Examination of the Standardized Use of the Pulmonary Embolism SOP in the Clinical Routine of the Emergency Department in Respect of the QEST Criteria (Quality, Efficacy, Safety and Transparency).
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Guideline adherence
研究概览
简要总结
Usage of a guideline-compliant SOP in each chest pain unit (CPU) is instrumental in establishing the diagnosis of a pulmonary embolism without time delay. With the integration of this SOP as a "clinical decision tool" (CDT) into the electronic database of the CPU, the standardized application of the pulmonary embolism SOP in the clinical routine of the CPU will be tested using a retro- and prospective approach.
详细描述
Summary:
The increasing number of patients in the emergency departments in recent years extends the time until diagnosis and treatment initiation and thus represents a serious problem in patient care and for the treating physician. This also includes patients with acute pulmonary embolism (PE), which is one of the most common differential diagnoses of patients presenting with unclear dyspnea, chest pain or other symptoms in the emergency department. Due to the potentially serious clinical outcome with a high overall mortality rate of > 10%, rapid diagnosis and initiation of therapy is essential.
The current guidelines of the European Society of Cardiology for the diagnosis and treatment of acute PE recommend a stringent diagnostic algorithm that includes clinical parameters as well as risk scores for estimating the pretest probability. Depending of their results the further diagnostic pathway by D-Dimer testing and / or CT angiography is chosen.
The aim of the present study is to examine the standardized application of guideline recommendations of the European Society of Cardiology (ESC). The diagnostic procedures were defined for the CPU of the University Hospital Heidelberg in a standard operating procedure (SOP). In the planned retrospective study, the implementation of this SOP will be examined on the basis of the QEST criteria (quality, efficacy, safety and transparency). Data for the "actual condition" are collected retrospectively for 6 months prior to August 2019, thereafter for another 6 months after implementation of the quality assurance measure.
Introduction and fundamental principles:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 18 with suspected pulmonary embolism in the CPU (with or without D-dimer determination)
排除标准
- •Patients in whom the determination of the D-dimer concentration was made for other reasons, such as venous thrombosis or aortic syndrome
- •Patients who have been suspected to have a pulmonary embolism already before presenting in the CPU
- •Patients with confirmed diagnosis or already measured D-dimers
结局指标
主要结局
Guideline adherence
时间窗: 6 months
• Percent guideline adherence or violation of guideline recommendations (quality)
Appropriateness of CT imaging
时间窗: 6 months
• Ratio of diagnostic CT: total CT
Missed pulmonary embolism
时间窗: 6 months
* Number of indicated but not performed CT examinations * Number of unnecessary CT at low pretest probability
次要结局
- Appropriate biomarker utilization(6 months)
- efficacy of CT imaging(6 months)
- Inappropriate biomarker utilization(6 months)
研究者
Evangelos Giannitsis
Principle Investigator
Heidelberg University
