RECRUITING

Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors (DANE)

Quick Facts

Study Start:2023-02-13

Study Completion:2028-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05373017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion 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 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 in the period prior to discharge from acute care	* 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)

Inclusion Criteria

Exclusion 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 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 in the period prior to discharge from acute care

* 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)

Contacts and Locations

Study Contact

Sarah Robbins

CONTACT

608-265-9138

robbins@surgery.wisc.edu

Principal Investigator

Ben Zarzaur, MD

PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Study Locations (Sites)

SwedishAmerican Hospital

Rockford, Illinois, 61104

United States

Indiana University

Indianapolis, Indiana, 47405

United States

University of Wisconsin

Madison, Wisconsin, 53705

United States

Meriter Hospital

Madison, Wisconsin, 53715

United States

East Madison Hospital

Madison, Wisconsin, 53718

United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

Ben Zarzaur, MD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-13

Study Completion Date2028-01-31

Study Record Updates

Study Start Date2023-02-13

Study Completion Date2028-01-31

Terms related to this study

Additional Relevant MeSH Terms

Delirium