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

University of Medicine and Pharmacy at Ho Chi Minh City

Status

Unknown

Conditions

Anticoagulation

Treatments

Other: Patient education and compliance

Study type

Interventional

Funder types

Other

Identifiers

NCT03996629

UMCAM01

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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