Outpatient Treatment of Pulmonary Embolism and Deep Vein Thrombosis: Impact of a New Protocol on Emergency Department Efficiency and Patient Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Efficiency & cost of clinical protocol
研究概览
简要总结
Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT) treatment.
详细描述
In the current protocol, we will study the outcomes most likely to influence emergency physician behavior, such as improved Emergency Department (ED) throughput, and decreased ED and Emergency Department Observation Unit (EDOU) length of stay. Metrics such as decreased admissions are also very important to hospital administrators so our results will have impact outside the ED as well. At the end of this study we will demonstrate that a carefully planned and data-driven approach to the outpatient treatment of Pulmonary Embolism (PE) is safe, improves operational metrics, and reduces cost.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subject is 18 years of age or older at time of enrollment.
- •Subject is diagnosed with acute VTE (DVT or PE) in the MGH or BWH ED or transferred to the MGH or BWH ED (e.g from a clinic or outside hospital) with a diagnosis of acute VTE.
- •Subject is treated as an outpatient (i.e. discharged) directly from the ED or admitted to the ED Observation Unit/ED Short Stay Unit on the outpatient treatment protocol.
排除标准
- •Subjects admitted from the ED to an inpatient service will not be enrolled as study subjects, but will be used as contemporary controls.
- •Subjects who are unable to understand or provide informed consent.
- •Subjects unable or unlikely to follow up (e.g. prisoners).
结局指标
主要结局
Efficiency & cost of clinical protocol
时间窗: Up to 30 days
To compare patients diagnosed with VTE after protocol implementation to those diagnosed with VTE prior to protocol implementation in terms of four measures of efficiency: A) ED length of stay - defined as time from ED registration to departure from the ED (to either the inpatient floor or to the EDOU). B) ED disposition time - defined as time from ED registration to bed request. C) Hospital length of stay - defined as time from ED registration to departure from the hospital. D) Cost - defined as the estimated cost of care including diagnostic testing, imaging, hospital inpatient/observation unit stay, medication/pharmacy costs.
Safety of clinical protocol
时间窗: Up to 30 days
To assess the safety of outpatient VTE treatment, specifically with regards to: A) recurrent venous thromboembolism; B) bleeding (major or minor); C) unscheduled return to hospital for any reason; D) death from any cause: occurring up to 30 days after their discharge.
次要结局
未报告次要终点
研究者
Christopher Kabrhel
Attending Physician
Massachusetts General Hospital