Family automated voice reorientation (FAVoR) intervention for mechanically ventilated patients in the intensive care unit: Study protocol for a randomized controlled trial

Contemp Clin Trials. 2021 Mar;102:106277. doi: 10.1016/j.cct.2021.106277. Epub 2021 Jan 19.

Abstract

Delirium in the intensive care unit (ICU) affects up to 80% of critically ill, mechanically ventilated (MV) adults. Delirium is associated with substantial negative outcomes, including increased hospital complications and long-term effects on cognition and health status in ICU survivors. The purpose of this randomized controlled trial is to test the effectiveness of a Family Automated Voice Reorientation (FAVoR) intervention on delirium among critically ill MV patients. The FAVoR intervention uses scripted audio messages, which are recorded by the patient's family and played at hourly intervals during daytime hours. 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. The study's primary aim is to test the effect of the FAVoR intervention on delirium in critically ill MV adults in the ICU. The secondary aims are to explore: (1) if the effect of FAVoR on delirium is mediated by sleep, (2) if selected biobehavioral factors moderate the effects of FAVoR on delirium, and (3) the effects of FAVoR on short-term and long-term outcomes, including cognition and health status. Subjects (n = 178) are randomly assigned to the intervention or control group within 48 h of initial ICU admission and intubation. The intervention group receives FAVoR over a 5-day period, while the control group receives usual care. Delirium-free days, sleep and activity, cognition, patient-reported health status and sleep quality, and data regarding iatrogenic/environmental and biobehavioral factors are collected.

Keywords: Cognition; Critical illness; Delirium; Mechanical ventilation; Randomized controlled trial; Sleep.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Critical Illness
  • Delirium*
  • Hospitalization
  • Humans
  • Intensive Care Units
  • Randomized Controlled Trials as Topic
  • Respiration, Artificial*