Delirium
Conditions
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.
Interventions
OTHERDANE Recovery Program
Virtual visits with care coordinator to carry out an individualized recovery plan
OTHERQuestionnaires
Physical, cognitive, and psychological assessments
Sponsors
University of Wisconsin, Madison
Indiana University
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in overall cognitive recovery | Baseline, 6 months, 12 months, and 18 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery (SPPB) | Baseline, 6 months, 12 months, and 18 months | 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. |
| Change in overall physical recovery | Baseline, 6 months, 12 months, and 18 months | 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). |
| Patient Health Questionnaire-9 (PHQ-9) | Baseline, 6 months, 12 months, and 18 months | 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. |
| General Anxiety Disorder-7 (GAD-7) . | Baseline, 6 months, 12 months, and 18 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBen Zarzaur, MD
University of Wisconsin, Madison
Outcome results
None listed