Clinical trial NCT03996629: Impact of Clinical Pharmacist Interventions in Vitamin K Antagonists Management at One Teaching Hospital in Vietnam
Official title: Impact of Clinical Pharmacist Interventions in Vitamin K Antagonists Management at One Teaching Hospital in Vietnam: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anticoagulation
Keywords: pharmacist-managed anticoagulation
warfarin
acenocoumarol
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time in the therapeutic range (TTR)
timeFrame: 12 months
measure: Bleeding events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center Ho Chi Minh City
Study officials:
affiliation: University Medical Center Ho Chi Minh City
name: Trang Dang, PhD
role: STUDY_CHAIR
References: