Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors

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: Delirium
• Intervention / Treatment: Other: EGS Delirium Recovery Program; Other: Questionnaires

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

• Study Contact: Name: Sarah Robbins; Phone Number: 608-265-9138; Email: robbins@surgery.wisc.edu

Study Locations

• United States
  • Illinois
    • Rockford, Illinois, United States, 61104
      • Not yet recruiting
      • SwedishAmerican Hospital
      • Contact: Sarah Robbins; Phone Number: 608-265-9138; Email: robbins@surgery.wisc.edu
      • Principal Investigator: Angela Ingraham, MD
  • Indiana
    • Indianapolis, Indiana, United States, 47405
      • Recruiting
      • Indiana University
      • Principal Investigator: Malaz Boustani, MD
      • Contact: Peggy Byland; Phone Number: 317-274-9139; Email: pbylund@regenstrief.org
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin
      • Contact: Sarah Robbins; Phone Number: 608-265-9138; Email: robbins@surgery.wisc.edu
      • Principal Investigator: Ben ZarZaur, MD
    • Madison, Wisconsin, United States, 53715
      • Not yet recruiting
      • Meriter Hospital
      • Contact: Sarah Robbins; Phone Number: 608-265-9138; Email: robbins@surgery.wisc.edu
      • Principal Investigator: Angela Ingraham, MD
    • Madison, Wisconsin, United States, 53718
      • Recruiting
      • East Madison Hospital
      • Contact: Sarah Robbins; Phone Number: 608-265-9138; Email: robbins@surgery.wisc.edu
      • Principal Investigator: Ben ZarZaur, MD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	Other: EGS Delirium Recovery Program; Virtual visits with care coordinator to carry out an individualized recovery plan; Other: Questionnaires; Physical, cognitive, and psychological assessments
Other: Usual Care; Participants will receive the usual rehabilitation and post-operative care.	Other: Questionnaires; Physical, cognitive, and psychological assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in overall cognitive recovery	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)	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	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)	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) .	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

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Aging (NIA); Indiana University; Unity Point Health - Meriter; SwedishAmerican Hospital
• Investigators: Principal Investigator: Ben Zarzaur, MD, University of Wisconsin, Madison

Study record dates

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

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Disease Attributes; Delirium; Emergencies
• 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