Medication Therapy Management With Pharmacogenetic Testing

Assessing Feasibility and Utility of Enhancing Medication Therapy Management With Pharmacist-Delivered Pharmacogenetic Testing

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01970774

Enrollment

Registered

2013-10-28

Start date

2013-11-30

Completion date

2014-10-31

Last updated

2015-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Therapy Management, Pharmacogenetics

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.

Interventions

OTHERMTM with PGx

Patients will attend MTM sessions and receive PGx testing

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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
Number of recommended drug selection/dosing adjustments	approximately 9 months	Drug selection/doing changes will be compared between study population and chart-review controls

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026