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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,919
The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program
Wellington Dufferin Guelph Public Health
Guelph, Ontario, Canada
Student fear
student self-reported fear during vaccination, rated on a 0-10 scale
Time frame: within 5 minutes after vaccination
Student pain
student self-reported pain during vaccination, rated on a 0-10 scale
Time frame: within 5 minutes after vaccination
Student dizziness
student self-reported dizziness during vaccination, rated on a 0-10 scale
Time frame: within 5 minutes of vaccination
Student fainting
student fainting during vaccination, yes/no, as assessed by immunizer
Time frame: within 1 hour after vaccination
Student post-immunization stress-related responses
student post-immunization stress-related responses, yes/no, as assessed by immunizer using the WHO immunization Stress Responses Criteria
Time frame: within 1 hour after vaccination
Utilization of coping strategies
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
Time frame: within 5 minutes after vaccination
Uptake of vaccination
proportion of students vaccinated (overall and for each vaccine)
Time frame: by end of school year
Implementation success of CARD
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
Time frame: within 3 months of vaccination clinics
Compliance with CARD
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
Time frame: within 3 months of vaccination clinics
Knowledge of effective coping strategies
knowledge of effective coping strategies, as assessed using a 10-point investigator-developed knowledge test, administered to implementers
Time frame: within 3 months after vaccination clinics
Perceptions about pain and fear
perceptions about pain and fear, as assessed using a 5-point likert scale (higher number represents better outcome) for implementers
Time frame: within 3 months of vaccination clinics
Perceptions about vaccination program
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
Time frame: within 3 months of vaccination clinics
Willingness to be vaccinated
student self-reported willingness to be vaccinated, as assessed using a 5-point likert scale (higher number represents better outcome)
Time frame: within 5 minutes after vaccination
Satisfaction with CARD
student self-reported satisfaction with CARD, as assessed using Student Feedback Survey, individual questions (5-point likert scale, higher number indicates better outcome)
Time frame: within 5 minutes after vaccination
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