Protocols and Hospital Mortality in Critically Ill Patients: The United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study

Jonathan E. Sevransky, MD, MHS; William Checkley, MD, PhD; Phabiola Herrera, MD; Brian W. Pickering, MD; Juliana Barr, MD; Samuel M. Brown, MD; Steven Y. Chang, MD; David Chong, MD; David Kaufman, MD; Richard D. Fremont, MD; Timothy D. Girard, MD; Jeffrey Hoag, MD; Steven B. Johnson, MD; Mehta P. Kerlin, MD; Janice Liebler, MD; James O'Brien, MD; Terence O'Keefe, MD; Pauline K. Park, MD; Stephen M. Pastores, MD; Namrata Patil, MD; Anthony P. Pietropaoli, MD; Maryann Putman, MD; Todd W. Rice, MD; Leo Rotello, MD; Jonathan Siner, MD; Sahul Sajid, MD; David J. Murphy, MD, PhD; Greg S. Martin, MD, MSCR


Crit Care Med. 2015;43(10):2076-2084. 

In This Article

Abstract and Introduction


Objective: Clinical protocols may decrease unnecessary variation in care and improve compliance with desirable therapies. We evaluated whether highly protocolized ICUs have superior patient outcomes compared with less highly protocolized ICUs.

Design: Observational study in which participating ICUs completed a general assessment and enrolled new patients 1 day each week.

Patients: A total of 6,179 critically ill patients.

Setting: Fifty-nine ICUs in the United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study.

Interventions: None.

Measurements and Main Results: The primary exposure was the number of ICU protocols; the primary outcome was hospital mortality. A total of 5,809 participants were followed prospectively, and 5,454 patients in 57 ICUs had complete outcome data. The median number of protocols per ICU was 19 (interquartile range, 15–21.5). In single-variable analyses, there were no differences in ICU and hospital mortality, length of stay, use of mechanical ventilation, vasopressors, or continuous sedation among individuals in ICUs with a high versus low number of protocols. The lack of association was confirmed in adjusted multivariable analysis (p = 0.70). Protocol compliance with two ventilator management protocols was moderate and did not differ between ICUs with high versus low numbers of protocols for lung protective ventilation in acute respiratory distress syndrome (47% vs 52%; p = 0.28) and for spontaneous breathing trials (55% vs 51%; p = 0.27).

Conclusions: Clinical protocols are highly prevalent in U.S. ICUs. The presence of a greater number of protocols was not associated with protocol compliance or patient mortality.


Patients with life-threatening illness are managed in critical care units with specialized monitoring and staffing requirements. The care of critically ill patients remains challenging because of patient acuity, competing time demands of other seriously ill patients, in addition to large amounts of clinical, mechanical ventilation, and laboratory information. In such an environment, it can be difficult to consistently provide desired care to each patient. Studies of patients with specific conditions, such as sepsis and the acute respiratory distress syndrome (ARDS), suggest that many patients do not receive desired care.[1–3]

The use of clinical protocols that target specific clinical syndromes is one method to decrease unnecessary variation in care and improve compliance with desired therapies.[4–6] Clinical protocols are prevalent in academic hospitals in the United States[7] and have been shown to be associated with desired treatments in patients with acute lung injury, ventilator weaning, and sedation management.[2,8–10] The use of clinical protocols in the ICU also appears to not adversely affect trainee knowledge.[11] However, the link between the number of protocols available in an ICU and patient outcomes is poorly understood.

The United States Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS) is a multicenter observational cohort study trial designed to understand the association between ICU organization and structural characteristics on hospital mortality.[12] The primary hypothesis being tested was whether highly protocolized ICUs would have improved patient outcomes compared with less highly protocolized ICUs.