lives in Canada than any other single intervention and is considered one of the most important advances in the prevention of disease. The process of vaccination, however, is stressful for individuals. School-based vaccinations in particular, are associated with high levels of fear and anxiety among students. This randomized cluster trial will implement a multi-faceted knowledge translation intervention called The CARD (C-Comfort A-Ask R-Relax D-Distract) System in school-based vaccinations and evaluate its effects on the experience of vaccination for students and implementation outcomes.
Detailed Description
The investigators developed a multi-faceted knowledge translation intervention called The CARD System to provide a framework for delivering vaccinations at school that integrates evidence-based strategies to mitigate pain, fear and fainting and promotes a student-centred approach to vaccination. CARD addresses 2 components of the vaccination delivery program: 1) pre-vaccination day preparation and 2) vaccination day activities. In a small controlled clinical trial in a public health unit in Niagara, Ontario, the investigators demonstrated benefits of CARD on student symptoms during vaccination, including fear, and dizziness-precursor of fainting, and satisfaction with CARD by all stakeholder groups (students, public health staff, school staff and parents). This study will evaluate CARD in a large cluster trial in Calgary, Alberta. This trial is the final phase of a 3-phase project, whereby the first 2 phases involve developing an implementation plan for the local context and evaluating feasibility of implementation. Eight community health centres that provide vaccination services to schools in their regions will be randomized in a 1:1 ratio to CARD or control (usual practices). Data will be collected for vaccination services carried out in grade 6 and grade 9 students in participating schools for the academic year 2019-2020.
Investigators
Anna Taddio
Professor
University of Toronto
Eligibility Criteria
Inclusion Criteria
- •grade 6 and 9 students eligible for vaccination at school
- •public health staff in community health centre involved in the study
- •school staff in a participating school involved in school vaccination
- •parent of a student eligible for vaccination at school
Exclusion Criteria
- •unable to understand and read English
Outcomes
Primary Outcomes
Student fear
Time Frame: within 5 minutes after vaccination
student self-reported fear during vaccination, rated on a 0-10 scale
Secondary Outcomes
- Uptake of vaccination(by end of school year)
- Student pain(within 5 minutes after vaccination)
- Student dizziness(within 5 minutes after vaccination)
- Student fainting(within 1 hour after vaccination)
- Student post-immunization stress-related responses(within 1 hour after vaccination)
- Utilization of coping strategies(within 5 minutes after vaccination)
- Implementation success of CARD(within 3 months after vaccination clinics)
- Compliance with CARD(within 3 months after vaccination clinics)