MedDataX Logo

Family Automated Voice Reorientation Study

NCT ID: NCT03128671

Last Updated: 2021-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-19

Study Completion Date

2021-05-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Delirium Cognitive Impairment Health, Subjective Sleep

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

intensive care unit critical care mechanical ventilation confusion polysomnography delirium adult

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomized, experimental design
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Study personnel evaluating delirium will use standardized tool (CAM-ICU) and will be blinded to subjects' group assignments.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

FAVoR Intervention

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of South Florida

OTHER

Sponsor Role collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cindy Munro

Dean and Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cindy L Munro, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Miami UHealth Tower

Miami, Florida, United States

Site Status

Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Tampa General Hospital

Tampa, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33560633 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00027039

Identifier Type: OTHER

Identifier Source: secondary_id

R01NR016702

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20170771

Identifier Type: -

Identifier Source: org_study_id