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

NCT03996629 | Unknown DMC

• 1 other identifier: UMCAM01
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulation

Keywords

pharmacist-managed anticoagulation; warfarin; acenocoumarol

Outcome Measures

Primary Outcomes (2)

• Time in the therapeutic range (TTR)

  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.

  12 months

• Bleeding events

  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.

  12 months

Study Arms (2)

Pharmacist-managed anticoagulation service

EXPERIMENTAL

Other: Patient education and compliance

Usual medical care

NO INTERVENTION

Interventions

Patient education and compliance OTHER

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.

Pharmacist-managed anticoagulation service

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

University Medical Center Ho Chi Minh City

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Interventions

Patient Education as Topic; Compliance

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Elasticity; Mechanical Phenomena; Physical Phenomena

Study Officials

• Trang Dang, PhD

  University Medical Center Ho Chi Minh City

  STUDY CHAIR

Central Study Contacts

Tien Hoang Tran, BSPharm

CONTACT

84 364 969 137; tien.th@umc.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 25, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2022
• Study Completion: December 31, 2022
• Last Updated: June 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)