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| Name | Class |
|---|---|
| Alberta Health services | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARD (multi-faceted knowledge translation intervention) | Experimental | 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) |
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| Control (standard care) | No Intervention | There are no specific procedures being undertaken to plan or execute clinics. Usual practices will be instituted (i.e., no education specific to CARD, nor clinic set-up or execution to incorporate interventions for pain, fear or fainting) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-faceted knowledge translation intervention | Other | The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program |
| Measure | Description | Time Frame |
|---|---|---|
| Student fear | student self-reported fear during vaccination, rated on a 0-10 scale | within 5 minutes after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Student pain | student self-reported pain during vaccination, rated on a 0-10 scale | within 5 minutes after vaccination |
| Student dizziness | student self-reported dizziness during vaccination, rated on a 0-10 scale |
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Inclusion Criteria:
Exclusion Criteria:
- unable to understand and read English
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| Name | Affiliation | Role |
|---|---|---|
| Anna Taddio, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Health Services Public Health - Calgary Zone | Calgary | Alberta | T2W 3N2 | Canada |
There is no plan to share IPD
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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.
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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
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| within 5 minutes after vaccination |
| Student fainting | student fainting during vaccination, yes/no, as assessed by immunizer | 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 | 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 | within 5 minutes after vaccination |
| Uptake of vaccination | proportion of students vaccinated (overall and for each vaccine) | 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 | 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). | within 3 months after vaccination clinics |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |