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临床试验/NCT02746107
NCT02746107已完成不适用

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.

Cristian Baicus1 个研究点 分布在 1 个国家目标入组 968 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
968
试验地点
1
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:

  1. 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)?
  2. 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?
  3. 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:

  1. Between the decision aid with 2 images (without treatment + with treatment) and the one with 1 image (risk only with treatment)
  2. Between the effect of the presentation of the stroke risk chart for 1 year and the stroke risk chart for 5 years.
  3. 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

研究组 & 干预措施

risk presented on 1 diagram

Experimental

decision aid with risk of stroke presented on 1 diagram (risk under OAC treatment)

干预措施: decision aid (Other)

risk presented on 2 diagrams

Active Comparator

decision aid with risk of stroke presented on 2 diagrams (one presenting risk without and one presenting risk with treatment)

干预措施: decision aid (Other)

1year risk estimate

Active Comparator

risk of stroke presented over a timeframe of 1 year

干预措施: decision aid (Other)

5year risk estimate

Experimental

risk of stroke presented over a timeframe of 5 years

干预措施: decision aid (Other)

CHA2DS2-VASC risk score 1

Other

CHA2DS2-VASC risk score =1

干预措施: decision aid (Other)

CHA2DS2-VASC risk score 2

Other

CHA2DS2-VASC risk score =2

干预措施: decision aid (Other)

CHA2DS2-VASC risk score 3

Other

CHA2DS2-VASC risk score =3

干预措施: decision aid (Other)

CHA2DS2-VASC risk score 4

Other

CHA2DS2-VASC risk score =4

干预措施: decision aid (Other)

CHA2DS2-VASC risk score 5

Other

CHA2DS2-VASC risk score =5

干预措施: decision aid (Other)

prescription to virtual patient

Active Comparator

prescription is done for a virtual patient

干预措施: decision aid (Other)

prescription to physician himself

Experimental

prescription is done to physician himself

干预措施: decision aid (Other)

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

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cristian Baicus

Professor of Internal Medicine

Carol Davila University of Medicine and Pharmacy

研究点 (1)

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