DeliriumFAVoRNCT03128671
Family Automated Voice Reorientation Study
A study testing FAVoR Intervention in people with Delirium and Cognitive Impairment, run by University of Miami at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Cognitive Impairment, Health, Subjective
- What is being tested?
- FAVoR Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 May 2017to 17 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Miami UHealth Tower
Miami, Florida, 33136-1003
Jackson Memorial Hospital
Miami, Florida, 33136-1005
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: Reorientation Intervention for Delirium in ICU
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.
Read the 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.
- Conditions
- Delirium, Cognitive Impairment, Health, Subjective, Sleep
- Being tested
- FAVoR Intervention
- Keywords
- intensive care unit, critical care, mechanical ventilation, confusion, polysomnography, delirium, adult
- Medical subject headings
- Delirium, Cognitive Dysfunction, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAVoR InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium-free Days
Delirium will be assessed by study personnel, blinded to the group assignment, using Confusion Assessment Method-Intensive Care Unit (CAM-ICU)
Measured: Up to 20 days in the intensive care unit (ICU)
Secondary outcomes (3)
Sleep
Sleep Profiler polysomnography
Measured: Up to 5 days in the ICU
Cognitive Function
NIH Cognitive Toolbox measures
Measured: At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge
Patient-reported Health Status
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scales
Measured: At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start19 May 2017
- Primary completion6 Nov 2020
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, experimental design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Cindy Munro, University of Miami
- Investigators
- Cindy L Munro, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128671
- Sponsor's protocol ID
- 20170771
- Other IDs
- Pro00027039, R01NR016702
- Acronym
- FAVoR
- Status last verified
- Nov 2021
- First submitted
- 11 Apr 2017
- Last updated
- 3 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41173649Munro 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.
PubMed 33560633
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reorientation Intervention for Delirium in ICU
- ClinicalTrials.gov ID
- NCT03128671
- Acronym / sponsor ID
- FAVoR / 20170771
- Conditions
- Delirium, Cognitive Impairment, Health, Subjective, Sleep
- Keywords
- intensive care unit, critical care, mechanical ventilation, confusion, polysomnography, delirium, adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- University of South Florida, National Institute of Nursing Research (NINR)
- Study start
- 19 May 2017 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Posted 3 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, experimental design
| Arm | Type | Receives |
|---|---|---|
| FAVoR Intervention Group | Experimental | Behavioral: FAVoR InterventionIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAVoR InterventionThe 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. | Behavioural | FAVoR Intervention Group |
Primary outcome
Delirium-free Days
Time frame: 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)
3 secondary outcomes
Sleep
Time frame: Up to 5 days in the ICU
Cognitive Function
Time frame: At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge
Patient-reported Health Status
Time frame: At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41173649Munro 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.
- Derived from this study: PubMed 33560633Munro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy L Munro, PhD principal investigator
University of South Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAVoR Intervention in people with Delirium and Cognitive Impairment, run by University of Miami at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium-free Days (time frame: Up to 20 days in the intensive care unit (ICU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03128671, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.