Effectiveness of combined non-pharmacological interventions in the prevention of delirium in critically ill patients: A randomized clinical trial.

Abstract

Delirium is a common dysfunction in the intensive care unit (ICU) and it is associated with negative short- and long-term outcomes. This study evaluated the effectiveness of combined non-pharmacological interventions in preventing delirium in critically ill patients. This is a single-center randomized controlled trial conducted in three Brazilian ICUs from February to September 2019. Patients assigned to the control group received standard care (n=72) and those assigned to the experimental group (n=72) received a bundle of non-pharmacological interventions (periodic reorientation, cognitive stimulation, correction of sensory deficits [visual or hearing impairment], environmental management and sleep promotion) throughout the ICU stay. Delirium was monitored twice a day with the Confusion Assessment Method for the Intensive Care Unit Flowsheet. The primary outcome was the incidence density of delirium. The incidence density of delirium was lower in the intervention group (1.3×10-2 person-days) than in the control group (2.3×10-2 person-days), with a hazard ratio of 0.40 (95% confidence intervals, 0.17-0.95; p = 0.04) after adjustment for Simplified Acute Physiology Score III, surgical admission and alcoholism. Combined non-pharmacological interventions reduced delirium in critically ill patients, compared to standard care. Brazilian Registry of Clinical Trials (ReBEC), Identifier RBR-6xq95s, October 03, 2018.