The Impact of Nursing Delirium Preventive Interventions in the Intensive Care Unit: A Multicenter Cluster Randomized Controlled Trial.

Rationale Delirium is common in critically ill patients and associated with deleterious outcomes. Non-pharmacologic interventions are recommended in current delirium guidelines, but their effects have not been unequivocally established. Objective To determine the effects of a multicomponent nursing intervention program on delirium in the Intensive Care Unit. Methods Stepped wedge cluster randomized controlled trial, conducted in Intensive care units of 10 centers. Adult critically ill surgical, medical or trauma patients at high risk to develop delirium were included. A multicomponent nursing intervention program focusing on modifiable risk factors was implemented as standard of care. Primary outcome was the number of delirium-free and coma-free days alive in 28 days after Intensive Care Unit admission. Measurements and main results A total of 1749 patients were included. Time spent per 8 hours shift on interventions was median [IQR] 38 [14-116] in the intervention period and median 32 [13-73] minutes in the control period (p=0.44). Patients in the intervention period had median 23 [4-27] delirium-free and coma-free days alive, compared to median 23 [5-27] days for patients in the control group (mean difference -1.21 days, 95%CI -2.84 to 0.42 days; p=0.15). Also, the number of delirium days was similar: median 2 [1-4] days (ratio of medians 0.90, 95%CI 0.75 to 1.09; p=0.27). Conclusion In this large randomized controlled trial in adult ICU patients, a limited increase was achieved of the use of nursing interventions, and no change in the number of delirium-free and coma-free days alive in 28 days could be determined. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT03002701.

RCT Entities:   Population Interventions Outcomes