RCT Concerning the Intention to Prescribe/Take Oral Anticoagulants for Atrial Fibrillation Depending on the Number of Risk Diagrams (w Treatment +/- w/Out Treatment), and Number of Years (1 or 5) for the Estimation of the Risk of Stroke.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 968
- 试验地点
- 2
- 主要终点
- Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Number of Decision Aid Diagrams
研究概览
简要总结
Randomized study concerning the effect of the number of risk diagrams (with treatment +/- without treatment), the period of stroke risk estimation (one year or five years) and the target of prescription (the patient with atrial fibrillation or the physician himself, imagining she/he has atrial fibrillation) on the intention to prescribe or not oral anticoagulation.
详细描述
Objectives:
To answer the questions:
- Concerning the decision to prescribe (take) treatment on the basis of a decision aid, are there necessary both diagrams (that with risk without treatment, and that with risk under treatment), or it is enough only the second (risk under treatment, which normally gives all the needed information)?
- Concerning the decision to prescribe (take) treatment, is it a difference between the effects of the presentation on decision aid of the risk of stroke for the next 1 year, and the presentation of the estimated risk of stroke for the next 5 years?
- Is the decision different if physicians prescribe the anticoagulant treatment to patients, over if they should take it themselves?
Study: 2x3 factorial randomized controlled trial (RCT) for comparison:
- Between the decision aid with 2 images (without treatment + with treatment) and the one with 1 image (risk only with treatment)
- Between the effect of the presentation of the stroke risk chart for 1 year and the stroke risk chart for 5 years.
- The decision to prescribe to patients over the decision to take the treatment themselves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 盲法
- None
入排标准
- 年龄范围
- 24 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •physicians who prescribe anticoagulant treatment for atrial fibrillation (cardiology, internal medicine, family medicine, hematology) or who deal with patients with stroke (neurology, pathology) or bleeding (gastroenterology)
排除标准
- •physicians who never prescribe anticoagulant treatments, or do not deal with patients with stroke or bleeding because of anticoagulants
结局指标
主要结局
Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Number of Decision Aid Diagrams
时间窗: after seeing the decision aid (5 min)
after regarding the risk diagram, the physician will decide to prescribe/take or not the treatment
次要结局
未报告次要终点
研究者
Cristian Baicus
Professor of Internal Medicine
Carol Davila University of Medicine and Pharmacy
