Implementation of a bundle of quality indicators for the early management of severe sepsis and septic shock is associated with decreased mortality* H. Bryant Nguyen, MD, MS; Stephen W. Corbett, MD, PhD; Robert Steele, MD; Jim Banta, PhD, MPH; Robin T. Clark, BS; Sean R. Hayes; Jeremy Edwards; Thomas W. Cho, MD; William A. Wittlake, MD P atients suffering from severe sepsis or septic shock have a mortality rate of 20 –54% (1–3). Among the 751,000 annual cases of severe sepsis in the United States, approximately 458,200 cases (or 61%) are first encountered in the emergency depart- ment (ED) (1, 4). Early appropriate antibi- otics (5–7), early goal-directed therapy (EGDT) (8), corticosteroids (9), recombi- nant human activated protein C (rhAPC) (10), and lung-protective strategies (11) have all been shown to be associated with survival benefits. These and other thera- peutic advances led to the development of the Surviving Sepsis Campaign (SSC) man- agement guidelines (12). For the early management of severe sepsis in particular, the SSC and the Institute for Healthcare Improvement recommend implementation of a 6-hr resuscitation bundle (13), espe- cially in the ED, that incorporates early recognition, early antibiotics, and EGDT. Although guidelines provide a road- map for patient care, their success relies on consistent patterns of clinician prac- tice in order to realize the most optimal outcome. The purpose of this study was to examine the incremental impact of im- plementing a sepsis management initia- tive in the ED while integrating quality indicators via a “bundling” approach. Monitoring compliance to the quality in- dicators serves as a mechanism for clini- cian feedback and culture change that are needed to achieve uniformity in the pro- cess of care. We hoped to show that im- plementation of a severe sepsis bundle using quality indicators specific to the ED Objective: The purpose of this study was to examine the outcome implications of implementing a severe sepsis bundle in an emergency department as a quality indicator set with feedback to modify physician behavior related to the early management of severe sepsis and septic shock. Design: Two-year prospective observational cohort. Setting: Academic tertiary care facility. Patients: Patients were 330 patients presenting to the emergency department who met criteria for severe sepsis or septic shock. Interventions: Five quality indicators comprised the bundle for severe sepsis management in the emergency department: a) initiate central venous pressure (CVP)/central venous oxygen sat- uration (ScvO 2 ) monitoring within 2 hrs; b) give broad-spectrum antibiotics within 4 hrs; c) complete early goal-directed therapy at 6 hrs; d) give corticosteroid if the patient is on vasopressor or if adrenal insufficiency is suspected; and e) monitor for lactate clearance. Measurements and Main Results: Patients had a mean age of 63.8  18.5 yrs, Acute Physiology and Chronic Health Evaluation II score 29.6  10.6, emergency department length of stay 8.5  4.4 hrs, hospital length of stay 11.3  12.9 days, and in-hospital mortality 35.2%. Bundle compliance increased from zero to 51.2% at the end of the study period. During the emergency department stay, patients with the bundle completed received more CVP/ ScvO 2 monitoring (100.0 vs. 64.8%, p < .01), more antibiotics (100.0 vs. 89.7%, p  .04), and more corticosteroid (29.9 vs. 16.2%, p  .01) compared with patients with the bundle not completed. In a multivariate regression analysis including the five quality indicators, completion of early goal-directed therapy was significantly associated with decreased mortality (odds ratio, 0.36; 95% confidence interval, 0.17– 0.79; p  .01). In-hospital mortality was less in patients with the bundle completed com- pared with patients with the bundle not completed (20.8 vs. 39.5%, p < .01). Conclusions: Implementation of a severe sepsis bundle us- ing a quality improvement feedback to modify physician be- havior in the emergency department setting was feasible and was associated with decreased in-hospital mortality. (Crit Care Med 2007; 35:1105–1112) KEY WORDS: sepsis bundle; sepsis quality indicators; early goal- directed therapy; emergency department *See also p. 1210. From the Department of Emergency Medicine (HBN, SWC, RS, RTC, SRH, JE, TWC, WAW) and De- partment of Epidemiology and Biostatistics (JB), Loma Linda University, Loma Linda, CA. Presented, in part, at the Society of Critical Care Medicine 34th Critical Care Congress, Phoenix, AZ, Jan- uary 2005, and the American College of Emergency Physicians Scientific Assembly, Washington, DC, September 2005. The authors received no external funding to per- form this study. Dr. Nguyen has received lecture hon- oraria from Edwards Lifesciences and Eli Lilly and research funding from Edwards Lifesciences. The re- maining authors have not disclosed any potential con- flicts of interest. For information regarding this article, E-mail: hbnguyen@llu.edu Copyright © 2007 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins DOI: 10.1097/01.CCM.0000259463.33848.3D 1105 Crit Care Med 2007 Vol. 35, No. 4