Clinical trial NCT05373017: Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors
Official title: Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors (DANE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delirium
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Indiana University
name: National Institute on Aging (NIA)
First posted: 2022-05-13
Enrollment: 528
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Change in overall cognitive recovery
timeFrame: Baseline, 6 months, 12 months, and 18 months
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline, 6 months, 12 months, and 18 months
measure: Change in overall physical recovery
timeFrame: Baseline, 6 months, 12 months, and 18 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 6 months, 12 months, and 18 months
measure: General Anxiety Disorder-7 (GAD-7) .
timeFrame: Baseline, 6 months, 12 months, and 18 months
Other outcomes:
Locations:
city: Rockford
country: United States
facility: SwedishAmerican Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Madison
country: United States
facility: Meriter Hospital
state: Wisconsin
city: Madison
country: United States
facility: East Madison Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ben Zarzaur, MD
role: PRINCIPAL_INVESTIGATOR
References: