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Effectiveness of CARD for Improving School-Based Immunizations

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: NCT03966391
Recruitment Status : Suspended (Study suspended because of Covid-19 - there are no vaccinations in schools)
First Posted : May 29, 2019
Last Update Posted : June 12, 2020
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
Anna Taddio, University of Toronto

Tracking Information
First Submitted Date  ICMJE May 25, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date June 12, 2020
Actual Study Start Date  ICMJE May 22, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2019)
Student fear [ Time Frame: within 5 minutes after vaccination ]
student self-reported fear during vaccination, rated on a 0-10 scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2019)
  • Student pain [ Time Frame: within 5 minutes after vaccination ]
    student self-reported pain during vaccination, rated on a 0-10 scale
  • Student dizziness [ Time Frame: within 5 minutes after vaccination ]
    student self-reported dizziness during vaccination, rated on a 0-10 scale
  • Student fainting [ Time Frame: within 1 hour after vaccination ]
    student fainting during vaccination, yes/no, as assessed by immunizer
  • 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
  • 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
  • Uptake of vaccination [ Time Frame: by end of school year ]
    proportion of students vaccinated (overall and for each vaccine)
  • 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, as well as focus groups with other stakeholder groups (secondary targets - school staff, students, parents)
  • Cost of CARD implementation [ Time Frame: within 3 months of vaccination clinics ]
    micro-costing of implementer activities - student education, vaccination clinic, planning for topical anesthetics, re-scheduling vaccinations
  • Compliance with CARD [ Time Frame: within 3 months after 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, as well as focus groups with other stakeholder groups (students, parents, school staff).
  • Knowledge of effective coping strategies [ Time Frame: within 3 months of vaccination clinics ]
    knowledge of effective coping strategies, as assessed using a 10-point investigator-developed knowledge test; administered to different stakeholder groups (public health, school staff, students, parents)
  • 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 different stakeholder groups (public health, school staff, students, parents)
  • Willingness to be vaccinated [ Time Frame: within 3 months of vaccination clinics ]
    student self-reported willingness to be vaccinated, as assessed using a 5-point likert scale (higher number represents better outcome)
  • Fear of needles [ Time Frame: within 3 months of vaccination clinics ]
    student self-reported fear of needles, rated on a 0-10 scale
  • Perceptions of Vaccination Program [ Time Frame: within 3 months of vaccination clinics ]
    perceptions of public health staff using the Vaccination Program Global Impression Checklist, individual questions (5-point likert scale, higher number represents better outcome).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of CARD for Improving School-Based Immunizations
Official Title  ICMJE Effectiveness of a Multi-faceted Knowledge Translation Intervention (The CARD System) for School Based Immunizations: a Cluster Trial
Brief Summary Vaccination is estimated to have saved more lives in Canada than any other single intervention and is considered one of the most important advances in the prevention of disease. The process of vaccination, however, is stressful for individuals. School-based vaccinations in particular, are associated with high levels of fear and anxiety among students. This randomized cluster trial will implement a multi-faceted knowledge translation intervention called The CARD (C-Comfort A-Ask R-Relax D-Distract) System in school-based vaccinations and evaluate its effects on the experience of vaccination for students and implementation outcomes.
Detailed Description

The investigators developed a multi-faceted knowledge translation intervention called The CARD System to provide a framework for delivering vaccinations at school that integrates evidence-based strategies to mitigate pain, fear and fainting and promotes a student-centred approach to vaccination. CARD addresses 2 components of the vaccination delivery program: 1) pre-vaccination day preparation and 2) vaccination day activities. In a small controlled clinical trial in a public health unit in Niagara, Ontario, the investigators demonstrated benefits of CARD on student symptoms during vaccination, including fear, and dizziness-precursor of fainting, and satisfaction with CARD by all stakeholder groups (students, public health staff, school staff and parents). This study will evaluate CARD in a large cluster trial in Calgary, Alberta. This trial is the final phase of a 3-phase project, whereby the first 2 phases involve developing an implementation plan for the local context and evaluating feasibility of implementation.

Eight community health centres that provide vaccination services to schools in their regions will be randomized in a 1:1 ratio to CARD or control (usual practices). Data will be collected for vaccination services carried out in grade 6 and grade 9 students in participating schools for the academic year 2019-2020.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Cluster trial involving 8 community health centres. They will be randomized to CARD or control (standard care) groups in a 1:1 ratio. Eligible schools (approximately 13/community health centre) will be included.
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 in the intervention will not deliver care to participants in the intervention group
Primary Purpose: Treatment
Condition  ICMJE
  • Vaccination; Complications
  • Vaccine Adverse Reaction
  • Fear
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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)
    Intervention: Other: Multi-faceted knowledge translation intervention
  • No Intervention: Control (standard 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 25, 2019)
7800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • grade 7 and 9 students eligible for vaccination at school
  • public health staff in community health centre involved in the study
  • school staff in a participating school involved in school vaccination
  • parent of a student eligible for vaccination at school

Exclusion Criteria:

- unable to understand and read English

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966391
Other Study ID Numbers  ICMJE 036893
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share IPD
Responsible Party Anna Taddio, University of Toronto
Study Sponsor  ICMJE University of Toronto
Collaborators  ICMJE Alberta Health Services
Investigators  ICMJE
Principal Investigator: Anna Taddio, PhD University of Toronto
PRS Account University of Toronto
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP