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NCT05373017 | Recruiting | Delirium


Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors
Sponsor:

University of Wisconsin, Madison

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.

Condition or disease

Delirium

Intervention/treatment

EGS Delirium Recovery Program

Questionnaires

Phase

Not Applicable

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.

Study Type : Interventional
Estimated Enrollment : 528 participants
Masking: Single
Primary Purpose: Treatment
Official Title: Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors (DANE)
Actual Study Start Date : February 13, 2023
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2028
Arm Intervention/treatment

Experimental: EGS Delirium Model

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.

Other: EGS Delirium Recovery Program

Other: Usual Care

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

Other: Questionnaires

Ages Eligible for Study: 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors

Location Details


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Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors

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Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, Illinois

SwedishAmerican Hospital

Rockford, Illinois, United States, 61104

Recruiting

United States, Indiana

Indiana University

Indianapolis, Indiana, United States, 47405

Recruiting

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53705

Not yet recruiting

United States, Wisconsin

Meriter Hospital

Madison, Wisconsin, United States, 53715

Recruiting

United States, Wisconsin

East Madison Hospital

Madison, Wisconsin, United States, 53718

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