Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy
1 other identifier
interventional
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 stroke
Started Dec 2011
Shorter than P25 for phase_1 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 16, 2011
CompletedFirst Posted
Study publicly available on registry
December 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJune 8, 2012
June 1, 2012
6 months
December 16, 2011
June 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Are unable to complete study materials (surveys) with or without assistance, including non-English speaking patients
- Are pregnant or nursing
- Have an allergy to aspirin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hilllead
- Kerr Drugcollaborator
- Laboratory Corporation of Americacollaborator
Study Sites (1)
Kerr Drug
Chapel Hill, North Carolina, 27517, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefanie Ferreri, PharmD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2011
First Posted
December 20, 2011
Study Start
December 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
June 8, 2012
Record last verified: 2012-06