Effectiveness of CARD for Improving School-Based Immunizations

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

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.

Study Overview

• Status: Completed
• Conditions: Vaccine Adverse Reaction; Fear; Vaccination; Complications
• Intervention / Treatment: Other: Multi-faceted knowledge translation intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 8839
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2W 3N2
      • Alberta Health Services Public Health - Calgary Zone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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; Other Names: CARD
No Intervention: Control (standard 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Student fear	student self-reported fear during vaccination, rated on a 0-10 scale	within 5 minutes after vaccination

Secondary Outcome Measures

Outcome Measure	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	within 5 minutes after 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
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
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

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: Alberta Health services
• Investigators: Principal Investigator: Anna Taddio, PhD, University of Toronto

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): March 12, 2020

Study Registration Dates

• First Submitted: May 25, 2019
• First Submitted That Met QC Criteria: May 25, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: cluster trial; pain management; knowledge translation; school vaccinations
• Other Study ID Numbers: 036893

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No