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Trial record 18 of 1105 for:    pharmacogenomics OR pharmacogenetics

The Implementation of Pharmacogenomics Into Primary Care in British Columbia (IPPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02383290
Recruitment Status : Completed
First Posted : March 9, 2015
Last Update Posted : December 18, 2015
Genome British Columbia
Merck Sharp & Dohme Corp.
Roche Pharma AG
Health Research Foundation
Janssen, LP
Information provided by (Responsible Party):
University of 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.

Condition or disease Intervention/treatment Phase
Pharmacogenetics Other: Decision support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Implementation of Pharmacogenomics Into Primary Care in British Columbia
Study Start Date : April 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

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
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.

Primary Outcome Measures :
  1. Feasibility of recruitment (reported numbers of physicians and patients) [ Time Frame: 6 months ]
  2. Feasibility of obtaining SNP data (Number of lab reports generated) [ Time Frame: 3 months ]
  3. 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 ]

Secondary Outcome Measures :
  1. Use of decision support by family physicians and pharmacists (Number of times link is made to TreatGx by physicians/pharmacists) [ Time Frame: 6 months ]
  2. Reported usability of tool (User interviews) [ Time Frame: 6 months ]
  3. Estimated level of inappropriate prescribing (User interviews) [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of British Columbia Identifier: NCT02383290     History of Changes
Other Study ID Numbers: H14-02979
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015