Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy

Stroke Clinical Trial

Official title:

Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495845
• Other study ID #: 10-1558
• Status: Completed
• Phase: Phase 1
• First received: December 16, 2011
• Last updated: June 7, 2012
• Start date: December 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the feasibility of pharmacogenomics testing in a community pharmacy using clopidogrel as an example. The investigators hypothesize that this testing is feasible in this setting.

Description:

To determine if the study is feasible, we will examine the change in patient perception of pharmacogenomics testing (before and after the study), the percentage of patients interested in this service, the response rate of providers to pharmacist recommendations, the pharmacist time requirement, and reimbursement rate for pharmacist services.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prescribed clopidogrel (Plavix) by their prescriber

• Aged 18 or older

• Currently on clopidogrel therapy for one of the following indicated uses: post-ACS, Recent PCI with stenting, History of TIA or stroke

Exclusion Criteria:

• Are unable to complete study materials (surveys) with or without assistance, including non-English speaking patients

• Are taking clopidogrel for a reason other than stated in inclusion criteria

• Are pregnant or nursing

• Have an allergy to aspirin

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Myocardial Infarction
• Stroke
• Transient Ischemic Attack

Intervention

Other:
• Pharmacogenomics testing for clopidogrel responsiveness
Patients must come to the pharmacy for all visits. At the 1st visit, the patient will provide consent, a complete list of medications, a complete pre-study questionnaire, a copy of their insurance card, and a buccal swab (collected by the pharmacist). The swab will be sent to the testing facility for genotypic testing of CYP2C19. Upon receipt of the results of the results, the pharmacist will propose an intervention to the prescriber based on the patient's indication for clopidogrel and the identification of certain genetic variations atCYP2C19. All patients will be asked to return to the pharmacy for explanation of the results and implementation of any changes approved by the prescriber and to complete a follow-up questionnaire. After the visit to explain the results of testing, the patient's insurance will be billed electronically for a medication therapy management visit; patients without insurance will not be billed. Patients may opt out of billing to insurance at any time.

Locations

Country	Name	City	State
United States	Kerr Drug	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Kerr Drug, Laboratory Corporation of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Pharmacogenomics testing in a Community pharmacy	Change in patient perception of testing, reimbursement for pharmacist time, provider acceptance, and amount of pharmacist time required will be measured as part of the provision of this service.	3 months	No