Family Automated Voice Reorientation Study

NCT03128671 | Completed Results DMC

• 3 other identifiers: 20170771Pro00027039R01NR016702
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 3

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.

Conditions

Delirium; Cognitive Impairment; Health, Subjective; Sleep

Keywords

intensive care unit; critical care; mechanical ventilation; confusion; polysomnography; delirium; adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sleep

  Up to 5 days in the ICU

• Cognitive Function

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

• Patient-reported Health Status

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

Study Arms (2)

FAVoR Intervention Group

EXPERIMENTAL

In the intervention group, scripted audio messages recorded by the patient's family (FAVoR intervention) will be played for the patient at hourly intervals during daytime hours. These messages will be personalized, delivered automatically, and provide information about the ICU environment. The FAVoR intervention, a standardized protocol developed and tested in preliminary work, will be delivered by audio recording for 5 consecutive days (120 hours), or until ICU discharge if discharge occurs within the first 5 days. The number of episodes of delirium during ICU stay is the primary outcome measure. Data will also be collected at 1 month and 6 months following hospital discharge for secondary aim 3.

Behavioral: FAVoR Intervention

Control Group

NO INTERVENTION

The control group will not receive the FAVoR intervention. The number of episodes of delirium during ICU stay is the primary outcome measure. Data will also be collected at 1 month and 6 months following hospital discharge for secondary aim 3.

Interventions

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.

FAVoR Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• University of South Florida: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (3)

University of Miami UHealth Tower

Miami, Florida, 33136-1003, United States

Location

Jackson Memorial Hospital

Miami, Florida, 33136-1005, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Related Publications (2)

• Munro CL, Liang Z, Elias MN, Ji M, Chen X, Kip PL, Greengold J, Ely EW, Calero K. Delirium Reduction via Scripted Family Voice Recordings in Critically Ill Patients Receiving Mechanical Ventilation. Am J Crit Care. 2025 Nov 1;34(6):429-437. doi: 10.4037/ajcc2025486.

  PMID: 41173649 DERIVED

• 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.

  PMID: 33560633 DERIVED

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction; Confusion

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Cindy Munro
• Organization: University of Miami

cmunro@miami.edu

305-284-2107

Study Officials

• Cindy L Munro, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study personnel evaluating delirium will use standardized tool (CAM-ICU) and will be blinded to subjects' group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean and Professor

Model Details: prospective, randomized, experimental design

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 25, 2017
• Study Start: May 19, 2017
• Primary Completion: November 6, 2020
• Study Completion: May 17, 2021
• Last Updated: December 3, 2021
• Results First Posted: December 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)