Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Kerr Drug
Laboratory Corporation of America
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01495845
First received: December 16, 2011
Last updated: June 7, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke Transient Ischemic Attack Myocardial Infarction |
Other: Pharmacogenomics testing for clopidogrel responsiveness |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- Feasibility of Pharmacogenomics testing in a Community pharmacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
| Enrollment: | 48 |
| Study Start Date: | December 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Other: Pharmacogenomics testing for clopidogrel responsiveness
- Personalized medicine
- Pharmacogenetics
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.
Other Names:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495845
Locations
| United States, North Carolina | |
| Kerr Drug | |
| Chapel Hill, North Carolina, United States, 27517 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Kerr Drug
Laboratory Corporation of America
Investigators
| Principal Investigator: | Stefanie Ferreri, PharmD | University of North Carolina, Chapel Hill |
More Information
No publications provided
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01495845 History of Changes |
| Other Study ID Numbers: | 10-1558 |
| Study First Received: | December 16, 2011 |
| Last Updated: | June 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
pharmacogenomics feasibility community pharmacy |
personalized medicine clopidogrel Plavix |
Additional relevant MeSH terms:
|
Ischemic Attack, Transient Infarction Myocardial Infarction Stroke Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Clopidogrel Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013