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

Fear Clinical Trial

Official title:

Playing CARDs to Improve the Vaccination Experience at School: a Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03966300
• Other study ID #: 37598
• Status: Terminated
• Phase: N/A
• Start date: September 19, 2019
• Est. completion date: November 22, 2019

Study information

• Verified date: June 2021
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1919
• Est. completion date: November 22, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fear
• Vaccination; Complications
• Vaccine Adverse Reaction

Intervention

Other:
• Multi-faceted knowledge translation intervention
The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program

Locations

Country	Name	City	State
Canada	Wellington Dufferin Guelph Public Health	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Student fear	student self-reported fear during vaccination, rated on a 0-10 scale	within 5 minutes after vaccination
Secondary	Student pain	student self-reported pain during vaccination, rated on a 0-10 scale	within 5 minutes after vaccination
Secondary	Student dizziness	student self-reported dizziness during vaccination, rated on a 0-10 scale	within 5 minutes of vaccination
Secondary	Student fainting	student fainting during vaccination, yes/no, as assessed by immunizer	within 1 hour after vaccination
Secondary	Student post-immunization stress-related responses	student post-immunization stress-related responses, yes/no, as assessed by immunizer using the WHO immunization Stress Responses Criteria	within 1 hour after vaccination
Secondary	Utilization of coping strategies	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	within 5 minutes after vaccination
Secondary	Uptake of vaccination	proportion of students vaccinated (overall and for each vaccine)	by end of school year
Secondary	Implementation success of CARD	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	within 3 months of vaccination clinics
Secondary	Compliance with CARD	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	within 3 months of vaccination clinics
Secondary	Knowledge of effective coping strategies	knowledge of effective coping strategies, as assessed using a 10-point investigator-developed knowledge test, administered to implementers	within 3 months after vaccination clinics
Secondary	Perceptions about pain and fear	perceptions about pain and fear, as assessed using a 5-point likert scale (higher number represents better outcome) for implementers	within 3 months of vaccination clinics
Secondary	Perceptions about vaccination program	perceptions about vaccination program, as assessed using the Vaccination Program Global Impresssion Checklist, individual questions (5-point likert scale, higher number represents better outcome) for implementers	within 3 months of vaccination clinics
Secondary	Willingness to be vaccinated	student self-reported willingness to be vaccinated, as assessed using a 5-point likert scale (higher number represents better outcome)	within 5 minutes after vaccination
Secondary	Satisfaction with CARD	student self-reported satisfaction with CARD, as assessed using Student Feedback Survey, individual questions (5-point likert scale, higher number indicates better outcome)	within 5 minutes after vaccination

External Links

•   Supplement issue of Paediatrics & Child Health - repository for prior research with CARD