Impact of Clinical Pharmacist Interventions in Vitamin K Antagonists Management at One Teaching Hospital in Vietnam: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Time in the therapeutic range (TTR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pharmacist-managed anticoagulation service
干预措施: Patient education and compliance (Other)
Usual medical care
结局指标
主要结局
Time in the therapeutic range (TTR)
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Tien Hoang Tran
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City