CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 178 enrolled
Drug / intervention
FAVoR Interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03128671
NCT03128671N/ACompleted

Reorientation Intervention for Delirium in ICU

University of Miami·interventional·Posted Apr 25, 2017·Updated Dec 3, 2021

In Brief

A clinical study evaluating FAVoR Intervention for Delirium and 3 related conditions. Completed, enrolled 178 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 25, 2017
Enrollment StartMay 19, 2017
Primary CompletionNov 6, 2020
Study CompletionMay 17, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.2 years ago

Interventions

FAVoR Interventionbehavioral

The FAVoR intervention includes a set of 8 scripted recorded messages, no longer than 2 minutes long, includes subject's name, uses simple terms, and is written at a 5th grade reading level. Messages include information about the critical care environment, the visual and auditory stimuli to be expected, and the availability of providers and family.