Effectiveness of CARD for Improving School-Based Immunizations

NCT03966391 | Completed

• 1 other identifier: 036893
• Study Type: interventional
• Target: 8,839
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccination; Complications; Vaccine Adverse Reaction; Fear

Keywords

school vaccinations; pain management; knowledge translation; cluster trial

Outcome Measures

Primary Outcomes (1)

• Student fear

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

  within 5 minutes after vaccination

Secondary Outcomes (8)

• Student pain

  within 5 minutes after vaccination

• Student dizziness

  within 5 minutes after vaccination

• Student fainting

  within 1 hour after vaccination

• Student post-immunization stress-related responses

  within 1 hour after vaccination

• Utilization of coping strategies

  within 5 minutes after vaccination

Study Arms (2)

CARD (multi-faceted knowledge translation intervention)

EXPERIMENTAL

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

Control (standard care)

NO INTERVENTION

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)

Interventions

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

Also known as: CARD

CARD (multi-faceted knowledge translation intervention)

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- unable to understand and read English

Sponsors & Collaborators

• University of Toronto: lead
• Alberta Health services: collaborator

Study Sites (1)

Alberta Health Services Public Health - Calgary Zone

Calgary, Alberta, T2W 3N2, Canada

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna Taddio, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Students will not be aware of whether they are in the intervention or control group. Care providers who are trained in the intervention are aware of the group allocation. They will not communicate with care providers not trained in the intervention. Care providers that are trained in the intervention will not deliver care to participants in the control group and care providers that are not trained in the intervention will not deliver care to participants in the intervention group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2019
• First Posted: May 29, 2019
• Study Start: September 25, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)