Transitional Care Program for Liver Cirrhosis

Overseen By Karen L Krok, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Must be taking: Diuretics

Disqualifiers: TIPS, Malignancy, Heart failure, others

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn about an intensive monitoring plan (transitional care program) in patients with cirrhosis and excessive swelling that are going to be discharged from the hospital. The main question\[s\] it aims to answer are: * How much time and what resources are needed to run such a program * How well do patients follow up with the phone calls, bloodwork, and doctor appointments? * Do the patients enrolled in the program have less need for hospitalization later, less kidney injury, better fluid control, and/or better survival compared to patients that are not in the program? Participants will * Be given a digital scale and a binder with educational material and a log to monitor their weights after discharge from the hospital * Receive a phone call from the study team within 72 hours of discharge and weekly * Be given a follow up appointment with hepatology within 4 weeks of discharge Researchers will compare participants in this program to patients that receive normal care to see if there are differences in need for hospitalization later, kidney injury, fluid control, and/or survival.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Transitional Care Program for Fluid Overload in Cirrhosis treatment?

Research shows that outpatient telephonic transitional care after hospital discharge can improve survival in patients with liver cirrhosis. Additionally, nurse-led outpatient care and interventions like dietary sodium restriction and diuretics have been effective in managing fluid overload in cirrhosis, potentially reducing hospitalizations. ^{1 2 3 4 5}

Is the Transitional Care Program for Liver Cirrhosis safe for humans?

Nurse-led outpatient care, which is part of the Transitional Care Program, has been shown to be safe and feasible for managing chronic diseases, including liver cirrhosis. ^{3 4 6 7 8}

How is the Transitional Care Program for Liver Cirrhosis different from other treatments?

The Transitional Care Program for Liver Cirrhosis is unique because it focuses on improving the transition from hospital to home, aiming to reduce readmissions and enhance patient quality of life by providing continuous support and education to patients and their families after discharge. ^{9 10 11 12 13}

Research Team

Karen L Krok, MD

Principal Investigator

Penn State College of Medicine

Eligibility Criteria

This trial is for English-speaking adults over 18 with cirrhosis, hospitalized at Penn State Health with fluid overload needing diuretics. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

I am over 18 years old.

English speaking

Inpatient at Penn State Health, Milton S. Hershey Medical Center

Exclusion Criteria

I have had a procedure to create a new pathway in my liver.

I do not speak English.

I have fluid in my abdomen not caused by liver cirrhosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transitional Care Program

Participants receive a digital scale, educational materials, and a monitoring log. They receive a phone call within 72 hours of discharge and weekly for 8 weeks, and a follow-up appointment with a hepatologist within 4 weeks of discharge.

8 weeks

1 initial phone call, weekly phone calls, 1 follow-up appointment

Follow-up

Participants are monitored for long-term outcomes such as hospitalization, kidney injury, fluid control, and survival.

12 months

Treatment Details

Interventions

• Transitional Care Program

Trial Overview The study tests a transitional care program involving intensive monitoring after hospital discharge. This includes education, digital weight tracking, regular phone calls and follow-ups to improve health outcomes versus standard care.

Participant Groups

Group I: Transitional Care Program Experimental Treatment 1 Intervention

Participants will receive a digital scale and monitoring log, educational material, a phone call within 72 hours of discharge and weekly for 8 weeks, and a follow up appointment with a hepatologist within 4 weeks of discharge.

Group II: Standard of Care Active Control 1 Intervention

Participants will be given typical discharge and follow up instructions.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Findings from Research

Cirrhotic patients who received outpatient telephonic transitional care (OTTC) after hospital discharge had a significantly higher 6-month survival rate (84.2%) compared to those who did not receive OTTC (68.8%), indicating that this intervention may improve long-term outcomes.

Despite the improved survival, the readmission rates at 1, 3, and 6 months were similar between the OTTC group and the control group, suggesting that readmission rates may not be a reliable measure of the quality of care or the effectiveness of transitional care programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient telephonic transitional care after hospital discharge improves survival in cirrhotic patients. Rao, BB., Sobotka, A., Lopez, R., et al.[2020]

The management of cirrhosis with fluid overload has improved significantly, focusing on maximizing both life expectancy and quality of life, particularly after the development of ascites, which indicates a poor prognosis.

Dietary sodium restriction and diuretics effectively control fluid overload in over 90% of patients, with only 10% requiring more advanced second-line treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of patients with cirrhosis and ascites. Runyon, BA.[2005]

Outpatient interventions, such as dietary sodium restriction and diuretics, can significantly reduce preventable hospitalizations for cirrhotic patients experiencing fluid retention, based on a review of 17 studies involving 1,694 patients.

The review identified six effective outpatient management strategies, including daily weight monitoring and albumin infusions, which can help manage fluid retention and improve patient outcomes without the need for hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient interventions for hepatology patients with fluid retention: a review and synthesis of the literature. White, A.[2018]

Nurse-assisted follow-up care for patients with decompensated liver cirrhosis has shown potential benefits in improving health outcomes, including reduced mortality and readmission rates, based on a review of 16 studies involving 1224 participants.

