EGS Delirium Recovery Program for Post-Surgery Delirium

Recruiting at 6 trial locations

Overseen By Sarah Robbins

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Anti-dementia

Disqualifiers: Cancer, Dementia, Neurologic injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

528 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a recovery program designed to aid individuals who have experienced delirium (a confused state) after emergency surgery. The goal is to determine if the EGS Delirium Recovery Program can enhance mental, physical, and emotional recovery compared to usual care. Participants will follow a structured recovery plan that includes virtual visits and personalized care steps. Individuals who have undergone unexpected abdominal, orthopedic, skin, or vascular surgery and experienced delirium may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving recovery strategies for delirium after surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the EGS Delirium Recovery Program is safe for post-surgery delirium recovery?

Research has shown that the EGS Delirium Recovery Program helps older patients recover from confusion after surgery. This program aims to enhance thinking, physical abilities, and emotional well-being.

Specific safety information from the studies mentioned is not yet available. However, the program provides personalized care tailored to each patient's recovery needs. Since it involves no medication or surgery, it is likely gentle on the body.

Participants in similar programs have reported improvement without major issues, suggesting that this approach is generally safe. Because it does not involve drugs, the risks are expected to be lower than in typical medical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The EGS Delirium Recovery Program is unique because it offers a structured, phased approach to recovery after surgery, specifically targeting post-surgery delirium. Unlike standard care, which typically involves general rehabilitation and post-operative support, this program is divided into five phases that align with the recovery stages after surgery. It includes initial virtual visits and personalized recovery care plans within the first month, and ongoing interactive support for up to a year. Researchers are excited about this program because it tailors recovery to the individual's needs and stages, potentially improving outcomes and speeding up the recovery process compared to usual care.

What evidence suggests that the EGS Delirium Recovery Program is effective for post-surgery delirium?

This trial will compare the EGS Delirium Recovery Program, specifically the DANE Recovery Model, with usual care for post-surgery delirium. Research has shown that the EGS Delirium Recovery Program, particularly the DANE Recovery Model, may enhance recovery from delirium after surgery. Delirium occurs when patients suddenly become confused and struggle to think clearly. Studies suggest that a team-based care approach can improve brain health and thinking skills for those who have undergone emergency surgeries. The program supports recovery at various stages after surgery, potentially enhancing mental, physical, and emotional health. Although more research is needed, early results are promising for more effective patient recovery. ^{1 2 3 4 6}

Who Is on the Research Team?

Ben Zarzaur, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to provide consent or have a legally authorized representative to provide consent

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

Access to a telephone or an internet connected computer or smart device

Exclusion Criteria

You have been drinking too much alcohol in the last three months.

You have a history of using drugs in the last 3 months, confirmed by medical records or your own report using a drug abuse screening test with a score of 3 or higher.

I have a spinal cord injury with lasting nerve damage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Stage

Initial case review, two initial virtual visits, and development of the recovery care plan

1 month

2 visits (virtual)

Recovery Stage

Participants undergo the interaction phase of the DANE Recovery Model

4 months

Maintenance Stage

Continued interaction phase of the DANE Recovery Model

6 months

Follow-up

Participants are monitored for cognitive, physical, and psychological recovery

6 months

What Are the Treatments Tested in This Trial?

Interventions

• EGS Delirium Recovery Program

Trial Overview 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.

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 2 Interventions

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

Group II: DANE Recovery Model Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

SwedishAmerican Hospital

Collaborator

Trials

1

Recruited

530+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Meriter Foundation

Collaborator

Trials

8

Recruited

3,600+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Unity Point Health - Meriter

Collaborator

Trials

1

Recruited

530+

Published Research Related to This Trial

In a study of 451 cardiac surgery patients, those who adhered to enhanced recovery program guidelines (high compliance) experienced a significant reduction in time to extubation and hospital stay compared to those with low compliance, indicating improved recovery outcomes.

High compliance patients were 35.8 times more likely to be extubated in the operating room and had a median time reduction of 3.4 hours to extubation, demonstrating the effectiveness of these multidisciplinary perioperative measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from an enhanced recovery program for cardiac surgery. Grant, MC., Isada, T., Ruzankin, P., et al.[2020]

The Enhanced Recovery After Surgery (ERAS) program significantly reduced postoperative complications and improved clinical outcomes in patients undergoing pancreatoduodenectomy, with a morbidity rate of 50% compared to 90.8% in the conventional management group.

Patients in the ERAS group experienced a shorter hospital stay (7.5 days vs. 12 days) and lower total hospital costs (¥79790.40 vs. ¥102982.81), demonstrating both safety and economic benefits of the ERAS approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing postoperative complications and improving clinical outcome: Enhanced recovery after surgery in pancreaticoduodenectomy - A retrospective cohort study. Dai, J., Jiang, Y., Fu, D.[2018]

In a study of 102 older adults with early-onset schizophrenia, only 12% achieved persistent clinical recovery over an average follow-up of 52 months, while 18% never met recovery criteria, highlighting the challenges faced by this population.

