Clinical trial NCT03966391: Effectiveness of CARD for Improving School-Based Immunizations
Official title: Effectiveness of a Multi-faceted Knowledge Translation Intervention (The CARD System) for School Based Immunizations: a Cluster Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination; Complications
Vaccine Adverse Reaction
Fear
Keywords: school vaccinations
pain management
knowledge translation
cluster trial
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2019-05-29
Enrollment: 8839
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster trial involving 8 community health centres. They will be randomized to CARD or control (standard care) groups in a 1:1 ratio. Eligible schools (approximately 13/community health centre) will be included.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Student fear
timeFrame: within 5 minutes after vaccination
Secondary outcomes:
measure: Student pain
timeFrame: within 5 minutes after vaccination
measure: Student dizziness
timeFrame: within 5 minutes after vaccination
measure: Student fainting
timeFrame: within 1 hour after vaccination
measure: Student post-immunization stress-related responses
timeFrame: within 1 hour after vaccination
measure: Utilization of coping strategies
timeFrame: within 5 minutes after vaccination
measure: Uptake of vaccination
timeFrame: by end of school year
measure: Implementation success of CARD
timeFrame: within 3 months after vaccination clinics
measure: Compliance with CARD
timeFrame: within 3 months after vaccination clinics
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Health Services Public Health - Calgary Zone
state: Alberta
Study officials:
affiliation: University of Toronto
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References: