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Feasibility of Implementation of CARD for School-Based Immunizations

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ClinicalTrials.gov Identifier: NCT03948633
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Anna Taddio, University of Toronto

Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date May 28, 2019
Actual Study Start Date  ICMJE April 25, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
percent complete data for student symptom survey [ Time Frame: within 5 minutes after vaccination ]
proportion of students that fill in questionnaire about their symptoms (fear, dizziness, pain) during vaccination
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • percent complete data for nurse feedback form [ Time Frame: within 5 minutes after vaccination ]
    proportion of immunizers that fill in questionnaire about interventions used during immunization (e.g., privacy, distraction)
  • percent of schools recruited [ Time Frame: within 1 week of school vaccination clinic ]
    proportion of schools that participate in the study
  • percent compliance with CARD (intervention) [ Time Frame: within 3 months after vaccination ]
    proportion of adherence to components of CARD protocol as assessed by CARD implementers using a self-reported 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).
  • perceived quality of CARD (intervention) program delivery [ Time Frame: within 3 months after vaccination ]
    perceptions of quality of CARD program delivery as reported by CARD implementers (primary targets) using the CARD Global Impression Checklist, individual quality 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).
  • perceived acceptability of CARD (intervention) [ Time Frame: within 3 months after vaccination ]
    perception of acceptability (satisfaction with CARD) by CARD implementers (primary targets) using the CARD Global Impression Checklist, individual acceptability 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • percent complete data for nurse feedback form [ Time Frame: within 5 minutes after vaccination ]
    proportion of immunizers that fill in questionnaire about interventions used during immunization (e.g., privacy, distraction)
  • percent of schools recruited [ Time Frame: within 1 week of school vaccination clinic ]
    proportion of schools that participate in the study
  • percent compliance with CARD (intervention) [ Time Frame: within 3 months after vaccination ]
    proportion of adherence to components of CARD protocol as assessed by CARD implementers using a self-reported 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).
  • perceived quality of CARD (intervention) program delivery [ Time Frame: within 3 months after vaccination ]
    perceptions of quality of CARD program delivery as reported by CARD implementers (primary targets) using a checklist, focus groups, and study notes. Supplemented by perceptions of other stakeholders (secondary targets - students, parents, school staff) during focus groups.
  • perceived acceptability of CARD (intervention) [ Time Frame: within 3 months after vaccination ]
    perception of acceptability (satisfaction with CARD) by stakeholders (primary target - implementers; secondary targets - school staff, students, parents) as assessed during focus groups and study notes
Current Other Pre-specified Outcome Measures
 (submitted: May 23, 2019)
  • perceived appropriateness of CARD (intervention) [ Time Frame: within 3 months of vaccination ]
    perception of appropriateness (fit of CARD) by CARD implementers (primary targets) using the CARD Global Impression Checklist, individual appropriateness 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).
  • perceived feasibility of CARD (intervention) [ Time Frame: within 3 months of vaccination ]
    perception of feasibility (extent to which CARD can be carried out) by CARD implementers (primary targets) using the CARD Global Impression Checklist, individual feasibility 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).
  • percent reliability of data collection [ Time Frame: within 1 day of activities described (education, immunization day, and nurse feedback) ]
    proportion of agreement between implementer and observer checklists for aspects of immunization program delivery (i.e., education, immunization day, nurse feedback form)
  • success of recruitment of secondary targets (school staff, students, parents) for focus groups [ Time Frame: within 3 months of vaccination ]
    proportion of focus groups successfully undertaken with secondary stakeholder targets.
Original Other Pre-specified Outcome Measures
 (submitted: May 9, 2019)
  • perceived appropriateness of CARD (intervention) [ Time Frame: within 3 months of vaccination ]
    perception of appropriateness (fit of CARD) by stakeholders (primary target - implementers; secondary targets - school staff, students, parents) as assessed during focus groups and study notes
  • perceived feasibility of CARD (intervention) [ Time Frame: within 3 months of vaccination ]
    perception of feasibility (extent to which CARD can be carried out) as assessed by implementers (primary targets) using a checklist and focus groups. Supplemented by focus groups in secondary targets - school staff, students, parents, and study notes.
  • percent reliability of data collection [ Time Frame: within 1 day of activities described (education, immunization day, and nurse feedback) ]
    proportion of agreement between implementer and observer checklists for aspects of immunization program delivery (i.e., education, immunization day, nurse feedback form)
  • success of recruitment of secondary targets (school staff, students, parents) for focus groups [ Time Frame: within 3 months of vaccination ]
    proportion of focus groups successfully undertaken with secondary stakeholder targets.
 
Descriptive Information
Brief Title  ICMJE Feasibility of Implementation of CARD for School-Based Immunizations
Official Title  ICMJE Improving the Vaccination Experience at School in Calgary
Brief Summary A multi-faceted knowledge translation intervention - The CARD (C-Comfort, A-Ask, R-Relax, D-Distract) System - was developed to improve the vaccination experience of students at school. CARD is a framework for delivering vaccinations that is student-centred that promotes coping. This study will examine the feasibility of CARD implementation procedures and measures in the school vaccination program in Calgary, Alberta for use in a larger cluster trial.
Detailed Description

Vaccination is estimated to have saved more lives in Canada over the last 50 years than any other single intervention and is considered one of the most important advances in the prevention of disease. One major drawback of vaccination, however, is that the usual route of administration involves a painful needle injection. In students undergoing school-based mass vaccinations, vaccine injections frequently cause sever distress and fainting, with some serious injuries resulting from fainting. Concerns about pain and/or needle fear are also directly responsible for vaccine refusal in this population.

An evidence based clinical practice guideline for mitigating vaccine injection pain, fear and fainting has been developed, however, it is not yet implemented across different school-based vaccination settings and students are not benefiting from the research evidence. In a prior small-scale project, investigators developed and implemented a multi-faceted knowledge translation intervention - The CARD (C-Comfort, A-Ask, R-Relax, D-Distract) System - in some schools in a small public health region in Niagara, Ontario. CARD is a framework for delivering vaccinations that is student-centred and promotes coping. It integrates recommendations from the guideline in two separate components of the vaccination delivery program: 1) pre-vaccination day preparation, and 2) vaccination day activities. Investigators found preliminary evidence of acceptability, appropriateness, satisfaction and clinical effectiveness of CARD when used in grade 7 students in Niagara.

In this study, investigators plan to determine the feasibility of implementing CARD in a diverse and more complex public health region in Calgary, Alberta. Specifically, investigators will determine recruitment rates, adherence to CARD protocol, response rates for questionnaires, acceptability, appropriateness (fit), and satisfaction. The results will inform a future cluster trial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a feasibility study including 2 community health centres that have been randomly selected to either the multi-faceted knowledge translation intervention (CARD) or control (standard care) out of 8 community health centres anticipated to participate in a future cluster trial. Within each community health centre, 5 individual schools will be randomly selected to participate.
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: Other
Condition  ICMJE Immunisation Anxiety Related Reaction
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
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • grade 9 student 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 program
  • 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 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Anna Taddio, PhD 416-978-8822 anna.taddio@utoronto.ca
Contact: Charlotte Logeman, MSc 416-978-2889 charlotte.logeman@utoronto.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948633
Other Study ID Numbers  ICMJE 36893
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 Not Provided
Investigators  ICMJE
Principal Investigator: Anna Taddio, PhD University of Toronto
PRS Account University of Toronto
Verification Date May 2019

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