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

NCT06216483 | Active Not Recruiting

• 2 other identifiers: 15767K23AG071945
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium in Old Age

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Inpatient falls

  During post-operative inpatient hospitalization through post-operative day 7

• Restraint Use

  During post-operative inpatient hospitalization through post-operative day 7

• Sedative Use

  During post-operative inpatient hospitalization through post-operative day 7

• Use of personal safety attendants

  During post-operative inpatient hospitalization through post-operative day 7

• Provider Satisfaction

  Within 2-6 weeks following participant discharge

Study Arms (2)

No PDM Alert

PLACEBO COMPARATOR

No PDM alert will be placed on subject's record

Other: PDM Alert

PDM Alert

EXPERIMENTAL

PDM alert will be placed on subject's record

Other: PDM Alert

Interventions

PDM Alert OTHER

passive digital marker (PDM) for postoperative delirium risk

No PDM Alert; PDM Alert

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years old Planned inpatient major surgery requiring inpatient stay ≥ 1 day

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 22, 2024
• Study Start: July 23, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)