Medication Therapy Management With Pharmacogenetic Testing

NCT01970774 | Completed DMC

• 1 other identifier: Pro00048123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacogenetics; Medication Therapy Management

Outcome Measures

Primary Outcomes (3)

• Patient satisfaction with MTM and PGx

  This will be assessed by a quantitative survey

  3 months after completion of MTM2

• Change in clinical biomarkers associated with drug therapy

  Changes in biomarkers before and after MTM/PGx will be measured. Biomarkers of study group will be compared to chart-review control

  baseline and 2 months

• Number of recommended drug selection/dosing adjustments

  Drug selection/doing changes will be compared between study population and chart-review controls

  approximately 9 months

Secondary Outcomes (1)

• Physician time to perform MTM and PGx

  end of study, approx. 9 months

Study Arms (1)

MTM and PGx

EXPERIMENTAL

Participants attend two MTM sessions and have PGx testing

Other: MTM with PGx

Interventions

MTM with PGx OTHER

Patients will attend MTM sessions and receive PGx testing

MTM and PGx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• if patient has ever had MTM or PGx

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Health Center at Southpoint

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Interventions

myotubularin

Study Officials

• Susanne Haga, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 28, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 20, 2015

Record last verified: 2014-10

Locations

US (1)