The Implementation of Pharmacogenomics Into Primary Care in British Columbia
NCT02383290
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Adult Trials: 18+ Years
- 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.
- Pregnant
- Breast feeding.
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | The Implementation of Pharmacogenomics Into Primary Care in British Columbia | ||
| Official Title ICMJE | The Implementation of Pharmacogenomics Into Primary Care in British Columbia | ||
| 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. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Not Applicable | ||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Health Services Research | ||
| Condition ICMJE | Pharmacogenetics | ||
| Intervention ICMJE | 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. | ||
| Study Arms ICMJE | 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 Intervention: Other: Decision support | ||
| Publications * | 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. eCollection 2016 Jul-Sep. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Actual Enrollment ICMJE | 190 | ||
| Original Estimated Enrollment ICMJE | 250 | ||
| Actual Study Completion Date ICMJE | December 2015 | ||
| Actual Primary Completion Date | October 2015 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Not Provided | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT02383290 | ||
| Other Study ID Numbers ICMJE | H14-02979 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | University of British Columbia | ||
| Study Sponsor ICMJE | University of British Columbia | ||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||
| PRS Account | University of British Columbia | ||
| Verification Date | December 2015 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||