Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors

NCT05373017 | Recruiting DMC

• 5 other identifiers: 2022-0545A539714Protocol Version 4/20/2025SMPH/SURGERY/TRAUMA1R01AG076489-01
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 6

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 delirium survivors will be improved through the use of the DANE Recovery Model. Participants can expect to be on the study for 18 months.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Short Physical Performance Battery (SPPB)

  Baseline, 6 months, 12 months, and 18 months

• Change in overall physical recovery

  Baseline, 6 months, 12 months, and 18 months

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, 6 months, 12 months, and 18 months

• General Anxiety Disorder-7 (GAD-7) .

  Baseline, 6 months, 12 months, and 18 months

Study Arms (2)

DANE Recovery Model

EXPERIMENTAL

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.

Other: DANE Recovery Program

Usual Care

OTHER

Participants will receive the usual rehabilitation and post-operative care.

Other: DANE Recovery Program; Other: Questionnaires

Interventions

DANE Recovery Program OTHER

Virtual visits with care coordinator to carry out an individualized recovery plan

DANE Recovery Model; Usual Care

Questionnaires OTHER

Physical, cognitive, and psychological assessments

Usual Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Indiana University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (6)

SwedishAmerican Hospital

Rockford, Illinois, 61104, United States

NOT YET RECRUITING

Indiana University

Indianapolis, Indiana, 47405, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

Meriter Hospital

Madison, Wisconsin, 53715, United States

RECRUITING

East Madison Hospital

Madison, Wisconsin, 53718, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 39609928 DERIVED

• 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.

  PMID: 37789461 DERIVED

• 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.

  PMID: 37720054 DERIVED

MeSH Terms

Conditions

Delirium

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ben Zarzaur, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Robbins

CONTACT

608-265-9138; robbins@surgery.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 13, 2022
• Study Start: February 13, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)