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

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

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.

Study Overview

• Status: Terminated
• Conditions: Vaccine Adverse Reaction; Fear; Vaccination; Complications
• Intervention / Treatment: Other: Multi-faceted knowledge translation intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 1919
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, L9W 1K3
      • Wellington Dufferin Guelph Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CARD (multi-faceted knowledge translation intervention); 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; The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program; Other Names: CARD
No Intervention: Control (standard/usual care); 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Student fear	student self-reported fear during vaccination, rated on a 0-10 scale	within 5 minutes after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Student pain	student self-reported pain during vaccination, rated on a 0-10 scale	within 5 minutes after vaccination
Student fainting	student fainting during vaccination, yes/no, as assessed by immunizer	within 1 hour after vaccination
Uptake of vaccination	proportion of students vaccinated (overall and for each vaccine)	by end of school year
Student dizziness	student self-reported dizziness during vaccination, rated on a 0-10 scale	within 5 minutes of vaccination
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Toronto
• Investigators: Principal Investigator: Anna Taddio, PhD, University of Toronto

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2019
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 22, 2019

Study Registration Dates

• First Submitted: May 25, 2019
• First Submitted That Met QC Criteria: May 25, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: pain management; knowledge translation; school vaccinations; vaccination hesitancy
• Other Study ID Numbers: 37598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No