Feasibility of Implementation of CARD for School-Based Immunizations

Improving the Vaccination Experience at School in Calgary

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.

Study Overview

• Status: Unknown
• Conditions: Immunisation Anxiety Related Reaction
• Intervention / Treatment: Other: Multi-faceted knowledge translation intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlotte Logeman, MSc; Phone Number: 416-978-2889; Email: charlotte.logeman@utoronto.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2W 3N2
      • Recruiting
      • Alberta Health Services Public Health - Calgary Zone
      • Contact: Joanne Coldham, MEd; Phone Number: 403 943-1197; Email: joanne.coldham@ahs.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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; Other Names: CARD
No Intervention: Control; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
percent of schools recruited	proportion of schools that participate in the study	within 1 week of school vaccination clinic
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)
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

Collaborators and Investigators

• Sponsor: University of Toronto
• Investigators: Principal Investigator: Anna Taddio, PhD, University of Toronto

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): August 31, 2019

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: pain management; knowledge translation; school vaccinations
• Other Study ID Numbers: 36893

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No