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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
8,839
The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program
Alberta Health Services Public Health - Calgary Zone
Calgary, Alberta, Canada
Student fear
student self-reported fear during vaccination, rated on a 0-10 scale
Time frame: within 5 minutes after vaccination
Student pain
student self-reported pain during vaccination, rated on a 0-10 scale
Time frame: within 5 minutes after vaccination
Student dizziness
student self-reported dizziness during vaccination, rated on a 0-10 scale
Time frame: within 5 minutes after vaccination
Student fainting
student fainting during vaccination, yes/no, as assessed by immunizer
Time frame: within 1 hour after vaccination
Student post-immunization stress-related responses
student post-immunization stress-related responses, yes/no, as assessed by immunizer using the WHO Immunization Stress Responses Criteria
Time frame: within 1 hour after vaccination
Utilization of coping strategies
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
Time frame: within 5 minutes after vaccination
Uptake of vaccination
proportion of students vaccinated (overall and for each vaccine)
Time frame: by end of school year
Implementation success of CARD
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
Time frame: within 3 months after vaccination clinics
Compliance with CARD
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).
Time frame: within 3 months after vaccination clinics
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