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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the EGS Delirium Recovery Program treatment for post-surgery delirium?

Recovery-oriented models of care, similar to the EGS Delirium Recovery Program, have been shown to improve patient satisfaction and outcomes, as well as reduce readmissions in psychiatric settings. This suggests that such recovery-focused approaches may also be beneficial in helping patients recover from post-surgery delirium. ^{1 2 3 4 5}

What makes the EGS Delirium Recovery Program unique compared to other treatments for post-surgery delirium?

The EGS Delirium Recovery Program is unique because it focuses on an enhanced recovery approach, which involves a combination of evidence-based practices to reduce surgical stress and improve recovery, rather than relying on new drugs or therapies. This multidisciplinary method aims to minimize complications and speed up recovery by managing factors like pain, gut function, and mobility. ^{6 7 8 9 10}

Research Team

Ben Zarzaur, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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® 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

NAVIGATE Program Directors' perspectives on treatment for early psychosis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Implementation of Recovery Programming on an Inpatient Acute Psychiatric Unit and Its Impact on Readmission. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of illness management and recovery program in patients with schizophrenia. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Recovery from schizophrenia and the recovery model. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Recovery and Recovering in Older Adults with Schizophrenia: A 5-Tier Model. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Development, Application and Analysis of an Enhanced Recovery Programme for Major Oesophagogastric Resection. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Results from an enhanced recovery program for cardiac surgery. [2020]

8. Portugal pubmed.ncbi.nlm.nih.gov

ERAS® Program in a Portuguese Hospital: Results from Elective Colorectal Surgery after One Year of Implementation. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Reducing postoperative complications and improving clinical outcome: Enhanced recovery after surgery in pancreaticoduodenectomy - A retrospective cohort study. [2018]

10. Japan pubmed.ncbi.nlm.nih.gov

[Enhanced recovery after surgery program]. [2011]