Safety Issues and SurvIval For Medical Outliers (SISIFO) - Not-for-profit Observational Study to Evaluate the Quality and Safety of Care in Patients "Outliers" Hospitalized With Medical Diseases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2,056
- 试验地点
- 31
- 主要终点
- Inhospital mortality
研究概览
简要总结
Each Investigator will have to record data concerning 70 patients. In particular 40 patients "outliers" and 30 patients "control".
详细描述
Phase 1 - Patients enrollment (October 2018 - May 2019) Each Investigator will have to record data concerning 70 patients. In particular 40 patients "outliers" (max 10 per month) and 30 patients "control" (max 6 per month). It will be collected clinical and organisational information. The Investigators of the wards that will not have patients "outliers" will have to enroll 70 patients "control" (max 15 per month).
Phase 2 - Database review and validation (June 2019 - October 2019) The data collected will be analysed to process the endpoints.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Age ≥ 18 years
- •Signature of informed consent
- •Patients coming from Emergency Room
- •Patients to be hospitalized in Internal Medicine or similar (not day-hospital)
- •Patients spending at least one night in another ward for lack of available beds
- •Consecutive cases
- •Age ≥ 18 years
- •Signature of informed consent
- •Patients coming from Emergency Room
- •Patients to be hospitalized in Internal Medicine or similar (not day-hospital)
- •Patients hospitalized ab initio in Internal Medicine or similar for at least one night
- •Consecutive cases
- •Exclusion Criteria (Outlier and Control):
- •Age < 18 years
- •Patients hospitalized in Internal Medicine or similar coming from other wards or directly from home
排除标准
- 未提供
结局指标
主要结局
Inhospital mortality
时间窗: 8 months
Evaluation of the inhospital mortality in patients "outliers" compared to patients that are hospitalized ab initio in the relevant ward (Internal Medicine - patients "control")
次要结局
- Adverse Events(8 months)
- Mortality rate(3 months)