NCT03996629

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: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anticoagulation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-08-01
• Primary completion: 2022-08-01
• Completion: 2022-12-31
• First posted: 2019-06-25
• Last updated: 2019-06-26

Locations

1 site across 1 country: Vietnam