Skip to main content
OpenTrials
Completed

NCT Number: NCT03128671

Family Automated Voice Reorientation Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Delirium Cognition Disorders Cognitive Dysfunction Cognitive Impairment Confusion Health, Subjective Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jackson Memorial Hospital, Miami, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FAVoR Intervention

Behavioral

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.

Primary outcomes

  1. Delirium-free Days

    Time frame: 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 outcomes

  1. Sleep

    Time frame: Up to 5 days in the ICU

    Sleep Profiler polysomnography

  2. Cognitive Function

    Time frame: At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge

    NIH Cognitive Toolbox measures

  3. Patient-reported Health Status

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • University of South Florida

Registry information

Official study title

Reorientation Intervention for Delirium in ICU

Acronym: FAVoR

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Apr 25, 2017
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.