Effectiveness of CARD for Improving School-Based Immunizations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8839 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-25

Study Completion Date

2020-03-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Vaccination is estimated to have saved more lives in Canada than any other single intervention and is considered one of the most important advances in the prevention of disease. The process of vaccination, however, is stressful for individuals. School-based vaccinations in particular, are associated with high levels of fear and anxiety among students. This randomized cluster trial will implement a multi-faceted knowledge translation intervention called The CARD (C-Comfort A-Ask R-Relax D-Distract) System in school-based vaccinations and evaluate its effects on the experience of vaccination for students and implementation outcomes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool

NCT05386355

COVID-19 Vaccines Telemedicine Vaccine Hesitancy +1 more

COMPLETED NA

Enabling Family Physicians to Reduce Vaccine Hesitancy and Increase Covid-19 Vaccine Uptake

NCT04963790

Covid19 COVID-19 Vaccine

TERMINATED NA

Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)

NCT03885232

Preventive Health Services (PREV HEALTH SERV)

COMPLETED NA

Effectiveness of an Intervention on Vaccine Hesitancy Among Pediatric Nurses and Pediatricians

NCT06489236

Vaccination Hesitancy Pediatric ALL Presumptive Communication +1 more

COMPLETED NA

Cluster-RCT Collective Nasopharyngeal COVID-19 Testing Amongst Pupils

NCT04993547

Peer Group Parents

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators developed a multi-faceted knowledge translation intervention called The CARD System to provide a framework for delivering vaccinations at school that integrates evidence-based strategies to mitigate pain, fear and fainting and promotes a student-centred approach to vaccination. CARD addresses 2 components of the vaccination delivery program: 1) pre-vaccination day preparation and 2) vaccination day activities. In a small controlled clinical trial in a public health unit in Niagara, Ontario, the investigators demonstrated benefits of CARD on student symptoms during vaccination, including fear, and dizziness-precursor of fainting, and satisfaction with CARD by all stakeholder groups (students, public health staff, school staff and parents). This study will evaluate CARD in a large cluster trial in Calgary, Alberta. This trial is the final phase of a 3-phase project, whereby the first 2 phases involve developing an implementation plan for the local context and evaluating feasibility of implementation.

Eight community health centres that provide vaccination services to schools in their regions will be randomized in a 1:1 ratio to CARD or control (usual practices). Data will be collected for vaccination services carried out in grade 6 and grade 9 students in participating schools for the academic year 2019-2020.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vaccination; Complications Vaccine Adverse Reaction Fear

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster trial involving 8 community health centres. They will be randomized to CARD or control (standard care) groups in a 1:1 ratio. Eligible schools (approximately 13/community health centre) will be included.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

Multi-faceted knowledge translation intervention

Intervention Type OTHER

The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program

Control (standard care)

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CARD

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* grade 6 and 9 students 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
* parent of a student eligible for vaccination at school