Condition or disease | Intervention/treatment | Phase |
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Immunisation Anxiety Related Reaction | Other: Multi-faceted knowledge translation intervention | Not Applicable |
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 : | 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 |
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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).
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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
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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).
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anna Taddio, PhD | 416-978-8822 | anna.taddio@utoronto.ca | |
Contact: Charlotte Logeman, MSc | 416-978-2889 | charlotte.logeman@utoronto.ca |
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 |
Principal Investigator: | Anna Taddio, PhD | University of Toronto |
Tracking Information | |||||
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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 |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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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. |
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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
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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
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Study Arms ICMJE |
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Publications * | Taddio A, Coldham J, Logeman C, McMurtry CM, Little C, Samborn T, Bucci LM, MacDonald NE, Shah V, Dribnenki C, Snider J, Stephens D. Feasibility of implementation of CARD™ for school-based immunizations in Calgary, Alberta: a cluster trial. BMC Public Health. 2021 Feb 1;21(1):260. doi: 10.1186/s12889-021-10247-4. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 13 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 | NCT03948633 | ||||
Other Study ID Numbers ICMJE | 36893 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Anna Taddio, University of Toronto | ||||
Study Sponsor ICMJE | University of Toronto | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |