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Active, not recruitingNCT05373017Updated Jul 7, 2026

Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors

An interventional study of DANE Recovery Program and Questionnaires in Delirium, sponsored by University of Wisconsin, Madison. Active, not recruiting at 6 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
528
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study 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.

Read the detailed description

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

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Conditions studied

  • Delirium

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03

In context

Delirium

1,058 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's planned enrollment of 528 is above the median of 120 across 599 interventional studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion 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 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

Exclusion Criteria:

  • 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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
528 participants (estimated)

Study arms

  • Experimental
    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.

    Other: DANE Recovery Program

  • Other
    Usual Care

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

    Other: DANE Recovery Program · Other: Questionnaires

Interventions

  • OtherDANE Recovery Program

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

  • OtherQuestionnaires

    Physical, cognitive, and psychological assessments

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What researchers measure

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)

    Time frame: Baseline, 6 months, 12 months, and 18 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 6 months, 12 months, and 18 months

  2. 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).

    Time frame: Baseline, 6 months, 12 months, and 18 months

  3. 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.

    Time frame: Baseline, 6 months, 12 months, and 18 months

  4. 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.

    Time frame: Baseline, 6 months, 12 months, and 18 months

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Study locations

6 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
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
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References and documents

Publications

  • 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. PubMed 39609928 ↗
  • 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. PubMed 37789461 ↗
  • 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. PubMed 37720054 ↗

Study documents

  • Informed consent form · May 14, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05373017
Lead sponsor
University of Wisconsin, Madison
Collaborators
Indiana University, National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
May 13, 2022
Start date
Feb 13, 2023
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jul 7, 2026

Study contacts

Ben Zarzaur, MD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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