Effectiveness of a Multi-faceted Knowledge Translation Intervention (The CARD System) for School Based Immunizations: a Cluster Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,839
- 试验地点
- 1
- 主要终点
- Student fear
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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
入排标准
- 年龄范围
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •unable to understand and read English
研究组 & 干预措施
CARD (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)
干预措施: Multi-faceted knowledge translation intervention (Other)
Control (standard care)
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)
结局指标
主要结局
Student fear
时间窗: within 5 minutes after vaccination
student self-reported fear during vaccination, rated on a 0-10 scale
次要结局
- Student pain(within 5 minutes after vaccination)
- Student dizziness(within 5 minutes after vaccination)
- Student fainting(within 1 hour after vaccination)
- Uptake of vaccination(by end of school year)
- Student post-immunization stress-related responses(within 1 hour after vaccination)
- Utilization of coping strategies(within 5 minutes after vaccination)
- Implementation success of CARD(within 3 months after vaccination clinics)
- Compliance with CARD(within 3 months after vaccination clinics)
研究者
Anna Taddio
Professor
University of Toronto