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

University of Toronto

Status: Terminated

Conditions: Fear; Vaccine Adverse Reaction; Vaccination; Complications

Treatments: Other: Multi-faceted knowledge translation intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03966300

37598

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,919 patients

Sex: All

Ages: 11+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,919 participants in 2 patient groups

CARD (multi-faceted knowledge translation intervention)

Experimental group

Description:

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)

Treatment:

Other: Multi-faceted knowledge translation intervention

Control (standard/usual care)

No Intervention group

Description:

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)