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Using EMR Data and AI to Develop a Passive Digital Marker to Predict Postoperative Delirium

StatusCompleted
PhaseNot applicable
Started2024-07-23
View on ClinicalTrials.gov ↗

Amendment history

2026-08-31
Study Status v7
Trial completed
Study completion confirmed: August 2026 (last estimated September 2026)
Completion dateestimated 2026-09-20→confirmed 2026-08-21
2026-06-17
Study Status, Study Design v6
Primary completion pushed: 2025-12-31 → 2026-03-20
Completion pushed: 2026-06-30 → 2026-09-20
2026-02-11
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Completion date2026-02-11→2026-06-30
Study sitesdetails revised at 1 of 1 site
2025-11-12
Study Status, Contacts/Locations v4
Study sitescontacts updated at 1 of 1 site
2024-12-18
Study Status, Oversight, Outcome Measures, Contacts/Locations v3
Completion date2026-12-31→2026-02-11
Start date2024-07-15→2024-07-23
Secondary endpoints3 to 5 entries
ReductionInpatient infalls Restraint theUse Sedative numberUse Use of inpatient falls as well as the use of restraints, sedatives, and personal safety attendants Patient Satisfaction
Primary endpoints4 to 3 entries
Reduction in deliriumDelirium incidence as measured by the 3D-CAM Reduction in deliriumDelirium incidence as measured by the CAM ICU Reduction in delirium severity as measured by the 3D-CAM Reduction in deliriumDelirium severity as measured by the CAM ICU
Study sitescontacts updated at 1 of 1 site
Show 2 earlier versions
2024-11-21
Study Status, Oversight, Outcome Measures, Contacts/Locations v2
Start date2024-06-01→2024-07-15
Primary endpoints1 to 4 entries
Reduction in delirium incidence andas measured by the 3D-CAM Reduction in delirium incidence as measured by the CAM ICU Reduction in delirium severity as measured by the 3D-CAM Reduction in delirium severity as measured by the CAM ICU
Study sitescontacts updated at 1 of 1 site
2024-06-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-03-01→confirmed 2024-06-01
Study sites0→1
2024-01-10
Original filing
This study will be a pilot randomized controlled trial that will determine the effect of an indicator of delirium risk, which will be delivered either via a paper form or via the electronic medical record, on (1)postoperative delirium incidence; and (2)the development of long term cognitive decline and dementia.
Trial Details
NCT Number NCT06216483
Lead Sponsor Indiana University
Collaborators: National Institute on Aging (NIA)
Conditions Delirium in Old Age
Enrollment 60 participants
Start Date 2024-07-23
Primary Completion 2026-03-20 (estimated)
Study Completion 2026-08-21 (estimated)
Updated on ClinicalTrials.gov 2026-09-01