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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vaccine Adverse Reaction, Vaccination; Complications, Fear

Intervention / Treatment
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* Other: Multi-faceted knowledge translation intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial; schools will be randomized to CARD or usual care and all students attending the schools will receive the allocated treatment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARD (multi-faceted knowledge translation intervention)<br>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) | Other: Multi-faceted knowledge translation intervention<br>* The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program<br>* Other names: CARD;|
| No Intervention: Control (standard/usual care)<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Student fear | student self-reported fear during vaccination, rated on a 0-10 scale | within 5 minutes after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Student pain | student self-reported pain during vaccination, rated on a 0-10 scale | within 5 minutes after vaccination | 
| Student dizziness | student self-reported dizziness during vaccination, rated on a 0-10 scale | within 5 minutes of vaccination | 
| Student fainting | student fainting during vaccination, yes/no, as assessed by immunizer | 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 | 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 | within 5 minutes after vaccination | 
| Uptake of vaccination | proportion of students vaccinated (overall and for each vaccine) | 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 | 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 | 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 | 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 | 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 | 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) | 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) | within 5 minutes after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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school vaccinations, pain management, vaccination hesitancy, knowledge translation