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A multicenter, phased, cluster-randomized controlled trial to reduce central line-associated bloodstream infections in intensive care units*

Marsteller, Jill A. PhD, MPP; Sexton, J. Bryan PhD; Hsu, Yea-Jen PhD, MHA; Hsiao, Chun-Ju PhD, MHS; Holzmueller, Christine G. BLA; Pronovost, Peter J. MD, PhD, FCCM; Thompson, David A. DNSc, MS, RN

doi: 10.1097/CCM.0b013e31825fd4d8
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Objectives: To determine the causal effects of an intervention proven effective in pre-post studies in reducing central line-associated bloodstream infections in the intensive care unit.

Design: We conducted a multicenter, phased, cluster-randomized controlled trial in which hospitals were randomized into two groups. The intervention group started in March 2007 and the control group started in October 2007; the study period ended September 2008. Baseline data for both groups are from 2006.

Setting: Forty-five intensive care units from 35 hospitals in two Adventist healthcare systems.

Interventions: A multifaceted intervention involving evidence-based practices to prevent central line-associated bloodstream infections and the Comprehensive Unit–based Safety Program to improve safety, teamwork, and communication.

Measurements and Results: We measured central line-associated bloodstream infections per 1,000 central line days and reported quarterly rates. Baseline average central line-associated bloodstream infections per 1,000 central line days was 4.48 and 2.71, for the intervention and control groups (p = .28), respectively. By October to December 2007, the infection rate declined to 1.33 in the intervention group compared to 2.16 in the control group (adjusted incidence rate ratio 0.19; p = .003; 95% confidence interval 0.06–0.57). The intervention group sustained rates <1/1,000 central line days at 19 months (an 81% reduction). The control group also reduced infection rates to <1/1,000 central line days (a 69% reduction) at 12 months.

Conclusions: This study demonstrated a causal relationship between the multifaceted intervention and the reduced central line-associated bloodstream infections. Both groups decreased infection rates after implementation and sustained these results over time, replicating the results found in previous, pre-post studies of this multifaceted intervention and providing further evidence that most central line-associated bloodstream infections are preventable.

From the Department of Health Policy and Management (JAM, JBS, Y-JH, C-JH, PJP), Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; and Department of Anesthesiology and Critical Care Medicine (JAM, JBS, CGH, PJP, DAT), Johns Hopkins School of Medicine, Baltimore, MD.

*See also p. 3083.

The work was performed at Adventist Health and the Adventist Health System.

Supported by a grant from the Robert Wood Johnson Foundation’s Interdisciplinary Nursing Quality Research Initiative.

Dr. Sexton received honoraria from Michigan Hospital Association & Trinity. Dr. Pronovost is a consultant for Leigh Bureau Association for Professionals in Infection Control and Epidemiology. He receives grant support from AHRQ, NIH, RAND, Common Wealth Fund, and receives royalties from his book, Safe Patients, Smart Hospitals. The remaining authors have not disclosed any potential conflicts of interest.

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© 2012 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins