# Reorientation Intervention for Delirium in the ICU

> **NIH NIH R01** · UNIVERSITY OF MIAMI CORAL GABLES · 2020 · $461,082

## Abstract

Project Summary
 Delirium in the intensive care unit (ICU) affects as many as 80% of critically ill, mechanically ventilated
adults. Delirium is associated with substantial negative outcomes, including increased complications during
hospitalization and long term effects on cognitive function and health status in ICU survivors. Sleep
disturbances, iatrogenic/environmental factors, and biobehavioral factors may affect risk of delirium. This
randomized clinical trial will test the effectiveness of a nonpharmacologic intervention to prevent delirium. 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. A prospective, randomized, experimental design will be used to accomplish the specific aims.
Subjects (n=178) will be randomly assigned to one of two groups (intervention or control) within 36 hours of
intubation and ICU admission. The intervention group will receive FAVoR over a 5-day period, while the control
group will not. Delirium free days, the primary outcome measure, will be assessed by Confusion Assessment
Method (CAM-ICU) over the 5 day period. During the 5 day period, continuous polysomnography and
actigraphy data and data related to iatrogenic/environmental and biobehavioral factors will be collected. After
ICU discharge and at 1 and 6 months post-hospital discharge, follow up data (including cognitive function,
patient reported health status, polysomnography, and actigraphy) will be collected. The effect of FAVoR on
delirium free days will be tested using a Chi-square test; if there are unbalanced covariates, then covariance
adjustment will be performed by using logistic regression that includes both the treatment assignment and the
unbalanced covariates. Partial least square structural equation models will be used to analyze the relative
importance and the pathways of secondary aim variables. FAVo...

## Key facts

- **NIH application ID:** 9829584
- **Project number:** 5R01NR016702-04
- **Recipient organization:** UNIVERSITY OF MIAMI CORAL GABLES
- **Principal Investigator:** CINDY L MUNRO
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $461,082
- **Award type:** 5
- **Project period:** 2016-12-09 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9829584

## Citation

> US National Institutes of Health, RePORTER application 9829584, Reorientation Intervention for Delirium in the ICU (5R01NR016702-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9829584. Licensed CC0.

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