- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02383290
The Implementation of Pharmacogenomics Into Primary Care in British Columbia (IPPC)
Study Overview
Detailed Description
We wish to develop and test a decision support tool, TreatGx. Using genetic information (single nucleotide polymorphisms - SNPs) and patient biophysical characteristics this tool creates drug and dose recommendations.
Each year in Canada, there are approximately 200,000 severe adverse drug events, claiming 10,000 to 22,000 lives, and costing $13.7 to $17.7 billion. Physicians cannot predict whether a patient will gain the desired benefit from a prescribed medication or whether they will experience harmful side effects. Genetic tests may reduce this potential harm for many medications; however there is currently no way of incorporating genetic information into routine prescribing processes.
We see a need to pilot test a, genetic based, prescribing decision support (TreatGx) for feasibility and usability.
Five Family Physicians and one pharmacy will be invited to participate. They will be requested to identify a total of 250 adults with chronic diseases to participate in the study.
Each participant will be invited to give a saliva sample for the SNP test. This sample will be sent to the laboratory for genetic testing; whole genome testing is not being undertaken. We have identified from published evidence a small panel of SNPs that will give information to guide prescribing. A genetic report will be fed back into the family physician's or pharmacist's electronic health record. The electronic health record will be linked to TreatGx; the next time the participant is seen by the family physician/pharmacist prescribing recommendations will be available for use. The family physician will be able to use TreatGx to give the participant a prescription that is personalized.
We will track how many times the system is used, gain feedback on usability, record timing between receiving samples, time to the laboratory, time to analysis, and time to electronic record.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- People attending specified pharmacy or Family Physicians.
- Aged 18 years or over, with a chronic disease that requires medication.
- Chronic diseases include: gout, chronic obstructive pulmonary disease, depression, osteoarthritis, hypertension, hyperlipidemia, atrial fibrillation, asthma, osteoporosis and epilepsy.
Exclusion Criteria:
- Pregnant
- Breast feeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Decision support
This is a feasibility trial so all patients will give a saliva sample and the pharmacist/ Family Physician will use the decision support for generating prescription recommendations
|
Saliva samples will be collected from each participant for genetic testing.
A genetic report will be fed back to the research server, and into the Family Physicians/pharmacist's electronic record.
The electronic record is linked to the UBC TreatGx computer; the next time the participant is seen by the Family Physician / Pharmacist personalized prescribing recommendations will be available for use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Feasibility of recruitment (reported numbers of physicians and patients)
Time Frame: 6 months
|
6 months
|
Feasibility of obtaining SNP data (Number of lab reports generated)
Time Frame: 3 months
|
3 months
|
Feasibility of integrating SNP data into EMR (Number of lab reports integrated into EMR, time of sample to reach laboratory, time to analysis, and time to electronic record)
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Use of decision support by family physicians and pharmacists (Number of times link is made to TreatGx by physicians/pharmacists)
Time Frame: 6 months
|
6 months
|
Reported usability of tool (User interviews)
Time Frame: 6 months
|
6 months
|
Estimated level of inappropriate prescribing (User interviews)
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H14-02979
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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