Feasibility of Implementation of CARD for School-Based Immunizations

NCT03948633 | Unknown

• 1 other identifier: 36893
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunisation Anxiety Related Reaction

Keywords

school vaccinations; pain management; knowledge translation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• percent complete data for nurse feedback form

  within 5 minutes after vaccination

• percent of schools recruited

  within 1 week of school vaccination clinic

• percent compliance with CARD (intervention)

  within 3 months after vaccination

• perceived quality of CARD (intervention) program delivery

  within 3 months after vaccination

• perceived acceptability of CARD (intervention)

  within 3 months after vaccination

Other Outcomes (4)

• perceived appropriateness of CARD (intervention)

  within 3 months of vaccination

• perceived feasibility of CARD (intervention)

  within 3 months of vaccination

• percent reliability of data collection

  within 1 day of activities described (education, immunization day, and nurse feedback)

Study Arms (2)

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).

Other: Multi-faceted knowledge translation intervention

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).

Interventions

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

Also known as: CARD

CARD (multi-faceted knowledge translation intervention)

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unable to understand and read English

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Alberta Health Services Public Health - Calgary Zone

Calgary, Alberta, T2W 3N2, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 33526030 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna Taddio, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Taddio, PhD

CONTACT

416-978-8822; anna.taddio@utoronto.ca

Charlotte Logeman, MSc

CONTACT

416-978-2889; charlotte.logeman@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 14, 2019
• Study Start: April 25, 2019
• Primary Completion: June 30, 2019
• Study Completion: August 31, 2019
• Last Updated: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)