Critical Illness
Conditions
Keywords
mortality, intensive care, critical care, intermediate care
Brief summary
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: 1. To compare Lengths Of ICU and Hospital Stay (LOIS and LOHS, respectively) of patients admitted to ICUs with or without availability of IMCU. 2. To assess the influence of IMCU on the rate of ICU readmissions. 3. 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.
Detailed description
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.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* admission to one of the Study Unit * any organ support allowed * age of at least 16 years
Exclusion criteria
* age lower than 16 years * patients admitted as donor for transplant * patients admitted with limitation of care stated before admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vital Status at Hospital Discharge | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU Stay | Max 90 days after admission to intensive care unit | Number of days (calendar days -1) from admission to and discharge from the Study Unit |
| Length of Hospital Stay | Max 90 days after admission to the Study Unit | Number of days (calendar days -1) from admission to the Study Unit to discharge from the hospital |
| Number of ICU Readmissions | Max 90 days after admission to the Study Unit | Number of readmissions to intensive care unit during the same hospital course |
Countries
Italy
Participant flow
Recruitment details
All admissions of patients aged ≥ 16 years to a study during 28-day period (from 7 Nov to 4 Dec 2011, or from 16 Jan to 12 Feb 2012), excludind admissions only for organ donation, and with any limitation of care stated before unit admission. Maximum number of admissions per unit was 100.
Pre-assignment details
Prospective observational study, without group assignment. Study units gave information about organization. 32 admissions to units with level of care lower than intensive care unit (ICU), 337 readmissions, 83 admissions out of the dates of enrollment slots, and 147 admissions with unknown vital status at hospital discharge were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Units With Intermediate Care Unit Patients admitted to intensive care unit with intermediate care unit in the hospital | 5,031 |
| Units Without Intermediate Care Unit Patients admitted to intensive care unit without intermediate care unit in the hospital | 803 |
| Total | 5,834 |
Baseline characteristics
| Characteristic | Units With Intermediate Care Unit | Units Without Intermediate Care Unit | Total |
|---|---|---|---|
| Age, Continuous | 65 years | 68 years | 65 years |
| Sex: Female, Male Female | 2002 Participants | 332 Participants | 2334 Participants |
| Sex: Female, Male Male | 3029 Participants | 471 Participants | 3500 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Vital Status at Hospital Discharge
Hospital mortality of the patients admitted to intensive care units with or without intermediate care unit in the hospital
Time frame: Max 90 days after admission to the Study Unit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Units in Hospitals With Intermediate Care Unit | Vital Status at Hospital Discharge | 1232 participants |
| Units in Hospitals Without Intermediate Care Unit | Vital Status at Hospital Discharge | 165 participants |
Length of Hospital Stay
Number of days (calendar days -1) from admission to the Study Unit to discharge from the hospital
Time frame: Max 90 days after admission to the Study Unit
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Units in Hospitals With Intermediate Care Unit | Length of Hospital Stay | 13.9 days |
| Units in Hospitals Without Intermediate Care Unit | Length of Hospital Stay | 11.0 days |
Length of ICU Stay
Number of days (calendar days -1) from admission to and discharge from the Study Unit
Time frame: Max 90 days after admission to intensive care unit
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Units in Hospitals With Intermediate Care Unit | Length of ICU Stay | 3.7 days |
| Units in Hospitals Without Intermediate Care Unit | Length of ICU Stay | 2.8 days |
Number of ICU Readmissions
Number of readmissions to intensive care unit during the same hospital course
Time frame: Max 90 days after admission to the Study Unit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Units in Hospitals With Intermediate Care Unit | Number of ICU Readmissions | 292 readmissions |
| Units in Hospitals Without Intermediate Care Unit | Number of ICU Readmissions | 40 readmissions |