NCT03128671

Family Automated Voice Reorientation Study

Reorientation Intervention for Delirium in ICU

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Delirium
• Cognitive Impairment
• Health, Subjective
• Sleep

Interventions

Type	Name	Description
BEHAVIORAL	FAVoR Intervention	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.

Timeline

• Start date: 2017-05-19
• Primary completion: 2020-11-06
• Completion: 2021-05-17
• First posted: 2017-04-25
• Last updated: 2021-12-03
• Results posted: 2021-12-03

Locations

3 sites across 1 country: United States