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Behavioural Intervention

EGS Delirium Recovery Program for Post-Surgery Delirium

N/A

Recruiting

Led By Ben Zarzaur, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Discharged to home or sub-acute rehabilitation

Adult age 65 years and older

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months, 12 months, and 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether the Emergency General Surgery Delirium Recovery Model can help people recover better from delirium. It will last 18 months.

Who is the study for?

This trial is for adults aged 65 or older who have had emergency abdominal surgery, experienced delirium before discharge, and can consent to participate. They must speak English and have access to a phone or internet device. Excluded are those with certain neurodegenerative diseases, severe brain injuries, cancer with short life expectancy, recent substance abuse issues, or undergoing chemotherapy/radiation.

What is being tested?

The study tests the EGS Delirium Recovery Model's effectiveness in aiding cognitive, physical and psychological recovery after surgery-related delirium in older patients. Participants will be involved for 18 months and engage with recovery programs alongside regular questionnaires.

What are the potential side effects?

Since this trial involves a recovery program rather than medication, traditional side effects like those seen with drugs are not expected. However, participants may experience discomfort or fatigue from engaging in the activities of the program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was sent home or to a rehab center after hospital discharge.

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I am 65 years old or older.

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I had emergency abdominal surgery, such as for a bowel issue or ulcer.

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I experienced confusion or delirium before leaving the hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no history of Alzheimer's, Parkinson's, or significant brain injury.

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I have a spinal cord injury with lasting nerve damage.

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I have had a serious brain injury or stroke recently.

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I have been told I have a short time to live due to cancer.

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I am currently undergoing chemotherapy or radiation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months, 12 months, and 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months, 12 months, and 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 12 months, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in overall cognitive recovery

Secondary study objectives

Change in overall physical recovery

General Anxiety Disorder-7 (GAD-7) .

Patient Health Questionnaire-9 (PHQ-9)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual CareExperimental Treatment2 Interventions

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

Group II: DANE Recovery ModelExperimental Treatment1 Intervention

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 DANE Recovery Model.

0 / 9Eligibility criteria met