The Implementation of Pharmacogenomics Into Primary Care in British Columbia

Pharmacogenetics Clinical Trial

— IPPC  

Official title:

The Implementation of Pharmacogenomics Into Primary Care in British Columbia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383290
• Other study ID #: H14-02979
• Status: Completed
• Phase: N/A
• First received: February 26, 2015
• Last updated: December 17, 2015
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Certain parts of the gene can predict how an individual person will respond to medication (pharmacogenetics). We will invite 250 individuals to give a sample of saliva. This sample will be sent to a laboratory for limited genomic analysis relating to pharmacogenetics. When personal data held by the participants, family physician, or pharmacist is joined with the genetic data personalized prescription recommendations are formed. The family physicians/pharmacists can view these recommendations through their electronic record. This should result in prescriptions that may be more beneficial and cause fewer adverse events.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pharmacogenetics

Intervention

Other:
• Decision support
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.

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
University of British Columbia	AstraZeneca, Genome British Columbia, GlaxoSmithKline, Health Research Foundation, Janssen, LP, Merck Sharp & Dohme Corp., Pfizer, Roche Pharma AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment (reported numbers of physicians and patients)		6 months	No
Primary	Feasibility of obtaining SNP data (Number of lab reports generated)		3 months	No
Primary	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)		3 months	No
Secondary	Use of decision support by family physicians and pharmacists (Number of times link is made to TreatGx by physicians/pharmacists)		6 months	No
Secondary	Reported usability of tool (User interviews)		6 months	No
Secondary	Estimated level of inappropriate prescribing (User interviews)		6 months	No