Feasibility of Implementation of CARD for School-Based Immunizations
- Conditions
- Immunisation Anxiety Related Reaction
- Interventions
- Other: Multi-faceted knowledge translation intervention
- Registration Number
- NCT03948633
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 260
- 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
- unable to understand and read English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CARD (multi-faceted knowledge translation intervention) 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).
- Primary Outcome Measures
Name Time Method percent complete data for student symptom survey within 5 minutes after vaccination proportion of students that fill in questionnaire about their symptoms (fear, dizziness, pain) during vaccination
- Secondary Outcome Measures
Name Time Method percent compliance with CARD (intervention) 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 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) 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).
percent of schools recruited within 1 week of school vaccination clinic proportion of schools that participate in the study
percent complete data for nurse feedback form within 5 minutes after vaccination proportion of immunizers that fill in questionnaire about interventions used during immunization (e.g., privacy, distraction)
Trial Locations
- Locations (1)
Alberta Health Services Public Health - Calgary Zone
🇨🇦Calgary, Alberta, Canada