Using EMR Data and AI to Develop a Passive Digital Marker to Predict Postoperative Delirium
Purpose
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.
Condition
- Delirium in Old Age
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- years old Planned inpatient major surgery requiring inpatient stay ≥ 1 day
Exclusion Criteria
- Baseline cognitive impairment or a diagnosis of Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD) - Alcohol or drug withdrawal - Prisoner status - Unable to communicate with research staff due to sensory impairments - Not fluent in English - Currently has a personal safety attendant
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator No PDM Alert |
No PDM alert will be placed on subject's record |
|
|
Experimental PDM Alert |
PDM alert will be placed on subject's record |
|
Recruiting Locations
Indianapolis 4259418, Indiana 4921868 46202
More Details
- NCT ID
- NCT06216483
- Status
- Recruiting
- Sponsor
- Indiana University
Detailed Description
Patients will be recruited from a large general, minimally invasive, colorectal, and oncologic, university-based surgical practice. English speaking individuals over the age of 65 with planned major abdominal surgery (encompassing abdominal wall, gastrointestinal and hepatobiliary procedures for benign and malignant diseases) will be screened for eligibility following an initial visit with their surgeon. Inclusion criteria will include a required inpatient stay for ≥ 24 hours following surgery and a scheduled preadmission testing and medical risk stratification visit with an internal medicine provider. Patients will be excluded if they have severe mental illness, hearing and visual impairment, alcohol intoxication or related delirium, central nervous disorder (e.g., stroke, traumatic brain injury), and pregnant or nursing status. Once enrolled, subjects will be randomized using a computer-generated scheme (permuted blocks of four and six) to the PDM or usual care, stratified according to type of surgery (hepatobiliary, gastrointestinal, abdominal wall).