The Implementation of Pharmacogenomics Into Primary Care in British Columbia

NCT02383290 | Completed

• 1 other identifier: H14-02979
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pharmacogenetics

Outcome Measures

Primary Outcomes (3)

• Feasibility of recruitment (reported numbers of physicians and patients)

  6 months

• Feasibility of obtaining SNP data (Number of lab reports generated)

  3 months

• 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

Secondary Outcomes (3)

• Use of decision support by family physicians and pharmacists (Number of times link is made to TreatGx by physicians/pharmacists)

  6 months

• Reported usability of tool (User interviews)

  6 months

• Estimated level of inappropriate prescribing (User interviews)

  6 months

Study Arms (1)

Decision support

EXPERIMENTAL

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

Interventions

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.

Decision support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant
• Breast feeding.

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 27730116 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 9, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 18, 2015

Record last verified: 2015-12