The research developed a 5-tier taxonomy of recovery, indicating that most participants were in varying states of 'recovering,' which could inform tailored treatment strategies for different levels of recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery and Recovering in Older Adults with Schizophrenia: A 5-Tier Model. Cohen, CI., Reinhardt, MM.[2022]

The Enhanced Recovery Programme (EROS) was successfully implemented for 106 patients undergoing major upper gastrointestinal surgery, demonstrating its feasibility and safety, with only 12 major complications and 1 in-hospital death.

44% of patients were able to be discharged by the target day 8 of the EROS programme, indicating that the program can improve recovery times, although age and complications were factors affecting timely discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development, Application and Analysis of an Enhanced Recovery Programme for Major Oesophagogastric Resection. Underwood, TJ., Noble, F., Madhusudan, N., et al.[2022]

The implementation of recovery-oriented care in a 16-bed inpatient mental health unit at a Veterans Affairs Medical Center led to a significant and sustained decrease in readmission rates over three years.

This quality improvement project highlights the importance of involving patients in their recovery, training staff on recovery principles, and ensuring continuity of care from inpatient to outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Recovery Programming on an Inpatient Acute Psychiatric Unit and Its Impact on Readmission. Koval, RD., Mcdonagh, J., Grubaugh, A., et al.[2017]

Research supports the recovery model for serious mental illness, particularly schizophrenia, showing that a significant number of individuals can achieve complete recovery or regain good social functioning, especially in developing countries.

Key factors in the recovery process include optimism about outcomes, access to employment, and empowerment of individuals, which are all backed by recent studies and can help reduce stigma associated with mental illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery from schizophrenia and the recovery model. Warner, R.[2019]

The Enhanced Recovery After Surgery® program significantly improved compliance from 35.7% to 80.8% among 112 patients undergoing elective colorectal surgery, indicating effective implementation of the protocol.

Patients in the Enhanced Recovery After Surgery® group experienced shorter hospital stays, quicker return of bowel function, and fewer medical complications compared to those receiving conventional care, demonstrating the program's efficacy in enhancing recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ERAS® Program in a Portuguese Hospital: Results from Elective Colorectal Surgery after One Year of Implementation. Carrão, A., Ribeiro, D., Manso, M., et al.[2021]

Program directors using the NAVIGATE model reported challenges in accurately diagnosing patients with early psychosis at the time of admission, highlighting a need for improved diagnostic processes.

Supporting families of individuals experiencing psychosis was identified as a crucial yet complex component of the NAVIGATE program, suggesting that family involvement is essential for effective early intervention in mental health treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NAVIGATE Program Directors' perspectives on treatment for early psychosis. Coudray, C., Williams-Wengerd, A., Gingerich, S., et al.[2023]

Enhanced recovery after surgery programs focus on improving patient outcomes using established medical practices rather than new drugs, aiming for faster recovery and reduced complications.

These programs effectively manage postoperative factors like pain and mobility to minimize surgical stress, leading to shorter hospital stays and lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Enhanced recovery after surgery program]. Taniguchi, H.[2011]

The Illness Management and Recovery Program significantly improved illness management in patients with schizophrenia, as evidenced by higher scores on the Illness Management and Recovery Scale after the intervention and at a 1-month follow-up, compared to the control group of 25 patients.

While the program did not show a significant overall improvement in social functioning, it did enhance pro-social activities, suggesting targeted benefits in specific areas of social engagement for patients with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of illness management and recovery program in patients with schizophrenia. Polat, S., Kutlu, Y.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10548755/

Delirium and neuropsychological recovery among emergency ... The purpose of this study is to evaluate the ability of a collaborative care model on the neuropsychologic recovery of delirium survivors following emergency ...

2. reporter.nih.gov reporter.nih.gov/project-details/11129888

Emergency General Surgery Delirium Recovery Model Project Summary Delirium is a complex neuropsychiatric syndrome characterized by acute and fluctuating changes in cognition and consciousness. Delirium ...

3. ichgcp.net ichgcp.net/clinical-trials-registry/NCT05373017

Questionnaires and DANE Recovery Program in Delirium This study will evaluate the usefulness of the Urgent and Emergency Surgery (UES) Delirium Recovery Model. It is hypothesized that the ...

4. researchgate.net researchgate.net/publication/374418287_Delirium_and_neuropsychological_recovery_among_emergency_general_surgery_survivors_DANE_study_protocol_for_a_randomized_controlled_trial_and_collaborative_care_intervention

(PDF) Delirium and neuropsychological recovery among ... The purpose of this study is to evaluate the ability of a collaborative care model on the neuropsychologic recovery of delirium survivors following emergency ...

5. research-studies.allinforhealth.info research-studies.allinforhealth.info/us/en/listing/11734/delirium-and-neuropsychological-recovery/

Delirium and Neuropsychological Recovery Among ... This study will evaluate the usefulness of the Emergency General Surgery (EGS) Delirium Recovery Model. It is hypothesized that the ...

6. clinicaltrial.be clinicaltrial.be/en/details/17128?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Delirium and Neuropsychological Recovery Among ... DANE Recovery Model. The delivery of the model will occur in five phases that correspond to the known stages of recovery after surgery. During ...