Playing CARDs to Improve the Vaccination Experience at School: a Cluster Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vaccine Adverse Reaction
- Sponsor
- University of Toronto
- Enrollment
- 1919
- Locations
- 1
- Primary Endpoint
- Student fear
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Anna Taddio
Professor
University of Toronto
Eligibility Criteria
Inclusion Criteria
- •grade 7 students eligible for vaccination at school
- •public health staff working in the school vaccination program
Exclusion Criteria
- •unable to understand and read English
Outcomes
Primary Outcomes
Student fear
Time Frame: within 5 minutes after vaccination
student self-reported fear during vaccination, rated on a 0-10 scale
Secondary Outcomes
- 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)
- Knowledge of effective coping strategies(within 3 months after vaccination clinics)
- Satisfaction with CARD(within 5 minutes after vaccination)
- Student post-immunization stress-related responses(within 1 hour after vaccination)
- Student pain(within 5 minutes after vaccination)
- Student fainting(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)