NCT03966300

Improving the School Vaccination Experience: What CARDs Are You Going to Play?

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,919 (actual)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: 11 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Vaccine Adverse Reaction
• Vaccination; Complications
• Fear

Interventions

Type	Name	Description
OTHER	Multi-faceted knowledge translation intervention	The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program

Timeline

• Start date: 2019-09-19
• Primary completion: 2019-11-20
• Completion: 2019-11-22
• First posted: 2019-05-29
• Last updated: 2021-06-29

Locations

1 site across 1 country: Canada