Pharmacogenetic Testing in Primary Care

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01600846
First received: May 15, 2012
Last updated: September 5, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to further integrate pharmacogenetic (PGx) testing into clinical practice by educating physicians about pharmacogenetics and offering testing to their patients. Pharmacogenetic testing may help physicians choose the best drug and dosage for their patients which can reduce side effects, increase effectiveness, and improve patient adherence.

Two clinics will be involved. One clinic will have a pharmacist on-site as a resource to physicians and to advise what patients may benefit from PGx testing; the other clinic will have a pharmacist on call.

Patient and physician perspectives about PGx testing and their utilization will be examined via surveys.

The investigators hypothesize that with education about PGx testing, more physicians will utilize testing.


Condition
Pharmacogenetic Testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Delivery of Pharmacogenetic Testing in a Primary Care Setting

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Use of PGx testing [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse drug reactions [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Physician population will be physicians practicing at the two clinics part of Duke University Medical Center Patient population will be patients who receive primary care at one of the two participating clinics.

Criteria

Inclusion Criteria:

  • must be a patient or physician at one of the participating clinics
  • patients must be prescribed a medication that has PGx testing available
  • 18 years of age or older
  • English-speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600846

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Susanne Haga, PhD Duke Unviersity Medical Center
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01600846     History of Changes
Other Study ID Numbers: Pro00031122, 2R01GM081416-04
Study First Received: May 15, 2012
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Duke University:
Pharmacogenetic testing
pharmacokinetics
Pharmacogenomics
genetics
pharmacy
drug response

ClinicalTrials.gov processed this record on October 20, 2014