Family Automated Voice Reorientation Study

Completed · Not applicable

Conditions studied: Delirium, Cognitive Impairment, Health, Subjective, Sleep

In brief

This randomized clinical trial tests a cognitive reorientation intervention to prevent delirium in the intensive care unit using 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 (the Family Automated Voice Reorientation intervention, FAVoR). The investigators hypothesize that providing ongoing orientation to the ICU environment through recorded audio messages in a voice familiar to the patient will enable the patient to more accurately interpret the environment and reduce risk of delirium. Increasing awareness of daytime by cuing patients during waking hours may also improve day/night orientation, nighttime sleep/rest, and further reduce risk of delirium.

Key facts

Study ID

NCT03128671

Run by

University of Miami

People needed

178

Starts

2017-05-19

Expected to finish

2021-05-17

Last updated by the study team

2021-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Miami UHealth Tower — Miami, Florida, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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