Effectiveness of CARD for Improving School-Based Immunizations
- Conditions
- Vaccine Adverse ReactionFearVaccination; Complications
- Interventions
- Other: Multi-faceted knowledge translation intervention
- Registration Number
- NCT03966391
- Lead Sponsor
- University of Toronto
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8839
- 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
- unable to understand and read English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CARD (multi-faceted knowledge translation intervention) Multi-faceted knowledge translation intervention CARD will be integrated into the school vaccination program. This includes pre-vaccination day preparation (e.g., planning of clinic spaces, student and school staff education about CARD) and vaccination day activities (e.g., clinic set-up, processes for triaging students, implementing pain/ fear/fainting mitigation interventions from CARD during vaccination)
- Primary Outcome Measures
Name Time Method Student fear within 5 minutes after vaccination student self-reported fear during vaccination, rated on a 0-10 scale
- Secondary Outcome Measures
Name Time Method Student dizziness within 5 minutes after vaccination student self-reported dizziness during vaccination, rated on a 0-10 scale
Student pain within 5 minutes after vaccination student self-reported pain during vaccination, rated on a 0-10 scale
Uptake of vaccination by end of school year proportion of students vaccinated (overall and for each vaccine)
Student fainting within 1 hour after vaccination student fainting during vaccination, yes/no, as assessed by immunizer
Student post-immunization stress-related responses within 1 hour after vaccination student post-immunization stress-related responses, yes/no, as assessed by immunizer using the WHO Immunization Stress Responses Criteria
Utilization of coping strategies within 5 minutes after vaccination use of individual coping strategies during vaccination (distraction, topical anesthetic, privacy, support person, deep breathing, muscle tension), yes/no, as assessed by immunizer using Documentation checklist
Implementation success of CARD within 3 months after vaccination clinics perceptions of implementation success of CARD program delivery as reported by CARD implementers (primary targets) using the CARD Global Impression Checklist, individual questions (5-point likert scale, higher number represents better outcome). This information will be supplemented with information from focus groups with implementers and study notes
Compliance with CARD within 3 months after vaccination clinics percent compliance with CARD implementation as assessed by implementers using a CARD compliance checklist. This information will be supplemented with information from focus groups with implementers and study notes, as well as focus groups with other stakeholder groups (students, parents, school staff).
Trial Locations
- Locations (1)
Alberta Health Services Public Health - Calgary Zone
🇨🇦Calgary, Alberta, Canada