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

Delirium in Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06216483
• Other study ID #: 15767
• Secondary ID: K23AG071945
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Indiana University
• Contact: Sanjay Mohanty
• Phone: 317-963-1449
• Email: mohantys[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age
• Emergence Delirium

Intervention

Other:
• PDM Alert
passive digital marker (PDM) for postoperative delirium risk

Locations

Country	Name	City	State
United States	Indiana University Health University Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in delirium incidence and severity	reduction in number of subjects diagnosed with delirium	1 year
Secondary	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
Secondary	Patient Satisfaction	determined by a likert scale from 0-5, with 0 being very dissatisfied and 5 being very satisfied	2 years
Secondary	Provider Satisfaction	determined by a likert scale from 0-5, with 0 being very dissatisfied and 5 being very satisfied	2 Years