跳至主要内容
临床试验/NCT02635685
NCT02635685进行中(未招募)不适用

Clinical Decision Support for Stroke Prevention in Atrial Fibrillation - a Cluster Randomized Trial in the Primary Care Setting

University Hospital, Linkoeping1 个研究点 分布在 1 个国家目标入组 442,105 人开始时间: 2016年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
442,105
试验地点
1
主要终点
Adherence to guidelines defined as the percentage of patients with atrial fibrillation and CHA2DS2VASc ≥ 1, (not only female gender) that are prescribed anticoagulant therapy (ATC-code B01A).

研究概览

简要总结

A cluster randomised study in the primary care setting to evaluate a electronic clinical decision tool for stroke prophylaxis in patients with atrial fibrillation.

详细描述

Atrial fibrillation is the most common form of arrhythmia, affecting more than three percent of the population. The condition carries an increased risk of thromboembolism, in particular stroke. In 2013 approximately 25000 acute strokes were diagnosed in Sweden, with the result of death or severe disability in nearly half of the cases. Numerous studies have shown that the risk for stroke can be reduced by approximately 60-70 % with the use of anticoagulant therapy to patients with one or several risk factors for stroke and concurrent atrial fibrillation. The European Society of Cardiology recommends use of the CHA2DS2VASc algorithm to identify persons at increased risk for stroke in the setting of atrial fibrillation. Prophylaxis is recommended if CHA2DS2VASc ≥ 1 (not only female gender).

The agents used include warfarin and the more recently developed non-vitamin k oral anticoagulants (NOACs). Despite good evidence and recommendations in current guidelines, however, there remains a substantial undertreatment in this group of patients.

The Swedish Association of Local Authorities and Regions have shown that only 63% of patients with a CHA2DS2VASc score ≥ 2 are prescribed anticoagulant therapy [7]. The reasons for this is most likely multifactorial, including ignorance of the CHA2DS2VASc algorithm as well as reluctance of the use of potent drugs from both doctors and patients. Furthermore, the high pace in modern medicine increase the risk of missing the diagnosis of atrial fibrillation and/or the conditions constituting the CHA2DS2VASc algorithm.

Clinical decision tools is a relatively new phenomena in modern medicine showing promising results, but evidence for clinical outcome are sparse. The clinical decision tool for stroke prevention (CDSS) has been developed in collaboration between Cambio Cosmic (the supplier of the electronic journal in the county of Östergötland), the Cardiology Department at Linköping University hospital and primary care professionals. The decision tool is activated when a patient is being logged into the electronic journal. If the patient has a diagnosis of atrial fibrillation (or atrial flutter) and a CHA2DS2VASc score ≥ 1 (not only female gender) without current anticoagulant therapy, a screen warning will appear. By clicking on the warning, the responsible physician will get an overview of the patient's diagnosis according to the CHA2DS2VASc algorithm. Furthermore, a calculation of the estimated stroke risk for the coming year will appear, and links to national guidelines be provided. The physician can thereafter decide to prescribe anticoagulant therapy in accordance with current guidelines or, alternatively, postpone the decision/make a decision to refrain from medication. In case the choice is made to refrain from medication the physician is asked to choose between a set of predetermined reasons in order to monitor the main reasons for deviation from guidelines.

If, on the other hand, the patient has anticoagulant therapy in accordance with current guidelines, no screen warning will appear.

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

性别
All
接受健康志愿者

入选标准

  • Primary care centers in the county of Östergötland, Sweden.

排除标准

  • 未提供

结局指标

主要结局

Adherence to guidelines defined as the percentage of patients with atrial fibrillation and CHA2DS2VASc ≥ 1, (not only female gender) that are prescribed anticoagulant therapy (ATC-code B01A).

时间窗: 12 months after study commencement

The data will be recorded through the electronic journal where the diagnosis for atrial fibrillation/flutter, the conditions constituting the CHA2DS2VASc algorithm as well as the medication list is logged.

次要结局

  • Cost-effectiveness of using clinical decision support tool for stroke prevention in the primary care setting.(12 months follow-up)
  • Reduction av thromboembolism. This will be analyzed through the electronic medical journal by identifying the patients with new (since commencement of the study) diagnosis of thromboembolism. ICD-10 codes I63-64, G45, I75 will be analyzed.(12 months after study commencement and 3 and 6 years after study finish.)
  • Analysis of reasons to deviate from guidelines. As part of the clinical decision tool there are prespecified reasons to choose from if no therapy is prescribed. The main reasons will be summarized.(12 months after study commencement)
  • Analysis of physician acceptance of a clinical decision tool in the primary care setting with questionnaires to randomly assigned general physicians.(Before study commencement and after 12 months)

研究者

发起方
University Hospital, Linkoeping
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lars Karlsson

MD, PhD

University Hospital, Linkoeping

研究点 (1)

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