Improving the School Vaccination Experience: What CARDs Are You Going to Play?
- Conditions
- Vaccine Adverse ReactionFearVaccination; Complications
- Interventions
- Other: Multi-faceted knowledge translation intervention
- Registration Number
- NCT03966300
- Lead Sponsor
- University of Toronto
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1919
- grade 7 students eligible for vaccination at school
- public health staff working in the school vaccination program
- unable to understand and read English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CARD (multi-faceted knowledge translation intervention) 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)
- Primary Outcome Measures
Name Time Method Student fear within 5 minutes after vaccination student self-reported fear during vaccination, rated on a 0-10 scale
- Secondary Outcome Measures
Name Time Method Student dizziness within 5 minutes of vaccination student self-reported dizziness during vaccination, rated on a 0-10 scale
Willingness to be vaccinated within 5 minutes after vaccination student self-reported willingness to be vaccinated, as assessed using a 5-point likert scale (higher number represents better outcome)
Utilization of coping strategies within 5 minutes after vaccination 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
Uptake of vaccination by end of school year proportion of students vaccinated (overall and for each vaccine)
Implementation success of CARD within 3 months of vaccination clinics 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
Knowledge of effective coping strategies within 3 months after vaccination clinics knowledge of effective coping strategies, as assessed using a 10-point investigator-developed knowledge test, administered to implementers
Satisfaction with CARD within 5 minutes after vaccination student self-reported satisfaction with CARD, as assessed using Student Feedback Survey, individual questions (5-point likert scale, higher number indicates better outcome)
Student pain within 5 minutes after vaccination student self-reported pain during vaccination, rated on a 0-10 scale
Student fainting within 1 hour after vaccination student fainting during vaccination, yes/no, as assessed by immunizer
Student post-immunization stress-related responses within 1 hour after vaccination student post-immunization stress-related responses, yes/no, as assessed by immunizer using the WHO immunization Stress Responses Criteria
Compliance with CARD within 3 months of vaccination clinics 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
Perceptions about pain and fear within 3 months of vaccination clinics perceptions about pain and fear, as assessed using a 5-point likert scale (higher number represents better outcome) for implementers
Perceptions about vaccination program within 3 months of vaccination clinics perceptions about vaccination program, as assessed using the Vaccination Program Global Impresssion Checklist, individual questions (5-point likert scale, higher number represents better outcome) for implementers
Trial Locations
- Locations (1)
Wellington Dufferin Guelph Public Health
🇨🇦Guelph, Ontario, Canada