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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01972971
First Posted: October 31, 2013
Last Update Posted: October 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose

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.


Condition Intervention
Intentional Warfarin Sodium Overdose Other: patient education

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: To Establish a Novel Prototype of Clinical Pharmacy Services by Warfarin Consultation in a Pharmacist Clinic

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • percentage of INR in therapeutic range and incidence of complications [ Time Frame: 3 months ]
    The INR value collected during the 3 months before enrollment and within 3 months after enrollment, which was proceeded by the one month wash-out period. The bleeding or thromboembolic events during this period were also collected. The outcome was assessed by the percentage of patient time with INR within the target range (1.8-2.4) and incidence of complications.


Secondary Outcome Measures:
  • patient's warfarin knowledge improvement [ Time Frame: 3 months ]
    Patient's warfarin-related knowledge would be assessed by questionnaire. The validity of the questionnaire were assessed by experts. This questionnaire contained 9 aspects. the pre-test of warfarin-related knowledge questionnaire was conducted before patient education, and the post-test was conducted 2 months after enrollment in the pharmacist clinic. The correct percentage between pre-test and post-test would be compared.

  • Patient's satisfaction to anticoagulation pharmacist clinic [ Time Frame: 3 months ]
    Patient's satisfaction would be assessed by questionnaire. The validity of the questionnaire was assessed by experts. The per-test was conducted before the patient enrolled to pharmacist clinic, and the post-test was conducted 2 months after enrollment. The difference between pre-test and post-test would be evaluated.


Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
pharmacist care Other: patient education
one by one patient education

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972971


Contacts
Contact: Fe-Lin L L WU, PHD 886-2-23123456 ext 88389 flwu@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10051
Contact: Fe-Lin L WU, PhD    886-2-23123456 ext 88389    flwu@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Fe-Lin L WU, PhD National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01972971     History of Changes
Other Study ID Numbers: 201105109RC
First Submitted: October 13, 2013
First Posted: October 31, 2013
Last Update Posted: October 31, 2013
Last Verified: October 2013

Keywords provided by National Taiwan University Hospital:
warfarin
pharmacist
anticoagulation

Additional relevant MeSH terms:
Warfarin
Anticoagulants