NCT03966391

Effectiveness of CARD for Improving School-Based Immunizations

Effectiveness of a Multi-faceted Knowledge Translation Intervention (The CARD System) for School Based Immunizations: a Cluster Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8,839 (actual)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vaccination; Complications
• Vaccine Adverse Reaction
• Fear

Interventions

Type	Name	Description
OTHER	Multi-faceted knowledge translation intervention	The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program

Timeline

• Start date: 2019-09-25
• Primary completion: 2020-03-12
• Completion: 2020-03-12
• First posted: 2019-05-29
• Last updated: 2023-03-16

Locations

1 site across 1 country: Canada