Effect of Systematic Intensive Care Unit Triage on Long-term Mortality Among Critically Ill Elderly Patients in France: A Randomized Clinical Trial

Abstract

Importance: The high mortality rate in critically ill elderly patients has led to questioning of the beneficial effect of intensive care unit (ICU) admission and to a variable ICU use among this population.

Objective: To determine whether a recommendation for systematic ICU admission in critically ill elderly patients reduces 6-month mortality compared with usual practice.

Design, setting, and participants: Multicenter, cluster-randomized clinical trial of 3037 critically ill patients aged 75 years or older, free of cancer, with preserved functional status (Index of Independence in Activities of Daily Living ≥4) and nutritional status (absence of cachexia) who arrived at the emergency department of one of 24 hospitals in France between January 2012 and April 2015 and were followed up until November 2015.

Interventions: Centers were randomly assigned either to use a program to promote systematic ICU admission of patients (n=1519 participants) or to follow standard practice (n=1518 participants).

Main outcomes and measures: The primary outcome was death at 6 months. Secondary outcomes included ICU admission rate, in-hospital death, functional status, and quality of life (12-Item Short Form Health Survey, ranging from 0 to 100, with higher score representing better self-reported health) at 6 months.

Results: One patient withdrew consent, leaving 3036 patients included in the trial (median age, 85 [interquartile range, 81-89] years; 1361 [45%] men). Patients in the systematic strategy group had an increased risk of death at 6 months (45% vs 39%; relative risk [RR], 1.16; 95% CI, 1.07-1.26) despite an increased ICU admission rate (61% vs 34%; RR, 1.80; 95% CI, 1.66-1.95). After adjustments for baseline characteristics, patients in the systematic strategy group were more likely to be admitted to an ICU (RR, 1.68; 95% CI, 1.54-1.82) and had a higher risk of in-hospital death (RR, 1.18; 95% CI, 1.03-1.33) but had no significant increase in risk of death at 6 months (RR, 1.05; 95% CI, 0.96-1.14). Functional status and physical quality of life at 6 months were not significantly different between groups.

Conclusions and relevance: Among critically ill elderly patients in France, a program to promote systematic ICU admission increased ICU use but did not reduce 6-month mortality. Additional research is needed to understand the decision to admit elderly patients to the ICU.

Trial registration: clinicaltrials.gov Identifier: NCT01508819.

Figure 1.. Flow of Hospitals and Participants Through the ICE-CUB 2 Trial

Cluster sizes are estimated according to the annual number of emergency department visits for all patients and for patients aged 75 years or older. There was no screening log in the emergency departments. The number of patients screened for inclusion in each hospital was estimated with the annual number of emergency department visits of patients aged 75 years or older, of which an estimated 8% (data from the ICE-CUB 1 study) were related to critical conditions, of which an estimated 33% (data from the ICE-CUB 1 study) fulfilled the inclusion criteria. Data are not available for the number of hospitals screened for eligibility or the number of or reasons for exclusion prior to randomization. ^aInformation on number of patients not eligible or included is not available. ^bParticipant recruitment ended when the target sample size was achieved.

Figure 2.. Unadjusted and Adjusted Probability of Survival

Median duration of follow-up in alive patients was of 6 months (interquartile range, 6.0-6.1 months) in both the systematic strategy and the standard practice groups. Panel A shows Kaplan-Meier curves of the unadjusted probability of survival between the systematic strategy group and the standard practice group from emergency department visit to 6 months. Patients from the systematic strategy group had a lower 6-month survival rate vs patients in the standard practice group (Kaplan-Meier estimates, 55.7% [95% CI, 53.2%-58.2%] vs 61.8% [95% CI, 59.4%-64.3%]; P < .001; hazard ratio, 1.24; 95% CI, 1.02-1.51). Panel B shows Kaplan-Meier curves of the inverse probability-weighted adjusted probability of survival from emergency department visit to 6 months. The P value from the inverse probability-weighted Cox regression model is shown in the graph. After adjustments for baseline characteristics, survival rates at 6 months were not significantly different between groups (hazard ratio, 1.10; 95% CI, 0.93-1.31).