Effectiveness of CARD for Improving School-Based Immunizations

Fear Clinical Trial

Official title:

Effectiveness of a Multi-faceted Knowledge Translation Intervention (The CARD System) for School Based Immunizations: a Cluster Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966391
• Other study ID #: 036893
• Status: Completed
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: March 12, 2020

Study information

• Verified date: March 2023
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Vaccination is estimated to have saved more lives in Canada than any other single intervention and is considered one of the most important advances in the prevention of disease. The process of vaccination, however, is stressful for individuals. School-based vaccinations in particular, are associated with high levels of fear and anxiety among students. This randomized cluster trial will implement a multi-faceted knowledge translation intervention called The CARD (C-Comfort A-Ask R-Relax D-Distract) System in school-based vaccinations and evaluate its effects on the experience of vaccination for students and implementation outcomes.

Description:

The investigators developed a multi-faceted knowledge translation intervention called The CARD System to provide a framework for delivering vaccinations at school that integrates evidence-based strategies to mitigate pain, fear and fainting and promotes a student-centred approach to vaccination. CARD addresses 2 components of the vaccination delivery program: 1) pre-vaccination day preparation and 2) vaccination day activities. In a small controlled clinical trial in a public health unit in Niagara, Ontario, the investigators demonstrated benefits of CARD on student symptoms during vaccination, including fear, and dizziness-precursor of fainting, and satisfaction with CARD by all stakeholder groups (students, public health staff, school staff and parents). This study will evaluate CARD in a large cluster trial in Calgary, Alberta. This trial is the final phase of a 3-phase project, whereby the first 2 phases involve developing an implementation plan for the local context and evaluating feasibility of implementation.

Eight community health centres that provide vaccination services to schools in their regions will be randomized in a 1:1 ratio to CARD or control (usual practices). Data will be collected for vaccination services carried out in grade 6 and grade 9 students in participating schools for the academic year 2019-2020.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8839
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

Inclusion Criteria:

• grade 6 and 9 students eligible for vaccination at school

• public health staff in community health centre involved in the study

• school staff in a participating school involved in school vaccination

• parent of a student eligible for vaccination at school

Exclusion Criteria:

• unable to understand and read English

Related Conditions & MeSH terms

• Fear
• Vaccination; Complications
• Vaccine Adverse Reaction

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	Alberta Health Services Public Health - Calgary Zone	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Alberta Health services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Student fear	student self-reported fear during vaccination, rated on a 0-10 scale	within 5 minutes after vaccination
Secondary	Student pain	student self-reported pain during vaccination, rated on a 0-10 scale	within 5 minutes after vaccination
Secondary	Student dizziness	student self-reported dizziness during vaccination, rated on a 0-10 scale	within 5 minutes after vaccination
Secondary	Student fainting	student fainting during vaccination, yes/no, as assessed by immunizer	within 1 hour after vaccination
Secondary	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
Secondary	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
Secondary	Uptake of vaccination	proportion of students vaccinated (overall and for each vaccine)	by end of school year
Secondary	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 after vaccination clinics
Secondary	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, as well as focus groups with other stakeholder groups (students, parents, school staff).	within 3 months after vaccination clinics

External Links

•   Description Supplement issue of Paediatrics & Child Health - repository for prior research with CARD