Medication Therapy Management With Pharmacogenetic Testing

Not Applicable

Completed

• Conditions: Medication Therapy Management; Pharmacogenetics
• Interventions: Other: MTM with PGx

• Registration Number: NCT01970774
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-28
• Study Start: 2013-11
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2015-04-17
• Last Update Posted: 2015-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

• if patient has ever had MTM or PGx

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MTM and PGx	MTM with PGx	Participants attend two MTM sessions and have PGx testing

Primary Outcome Measures

Name	Time	Method
Number of recommended drug selection/dosing adjustments	approximately 9 months	Drug selection/doing changes will be compared between study population and chart-review controls
Patient satisfaction with MTM and PGx	3 months after completion of MTM2	This will be assessed by a quantitative survey
Change in clinical biomarkers associated with drug therapy	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

Secondary Outcome Measures

Name	Time	Method
Physician time to perform MTM and PGx	end of study, approx. 9 months

Trial Locations

Locations (1)

Duke Health Center at Southpoint; 🇺🇸 Durham, North Carolina, United States