Objective: To test the effects of three multifaceted safety programs designed to decrease insulin administration errors, anticoagulant prescription and administration errors, and errors leading to accidental removal of endotracheal tubes and central venous catheters, respectively. Medical errors and adverse events are associated with increased mortality in intensive care patients, indicating an urgent need for prevention programs. Design: Multicenter cluster-randomized study. Setting: One medical intensive care unit in a university hospital and two medical–surgical intensive care units in community hospitals belonging to the Outcomerea Study Group. Patients: Consecutive patients >18 yrs admitted from January 2007 to January 2008 to the intensive care units. Interventions: We tested three multifaceted safety programs vs. standard care in random order, each over 2.5 months, after a 1.5-month observation period. Measurements and Main Results: Incidence rates of medical errors/1000 patient-days in the multifaceted safety program and standard-care groups were compared using adjusted hierarchical models. In 2117 patients with 15,014 patient-days, 8520 medical errors (567.5/1000 patient-days) were reported, including 1438 adverse events (16.9%, 95.8/1000 patient-days). The insulin multifaceted safety program significantly decreased errors during implementation (risk ratio 0.65; 95% confidence interval [CI] 0.52–0.82; p = .0003) and after implementation (risk ratio 0.51; 95% CI 0.35–0.73; p = .0004). A significant Hawthorne effect was found. The accidental tube/catheter removal multifaceted safety program decreased errors significantly during implementation (odds ratio [OR] 0.34; 95% CI 0.15–0.81; p = .01]) and nonsignificantly after implementation (OR 1.65; 95% CI 0.78–3.48). The anticoagulation multifaceted safety program was not significantly effective (OR 0.64; 95% CI 0.26–1.59) but produced a significant Hawthorne effect. Conclusions: A multifaceted program was effective in preventing insulin errors and accidental tube/catheter removal. Significant Hawthorne effects occurred, emphasizing the need for appropriately designed studies before definitively implementing strategies. Trial Registration: clinicaltrails.gov Identifier: NCT00461461.
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