FAVoR: Family Automated Voice Reorientation Study

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT03128671
• Collaborator: University of South Florida (Other), National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 178
• Locations: 3
• Arms: 2
• Actual Duration (Months): 47.9
• Patients Per Site: 59.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium; Cognitive Impairment; Health, Subjective; Sleep	Behavioral: FAVoR Intervention	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 178 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: prospective, randomized, experimental designprospective, randomized, experimental design
• Masking: Single (Outcomes Assessor)
• Masking Description: Study personnel evaluating delirium will use standardized tool (CAM-ICU) and will be blinded to subjects' group assignments.
• Primary Purpose: Prevention
• Official Title: Reorientation Intervention for Delirium in ICU
• Actual Study Start Date: May 19, 2017
• Actual Primary Completion Date: Nov 6, 2020
• Actual Study Completion Date: May 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FAVoR Intervention Group 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; 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.
No Intervention: Control Group 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.

Outcome Measures

Primary Outcome Measures

1. Delirium-free Days [Up to 20 days in the intensive care unit (ICU)]

   Delirium will be assessed by study personnel, blinded to the group assignment, using Confusion Assessment Method-Intensive Care Unit (CAM-ICU)

Secondary Outcome Measures

1. Sleep [Up to 5 days in the ICU]

   Sleep Profiler polysomnography

2. Cognitive Function [At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge]

   NIH Cognitive Toolbox measures

3. Patient-reported Health Status [At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge]

   Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scales

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami UHealth Tower	Miami	Florida	United States	33136-1003
2	Jackson Memorial Hospital	Miami	Florida	United States	33136-1005
3	Tampa General Hospital	Tampa	Florida	United States	33606

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Cindy L Munro, PhD, University of South Florida

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 10, 2021

More Information

Publications

None provided.

• Responsible Party: Cindy Munro, Dean and Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT03128671
• Other Study ID Numbers: 20170771; Pro00027039; R01NR016702
• First Posted: Apr 25, 2017
• Last Update Posted: Dec 3, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cindy Munro, Dean and Professor, University of Miami: intensive care unit; critical care; mechanical ventilation; confusion; polysomnography; delirium; adult
• Additional relevant MeSH terms: Delirium

Study Results

Participant Flow

Arm/Group Title	FAVoR Intervention Group	Control Group
Arm/Group Description	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. 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.	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.
Period Title: Enrollment
STARTED	89	89
COMPLETED	89	89
NOT COMPLETED	0	0
Period Title: Enrollment
STARTED	89	89
COMPLETED	80	89
NOT COMPLETED	9	0
Period Title: Enrollment
STARTED	80	89
COMPLETED	44	55
NOT COMPLETED	36	34

Baseline Characteristics

Arm/Group Title	FAVoR Intervention Group	Control Group	Total
Arm/Group Description	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. 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.	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.	Total of all reporting groups
Overall Participants	89	89	178
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.96 (16.78)	60.62 (17.45)	59.29 (17.12)
Sex: Female, Male (Count of Participants)
Female	31 34.8%	40 44.9%	71 39.9%
Male	58 65.2%	49 55.1%	107 60.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	51 57.3%	56 62.9%	107 60.1%
Not Hispanic or Latino	38 42.7%	33 37.1%	71 39.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	22 24.7%	15 16.9%	37 20.8%
White	66 74.2%	73 82%	139 78.1%
More than one race	1 1.1%	1 1.1%	2 1.1%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Delirium-free Days
Description	Delirium will be assessed by study personnel, blinded to the group assignment, using Confusion Assessment Method-Intensive Care Unit (CAM-ICU)
Time Frame	Up to 20 days in the intensive care unit (ICU)

Outcome Measure Data

Analysis Population Description

Delirium assessment were not conducted for all participants due to the following reasons: subject remained deeply sedated and so did not pass criteria for proceeding with the Confusion Assessment Method - Intensive Care Unit (CAM-ICU) assessment and/or subject was extubated prior to the scheduled delirium assessment.

Arm/Group Title	FAVoR Intervention Group	Control Group
Arm/Group Description	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. 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.	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.
Measure Participants	44	43
Mean (Standard Deviation) [days]	8.4 (9.07)	7.2 (5.8)

2. Secondary Outcome

Title	Sleep
Description	Sleep Profiler polysomnography
Time Frame	Up to 5 days in the ICU

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Cognitive Function
Description	NIH Cognitive Toolbox measures
Time Frame	At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Patient-reported Health Status
Description	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scales
Time Frame	At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Up to 6 months
Arm/Group Title	FAVoR Intervention Group		Control Group
Arm/Group Description	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. 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.		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.
All Cause Mortality
	FAVoR Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/89 (15.7%)		11/89 (12.4%)
Serious Adverse Events
	FAVoR Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/89 (0%)		0/89 (0%)
Other (Not Including Serious) Adverse Events
	FAVoR Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/89 (1.1%)		0/89 (0%)
Cardiac disorders
Blood Pressure Fluctuation	1/89 (1.1%)	1	0/89 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.