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出境医 / 临床实验 / Impact of Clinical Pharmacist Interventions in Vitamin K Antagonists Management at One Teaching Hospital in Vietnam

Impact of Clinical Pharmacist Interventions in Vitamin K Antagonists Management at One Teaching Hospital in Vietnam

Study Description
Brief Summary:

For decades, vitamin K antagonists are the main oral anticoagulants used for primary and secondary prevention of arterial and venous thromboembolic events. Both observational and randomized controlled trials have confirmed an outstanding outcome (the percentage of time in the therapeutic range-TTR, effectiveness and safety) in patients received anticoagulation management provided by pharmacists (AMPP) in comparing with usual physician care.

However, at present, pharmacist-managed anticoagulation services are still not popular in developing countries. In addition, there are few studies evaluating the patient outcomes with the AMPP model in Vietnam. Above all, it is important to explore whether AMPP is superior to other usual models in the improvement of effectiveness and safety.


Condition or disease Intervention/treatment Phase
Anticoagulation Other: Patient education and compliance Not Applicable

Detailed Description:

The study is a randomized controlled trial. Patients who will use VKA are prospectively divided into routine group and pharmacist intervention group.

For the intervention group, patients receive an intensive medical education from pharmacists in anticoagulation management service. Pharmacists regularly provide telephone and outpatient follow-up. At the end of the 12-month follow-up, the percentage of TTR and major bleeding events will be evaluated in both groups.

Clinical data is designed to be collected from 800 patients, 400 patients in each group. Data will be analyzed by SPSS 20.0 software. P < 0.05 is considered significant.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Clinical Pharmacist Interventions in Vitamin K Antagonists Management at One Teaching Hospital in Vietnam: A Randomized Controlled Trial
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Pharmacist-managed anticoagulation service Other: Patient education and compliance
When the patient is enrolled in the intervention group, pharmacists provide medical education about the pathophysiology, medications, lifestyle, how to prevent, recognize and take care of bleeding events, etc. Establish a medical record for every follow-up examination and remind follow-ups by message, phone every month.
No Intervention: Usual medical care
Outcome Measures
Primary Outcome Measures :
  1. Time in the therapeutic range (TTR) [ Time Frame: 12 months ]
    The time in the therapeutic range (TTR) has been used as a measure of warfarin therapy quality. The percentage of TTR is the percentage of the number of patient's INR achieved therapeutic range on the total number of patient's INR test in the 12-month follow-up of each patient.

  2. Bleeding events [ Time Frame: 12 months ]
    Major bleeding is considered to be those events that resulted in death or the need for acute medical or surgical intervention, also as defined by previously described criteria. Minor bleeding includes increased bruising on the skin and other bleeding episodes not meeting the criteria for major bleeding.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients received a discharge prescription with VKA therapy from November 2018
  • Patients agree to participate in the study
  • Age 18 and older
  • Duration of VKA therapy ≥12 months

Exclusion Criteria:

  • Patients with cognitive impairment as diagnosed by physician
  • Geographical and financial conditions do not allow patients to guarantee follow-up examination on schedule
  • Patient has less than 3 INR test results after the first day participating in the study
  • Cannot contact patient by phone call or face-to-face communication after the first day participating in the study
Contacts and Locations

Contacts
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Contact: Tien Hoang Tran, BSPharm 84 364 969 137 tien.th@umc.edu.vn

Locations
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Vietnam
University Medical Center Ho Chi Minh City
Ho Chi Minh City, Vietnam, 70000
Contact: Tien Hoang Tran, BSPharm    84 364 969 137    tien.th@umc.edu.vn   
Contact: Trang Dang, PhD    84 909 907 976    trang.dnd@umc.edu.vn   
Principal Investigator: Tien Hoang Tran, BSPharm         
Sponsors and Collaborators
Ho Chi Minh City University of Medicine and Pharmacy
Investigators
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Study Chair: Trang Dang, PhD University Medical Center Ho Chi Minh City
Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date June 26, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Time in the therapeutic range (TTR) [ Time Frame: 12 months ]
    The time in the therapeutic range (TTR) has been used as a measure of warfarin therapy quality. The percentage of TTR is the percentage of the number of patient's INR achieved therapeutic range on the total number of patient's INR test in the 12-month follow-up of each patient.
  • Bleeding events [ Time Frame: 12 months ]
    Major bleeding is considered to be those events that resulted in death or the need for acute medical or surgical intervention, also as defined by previously described criteria. Minor bleeding includes increased bruising on the skin and other bleeding episodes not meeting the criteria for major bleeding.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Clinical Pharmacist Interventions in Vitamin K Antagonists Management at One Teaching Hospital in Vietnam
Official Title  ICMJE Impact of Clinical Pharmacist Interventions in Vitamin K Antagonists Management at One Teaching Hospital in Vietnam: A Randomized Controlled Trial
Brief Summary

For decades, vitamin K antagonists are the main oral anticoagulants used for primary and secondary prevention of arterial and venous thromboembolic events. Both observational and randomized controlled trials have confirmed an outstanding outcome (the percentage of time in the therapeutic range-TTR, effectiveness and safety) in patients received anticoagulation management provided by pharmacists (AMPP) in comparing with usual physician care.

However, at present, pharmacist-managed anticoagulation services are still not popular in developing countries. In addition, there are few studies evaluating the patient outcomes with the AMPP model in Vietnam. Above all, it is important to explore whether AMPP is superior to other usual models in the improvement of effectiveness and safety.
Detailed Description

The study is a randomized controlled trial. Patients who will use VKA are prospectively divided into routine group and pharmacist intervention group.

For the intervention group, patients receive an intensive medical education from pharmacists in anticoagulation management service. Pharmacists regularly provide telephone and outpatient follow-up. At the end of the 12-month follow-up, the percentage of TTR and major bleeding events will be evaluated in both groups.

Clinical data is designed to be collected from 800 patients, 400 patients in each group. Data will be analyzed by SPSS 20.0 software. P < 0.05 is considered significant.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Anticoagulation
Intervention  ICMJE Other: Patient education and compliance
When the patient is enrolled in the intervention group, pharmacists provide medical education about the pathophysiology, medications, lifestyle, how to prevent, recognize and take care of bleeding events, etc. Establish a medical record for every follow-up examination and remind follow-ups by message, phone every month.
Study Arms  ICMJE
  • Experimental: Pharmacist-managed anticoagulation service
    Intervention: Other: Patient education and compliance
  • No Intervention: Usual medical care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 21, 2019) 		800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients received a discharge prescription with VKA therapy from November 2018
  • Patients agree to participate in the study
  • Age 18 and older
  • Duration of VKA therapy ≥12 months

Exclusion Criteria:

  • Patients with cognitive impairment as diagnosed by physician
  • Geographical and financial conditions do not allow patients to guarantee follow-up examination on schedule
  • Patient has less than 3 INR test results after the first day participating in the study
  • Cannot contact patient by phone call or face-to-face communication after the first day participating in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tien Hoang Tran, BSPharm 84 364 969 137 tien.th@umc.edu.vn
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03996629
Other Study ID Numbers  ICMJE UMCAM01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tien Hoang Tran, Ho Chi Minh City University of Medicine and Pharmacy
Study Sponsor  ICMJE Ho Chi Minh City University of Medicine and Pharmacy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Trang Dang, PhD University Medical Center Ho Chi Minh City
PRS Account Ho Chi Minh City University of Medicine and Pharmacy
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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