Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors

July 6, 2023 updated by: University of Wisconsin, Madison

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

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

528

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Illinois
      • Rockford, Illinois, United States, 61104
        • Not yet recruiting
        • SwedishAmerican Hospital
        • Contact:
        • Principal Investigator:
          • Angela Ingraham, MD
    • Indiana
      • Indianapolis, Indiana, United States, 47405
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Malaz Boustani, MD
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin
        • Contact:
        • Principal Investigator:
          • Ben ZarZaur, MD
      • Madison, Wisconsin, United States, 53715
        • Not yet recruiting
        • Meriter Hospital
        • Contact:
        • Principal Investigator:
          • Angela Ingraham, MD
      • Madison, Wisconsin, United States, 53718
        • Recruiting
        • East Madison Hospital
        • Contact:
        • Principal Investigator:
          • Ben ZarZaur, MD

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.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult age 65 years and older
  • Admitted to one of the participating hospitals
  • Undergone an abdominal surgery in an emergency or unplanned fashion (e.g. partial colectomy, small bowel resection, repair of peptic ulcer disease, lysis of adhesions, or laparotomy)
  • 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

Exclusion Criteria:

  • A self-reported diagnosis of cancer with short life expectancy
  • Current chemotherapy or radiation therapy confirmed by electronic medical record
  • 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
  • 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)
  • History of alcohol misuse or abuse within the last three months, defined as ≥8 drinks per week on average for women or ≥15 drinks per week for men (confirmed by self-report or EMR)
  • History of drug abuse within the last 3 months confirmed by EMR or self-report with Drug Abuse and Screening Test (DAST-10) score ≥ 3.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EGS Delirium 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 EGS Delirium Recovery Model.
Virtual visits with care coordinator to carry out an individualized recovery plan
Physical, cognitive, and psychological assessments
Other: Usual Care
Participants will receive the usual rehabilitation and post-operative care.
Physical, cognitive, and psychological assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in overall cognitive recovery
Time Frame: Baseline, 6 months, 12 months, and 18 months
Change in score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) cognitive screening assessment. The measure consists of 12 subtests that contribute to a total score and Index scores across five domains: Immediate Memory, Visuospatial-Constructional, Language, Attention, and Delayed Memory. Index scores are converted to age-based standard scores (Mean = 100, Standard Deviation = 15)
Baseline, 6 months, 12 months, and 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Physical Performance Battery (SPPB)
Time Frame: 6 months, 12 months, and 18 months
Change in overall physical recovery will be assessed using Short Physical Performance Battery (SPPB). SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests, and yields a performance score of 0-12; 0-4 poor, 5-7 intermediate, 8-12 good.
6 months, 12 months, and 18 months
Change in overall physical recovery
Time Frame: 6 months, 12 months, and 18 months
Change in overall physical recovery will be assessed using 36-Item Short Form Survey (SF-36). SF-36 scale has eight components (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health).
6 months, 12 months, and 18 months
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 6 months, 12 months, and 18 months
Change in overall psychological recovery will be assessed using Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a nine-item depression scale with a total score from 0 to 27, with higher scores indicating greater depression.
6 months, 12 months, and 18 months
General Anxiety Disorder-7 (GAD-7) .
Time Frame: 6 months, 12 months, and 18 months
Change in overall psychological recovery will be assessed using General Anxiety Disorder-7 (GAD-7) to determine the impact of the intervention on participant's mood and anxiety. The GAD-7 is a seven-item anxiety scale with a total score from 0 to 27, with higher scores indicating greater anxiety.
6 months, 12 months, and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ben Zarzaur, MD, 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 Major Dates

Study Start (Actual)

February 13, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

May 5, 2022

First Submitted That Met QC Criteria

May 12, 2022

First Posted (Actual)

May 13, 2022

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022-0545
  • A539714 (Other Identifier: UW Madison)
  • SMPH/SURGERY/TRAUMA (Other Identifier: UW Madison)
  • 1R01AG076489-01 (U.S. NIH Grant/Contract)
  • Protocol Version 4/5/2023 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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