NCT01600846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 28, 2017

Status Verified

August 1, 2014

Enrollment Period

7 months

First QC Date

May 15, 2012

Last Update Submit

July 27, 2017

Conditions

Keywords

Pharmacogenetic testingpharmacokineticsPharmacogenomicsgeneticspharmacydrug response

Outcome Measures

Primary Outcomes (1)

  • Use of PGx testing

    6 months, 12 months

Secondary Outcomes (1)

  • Number of adverse drug reactions

    6 months, 12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • must be a patient or physician at one of the participating clinics
  • patients must be prescribed a medication that has PGx testing available
  • years of age or older
  • English-speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

Study Officials

  • Susanne Haga, PhD

    Duke Unviersity Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 17, 2012

Study Start

December 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 28, 2017

Record last verified: 2014-08

Locations