Clinical trial NCT02383290: The Implementation of Pharmacogenomics Into Primary Care in British Columbia
Official title: The Implementation of Pharmacogenomics Into Primary Care in British Columbia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacogenetics
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Genome British Columbia
name: Pfizer
name: Merck Sharp & Dohme LLC
name: Roche Pharma AG
name: GlaxoSmithKline
name: AstraZeneca
name: Health Research Foundation
name: Janssen, LP
First posted: 2015-03-09
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of recruitment (reported numbers of physicians and patients)
timeFrame: 6 months
measure: Feasibility of obtaining SNP data (Number of lab reports generated)
timeFrame: 3 months
measure: 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)
timeFrame: 3 months
Secondary outcomes:
measure: Use of decision support by family physicians and pharmacists (Number of times link is made to TreatGx by physicians/pharmacists)
timeFrame: 6 months
measure: Reported usability of tool (User interviews)
timeFrame: 6 months
measure: Estimated level of inappropriate prescribing (User interviews)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Dawes M, Aloise MN, Ang JS, Cullis P, Dawes D, Fraser R, Liknaitzky G, Paterson A, Stanley P, Suarez-Gonzalez A, Katzov-Eckert H. Introducing pharmacogenetic testing with clinical decision support into primary care: a feasibility study. CMAJ Open. 2016 Sep 21;4(3):E528-E534. doi: 10.9778/cmajo.20150070. eCollection 2016 Jul-Sep.