Clinical trial NCT03128671: Family Automated Voice Reorientation Study
Official title: Reorientation Intervention for Delirium in ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Cognitive Impairment
Health, Subjective
Sleep
Keywords: intensive care unit
critical care
mechanical ventilation
confusion
polysomnography
delirium
adult
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: University of South Florida
name: National Institute of Nursing Research (NINR)
First posted: 2017-04-25
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, experimental design
Primary purpose: PREVENTION

Brief 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.

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

Primary outcomes:
measure: Delirium-free Days
timeFrame: Up to 20 days in the intensive care unit (ICU)
Secondary outcomes:
measure: Sleep
timeFrame: Up to 5 days in the ICU
measure: Cognitive Function
timeFrame: At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge
measure: Patient-reported Health Status
timeFrame: At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami UHealth Tower
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: University of South Florida
name: Cindy L Munro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munro CL, Liang Z, Elias MN, Ji M, Chen X, Calero K. Sleep and Activity Patterns Are Altered During Early Critical Illness in Mechanically Ventilated Adults. Dimens Crit Care Nurs. 2021 Jan-Feb 01;40(1):29-35. doi: 10.1097/DCC.0000000000000455.