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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARD (multi-faceted knowledge translation intervention) | Experimental | 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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| Control | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-faceted knowledge translation intervention | Other | The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program |
| Measure | Description | Time Frame |
|---|---|---|
| percent complete data for student symptom survey | proportion of students that fill in questionnaire about their symptoms (fear, dizziness, pain) during vaccination | within 5 minutes after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| percent complete data for nurse feedback form | proportion of immunizers that fill in questionnaire about interventions used during immunization (e.g., privacy, distraction) | within 5 minutes after vaccination |
| percent of schools recruited |
| Measure | Description | Time Frame |
|---|---|---|
| perceived appropriateness of CARD (intervention) | 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Taddio, PhD | Contact | 416-978-8822 | anna.taddio@utoronto.ca | |
| Charlotte Logeman, MSc | Contact | 416-978-2889 | charlotte.logeman@utoronto.ca |
| Name | Affiliation | Role |
|---|---|---|
| Anna Taddio, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Health Services Public Health - Calgary Zone | Recruiting | Calgary | Alberta | T2W 3N2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33526030 | Derived | 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. |
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There is no plan to share IPD
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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.
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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.
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proportion of schools that participate in the study
| within 1 week of school vaccination clinic |
| percent compliance with CARD (intervention) | 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). | within 3 months after vaccination |
| perceived quality of CARD (intervention) program delivery | 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). | within 3 months after vaccination |
| perceived acceptability of CARD (intervention) | 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). | within 3 months after vaccination |
| within 3 months of vaccination |
| perceived feasibility of CARD (intervention) | 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). | within 3 months of vaccination |
| percent reliability of data collection | proportion of agreement between implementer and observer checklists for aspects of immunization program delivery (i.e., education, immunization day, nurse feedback form) | within 1 day of activities described (education, immunization day, and nurse feedback) |
| success of recruitment of secondary targets (school staff, students, parents) for focus groups | proportion of focus groups successfully undertaken with secondary stakeholder targets. | within 3 months of vaccination |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |