Cognitive Impairment, Delirium, Health, Subjective, Sleep
Conditions
Keywords
intensive care unit, critical care, mechanical ventilation, confusion, polysomnography, delirium, adult
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.
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.
Interventions
BEHAVIORALFAVoR 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.
Sponsors
University of South Florida
National Institute of Nursing Research (NINR)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Study personnel evaluating delirium will use standardized tool (CAM-ICU) and will be blinded to subjects' group assignments.
Intervention model description
prospective, randomized, experimental design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep | Up to 5 days in the ICU | Sleep Profiler polysomnography |
| Cognitive Function | At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge | NIH Cognitive Toolbox measures |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 89 |
| 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. | 89 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Allocation | Death | 1 | 0 |
| Allocation | ICU discharge prior to intervention initiation | 4 | 0 |
| Allocation | Withdrawal by Subject | 4 | 0 |
| Intervention | Death | 13 | 11 |
| Intervention | Interrupted by hurricane | 1 | 0 |
| Intervention | Palliative/hospice care initiated | 9 | 10 |
| Intervention | Physician Decision | 2 | 3 |
| Intervention | Withdrawal by Subject | 11 | 10 |
Baseline characteristics
| Characteristic | Control Group | Total | FAVoR Intervention Group |
|---|---|---|---|
| Age, Continuous | 60.62 years STANDARD_DEVIATION 17.45 | 59.29 years STANDARD_DEVIATION 17.12 | 57.96 years STANDARD_DEVIATION 16.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 56 Participants | 107 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 71 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 37 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 73 Participants | 139 Participants | 66 Participants |
| Sex: Female, Male Female | 40 Participants | 71 Participants | 31 Participants |
| Sex: Female, Male Male | 49 Participants | 107 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 14 / 89 | 11 / 89 |
| other Total, other adverse events | 1 / 89 | 0 / 89 |
| serious Total, serious adverse events | 0 / 89 | 0 / 89 |
Outcome results
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FAVoR Intervention Group | Delirium-free Days | 8.4 days | Standard Deviation 9.07 |
| Control Group | Delirium-free Days | 7.2 days | Standard Deviation 5.8 |
Secondary
Cognitive Function
NIH Cognitive Toolbox measures
Time frame: 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
Time frame: At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge
Secondary
Sleep
Sleep Profiler polysomnography
Time frame: Up to 5 days in the ICU