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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

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.

Condition or disease Intervention/treatment Phase
Immunisation Anxiety Related Reaction Other: Multi-faceted knowledge translation intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
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
Official Title: Improving the Vaccination Experience at School in Calgary
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : August 31, 2019

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
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. 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


Secondary Outcome Measures :
  1. 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)

  2. percent of schools recruited [ Time Frame: within 1 week of school vaccination clinic ]
    proportion of schools that participate in the study

  3. 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).

  4. 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).

  5. 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).


Other Outcome Measures:
  1. 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).

  2. 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).

  3. 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)

  4. 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.



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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03948633


Contacts
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Contact: Anna Taddio, PhD 416-978-8822 anna.taddio@utoronto.ca
Contact: Charlotte Logeman, MSc 416-978-2889 charlotte.logeman@utoronto.ca

Locations
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Canada, Alberta
Alberta Health Services Public Health - Calgary Zone Recruiting
Calgary, Alberta, Canada, T2W 3N2
Contact: Joanne Coldham, MEd    403 943-1197    joanne.coldham@ahs.ca   
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: NCT03948633    
Other Study ID Numbers: 36893
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is 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
knowledge translation