Clinical trial NCT06216483: Using EMR Data and AI to Develop a Passive Digital Marker to Predict Postoperative Delirium
Official title: Using EMR Data and AI to Develop a Passive Digital Marker to Predict Postoperative Delirium
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delirium in Old Age
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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).

Eligibility criteria: Inclusion Criteria:

65 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

Primary outcomes:
measure: Delirium incidence as measured by the 3D-CAM
timeFrame: Daily during post-operative inpatient hospitalization through post-operative day 7
measure: Delirium incidence as measured by the CAM ICU
timeFrame: Daily during post-operative inpatient hospitalization through post-operative day 7
measure: Delirium severity as measured by the CAM ICU
timeFrame: Daily during post-operative inpatient hospitalization through post-operative day 7
Secondary outcomes:
measure: Inpatient falls
timeFrame: During post-operative inpatient hospitalization through post-operative day 7
measure: Restraint Use
timeFrame: During post-operative inpatient hospitalization through post-operative day 7
measure: Sedative Use
timeFrame: During post-operative inpatient hospitalization through post-operative day 7
measure: Use of personal safety attendants
timeFrame: During post-operative inpatient hospitalization through post-operative day 7
measure: Provider Satisfaction
timeFrame: Within 2-6 weeks following participant discharge
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
Study officials:
References: