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

Anticoagulation Clinical Trial

Official title:

Impact of Clinical Pharmacist Interventions in Vitamin K Antagonists Management at One Teaching Hospital in Vietnam: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03996629
• Other study ID #: UMCAM01
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2019
• Source: Ho Chi Minh City University of Medicine and Pharmacy
• Contact: Tien Hoang Tran, BSPharm
• Phone: 84 364 969 137
• Email: tien.th[@]umc.edu.vn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: December 31, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulation

Intervention

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.

Locations

Country	Name	City	State
Vietnam	University Medical Center Ho Chi Minh City	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Ho Chi Minh City University of Medicine and Pharmacy

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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