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Electronic Alerts for Stroke Prevention in Patients With Atrial Fibrillation or Atrial Flutter (AF-ALERT)

2018年10月29日 更新者：Samuel Z.Goldhaber, MD、Brigham and Women's Hospital

Alert-Based Computerized Decision Support for Stroke Prevention in High-Risk Hospitalized Patients With Atrial Fibrillation: A Randomized, Controlled Trial (AF-ALERT)

Atrial fibrillation (AF) is the most preventable cause of stroke. CHADS and CHA2DS2VASc scores predict the likelihood of stroke in patients with nonvalvular AF. Atrial flutter confers a similar risk of stroke as atrial fibrillation. Anticoagulant therapy with warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban is effective for prevention of thromboembolic stroke in most patients with AF. However, despite widely available risk stratification tools, five options for anticoagulation, and evidence-based practice guidelines, thromboprophylaxis for stroke prevention in AF is under-prescribed in the U.S., Europe, and worldwide. The investigators have previously demonstrated the efficacy of an alert-based computerized decision support (CDS) strategy for prevention of symptomatic venous thromboembolism (VTE) in at-risk hospitalized patients not receiving any thromboprophylaxis. The investigators' goal is to create and evaluate an alert-based CDS strategy for stroke prevention in patients with nonvalvular AF or atrial flutter in a randomized controlled trial.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Atrial fibrillation (AF) is the most preventable cause of stroke. CHADS and CHA2DS2VASc scores predict the likelihood of stroke in patients with nonvalvular AF. Atrial flutter confers a similar risk of stroke as atrial fibrillation. Anticoagulant therapy with warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban is effective for prevention of thromboembolic stroke in most patients with AF. However, despite widely available risk stratification tools, five options for anticoagulation, and evidence-based practice guidelines, thromboprophylaxis for stroke prevention in AF is under-prescribed in the U.S., Europe, and worldwide. The investigators have previously demonstrated the efficacy of an alert-based computerized decision support (CDS) strategy for prevention of symptomatic venous thromboembolism (VTE) in at-risk hospitalized patients not receiving any thromboprophylaxis. The investigators' goal is to create and evaluate an alert-based CDS strategy for stroke prevention in patients with nonvalvular AF or atrial flutter in a randomized controlled trial. The investigators have the following specific aims:

Aim #1 (Primary Efficacy Endpoint)- To assess whether an alert-based computerized decision support strategy increases prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.

Hypothesis #1- An alert-based computer decision support (CDS) strategy will increase prescription of prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.

Aim #2 (Secondary Efficacy Endpoint)- To determine the potential impact of an alert-based computerized decision support strategy on the frequency of a composite of major adverse cardiovascular events at 90 days, defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment.

Hypothesis #2- This study will provide proof-of-concept data, including event rates, from which to design a larger randomized control trial to assess whether an alert-based CDS strategy will reduce the frequency of a composite of major adverse cardiovascular events at 90 days, defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment.

研究类型

介入性

注册 (实际的)

458

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Brigham and Women's Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • High-risk patients ≥ 21 years old with paroxysmal, persistent, or permanent nonvalvular AF or atrial flutter (CHA2DS2VASc score ≥ 1) who are not prescribed anticoagulant therapy for stroke prevention and are hospitalized at BWH will be eligible for randomization.

Exclusion Criteria:

  • <21 years old
  • no diagnosis of AF or atrial flutter
  • not hospitalized at BWH

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Alert Group
If the patient is randomized to the alert group, their ordering provider will receive a computer electronic alert notifying the responsible provider that his or her patient is high-risk for stroke due to AF or atrial flutter and that the patient is not ordered to receive anticoagulant therapy.
其他：Computer Electronic Alert
A computer program that will issue an on-screen electronic alert notifying the responsible provider that his or her patient is high-risk for stroke due to AF or atrial flutter and that the patient is not ordered to receive anticoagulant therapy. The alert will provide options for anticoagulation for stroke prevention in AF as well as additional information in the form of suggested reading.
无干预：Control Group
If the patient is randomized to the control group, the computer program will not issue an on-screen electronic alert.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Frequency of prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.
大体时间：90 days
Defined as prescription of therapeutic dose anticoagulation
90 days

次要结果测量

结果测量
措施说明
大体时间
Frequency of composite of major adverse cardiovascular events at 90 days
大体时间：90 days
Defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment
90 days
Frequency of stroke or transient ischemic attack (TIA) at 90 days
大体时间：90 days
An acute stroke was defined as a new, focal neurologic deficit of sudden onset, lasting at least 24 hours, not due to a readily identifiable nonvascular cause (e.g., brain tumor, trauma), as confirmed by a neurologist. All strokes required confirmation by imaging or autopsy. TIA was defined as a transient episode of neurologic dysfunction caused by suspected focal cerebral, spinal cord, or retinal ischemia without evidence of acute infarction and confirmed by a neurologist.
90 days
Frequency of acute myocardial infarction at 90 days
大体时间：90 days
Acute MI was defined as the detection of a rise and/or fall of cardiac biomarkers (cardiac troponin T), with at least one value being elevated above the 99th percentile upper reference limit and with at least one of the following: 1) symptoms of myocardial ischemia; 2) new (or presumably new) significant ST-segment/T-wave changes or left bundle branch block; 3) development of pathological Q waves on ECG; 4) new loss of viable myocardium or regional wall motion abnormality by imaging; or 5) identification of intracoronary thrombus by angiography or autopsy.
90 days
Frequency of all cause mortality at 90 days
大体时间：90 days
All-cause mortality was determined by review of the EHR. Causes of death were classified as stroke, myocardial infarction, pulmonary embolism, other cardiovascular cause, bleeding, cancer, or non-cardiovascular and non-cancer.
90 days
Frequency of major bleeding or clinically relevant non-major bleeding at 90 days
大体时间：90 days
Defined by the International Society on Thrombosis and Haemostasis [ISTH] bleeding classification system) at 90 days from enrollment.14 Using the ISTH classification, bleeding was defined as major if it was overt and associated with a decrease in the hemoglobin level of 2 g/dL or more, required the transfusion of 2 or more units of blood, occurred into a critical site, or contributed to death. Clinically relevant non-major bleeding was defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, surgical intervention, or interruption of the study drug.
90 days
Frequency of systemic embolism at 90 days
大体时间：90 days
Systemic embolism was defined as sudden loss of perfusion of a limb or extracranial organ
90 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Brigham and Women's Hospital

合作者

Daiichi Sankyo, Inc.

调查人员

  • 首席研究员：Samuel Z Goldhaber, MD、Brigham and Women's Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年5月1日

初级完成 (实际的)

2018年2月1日

研究完成 (实际的)

2018年9月1日

研究注册日期

首次提交

2015年1月6日

首先提交符合 QC 标准的

2015年1月12日

首次发布 (估计)

2015年1月15日

研究记录更新

最后更新发布 (实际的)

2018年10月31日

上次提交的符合 QC 标准的更新

2018年10月29日

最后验证

2018年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2014P002317

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Computer Electronic Alert的临床试验

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赞助者和合作者

医疗条件

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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