Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments

Study Overview
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Brief Summary
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Admitting a very elderly patient to the Intensive Care Unit (ICU) is one of the most difficult clinical challenges in medicine. There are few data to help guide clinicians in this area: estimates of the benefits of ICU admission, especially in the very elderly, are sparse. Rates of ICU admission of very elderly thus vary widely by hospitals. The ICE-CUB1 (PHRC AOR 03 035) project has studied the ICU admission decision process of patients over 80 arriving in Emergency Departments (ED) with conditions that potentially warrant ICU admission and their outcome six months after ED visit. Overall rate of patients deemed eligible for ICU admission was of 12% (Garrouste et al. Crit Care Med 2009) but ranged from 5% to 38% across the participating centers. This variability persisted after adjustment for patients' characteristics (MOR 2.25, 1.60-3.58; hospital-related variance 18%). The analysis also revealed that high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and the absence of cancer were of good prognosis for outcome six months after ED visit. Only 23% of patients visiting the ED with a life-threatening condition and all positive prognostic factors mentioned above were admitted to an ICU in the ICE-CUB1 study. Hypothesis Elderly patients visiting the ED with a life-threatening condition, high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and no cancer will potentially benefit from ICU care and should thus be admitted. Main objective Determine whether a strategy consisting of recommendations of ICU admission of all patients over 75 visiting the ED with a life threatening condition, no cancer, good functional and nutritional status prior to ED visit decreases the mortality of these patients six months after ED visit. Secondary objective : Assess the impact of the strategy on: In-hospital mortality Rate of ICU admission Place of living and quality of life six months after ED visit Primary outcome :Mortality six months after ED visit Secondary outcomes In-hospital mortality ICU admission Change in functional status six months after ED visit institutionalization Quality of life six months after ED visit

Detailed Description
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Admitting a very elderly patient to the Intensive Care Unit (ICU) is one of the most difficult clinical challenges in medicine. There are few data to help guide clinicians in this area: estimates of the benefits of ICU admission, especially in the very elderly, are sparse. Rates of ICU admission of very elderly thus vary widely by hospitals. The ICE-CUB1 (PHRC AOR 03 035) project has studied the ICU admission decision process of patients over 80 arriving in Emergency Departments (ED) with conditions that potentially warrant ICU admission and their outcome six months after ED visit. Overall rate of patients deemed eligible for ICU admission was of 12% (Garrouste et al. Crit Care Med 2009) but ranged from 5% to 38% across the participating centers. This variability persisted after adjustment for patients' characteristics (MOR 2.25, 1.60-3.58; hospital-related variance 18%). The analysis also revealed that high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and the absence of cancer were of good prognosis for outcome six months after ED visit. Only 23% of patients visiting the ED with a life-threatening condition and all positive prognostic factors mentioned above were admitted to an ICU in the ICE-CUB1 study. Hypothesis Elderly patients visiting the ED with a life-threatening condition, high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and no cancer will potentially benefit from ICU care and should thus be admitted. Main objective Determine whether a strategy consisting of recommendations of ICU admission of all patients over 75 visiting the ED with a life threatening condition, no cancer, good functional and nutritional status prior to ED visit decreases the mortality of these patients six months after ED visit. Secondary objective : Assess the impact of the strategy on: In-hospital mortality Rate of ICU admission Place of living and quality of life six months after ED visit Primary outcome :Mortality six months after ED visit Secondary outcomes In-hospital mortality ICU admission Change in functional status six months after ED visit institutionalization Quality of life six months after ED visit Type of study Cluster stratified randomized controlled trial. Stratification criteria are existence of an acute geriatric ward, capacity of the emergency department and location of the hospital (in or out Paris area)

Official Title
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Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments: a Cluster Randomized Controlled Trial

Conditions
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Elderly Patients Visiting the Emergency Department

Intervention / Treatment
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* Other: recommendations to admit to ICU all the patients included


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 75 years old At least one organ failure No cachexia No active known cancer Good functional status (as assessed by an ADL score > 4) or not evaluable Affiliated to social security Exclusion Criteria: refusal

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Guidelines for ICU admission of elderly patients arriving in Emergency Departments with a life threatening conditions | Other: recommendations to admit to ICU all the patients included<br>* recommendations to emergency and ICU physicians to admit to ICU all the patients included in the trial<br>|
| 2<br>no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality six months after emergency department visit |  | 6 months after emergency department visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital mortality |  | up to 6 months | 
| ICU admission rate |  | length of hospital stay | 
| change in functional status |  | 6 months after emergency department visit | 
| institutionalization |  | 6 months after emergency department visit | 
| quality of life |  | 6 months after emergency department visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients over 75, acute pathology, ICU admission