European Mortality & Length Of Intensive Care Unit (ICU) Stay Evaluation (ELOISE) (ELOISE)

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness

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.

• Study Type: Observational
• Enrollment (Actual): 6433

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44121
    • Maurizia Capuzzo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All adult patients consecutively admitted to the Study Units during one month (from 7th November to 4th December 2010)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara
• Collaborators: European Society of Intensive Care Medicine; University Hospital of Ferrara
• Investigators: Principal Investigator: Maurizia Capuzzo, MD, Azienda Ospedaliero-Universitaria di Ferrara, Italy; Study Chair: 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, UK; Study Chair: Andreas Valentin, MD, University of Vienna, Austria

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: August 19, 2011
• First Submitted That Met QC Criteria: August 22, 2011
• First Posted (ESTIMATE): August 23, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 21, 2015
• Last Update Submitted That Met QC Criteria: July 31, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: critical care; intensive care; mortality; intermediate care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 80-2011