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Completed

NCT Number: NCT01970774

Medication Therapy Management With Pharmacogenetic Testing

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.

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Key information

Conditions

Pharmacogenetics Medication Therapy Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Health Center at Southpoint

Durham, North Carolina, 27713, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MTM with PGx

Other

Patients will attend MTM sessions and receive PGx testing

Primary outcomes

  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 outcomes

  1. Physician time to perform MTM and PGx

    Time frame: end of study, approx. 9 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 28, 2013
Registry last updated
Apr 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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