Trial Outcomes & Findings for Family Automated Voice Reorientation Study (NCT NCT03128671)
NCT ID: NCT03128671
Last Updated: 2021-12-03
Results Overview
Delirium will be assessed by study personnel, blinded to the group assignment, using Confusion Assessment Method-Intensive Care Unit (CAM-ICU)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
178 participants
Primary outcome timeframe
Up to 20 days in the intensive care unit (ICU)
Results posted on
2021-12-03
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
|
|---|---|---|
|
Enrollment
STARTED
|
89
|
89
|
|
Enrollment
COMPLETED
|
89
|
89
|
|
Enrollment
NOT COMPLETED
|
0
|
0
|
|
Allocation
STARTED
|
89
|
89
|
|
Allocation
COMPLETED
|
80
|
89
|
|
Allocation
NOT COMPLETED
|
9
|
0
|
|
Intervention
STARTED
|
80
|
89
|
|
Intervention
COMPLETED
|
44
|
55
|
|
Intervention
NOT COMPLETED
|
36
|
34
|
Reasons for withdrawal
| Measure |
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.
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.
|
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.
|
|---|---|---|
|
Allocation
ICU discharge prior to intervention initiation
|
4
|
0
|
|
Allocation
Death
|
1
|
0
|
|
Allocation
Withdrawal by Subject
|
4
|
0
|
|
Intervention
Withdrawal by Subject
|
11
|
10
|
|
Intervention
Palliative/hospice care initiated
|
9
|
10
|
|
Intervention
Death
|
13
|
11
|
|
Intervention
Interrupted by hurricane
|
1
|
0
|
|
Intervention
Physician Decision
|
2
|
3
|
Baseline Characteristics
Family Automated Voice Reorientation Study
Baseline characteristics by cohort
| Measure |
FAVoR Intervention Group
n=89 Participants
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.
|
Control Group
n=89 Participants
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
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.96 years
STANDARD_DEVIATION 16.78 • n=5 Participants
|
60.62 years
STANDARD_DEVIATION 17.45 • n=7 Participants
|
59.29 years
STANDARD_DEVIATION 17.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
51 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 20 days in the intensive care unit (ICU)Population: 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.
Delirium will be assessed by study personnel, blinded to the group assignment, using Confusion Assessment Method-Intensive Care Unit (CAM-ICU)
Outcome measures
| Measure |
FAVoR Intervention Group
n=44 Participants
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.
|
Control Group
n=43 Participants
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.
|
|---|---|---|
|
Delirium-free Days
|
8.4 days
Standard Deviation 9.07
|
7.2 days
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Up to 5 days in the ICUSleep Profiler polysomnography
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital dischargeNIH Cognitive Toolbox measures
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital dischargePatient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scales
Outcome measures
Outcome data not reported
Adverse Events
FAVoR Intervention Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 14 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 11 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FAVoR Intervention Group
n=89 participants at risk
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.
|
Control Group
n=89 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Blood Pressure Fluctuation
|
1.1%
1/89 • Number of events 1 • Up to 6 months
|
0.00%
0/89 • Up to 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place