Feasibility of Implementation of CARD for School-Based Immunizations

Immunisation Anxiety Related Reaction Clinical Trial

Official title:

Improving the Vaccination Experience at School in Calgary

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03948633
• Other study ID #: 36893
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: May 2019
• Source: University of Toronto
• Contact: Anna Taddio, PhD
• Phone: 416-978-8822
• Email: anna.taddio[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: August 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunisation Anxiety Related Reaction

Intervention

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

Locations

Country	Name	City	State
Canada	Alberta Health Services Public Health - Calgary Zone	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	within 3 months of vaccination
Other	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
Other	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)
Other	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
Primary	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
Secondary	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
Secondary	percent of schools recruited	proportion of schools that participate in the study	within 1 week of school vaccination clinic
Secondary	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
Secondary	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
Secondary	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

External Links

•   Supplement issue of Paediatrics & Child Health - repository for prior research with CARD