Fear, Vaccination; Complications, Vaccine Adverse Reaction
Conditions
Keywords
school vaccinations, pain management, knowledge translation, cluster trial
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.
Interventions
The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program
Sponsors
Alberta Health services
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Students will not be aware of whether they are in the intervention or control group. Care providers who are trained in the intervention are aware of the group allocation. They will not communicate with care providers not trained in the intervention. Care providers that are trained in the intervention will not deliver care to participants in the control group and care providers that are not trained in the intervention will not deliver care to participants in the intervention group
Intervention model description
Cluster trial involving 8 community health centres. They will be randomized to CARD or control (standard care) groups in a 1:1 ratio. Eligible schools (approximately 13/community health centre) will be included.
Eligibility
Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Student fear | within 5 minutes after vaccination | student self-reported fear during vaccination, rated on a 0-10 scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Student dizziness | within 5 minutes after vaccination | student self-reported dizziness during vaccination, rated on a 0-10 scale |
| 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 |
| 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) |
| 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). |
| 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 |
Countries
Canada
Outcome results
None listed