Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors
NCT ID: NCT05373017
Last Updated: 2025-04-30
Study Results
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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RECRUITING
NA
528 participants
INTERVENTIONAL
2023-02-13
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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DANE Recovery Model
The delivery of the model will occur in five phases that correspond to the known stages of recovery after surgery. During the acute stage (0 - 1 month after surgery), participants will undergo the initial case review and two initial virtual visits, and the development of the recovery care plan. During the recovery (2 - 6 months after surgery) and maintenance (7-12 months after surgery) stages, the participants will undergo the interaction phase of the DANE Recovery Model.
DANE Recovery Program
Virtual visits with care coordinator to carry out an individualized recovery plan
Usual Care
Participants will receive the usual rehabilitation and post-operative care.
DANE Recovery Program
Virtual visits with care coordinator to carry out an individualized recovery plan
Questionnaires
Physical, cognitive, and psychological assessments
Interventions
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DANE Recovery Program
Virtual visits with care coordinator to carry out an individualized recovery plan
Questionnaires
Physical, cognitive, and psychological assessments
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
65 Years
ALL
No
Sponsors
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Indiana University
OTHER
National Institute on Aging (NIA)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Ben Zarzaur, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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SwedishAmerican Hospital
Rockford, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Wisconsin
Madison, Wisconsin, United States
Meriter Hospital
Madison, Wisconsin, United States
East Madison Hospital
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Gardner L, Bylund P, Robbins S, Holler E, Shojaei F, Shojaei F, Seidman M, Holden RJ, Fowler NR, Zarzaur B, Barboi C, Boustani M. Agile monitoring dashboard for clinical research studies. Trials. 2024 Nov 29;25(1):802. doi: 10.1186/s13063-024-08646-0.
Mohanty S, Holler E, Ortiz D, Meagher A, Perkins A, Bylund P, Khan B, Unverzagt F, Xu H, Ingraham A, Boustani M, Zarzaur B. Delirium and neuropsychological recovery among emergency general surgery survivors (DANE): study protocol for a randomized controlled trial and collaborative care intervention. Trials. 2023 Oct 3;24(1):634. doi: 10.1186/s13063-023-07670-w.
Mohanty S, Holler E, Ortiz D, Meagher A, Perkins A, Bylund P, Khan B, Unverzagt F, Xu H, Ingraham A, Boustani M, Zarzaur B. Delirium and Neuropsychological Recovery among Emergency General Surgery Survivors (DANE): study protocol for a randomized controlled trial and collaborative care intervention. Res Sq [Preprint]. 2023 Sep 7:rs.3.rs-3185716. doi: 10.21203/rs.3.rs-3185716/v1.
Other Identifiers
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A539714
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 4/20/2025
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/SURGERY/TRAUMA
Identifier Type: OTHER
Identifier Source: secondary_id
2022-0545
Identifier Type: -
Identifier Source: org_study_id
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