"Reorientation Intervention for Delirium in the ICU (the FAVoR Study)"

Delirium in the intensive care unit (ICU) affects as many as 80% of critically ill, mechanically ventilated adults. Delirium is associated with substantial negative outcomes, including increased complications during hospitalization and long term effects on cognitive function and health status in ICU survivors. Sleep disturbances, iatrogenic/environmental factors, and biobehavioral factors may affect risk of delirium. This randomized clinical trial is testing the effectiveness of a nonpharmacologic intervention to prevent delirium. The Family Automated Voice Reorientation (FAVoR) intervention uses scripted audio messages, recorded by the patient's family and played at hourly intervals during daytime hours, to provide information about the ICU environment to the patient; this ongoing orientation to the ICU environment through recorded messages in a voice familiar to the patient may enable the patient to more accurately interpret the environment and thus reduce risk of delirium. Increasing awareness of daytime by cuing patients during waking hours may also improve day/night orientation and nighttime sleep, further reducing risk of delirium. The primary specific aim of the project is to test the effect of the FAVoR intervention on delirium in critically ill, mechanically ventilated adults during hospitalization in the ICU. Secondary aims are to: (1) explore if the effect of FAVoR on delirium is mediated by sleep, (2) explore if selected biobehavioral factors may potentially moderate the effects of FAVoR on delirium, and (3) examine the effects of FAVoR on short term (immediately after ICU discharge) and long term (1 and 6 months after hospital discharge) outcomes, including cognitive function and patient-reported health status. A prospective, randomized, experimental design is being used to accomplish the specific aims. FAVoR holds promise for reducing delirium in critically ill adults, improving sleep in the ICU, and secondarily benefitting cognitive function and health status in ICU survivors. Funded by NIH National Institute of Nursing Research R01NR016702, 12/9/16-11/30/20.