Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors

Last updated: April 28, 2025
Sponsor: University of Wisconsin, Madison
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Treatment

EGS Delirium Recovery Program

Questionnaires

DANE Recovery Program

Clinical Study ID

NCT05373017
2022-0545
A539714
Protocol Version 4/5/2023
Protocol Version 1/15/2025
Protocol Version 4/2/2024
Protocol Version 8/2/2024
1R01AG076489-01
Protocol Version 4/20/2025
SMPH/SURGERY/TRAUMA
  • Ages > 65
  • All Genders

Study Summary

This study will evaluate the usefulness of the Urgent and Emergency Surgery (UES) Delirium Recovery Model. It is hypothesized that the cognitive, physical and psychological recovery of older UES delirium survivors will be improved through the use of the DANE Recovery Model. Participants can expect to be on the study for 18 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult age 65 years and older

  • Admitted to one of the participating hospitals

  • Undergone an abdominal orthopedic, skin, or vascular surgery in an emergency orunplanned fashion

  • English-speaking

  • Able to provide consent or have a legally authorized representative to provideconsent

  • Access to a telephone or an internet connected computer or smart device

  • Discharged to home or sub-acute rehabilitation

  • At least one episode of delirium or subsyndromal delirium, i.e. screen positive onat least one out of the four items on the Confusion Assessment Method-ICU (CAM-ICU)in the period prior to discharge from acute care.

Exclusion

Exclusion Criteria:

  • A self-reported diagnosis of cancer with short life expectancy

  • A history of dementing illnesses and other neurodegenerative disease such asAlzheimer's disease (AD), Parkinson disease, or vascular dementia, or currentprescription of anti-dementia medication, or ruled out by Functional ActivitiesQuestionnaire (FAQ) score defining dementia; a history of significant traumaticbrain injury

  • Acute or subacute neurologic deficit expected to prevent independent living afterhospital discharge, e.g., a history of a significant traumatic brain injury

  • Have any spinal cord injury with persistent neurologic deficit at the time of studyenrollment

  • Incarcerated or homeless at the time of study enrollment

  • Acquired neurologic injury (stroke, traumatic brain injury, cerebral edema/swelling,anoxic brain injury, or any other acute/subacute severe neurologic deficit) as theadmitting diagnosis or a new event during the course of hospitalization (confirmedby EMR)

  • A history of bipolar disorder or schizophrenia (confirmed by EMR)

Study Design

Total Participants: 528
Treatment Group(s): 3
Primary Treatment: EGS Delirium Recovery Program
Phase:
Study Start date:
February 13, 2023
Estimated Completion Date:
June 30, 2027

Study Description

This is a multi-site, two-arm, single-blinded randomized controlled clinical trial to evaluate the efficacy of the DANE Recovery Model to improve the cognitive, physical and psychological recovery of older UES delirium survivors. At or near the time of discharge, enrolled participants will be randomized to receive the DANE Recovery Model or usual care. The hypothesis is that, after 18 months, older UES delirium survivors who are randomized to the DANE Recovery Model will experience more favorable cognitive, physical and psychological recovery in comparison to those randomized to usual care.

Connect with a study center

  • SwedishAmerican Hospital

    Rockford, Illinois 61104
    United States

    Site Not Available

  • Indiana University

    Bloomington, Indiana 47405
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 47405
    United States

    Active - Recruiting

  • East Madison Hospital

    Madison, Wisconsin 53718
    United States

    Active - Recruiting

  • Meriter Hospital

    Madison, Wisconsin 53715
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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