Automating Delirium Severity in the ICU
This observational study aims to develop a new way to measure how severe delirium is in patients over 50 years old who are in the Intensive Care Unit (ICU). Delirium is a serious change in mental abilities that results in confused thinking and reduced awareness of your surroundings. Researchers will use video cameras to record patients 24 hours a day and compare this information with standard delirium assessments. The goal is to see if this new "passive digital marker" can accurately measure delirium severity and if it is acceptable and easy to use for nurses, patients, and their families. The study plans to include 400 participants and is currently unclear about its recruitment status. You might be able to join if you are over 50, expected to stay in the ICU for more than 24 hours, and not admitted for alcohol or drug-related issues.
- Study design
- This is an observational study with a planned enrollment of 400 participants. It aims to develop and test a new method for measuring delirium severity.
- What's involved
- Study participation involves 24-hour video camera recording while you are in the ICU. Study staff will visit you four times daily to ask questions and perform assessments of your mental and emotional health, mood, memory, and alertness.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure delirium severity between 12 and 48 months, and the acceptability and usability of the digital marker between 48 and 60 months.
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Automating Delirium Severity in the ICU
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Inclusion
Exclusion
What this trial measures
- Delirium Severity12-48 months
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).
- Acceptability of passive digital marker for delirium severity48 months - 60 months
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.
- Usability of passive digital marker for delirium severity48 months - 60 months
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.