N/A N=178 Randomized Single-blind Prevention

Family Automated Voice Reorientation Study

Delirium · Cognitive Impairment · Health, Subjective · Sleep

Bottom Line

View on ClinicalTrials.gov: NCT03128671 ↗

Enrolled (actual)

178

Serious AEs

0.0%

Results posted

Dec 2021

Primary outcome: Primary: Delirium-free Days — 8.4; 7.2 days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FAVoR Intervention (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Miami
Primary completion: Nov 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Delirium-free Days	8.4; 7.2	—
SECONDARY Sleep	—	—
SECONDARY Cognitive Function	—	—
SECONDARY Patient-reported Health Status	—	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03128671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.