Family Automated Voice Reorientation Study

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
FAVoR Intervention Group	FAVoR Intervention	In the intervention group, scripted audio messages recorded by the patient's family (FAVoR intervention) will be played for the patient at hourly intervals during daytime hours. These messages will be personalized, delivered automatically, and provide information about the ICU environment. The FAVoR intervention, a standardized protocol developed and tested in preliminary work, will be delivered by audio recording for 5 consecutive days (120 hours), or until ICU discharge if discharge occurs within the first 5 days. The number of episodes of delirium during ICU stay is the primary outcome measure. Data will also be collected at 1 month and 6 months following hospital discharge for secondary aim 3.

Primary Outcome Measures

Name	Time	Method
Delirium-free Days	Up to 20 days in the intensive care unit (ICU)	Delirium will be assessed by study personnel, blinded to the group assignment, using Confusion Assessment Method-Intensive Care Unit (CAM-ICU)

Secondary Outcome Measures

Name	Time	Method
Sleep	Up to 5 days in the ICU	Sleep Profiler polysomnography
Cognitive Function	At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge	NIH Cognitive Toolbox measures
Patient-reported Health Status	At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scales

Locations (3): Tampa General Hospital
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Tampa, Florida, United States
Jackson Memorial Hospital
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Miami, Florida, United States
University of Miami UHealth Tower
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Miami, Florida, United States