Improving recovery for older patients after emergency surgery
Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors (DANE)
This study is testing a new recovery program to see if it helps older patients who had emergency surgery and experienced confusion feel better and recover faster compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 528 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 6 sites (Rockford, Illinois and 5 other locations) |
| Trial ID | NCT05373017 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the DANE Recovery Model aimed at enhancing cognitive, physical, and psychological recovery in older patients who have experienced delirium following emergency general surgery. Participants aged 65 and older will be randomized to receive either the DANE Recovery Model or standard care at discharge. The study will track their recovery over an 18-month period to determine the effectiveness of the intervention compared to usual care. The trial is multi-site and single-blinded, ensuring a robust evaluation of the recovery model's efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 and older who have undergone emergency abdominal, orthopedic, skin, or vascular surgery and have experienced at least one episode of delirium.
Not a fit: Patients with a self-reported diagnosis of cancer with a short life expectancy or those with a history of dementia or other neurodegenerative diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the recovery outcomes for older patients who experience delirium after emergency surgeries.
How similar studies have performed: Other studies have shown promise in improving recovery outcomes for delirium patients, but the DANE Recovery Model is a novel approach in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Rockford, Illinois and 5 other locations
- SwedishAmerican Hospital — Rockford, Illinois, United States (Not_yet_recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
- Meriter Hospital — Madison, Wisconsin, United States (Recruiting)
- East Madison Hospital — Madison, Wisconsin, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Ben Zarzaur, MD — University of Wisconsin, Madison
- Study coordinator: Sarah Robbins
- Email: robbins@surgery.wisc.edu
- Phone: 608-265-9138
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.