Status:
RECRUITING
Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Indiana University
National Institute on Aging (NIA)
Conditions:
Delirium
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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 delir...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Adult age 65 years and older
- Admitted to one of the participating hospitals
- Undergone an abdominal orthopedic, skin, or vascular surgery in an emergency or unplanned fashion
- English-speaking
- Able to provide consent or have a legally authorized representative to provide consent
- 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 on at 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
- A self-reported diagnosis of cancer with short life expectancy
- A history of dementing illnesses and other neurodegenerative disease such as Alzheimer's disease (AD), Parkinson disease, or vascular dementia, or current prescription of anti-dementia medication, or ruled out by Functional Activities Questionnaire (FAQ) score defining dementia; a history of significant traumatic brain injury
- Acute or subacute neurologic deficit expected to prevent independent living after hospital discharge, e.g., a history of a significant traumatic brain injury
- Have any spinal cord injury with persistent neurologic deficit at the time of study enrollment
- 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 the admitting diagnosis or a new event during the course of hospitalization (confirmed by EMR)
- A history of bipolar disorder or schizophrenia (confirmed by EMR)
Key Trial Info
Start Date :
February 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
528 Patients enrolled
Trial Details
Trial ID
NCT05373017
Start Date
February 13 2023
End Date
June 30 2027
Last Update
April 30 2025
Active Locations (6)
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1
SwedishAmerican Hospital
Rockford, Illinois, United States, 61104
2
Indiana University
Indianapolis, Indiana, United States, 47405
3
University of Wisconsin
Madison, Wisconsin, United States, 53705
4
Meriter Hospital
Madison, Wisconsin, United States, 53715