Critical Illness Outcome Study: An Observational Study on Protocols and Mortality in Intensive Care Units

Area of Science:

• Critical Care Medicine
• Health Services Research
• Clinical Epidemiology

Background:

• Intensive Care Unit (ICU) characteristics like staffing and team structure impact patient outcomes.
• Clinical care in ICUs is increasingly operationalized through complex treatment protocols.
• The United States Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS) protocol was developed to address these factors.

Purpose of the Study:

• To determine if the extent of protocol availability and use in ICUs is associated with hospital survival.
• To analyze the relationship between the number of protocols and hospital mortality in ICU patients.
• To inform effective ICU and care team design and impact intensive care delivery.

Main Methods:

• Prospective, observational, multi-centered cohort study of mixed ICUs in the U.S.
• Data collection includes ICU organizational information (protocol availability/utilization, staffing) and patient-level data (demographics, conditions).
• Primary outcome is all-cause hospital mortality; analysis uses regression modeling, powered to detect a 3% difference in mortality between high and low protocol use ICUs.

Main Results:

• The study is powered to detect a 3% difference in crude hospital mortality between high and low protocol use ICUs.
• Regression modeling will adjust for outcome clustering by ICU.
• Secondary analyses include linear analysis of protocol number and mortality.

Conclusions:

• USCIITG-CIOS is a large study examining the effect of ICU protocol use on patient outcomes.
• Results will enhance understanding of the relationship between protocol availability, use, and patient outcomes in the ICU.
• Findings can promote more effective ICU design and impact intensive care delivery globally.