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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03966300
Recruitment Status : Suspended (Study suspended because of Covid-19 - no vaccinations are occurring in schools)
First Posted : May 29, 2019
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Anna Taddio, University of Toronto

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.

Condition or disease Intervention/treatment Phase
Vaccine Adverse Reaction Vaccination; Complications Fear Other: Multi-faceted knowledge translation intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Participant)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Playing CARDs to Improve the Vaccination Experience at School: a Cluster Randomized Controlled Trial
Actual Study Start Date : June 12, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

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 Name: 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)



Primary Outcome Measures :
  1. Student fear [ Time Frame: within 5 minutes after vaccination ]
    student self-reported fear during vaccination, rated on a 0-10 scale


Secondary Outcome Measures :
  1. Student pain [ Time Frame: within 5 minutes after vaccination ]
    student self-reported pain during vaccination, rated on a 0-10 scale

  2. Student dizziness [ Time Frame: within 5 minutes of vaccination ]
    student self-reported dizziness during vaccination, rated on a 0-10 scale

  3. Student fainting [ Time Frame: within 1 hour after vaccination ]
    student fainting during vaccination, yes/no, as assessed by immunizer

  4. Student post-immunization stress-related responses [ Time Frame: within 1 hour after vaccination ]
    student post-immunization stress-related responses, yes/no, as assessed by immunizer using the WHO immunization Stress Responses Criteria

  5. Utilization of coping strategies [ Time Frame: within 5 minutes after vaccination ]
    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

  6. Uptake of vaccination [ Time Frame: by end of school year ]
    proportion of students vaccinated (overall and for each vaccine)

  7. Implementation success of CARD [ Time Frame: within 3 months of vaccination clinics ]
    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

  8. Compliance with CARD [ Time Frame: within 3 months of vaccination clinics ]
    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

  9. Knowledge of effective coping strategies [ Time Frame: within 3 months after vaccination clinics ]
    knowledge of effective coping strategies, as assessed using a 10-point investigator-developed knowledge test, administered to implementers

  10. Perceptions about pain and fear [ Time Frame: within 3 months of vaccination clinics ]
    perceptions about pain and fear, as assessed using a 5-point likert scale (higher number represents better outcome) for implementers

  11. Perceptions about vaccination program [ Time Frame: within 3 months of vaccination clinics ]
    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

  12. Willingness to be vaccinated [ Time Frame: within 5 minutes after vaccination ]
    student self-reported willingness to be vaccinated, as assessed using a 5-point likert scale (higher number represents better outcome)

  13. Satisfaction with CARD [ Time Frame: within 5 minutes after vaccination ]
    student self-reported satisfaction with CARD, as assessed using Student Feedback Survey, individual questions (5-point likert scale, higher number indicates better outcome)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03966300


Locations
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Canada, Ontario
Wellington Dufferin Guelph Public Health
Guelph, Ontario, Canada, L9W 1K3
Sponsors and Collaborators
University of Toronto
Investigators
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Principal Investigator: Anna Taddio, PhD University of Toronto
Additional Information:
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Responsible Party: Anna Taddio, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT03966300    
Other Study ID Numbers: 37598
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Taddio, University of Toronto:
school vaccinations
pain management
vaccination hesitancy
knowledge translation