Automating Delirium Severity in the ICU
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorMayo Clinic
About this trial
The goal of this observational study is to develop a passive digital marker (PDM) for delirium severity and examine its performance in comparison to validated delirium severity tools in ICU patients \>50 years of age.
The main questions it aims to answer are:
* Is the trained convolutional neural network able to reliably measure delirium severity. * Is the Passive Digital Marker able to accurately measure delirium severity * Is the Passive Digital Marker acceptable and usable by frontline ICU nurse clinicians, patients, and their identified proxies (i.e., caregivers).
Participants will:
* Study participation involves a video camera recording you 24 hours per day while you are a patient in the Intensive Care Unit (ICU). * Study staff will visit you 4 times each day you are in the ICU. You will be asked questions each time they visit to train the digital marker and see differences between assessments and camera data.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Estimated length of stay >24 hours in ICU; and
Are not admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal.
Disqualifiers
Admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal.
Admitted for acute neuronal injury
Unable to communicate with research team due to sensory deficits (aphasic, blind, deaf) or language (does not speak English)
Trial population
Aging adults admitted to an intensive care unit
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 2 trial groupsGroup A: No Delirium Severity
Group B: Delirium Severity
Trial outcomes
Primary outcomes
1
Delirium Severity
The level of delirium severity will be measured by two types of prospective data collection. The first method is completed by study team members. A trained member of the study team will administer validated assessment tools 4xdaily from enrollment until ICU discharge or death. The Confusion Assessment Method for the Intensive Care Unit Severy Scale (CAM-ICU-7) is the gold standard for delirium severity measurement in the ICU. It is a 7-point scale, with 7 being severe delirium and 0 being no delirium. The second method is a passive digital marker (in development).
Time frame
12-48 months2
Acceptability of passive digital marker for delirium severity
Participants and their identified care partners will be randomized 1:1 to either the Passive Digital Marker for Delirium Severity or usual care. The acceptability of the PDM by clinicians, patients, and care partners will be evaluated. The 4-question tool named Treatment Acceptability and Preference Questionnaire (TAPQ) is scored on a 5-point Likert scale. A higher score indicates higher acceptability.
Time frame
48 months - 60 months3
Usability of passive digital marker for delirium severity
Participants and their identified care partners will be randomized 1:1 to either the Passive Digital Marker for Delirium Severity or usual care. The usability of the PDM by clinicians, patients, and care partners will be evaluated. The 10-question System Usability Scale is scored on a Likert scale from 1-5. A higher score (0-100 range) indicates higher usability.
Time frame
48 months - 60 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov