Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02383290
Previous Study | Return to List | Next Study

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.
 
ClinicalTrials.gov Identifier: NCT02383290
Recruitment Status : Completed
First Posted : March 9, 2015
Last Update Posted : December 18, 2015
Sponsor:
Collaborators:
Genome British Columbia
Pfizer
Merck Sharp & Dohme Corp.
Roche Pharma AG
GlaxoSmithKline
AstraZeneca
Health Research Foundation
Janssen, LP
Information provided by (Responsible Party):
University of British Columbia

Tracking Information
First Submitted Date  ICMJE February 26, 2015
First Posted Date  ICMJE March 9, 2015
Last Update Posted Date December 18, 2015
Study Start Date  ICMJE April 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • Feasibility of recruitment (reported numbers of physicians and patients) [ Time Frame: 6 months ]
  • Feasibility of obtaining SNP data (Number of lab reports generated) [ Time Frame: 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) [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • Use of decision support by family physicians and pharmacists (Number of times link is made to TreatGx by physicians/pharmacists) [ Time Frame: 6 months ]
  • Reported usability of tool (User interviews) [ Time Frame: 6 months ]
  • Estimated level of inappropriate prescribing (User interviews) [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
 (submitted: December 17, 2015)
190
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2015)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
  • Genome British Columbia
  • Pfizer
  • Merck Sharp & Dohme Corp.
  • Roche Pharma AG
  • GlaxoSmithKline
  • AstraZeneca
  • Health Research Foundation
  • Janssen, LP
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