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Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors

Primary Purpose

Delirium

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EGS Delirium Recovery Program
Questionnaires
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult age 65 years and older
  • Admitted to one of the participating hospitals
  • Undergone an abdominal surgery in an emergency or unplanned fashion (e.g. partial colectomy, small bowel resection, repair of peptic ulcer disease, lysis of adhesions, or laparotomy)
  • 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
  • Current chemotherapy or radiation therapy confirmed by electronic medical record
  • 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)
  • History of alcohol misuse or abuse within the last three months, defined as ≥8 drinks per week on average for women or ≥15 drinks per week for men (confirmed by self-report or EMR)
  • History of drug abuse within the last 3 months confirmed by EMR or self-report with Drug Abuse and Screening Test (DAST-10) score ≥ 3.

Sites / Locations

  • SwedishAmerican Hospital
  • Indiana UniversityRecruiting
  • University of WisconsinRecruiting
  • Meriter Hospital
  • East Madison HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

EGS Delirium Model

Usual Care

Arm 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 EGS Delirium Recovery Model.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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).
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.
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.

Full Information

First Posted
May 5, 2022
Last Updated
July 6, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
Indiana University, Unity Point Health - Meriter, SwedishAmerican Hospital, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05373017
Brief Title
Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors
Official Title
Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors (DANE)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Indiana University, Unity Point Health - Meriter, SwedishAmerican Hospital, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
528 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EGS Delirium Model
Arm Type
Experimental
Arm 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 EGS Delirium Recovery Model.
Arm Title
Usual Care
Arm Type
Other
Arm Description
Participants will receive the usual rehabilitation and post-operative care.
Intervention Type
Other
Intervention Name(s)
EGS Delirium Recovery Program
Intervention Description
Virtual visits with care coordinator to carry out an individualized recovery plan
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Physical, cognitive, and psychological assessments
Primary Outcome Measure Information:
Title
Change in overall cognitive recovery
Description
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)
Time Frame
Baseline, 6 months, 12 months, and 18 months
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery (SPPB)
Description
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.
Time Frame
6 months, 12 months, and 18 months
Title
Change in overall physical recovery
Description
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).
Time Frame
6 months, 12 months, and 18 months
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
6 months, 12 months, and 18 months
Title
General Anxiety Disorder-7 (GAD-7) .
Description
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.
Time Frame
6 months, 12 months, and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult age 65 years and older Admitted to one of the participating hospitals Undergone an abdominal surgery in an emergency or unplanned fashion (e.g. partial colectomy, small bowel resection, repair of peptic ulcer disease, lysis of adhesions, or laparotomy) 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 Current chemotherapy or radiation therapy confirmed by electronic medical record 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) History of alcohol misuse or abuse within the last three months, defined as ≥8 drinks per week on average for women or ≥15 drinks per week for men (confirmed by self-report or EMR) History of drug abuse within the last 3 months confirmed by EMR or self-report with Drug Abuse and Screening Test (DAST-10) score ≥ 3.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Robbins
Phone
608-265-9138
Email
robbins@surgery.wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Zarzaur, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
SwedishAmerican Hospital
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Robbins
Phone
608-265-9138
Email
robbins@surgery.wisc.edu
First Name & Middle Initial & Last Name & Degree
Angela Ingraham, MD
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peggy Byland
Phone
317-274-9139
Email
pbylund@regenstrief.org
First Name & Middle Initial & Last Name & Degree
Malaz Boustani, MD
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Robbins
Phone
608-265-9138
Email
robbins@surgery.wisc.edu
First Name & Middle Initial & Last Name & Degree
Ben Zarzaur, MD
Facility Name
Meriter Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Robbins
Phone
608-265-9138
Email
robbins@surgery.wisc.edu
First Name & Middle Initial & Last Name & Degree
Angela Ingraham, MD
Facility Name
East Madison Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Robbins
Phone
608-265-9138
Email
robbins@surgery.wisc.edu
First Name & Middle Initial & Last Name & Degree
Ben ZarZaur, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors

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