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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Delirium in Old Age
• Intervention / Treatment: Other: PDM Alert

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).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: No PDM Alert; No PDM alert will be placed on subject's record	Other: PDM Alert; passive digital marker (PDM) for postoperative delirium risk
Experimental: PDM Alert; PDM alert will be placed on subject's record	Other: PDM Alert; passive digital marker (PDM) for postoperative delirium risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium incidence as measured by the 3D-CAM	The number of subjects diagnosed with delirium via the 3D-CAM questionnaire will be measured. The 3D-CAM is a brief verbal assessment tool that can be used to test patients and study participants for delirium via the Confusion Assessment Method (CAM). The 3D-CAM assessment is scored as either delirium present or delirium not present. Participants will be evaluated daily during the acute post-operative phase of the study (Post-Operative Days 0-7).	Daily during post-operative inpatient hospitalization through post-operative day 7
Delirium incidence as measured by the CAM ICU	The number of subjects diagnosed with delirium as assessed by the Confusion Assessment Method ICU will be measured. The CAM ICU is a tool used to assess delirium in adult ICU patients. CAM ICU scoring ranges from 0-7 with scores between 0-2 indicating no delirium, between 3-5 indicating mild to moderate delirium, and between 6-7 indicating severe delirium. Participants will be evaluated daily during the acute post-operative phase of the study (Post-Operative Days 0-7).	Daily during post-operative inpatient hospitalization through post-operative day 7
Delirium severity as measured by the CAM ICU	Delirium severity will be assessed via the Confusion Assessment Method ICU, a tool used to assess delirium in adult ICU patients. The CAM ICU is a tool used to assess delirium in adult ICU patients. CAM ICU scoring ranges from 0-7 with scores between 0-2 indicating no delirium, between 3-5 indicating mild to moderate delirium, and between 6-7 indicating severe delirium. Participants will be evaluated daily during the acute post-operative phase of the study (Post-Operative Days 0-7).	Daily during post-operative inpatient hospitalization through post-operative day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inpatient falls	The number of inpatient falls will be compared between groups. This data will be extracted from the participants' Electronic Medical Record.	During post-operative inpatient hospitalization through post-operative day 7
Restraint Use	Use of restraints will be compared between groups. This data will be extracted from the participants' Electronic Medical Record.	During post-operative inpatient hospitalization through post-operative day 7
Sedative Use	Sedative use will be compared between groups. This data will be extracted from the participants' Electronic Medical Record.	During post-operative inpatient hospitalization through post-operative day 7
Use of personal safety attendants	Personal safety attendant use will be compared between groups. This data will be extracted from the participants' Electronic Medical Record.	During post-operative inpatient hospitalization through post-operative day 7
Provider Satisfaction	Provider satisfaction will be measured determined by a Simplified System Usability Scale (SSUS). The SSUS will be administered to providers within two weeks of the participant's discharge from the hospital, and providers will be asked to respond within 4 weeks of survey receipt. The SSUS yields a single number representing a composite measure of the overall usability of the system. Scores can range from 0 to 100, with higher scores indicating better usability.	Within 2-6 weeks following participant discharge

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium
• Other Study ID Numbers: 15767; K23AG071945 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No