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Completed

NCT Number: NCT03966391

Effectiveness of CARD for Improving School-Based Immunizations

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.

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Key information

Conditions

Vaccination; Complications Agnosia Fear Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Vaccine Adverse Reaction

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Health Services Public Health - Calgary Zone

Calgary, Alberta, T2W 3N2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: CARD

Primary outcomes

  1. Student fear

    Time frame: within 5 minutes after vaccination

    student self-reported fear during vaccination, rated on a 0-10 scale

Secondary outcomes

  1. Student pain

    Time frame: within 5 minutes after vaccination

    student self-reported pain during vaccination, rated on a 0-10 scale

  2. Student dizziness

    Time frame: within 5 minutes after vaccination

    student self-reported dizziness during vaccination, rated on a 0-10 scale

  3. Student fainting

    Time frame: within 1 hour after vaccination

    student fainting during vaccination, yes/no, as assessed by immunizer

  4. Student post-immunization stress-related responses

    Time frame: within 1 hour after vaccination

    student post-immunization stress-related responses, yes/no, as assessed by immunizer using the WHO Immunization Stress Responses Criteria

  5. Utilization of coping strategies

    Time frame: within 5 minutes after vaccination

    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

  6. Uptake of vaccination

    Time frame: by end of school year

    proportion of students vaccinated (overall and for each vaccine)

  7. Implementation success of CARD

    Time frame: within 3 months after vaccination clinics

    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

  8. Compliance with CARD

    Time frame: within 3 months after vaccination clinics

    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).

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Alberta Health services

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 29, 2019
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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