Improving the School Vaccination Experience: What CARDs Are You Going to Play?

NCT03966300 | Terminated

• 1 other identifier: 37598
• Study Type: interventional
• Target: 1,919
• Locations: 1 country
• Sites: 1

Brief Summary

Vaccination hesitancy is identified as a threat to global health by the World Health Organization (WHO). For adolescents undergoing vaccination at school, prior studies demonstrate that concerns about pain and/or fear of needles contribute to negative experiences with vaccination and non-compliance with vaccination. The investigators developed an intervention that addresses vaccination hesitancy. In this study, investigators will evaluate the effectiveness of this intervention in a randomized controlled trial.

Conditions

Vaccine Adverse Reaction; Vaccination; Complications; Fear

Keywords

school vaccinations; pain management; vaccination hesitancy; knowledge translation

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 (13)

• Student pain

  within 5 minutes after vaccination

• Student dizziness

  within 5 minutes of 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/usual 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 7 students eligible for vaccination at school
• public health staff working in the school vaccination program

You may not qualify if:

• unable to understand and read English

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Wellington Dufferin Guelph Public Health

Guelph, Ontario, L9W 1K3, Canada

Location

Related Publications (1)

• Taddio A, Gudzak V, Jantzi M, Logeman C, Bucci LM, MacDonald NE, Moineddin R. Impact of the CARD (Comfort Ask Relax Distract) system on school-based vaccinations: A cluster randomized trial. Vaccine. 2022 Apr 26;40(19):2802-2809. doi: 10.1016/j.vaccine.2022.02.069. Epub 2022 Mar 29.

  PMID: 35365344 DERIVED

MeSH Terms

Conditions

Agnosia; Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

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 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: Randomized controlled trial; schools will be randomized to CARD or usual care and all students attending the schools will receive the allocated treatment

Study Record Dates

• First Submitted: May 25, 2019
• First Posted: May 29, 2019
• Study Start: September 19, 2019
• Primary Completion: November 20, 2019
• Study Completion: November 22, 2019
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)