Family Automated Voice Reorientation Study

This randomized clinical trial will test the effectiveness of a nonpharmacologic intervention
to prevent delirium in the intensive care unit (ICU), which affects as many as 80% of
critically ill, mechanically ventilated adults.. 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.

Inclusion Criteria:

- mechanically ventilated patients

- within 36 hours of ICU admission

- patient or legally authorized representative (LAR) must be able to provide informed
consent in English or Spanish

- a family member able to speak English or Spanish must be available and willing to
audio record scripted messages

Exclusion Criteria:

- dementia (because it complicates planned longitudinal cognitive assessments)

- anticipation by the clinical provider of imminent patient death

- medical contraindication to the intervention (for example, psychiatric history of
auditory hallucinations, or profoundly deaf)

- inability to speak either English or Spanish