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OpenTrials
Completed

NCT Number: NCT02383290

The Implementation of Pharmacogenomics Into Primary Care in British Columbia

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.

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Key information

Conditions

Pharmacogenetics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Decision support

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • AstraZeneca
  • Genome British Columbia
  • GlaxoSmithKline
  • Health Research Foundation
  • Janssen, LP
  • Merck Sharp & Dohme LLC
  • Pfizer
  • Roche Pharma AG

Registry information

Acronym: IPPC

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 9, 2015
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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