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

Not Applicable

• Conditions: Anticoagulation
• Interventions: Other: Patient education and compliance

• Registration Number: NCT03996629
• Lead Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

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 Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-25
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-26
• Study Start: 2019-08-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist-managed anticoagulation service	Patient education and compliance	-

Primary Outcome Measures

Name	Time	Method
Time in the therapeutic range (TTR)	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	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.

Trial Locations

Locations (1)

University Medical Center Ho Chi Minh City; 🇻🇳 Ho Chi Minh City, Vietnam