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Medication Therapy Management With Pharmacogenetic Testing

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. Identifier: NCT01970774
Recruitment Status : Completed
First Posted : October 28, 2013
Last Update Posted : April 20, 2015
Information provided by (Responsible Party):
Duke University

Brief Summary:
This study aims to investigate the benefit and feasibility of providing pharmacogenetic (PGx) testing as part of a standard medication therapy management (MTM) session for patients taking multiple medications, a high-risk population for adverse drug reactions and non-response. Research participants will attend two MTM sessions and undergo PGx testing to inform the MTM plan. Participants will also complete 2 surveys pre and post-MTM/PGx testing. Data analysis will assess the impact of MTM/PGx testing on recommendations for drug dosing, clinical outcomes, patient satisfaction, and feasibility of service delivery. Safety issues are minimal with the primary risks being associated with loss of confidentiality, typical discomfort associated with acquiring blood samples, and genetic discrimination.

Condition or disease Intervention/treatment Phase
Pharmacogenetics Medication Therapy Management Other: MTM with PGx Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessing Feasibility and Utility of Enhancing Medication Therapy Management With Pharmacist-Delivered Pharmacogenetic Testing
Study Start Date : November 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: MTM and PGx
Participants attend two MTM sessions and have PGx testing
Other: MTM with PGx
Patients will attend MTM sessions and receive PGx testing

Primary Outcome Measures :
  1. Patient satisfaction with MTM and PGx [ Time Frame: 3 months after completion of MTM2 ]
    This will be assessed by a quantitative survey

  2. Change in clinical biomarkers associated with drug therapy [ Time Frame: baseline and 2 months ]
    Changes in biomarkers before and after MTM/PGx will be measured. Biomarkers of study group will be compared to chart-review control

  3. Number of recommended drug selection/dosing adjustments [ Time Frame: approximately 9 months ]
    Drug selection/doing changes will be compared between study population and chart-review controls

Secondary Outcome Measures :
  1. Physician time to perform MTM and PGx [ Time Frame: end of study, approx. 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • currently prescribed 3 medications, one of which must be simvastatin or clopidogrel
  • 18 years of age or older
  • English speaking
  • patients of Mahesh Patel or William Kraus at Duke Southpoint Clinic

Exclusion Criteria:

  • if patient has ever had MTM or PGx

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 identifier (NCT number): NCT01970774

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United States, North Carolina
Duke Health Center at Southpoint
Durham, North Carolina, United States, 27713
Sponsors and Collaborators
Duke University
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Principal Investigator: Susanne Haga, PhD Duke University

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Responsible Party: Duke University Identifier: NCT01970774     History of Changes
Other Study ID Numbers: Pro00048123
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: April 20, 2015
Last Verified: October 2014