To Establish a Novel Prototype of Clinical Pharmacy Services by Warfarin Consultation in a Pharmacist Clinic

NCT ID: NCT01972971

Last Updated: 2013-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-07-31

Brief Summary

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Warfarin, the major oral anticoagulant currently available in Taiwan, is used for the prevention and treatment of a variety of thromboembolic disorders. Under dosing of warfarin may cause treatment failure and over dosing may cause bleeding because of its narrow therapeutic index. Therefore, it is important to monitor prothrombin time (PT) and international normalize ratio (INR) periodically in order to evaluate the appropriateness of warfarin dosing.

Lots of factors influencing warfarin anticoagulation effects include polymorphisms of Cytochrome P450 2C9(CYP2C9)and Vitamin K epoxide reductase complex subunit 1(VKORC1)genes, age, weight, diet and concurrent medications. Taking into consideration of physicians' work load, pharmacist-managed anticoagulation clinics were set up to help strengthen patient care in US to ensure patient medication safety. In addition, differences in genetic polymorphisms between Chinese and Caucasian have great impacts on warfarin dosage, and there is still no consensus on warfarin utilization guideline in Taiwan. Pharmacist-managed anticoagulation clinics provide individualized care, consistent monitoring and patient education. Through this service, physicians can get the latest integrated information about their patients, patients themselves are more familiar with their medication, and adherence can be improved. Therefore, those who take warfarin will get better INR control, less adverse drug-related events and treatment failure.

This is the first prototype of pharmacist clinic for a specific medication in our hospital. The adverse drug events and coagulation function data collected through this program can be used for the implementation of warfarin treatment guideline in Taiwan in the future. The impact of pharmacist clinic can be evaluated by questionnaire of satisfaction and knowledge survey. It can be used as a model for implementing other pharmacist-managed clinics and improving patient medication safety.

Detailed Description

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Conditions

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Intentional Warfarin Sodium Overdose

Keywords

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warfarin pharmacist anticoagulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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pharmacist care

Group Type OTHER

patient education

Intervention Type OTHER

one by one patient education

Interventions

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patient education

one by one patient education

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \>20 y/o
* Has been received warfarin therapy for 3 months and anticipated treatment duration of more than 3 months and a week
* Has legitimate indication for warfarin
* Has the capacity to understand the condition and implications of anticoagulant therapy

Exclusion Criteria

* Who can't be regular follow-up at National Taiwan University Hospital.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fe-Lin L WU, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Fe-Lin L L WU, PHD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Fe-Lin L WU, PhD

Role: primary

Other Identifiers

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201105109RC

Identifier Type: -

Identifier Source: org_study_id