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: Not yet 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 Contact: Name: Sanjay Mohanty; Phone Number: 317-963-1449; Email: mohantys@iu.edu

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
Reduction in delirium incidence and severity	reduction in number of subjects diagnosed with delirium	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in the number of inpatient falls as well as the use of restraints, sedatives, and personal safety attendants	determined from data extracted from Electronic Medical Record	2 years
Patient Satisfaction	determined by a likert scale from 0-5, with 0 being very dissatisfied and 5 being very satisfied	2 years
Provider Satisfaction	determined by a likert scale from 0-5, with 0 being very dissatisfied and 5 being very satisfied	2 Years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 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): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence 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