Fear, Vaccination; Complications, Vaccine Adverse Reaction
Conditions
Keywords
school vaccinations, pain management, vaccination hesitancy, knowledge translation
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.
Interventions
The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program
Sponsors
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Students will not be aware of whether they are in the intervention or control group. Care providers who are trained in the intervention are aware of the group allocation. They will not communicate with care providers not trained in the intervention. Care providers that are trained in the intervention will not deliver care to participants in the control group and care providers that are not trained will not deliver care to participants in the intervention group
Intervention 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
Eligibility
Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Student fear | within 5 minutes after vaccination | student self-reported fear during vaccination, rated on a 0-10 scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Student dizziness | within 5 minutes of vaccination | student self-reported dizziness 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 |
| 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 |
| Student pain | within 5 minutes after vaccination | student self-reported pain during vaccination, rated on a 0-10 scale |
| 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 |
| 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 |
| 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) |
| 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) |
| 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 |
Countries
Canada
Outcome results
None listed