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Study was terminated due to inability to: 1) vaccinate at school, 2) control and track vaccinations, 3) continue the intervention as proposed. Data collected during fall 2019 clinics are being transferred to researchers and verified.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARD (multi-faceted knowledge translation intervention) | Experimental | 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) |
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| Control (standard/usual care) | No Intervention | 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-faceted knowledge translation intervention | Other | The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program |
| Measure | Description | Time Frame |
|---|---|---|
| Student fear | student self-reported fear during vaccination, rated on a 0-10 scale | within 5 minutes after vaccination |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Taddio, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellington Dufferin Guelph Public Health | Guelph | Ontario | L9W 1K3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35365344 | Derived | Taddio A, Gudzak V, Jantzi M, Logeman C, Bucci LM, MacDonald NE, Moineddin R. Impact of the CARD (Comfort Ask Relax Distract) system on school-based vaccinations: A cluster randomized trial. Vaccine. 2022 Apr 26;40(19):2802-2809. doi: 10.1016/j.vaccine.2022.02.069. Epub 2022 Mar 29. |
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No plan to share IPD
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Randomized controlled trial; schools will be randomized to CARD or usual care and all students attending the schools will receive the allocated treatment
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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
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| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |