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| Name | Class |
|---|---|
| University Hospital of Ferrara | OTHER |
| European Society of Intensive Care Medicine | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients admitted to the Study Units | Consecutive adult patients consecutively admitted to the Study Units during one month (either from 7th November to 4th December 2010, or from 16th January to 12th February 2012) |
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| Measure | Description | Time Frame |
|---|---|---|
| Vital Status at Hospital Discharge | Hospital mortality of the patients admitted to intensive care units with or without intermediate care unit in the hospital | Max 90 days after admission to the Study Unit |
| Measure | Description | Time Frame |
|---|---|---|
| Length of ICU Stay | Number of days (calendar days -1) from admission to and discharge from the Study Unit | Max 90 days after admission to intensive care unit |
| Length of Hospital Stay | Number of days (calendar days -1) from admission to the Study Unit to discharge from the hospital |
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Inclusion Criteria:
Exclusion Criteria:
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All adult patients consecutively admitted to the Study Units during one month (from 7th November to 4th December 2010)
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| Name | Affiliation | Role |
|---|---|---|
| Maurizia Capuzzo, MD | Azienda Ospedaliero-Universitaria di Ferrara, Italy | Principal Investigator |
| Christophe Combescure, Statistician | University of Geneva, Switzerland | Study Chair |
| Bertrand Guidet, PhD | Hôpital Saint-Antoine, Paris, France | Study Chair |
| Gaetano Iapichino, MD | Hospital San Paolo, University of Milan, Italy | Study Chair |
| Paolo Merlani, MD | University of Geneva, Switzerland | Study Chair |
| Rui P Moreno, PhD | Hospital de Santo Antonio dos Capuchos, Lisbon, Portugal | Study Chair |
| Thomas Perneger, Statistician | University of Geneva, Switzerland | Study Chair |
| Andrew Rhodes, PhD | St. George's Hospital, London | Study Chair |
| Andreas Valentin, MD | University of Vienna, Austria | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maurizia Capuzzo | Ferrara | 44121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25664865 | Result | Capuzzo M, Volta C, Tassinati T, Moreno R, Valentin A, Guidet B, Iapichino G, Martin C, Perneger T, Combescure C, Poncet A, Rhodes A; Working Group on Health Economics of the European Society of Intensive Care Medicine. Hospital mortality of adults admitted to Intensive Care Units in hospitals with and without Intermediate Care Units: a multicentre European cohort study. Crit Care. 2014 Oct 9;18(5):551. doi: 10.1186/s13054-014-0551-8. | |
| 28376908 |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Units in Hospitals With Intermediate Care Unit | Adult patients consecutively admitted to Intensive Care Units in hospitals with intermediate care unit |
| FG001 | Units in Hospitals Without Intermediate Care Unit | Adult patients consecutively admitted to Intensive Care Units in hospitals without intermediate care unit |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
337 readmissions, 83 admissions with inconsistencies in dates and 147 patients with unknown vital status at hospital discharge (82 still in hospital at 90 days and 65 with missing vital status) were excluded from the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Units With Intermediate Care Unit | Patients admitted to intensive care unit with intermediate care unit in the hospital |
| BG001 | Units Without Intermediate Care Unit | Patients admitted to intensive care unit without intermediate care unit in the hospital |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Vital Status at Hospital Discharge | Hospital mortality of the patients admitted to intensive care units with or without intermediate care unit in the hospital | Posted | Number | participants | Max 90 days after admission to the Study Unit |
|
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Adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adverse Events Not Collected | Adverse events were not collected |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Maurizia Capuzzo | Università degli Studi di Ferrara | +393355932642 | cpm@unife.it |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Max 90 days after admission to the Study Unit |
| Number of ICU Readmissions | Number of readmissions to intensive care unit during the same hospital course | Max 90 days after admission to the Study Unit |
| Derived |
| Poncet A, Perneger TV, Merlani P, Capuzzo M, Combescure C. Determinants of the calibration of SAPS II and SAPS 3 mortality scores in intensive care: a European multicenter study. Crit Care. 2017 Apr 4;21(1):85. doi: 10.1186/s13054-017-1673-6. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Length of ICU Stay | Number of days (calendar days -1) from admission to and discharge from the Study Unit | Posted | Median | Inter-Quartile Range | days | Max 90 days after admission to intensive care unit |
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|
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| Secondary | Length of Hospital Stay | Number of days (calendar days -1) from admission to the Study Unit to discharge from the hospital | Posted | Median | Inter-Quartile Range | days | Max 90 days after admission to the Study Unit |
|
|
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| Secondary | Number of ICU Readmissions | Number of readmissions to intensive care unit during the same hospital course | Posted | Number | readmissions | Max 90 days after admission to the Study Unit |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
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| Superiority or Other |