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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03128671
Other study ID # 20170771
Secondary ID Pro00027039R01NR
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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