Family Automated Voice Reorientation Study

Cognitive Impairment Clinical Trial

— FAVoR  

Official title:

Reorientation Intervention for Delirium in ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03128671
• Other study ID #: 20170771
• Secondary ID: Pro00027039R01NR
• Status: Completed
• Phase: N/A
• Start date: May 19, 2017
• Est. completion date: May 17, 2021

Study information

• Verified date: November 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: May 17, 2021
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Impairment
• Delirium
• Health, Subjective
• Sleep

Intervention

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.

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida
United States	University of Miami UHealth Tower	Miami	Florida
United States	Tampa General Hospital	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	National Institute of Nursing Research (NINR), University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium-free Days	Delirium will be assessed by study personnel, blinded to the group assignment, using Confusion Assessment Method-Intensive Care Unit (CAM-ICU)	Up to 20 days in the intensive care unit (ICU)
Secondary	Sleep	Sleep Profiler polysomnography	Up to 5 days in the ICU
Secondary	Cognitive Function	NIH Cognitive Toolbox measures	At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge
Secondary	Patient-reported Health Status	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scales	At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge