Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors

Delirium Clinical Trial

Official title:

Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors (DANE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05373017
• Other study ID #: 2022-0545
• Secondary ID: A539714Protocol
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: January 31, 2028

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: Sarah Robbins
• Phone: 608-265-9138
• Email: robbins[@]surgery.wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the usefulness of the Emergency General Surgery (EGS) Delirium Recovery Model. It is hypothesized that the cognitive, physical and psychological recovery of older EGS delirium survivors will be improved through the use of the EGS Delirium Recovery Model. Participants can expect to be on the study for 18 months.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 528
• Est. completion date: January 31, 2028
• Est. primary completion date: January 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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 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
• 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)

Related Conditions & MeSH terms

• Delirium
• Emergencies

Intervention

Other:
• EGS Delirium Recovery Program
Virtual visits with care coordinator to carry out an individualized recovery plan
• Questionnaires
Physical, cognitive, and psychological assessments

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana
United States	East Madison Hospital	Madison	Wisconsin
United States	Meriter Hospital	Madison	Wisconsin
United States	University of Wisconsin	Madison	Wisconsin
United States	SwedishAmerican Hospital	Rockford	Illinois

Sponsors (5)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Indiana University, National Institute on Aging (NIA), SwedishAmerican Hospital, Unity Point Health - Meriter

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline, 6 months, 12 months, and 18 months
Secondary	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.	6 months, 12 months, and 18 months
Secondary	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).	6 months, 12 months, and 18 months
Secondary	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.	6 months, 12 months, and 18 months
Secondary	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.	6 months, 12 months, and 18 months