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

NCT ID: NCT06216483

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-23

Study Completion Date

2026-02-11

Brief Summary

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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

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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).

Conditions

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Delirium in Old Age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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No PDM Alert

No PDM alert will be placed on subject's record

Group Type PLACEBO_COMPARATOR

PDM Alert

Intervention Type OTHER

passive digital marker (PDM) for postoperative delirium risk

PDM Alert

PDM alert will be placed on subject's record

Group Type EXPERIMENTAL

PDM Alert

Intervention Type OTHER

passive digital marker (PDM) for postoperative delirium risk

Interventions

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PDM Alert

passive digital marker (PDM) for postoperative delirium risk

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Sanjay Mohanty

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Indiana University Health University Hospital

Indianapolis, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sanjay Mohanty

Role: CONTACT

Phone: 317-963-1449

Email: [email protected]

Facility Contacts

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Sanja Mohanty, MD

Role: primary

Other Identifiers

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K23AG071945

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15767

Identifier Type: -

Identifier Source: org_study_id