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

NCT ID: NCT03966300

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1919 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-19
• Study Completion Date: 2019-11-22

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.

Conditions

Vaccine Adverse Reaction; Vaccination; Complications; Fear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CARD (multi-faceted knowledge translation intervention)

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)

Group Type: EXPERIMENTAL

Multi-faceted knowledge translation intervention

Intervention Type: OTHER

The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program

Control (standard/usual care)

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multi-faceted knowledge translation intervention

The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program

Intervention Type: OTHER

Other Intervention Names

CARD

Eligibility Criteria

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

• Minimum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Anna Taddio

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Taddio, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Wellington Dufferin Guelph Public Health

Guelph, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 35365344 (View on PubMed)

Other Identifiers

37598

Identifier Type: -

Identifier Source: org_study_id