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Pharmacogenetic Testing in Primary Care

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ClinicalTrials.gov Identifier: NCT01600846
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : July 28, 2017
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Duke University

Brief Summary:

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 or disease
Pharmacogenetic Testing

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Delivery of Pharmacogenetic Testing in a Primary Care Setting
Study Start Date : December 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013



Primary Outcome Measures :
  1. Use of PGx testing [ Time Frame: 6 months, 12 months ]

Secondary Outcome Measures :
  1. Number of adverse drug reactions [ Time Frame: 6 months, 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600846


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Duke University
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Susanne Haga, PhD Duke Unviersity Medical Center

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01600846     History of Changes
Other Study ID Numbers: Pro00031122
2R01GM081416-04 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: August 2014

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