Clinical trial NCT03966300: Improving the School Vaccination Experience: What CARDs Are You Going to Play?
Official title: Playing CARDs to Improve the Vaccination Experience at School: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vaccine Adverse Reaction
Vaccination; Complications
Fear
Keywords: school vaccinations
pain management
vaccination hesitancy
knowledge translation
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 1919
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial; schools will be randomized to CARD or usual care and all students attending the schools will receive the allocated treatment
Primary purpose: TREATMENT

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.

Detailed description: Vaccination hesitancy is identified by the World Health Organization (WHO) as one of ten threats to global health. The WHO's 3C model of vaccination hesitancy identifies 3 domains of vaccine hesitancy: 1) Confidence (trust in health care providers), 2) Complacency (perceived importance of vaccine-preventable disease) and 3) Convenience (improving clinic processes). The investigators developed a multifaceted knowledge translation intervention that addresses vaccination hesitancy in school-based vaccinations. The intervention is called The CARD(TM) System (C-Comfort, A-Ask, R-Relax, D-Distract). CARD is a framework for delivering vaccinations that is student-centred and promotes coping. CARD integrates evidence-based interventions related to planning and execution of school vaccination clinics to directly tackle all 3 domains of vaccination hesitancy. It tackles Confidence by improving pain/fear management (it teaches students and public health staff how to reduce student symptoms which improves the vaccination experience and improves student trust in health care providers). It tackles Complacency by educating students about what vaccines are, why they are needed, community immunity, as well as the specific diseases they are being protected against. It tackles Convenience by improving school-based clinic processes by integrating student preferences (e.g., privacy, having a support person present).

In this randomized controlled trial, the investigators will evaluate the impact of CARD (vs. usual care) on student important outcomes and process outcomes.

Eligibility criteria: Inclusion Criteria:

* grade 7 students eligible for vaccination at school
* public health staff working in the school vaccination program

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 of 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 of vaccination clinics
measure: Compliance with CARD
timeFrame: within 3 months of vaccination clinics
measure: Knowledge of effective coping strategies
timeFrame: within 3 months after vaccination clinics
measure: Perceptions about pain and fear
timeFrame: within 3 months of vaccination clinics
measure: Perceptions about vaccination program
timeFrame: within 3 months of vaccination clinics
measure: Willingness to be vaccinated
timeFrame: within 5 minutes after vaccination
measure: Satisfaction with CARD
timeFrame: within 5 minutes after vaccination
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Wellington Dufferin Guelph Public Health
state: Ontario
Study officials:
affiliation: University of Toronto
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.