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Studies

Observational Recruiting

NCT06172491 on ClinicalTrials.gov

Automating Delirium Severity in the ICU

Official title: Harnessing the Power of Technology to Transform Delirium Severity Measurement in the ICU

  • Sponsor: Mayo Clinic (Group)
  • Enrollment: 400 (Estimated)
  • Study start: 2023-01-15 (Actual)
  • Primary completion: 2027-05-31 (Estimated)
  • Study completion: 2028-05-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

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.

Conditions

  • Intensive Care Unit Delirium
  • Encephalopathy
  • Delirium

Primary Outcome Measures

  • Delirium Severity (12-48 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 severity (48 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 severity (48 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.

Countries

United States

Locations and Investigators

  • Mayo Clinic, Rochester, United States (Recruiting)
    • Hannah Friesen
    • Heidi Lindroth, Ph.D., R.N. (Principal Investigator)
    • Anirban Bhattacharyya, M.D.,M.S
    • Arun Jayaraman, M.D,Ph.D
    • Linda Chlan, Ph.D
    • Vitaly Herasevich, M.D.,Ph.D
    • Alejandro Rabinstein, M.D.
    • Malaz Boustani, M.D. M.P.H.