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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00027039 | Other Identifier | USF IRB | |
| R01NR016702 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of South Florida | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep | Sleep Profiler polysomnography | Up to 5 days in the ICU |
| Cognitive Function | NIH Cognitive Toolbox measures | At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy L Munro, PhD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami UHealth Tower | Miami | Florida | 33136-1003 | United States | ||
| Jackson Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41173649 | Derived | 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. | |
| 33560633 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
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| Allocation |
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| Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Posted | Mean | Standard Deviation | days | Up to 20 days in the intensive care unit (ICU) |
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Up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Pressure Fluctuation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cindy Munro | University of Miami | 305-284-2107 | cmunro@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2021 | Nov 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D060825 | Cognitive Dysfunction |
| D003221 | Confusion |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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prospective, randomized, experimental design
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Study personnel evaluating delirium will use standardized tool (CAM-ICU) and will be blinded to subjects' group assignments.
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| 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 |
| Miami |
| Florida |
| 33136-1005 |
| United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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. |
|
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| Secondary | Sleep | Sleep Profiler polysomnography | Not Posted | Up to 5 days in the ICU | Participants |
| Secondary | Cognitive Function | NIH Cognitive Toolbox measures | Not Posted | At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge | Participants |
| Secondary | Patient-reported Health Status | Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scales | Not Posted | At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge | Participants |
| 14 |
| 89 |
| 0 |
| 89 |
| 1 |
| 89 |
| EG001 | 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. | 11 | 89 | 0 | 89 | 0 | 89 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |