Clinical trial NCT03948633: Feasibility of Implementation of CARD for School-Based Immunizations
Official title: Improving the Vaccination Experience at School in Calgary
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immunisation Anxiety Related Reaction
Keywords: school vaccinations
pain management
knowledge translation
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 260
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: percent complete data for student symptom survey
timeFrame: within 5 minutes after vaccination
Secondary outcomes:
measure: percent complete data for nurse feedback form
timeFrame: within 5 minutes after vaccination
measure: percent of schools recruited
timeFrame: within 1 week of school vaccination clinic
measure: percent compliance with CARD (intervention)
timeFrame: within 3 months after vaccination
measure: perceived quality of CARD (intervention) program delivery
timeFrame: within 3 months after vaccination
measure: perceived acceptability of CARD (intervention)
timeFrame: within 3 months after vaccination
Other outcomes:
measure: perceived appropriateness of CARD (intervention)
timeFrame: within 3 months of vaccination
measure: perceived feasibility of CARD (intervention)
timeFrame: within 3 months of vaccination
measure: percent reliability of data collection
timeFrame: within 1 day of activities described (education, immunization day, and nurse feedback)
measure: success of recruitment of secondary targets (school staff, students, parents) for focus groups
timeFrame: within 3 months of vaccination
Locations:
city: Calgary
country: Canada
facility: Alberta Health Services Public Health - Calgary Zone
state: Alberta
Study officials:
affiliation: University of Toronto
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.