Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System

Recruiting

• Conditions: Adverse Drug Reaction (ADR)

• Registration Number: NCT04249375
• Lead Sponsor: University of British Columbia

Brief Summary

This project addresses the problem of adverse drug reactions in the three most frequently prescribed therapeutic classes of drugs in children: antibiotics, analgesics, and mental health medications.

We will conduct pilot testing of a pharmacogenomic testing panel and study how the tests and generated test results are utilized and understood by physicians, pharmacists, patients and their families.

Detailed Description

The specific objectives are to:

1. Implement a pilot pharmacogenomics program to test medication safety and effectiveness of antibiotics, analgesics and mental health medication to enhance prescribing decision-making.

2. Develop data collection forms to collect necessary patient information from the prescribing physicians.

3. Develop pharmacogenomics reports to return results to physicians, pharmacists, patients and their families.

4. Determine how the tests and results are perceived and utilized by physicians, pharmacists, patients and their families.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-30
• Study Start: 2020-02-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Participants will be enrolled if they can benefit from pharmacogenomic testing. This means their physician is considering the use of a drug that is part of the panels (analgesics, antibiotics, and mental health medication) or they are already using one.

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Exclusion Criteria

• Patients who do not speak or understand English.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
150 participants on analgesics, anti-infectives and psychotropics will be given pharmacogenomic recommendations for the risk of gene related adverse events prior to or during treatment.	June 2020	We will be able to determine the barriers and facilitators of the implementation of the pharmacogenomic service in a health care facility.; This will be done by using standardized questionnaires after each pharmacogenomic report is issued. The prescriber and the patient will both answer questions about the utility of the genetic results, the format of the report and the clarity of the content.; Results will be recorded and summarized every 25 patients in order to improve the service and the recommendations through the study.

Trial Locations

Locations (2)

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada

Children's and Women's Health Centre of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada