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临床试验/NCT03966300
NCT03966300终止不适用

Playing CARDs to Improve the Vaccination Experience at School: a Cluster Randomized Controlled Trial

University of Toronto1 个研究点 分布在 1 个国家目标入组 1,919 人开始时间: 2019年9月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
1,919
试验地点
1
主要终点
Student fear

研究概览

简要总结

Vaccination hesitancy is identified as a threat to global health by the World Health Organization (WHO). For adolescents undergoing vaccination at school, prior studies demonstrate that concerns about pain and/or fear of needles contribute to negative experiences with vaccination and non-compliance with vaccination. The investigators developed an intervention that addresses vaccination hesitancy. In this study, investigators will evaluate the effectiveness of this intervention in a randomized controlled trial.

详细描述

Vaccination hesitancy is identified by the World Health Organization (WHO) as one of ten threats to global health. The WHO's 3C model of vaccination hesitancy identifies 3 domains of vaccine hesitancy: 1) Confidence (trust in health care providers), 2) Complacency (perceived importance of vaccine-preventable disease) and 3) Convenience (improving clinic processes). The investigators developed a multifaceted knowledge translation intervention that addresses vaccination hesitancy in school-based vaccinations. The intervention is called The CARD(TM) System (C-Comfort, A-Ask, R-Relax, D-Distract). CARD is a framework for delivering vaccinations that is student-centred and promotes coping. CARD integrates evidence-based interventions related to planning and execution of school vaccination clinics to directly tackle all 3 domains of vaccination hesitancy. It tackles Confidence by improving pain/fear management (it teaches students and public health staff how to reduce student symptoms which improves the vaccination experience and improves student trust in health care providers). It tackles Complacency by educating students about what vaccines are, why they are needed, community immunity, as well as the specific diseases they are being protected against. It tackles Convenience by improving school-based clinic processes by integrating student preferences (e.g., privacy, having a support person present).

In this randomized controlled trial, the investigators will evaluate the impact of CARD (vs. usual care) on student important outcomes and process outcomes.

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 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

入选标准

  • grade 7 students eligible for vaccination at school
  • public health staff working in the school vaccination program

排除标准

  • unable to understand and read English

研究组 & 干预措施

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)

干预措施: Multi-faceted knowledge translation intervention (Other)

Control (standard/usual 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)

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

  • Knowledge of effective coping strategies(within 3 months after vaccination clinics)
  • Satisfaction with CARD(within 5 minutes after vaccination)
  • Student pain(within 5 minutes after vaccination)
  • Student dizziness(within 5 minutes of vaccination)
  • Willingness to be vaccinated(within 5 minutes after vaccination)
  • Utilization of coping strategies(within 5 minutes after vaccination)
  • Uptake of vaccination(by end of school year)
  • Implementation success of CARD(within 3 months of vaccination clinics)
  • Student fainting(within 1 hour after vaccination)
  • Student post-immunization stress-related responses(within 1 hour after vaccination)
  • Compliance with CARD(within 3 months of vaccination clinics)
  • Perceptions about pain and fear(within 3 months of vaccination clinics)
  • Perceptions about vaccination program(within 3 months of vaccination clinics)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Taddio

Professor

University of Toronto

研究点 (1)

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