Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors

University of Wisconsin (UW)

Status: Enrolling

Conditions: Delirium

Treatments: Other: Questionnaires; Other: DANE Recovery Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05373017

A539714 (Other Identifier)

1R01AG076489-01 (U.S. NIH Grant/Contract)

Protocol Version 4/20/2025 (Other Identifier)

SMPH/SURGERY/TRAUMA (Other Identifier)

2022-0545

Details and patient eligibility

About

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.

Full 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.

Enrollment: 528 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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528 participants in 2 patient groups

DANE Recovery Model

Experimental group

Description:

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.

Treatment:

Other: DANE Recovery Program

Usual Care

Other group

Description:

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

Treatment:

Other: DANE Recovery Program

Other: Questionnaires