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

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.