A Multi-centre European Observational Study to Assess Whether Patients Admitted to the ICUs With Availability of Intermediate Care Unit (IMCU) Have Lower Hospital Mortality Than Those Admitted to the ICUs Without Availability of IMCU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,433
- 试验地点
- 1
- 主要终点
- Vital Status at Hospital Discharge
研究概览
简要总结
The starting point of ELOISE is the significant number of Intensive Care Unit (ICU) survivors who die after the transfer to ward. This mortality rate nullifies the sophisticated diagnostics and the life-support therapies adopted in the ICU.
The inadequate care available at the destination ward has been suggested as one of the reasons to explain the bad outcome of some ICU survivors, but most hospitals do not have enough ICU beds to prolong the ICU stay until the patient has fully recovered. Therefore, Inter Mediate Care Units (IMCU) with levels of nursing staff and costs lower than ICU but higher than wards have been proposed to facilitate discharges of ICU patients. Unfortunately the literature does provide evidence of efficacy of IMCU.
The primary aim of the study is to assess whether the patients admitted to ICUs with availability of IMCU have lower hospital mortality than those admitted to the ICU without availability of IMCU.
Secondary aims are as follows:
- To compare Lengths Of ICU and Hospital Stay (LOIS and LOHS, respectively) of patients admitted to ICUs with or without availability of IMCU.
- To assess the influence of IMCU on the rate of ICU readmissions.
- To compare the hospital survival of patients discharged to IMCU and general ward (in hospital with or without availability of IMCU) adjusted for severity of illness and nursing workload at ICU discharge. This last aim will require a larger sample size (more than 10,000), but we hope to collect such a sample.
详细描述
Despite the high cost of Intensive Care Unit (ICU), a significant number of patients surviving intensive care die subsequently in hospital after the transfer to ward. Mortality rates after discharge from ICU have been reported to range from 6.1 to 27%
In 2000, it was reported that premature discharge from ICU was more likely to occur at night and was associated with higher death rates. Suggested factors that might account for a worse outcome for night discharges were poorer quantity and quality of care available at night both during transfer and at the destination. The implication of this study for the health system was that many hospitals did not have enough ICU beds. To facilitate earlier ICU discharges of ICU patients who are thought to need more care than those which can be provided on wards, InterMediate Care Units (IMCU) with level of nursing staff (and costs) lower than ICU were proposed more than a decade ago.
Despite the relevance of the topic, the literature on the efficacy and cost-effectiveness of IMCU available at present shows variable results. And the potential benefits of IMCUs remain uncertain.
The most striking are probably the following questions:
- Does IMCU decrease the hospital mortality rate of ICU patients?
- Does IMCU allow earlier ICU discharge and hence improve patients flux through the ICU and reduce ICU cost?
- Does IMCU permit a reduction of ICU readmissions? We propose to address these issues in a large multinational, multicentre study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admission to one of the Study Unit
- •any organ support allowed
- •age of at least 16 years
排除标准
- •age lower than 16 years
- •patients admitted as donor for transplant
- •patients admitted with limitation of care stated before admission
结局指标
主要结局
Vital Status at Hospital Discharge
时间窗: Max 90 days after admission to the Study Unit
Hospital mortality of the patients admitted to intensive care units with or without intermediate care unit in the hospital
次要结局
- Length of ICU Stay(Max 90 days after admission to intensive care unit)
- Length of Hospital Stay(Max 90 days after admission to the Study Unit)
- Number of ICU Readmissions(Max 90 days after admission to the Study Unit)
研究者
Maurizia Capuzzo
Medical Doctor
Università degli Studi di Ferrara