Medication Therapy Management With Pharmacogenetic Testing

Medication Therapy Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970774
• Other study ID #: Pro00048123
• Status: Completed
• Phase: N/A
• First received: October 23, 2013
• Last updated: April 17, 2015
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Medication Therapy Management
• Pharmacogenetics

Intervention

Other:
• MTM with PGx
Patients will attend MTM sessions and receive PGx testing

Locations

Country	Name	City	State
United States	Duke Health Center at Southpoint	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction with MTM and PGx	This will be assessed by a quantitative survey	3 months after completion of MTM2	No
Primary	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	Yes
Primary	Number of recommended drug selection/dosing adjustments	Drug selection/doing changes will be compared between study population and chart-review controls	approximately 9 months	Yes
Secondary	Physician time to perform MTM and PGx		end of study, approx. 9 months	No