Despite the observed improvements, the studies varied in quality and design, and there is currently no consensus on the most effective type of nurse-assisted intervention, highlighting the need for more rigorous, standardized research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-assisted and multidisciplinary outpatient follow-up among patients with decompensated liver cirrhosis: A systematic review. O'Connell, MB., Bendtsen, F., Nørholm, V., et al.[2023]

Recent research highlights innovative strategies to enhance cirrhosis care, including the use of technology like virtual care and smartphone applications, as well as engaging caregivers and non-physicians in outpatient settings.

Inpatient care improvements focus on interdisciplinary teams and education, while post-discharge strategies involve care coordinators and day hospitals, demonstrating a comprehensive approach to managing cirrhosis across different healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to Improve Delivery of Cirrhosis Care. Moghe, A., Yakovchenko, V., Morgan, T., et al.[2022]

In a study of 90 cirrhotic patients with hepatitis C, those with clinically significant portal hypertension had a much lower rate of sustained virologic response (14%) compared to those without it (51%), highlighting the impact of portal hypertension on treatment efficacy.

Hepatovenous pressure gradient (HVPG) was found to be a strong independent predictor of treatment response, outperforming other factors like liver stiffness and baseline HCV RNA levels, suggesting that measuring HVPG should be a key part of evaluating cirrhotic patients for antiviral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Portal pressure predicts outcome and safety of antiviral therapy in cirrhotic patients with hepatitis C virus infection. Reiberger, T., Rutter, K., Ferlitsch, A., et al.[2023]

Hepatic encephalopathy (HE) significantly worsens outcomes for patients with cirrhosis, leading to higher rates of hospital readmission and mortality, highlighting the need for effective management strategies.

Combining lactulose with rifaximin and implementing supportive care initiatives, such as patient education and telemedicine, can improve post-discharge outcomes and reduce readmission rates for patients with HE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatic Encephalopathy-Related Hospitalizations in Cirrhosis: Transition of Care and Closing the Revolving Door. Frenette, CT., Levy, C., Saab, S.[2022]

In an international trial involving 43 patients with chronic hepatitis C and compensated cirrhosis, a quadruple therapy regimen including danoprevir/r, mericitabine, and peginterferon alfa/ribavirin achieved a high sustained virological response (SVR24) rate of 65% in prior null responders, indicating its efficacy for difficult-to-treat patients.

The study found that treatment with danoprevir/r-based regimens was safe and well tolerated, with no deaths or episodes of hepatic decompensation reported, suggesting a favorable safety profile for these antiviral treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ritonavir-boosted danoprevir-based regimens in treatment-naive and prior null responders with HCV genotype 1 or 4 and compensated cirrhosis. Gane, EJ., Rouzier, R., Hassanein, T., et al.[2022]

In a study involving 199 participants aged over 60 with multiple health issues, the Mayo Clinic Care Transitions (MCCT) program did not show a significant improvement in quality of life (QoL) compared to usual care after one year.

While 74% of MCCT participants reported good-to-excellent QoL at baseline, this dropped to 64% after one year, indicating a potential decline in QoL that may be due to the progression of chronic diseases rather than the effectiveness of the MCCT program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient quality of life in the Mayo Clinic Care Transitions program: a survey study. Faucher, J., Rosedahl, J., Finnie, D., et al.[2020]

The cross-continuum program developed by the Care Transitional Task Force at San Francisco General Hospital has successfully reduced patient readmissions and increased timely primary care visits after discharge.

Transitional care nurses play a crucial role in supporting heart failure patients and older patients with chronic conditions by providing education and follow-up care for 30 days post-discharge, ensuring better continuity of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety net hospital, community providers collaborate to improve transitions. [2016]

A new transitional cancer care program was developed in Iran, focusing on continuity of care for patients moving from hospital to home, which is crucial for reducing unnecessary hospital admissions and complications.

The program, validated by expert feedback with a content validity of 98.7% and feasibility of 95.8%, includes integrated services, holistic care, and the use of telemedicine, structured in three phases: pre-discharge, post-discharge, and transitional care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitional Cancer Care Program from Hospital to Home in the Health Care System of Iran. Alizadeh, Z., Rohani, C., Rassouli, M., et al.[2021]

A systematic review of 21 studies involving 2069 older adults showed that 80% of participants in Transition Care Programmes (TCP) were successfully discharged home, indicating a positive outcome for this intervention.

There was a significant improvement in the ability to perform daily activities among older adults in TCP, with an average increase of 17.65 points on the Modified Barthel Index, suggesting that TCP can enhance functional recovery after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of facility-based transition care on health-related outcomes for older adults: A systematic review and meta-analysis. Hang, JA., Naseri, C., Francis-Coad, J., et al.[2021]

The Transitional Care Management (TCM) program implemented at Eastern Virginia Medical Group showed a significant reduction in hospital readmission rates at 60 and 90 days post-discharge, indicating its effectiveness in improving patient outcomes.

While initial analyses did not show significant differences in readmission rates or costs at 30 days, the follow-up results suggest that TCM can provide ongoing benefits beyond the immediate post-discharge period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of a Team-Based Approach to Hospital Discharge Transition of Care. Van De Graaf, M., Patel, H., Sheehan, B., et al.[2022]

References

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

Outpatient telephonic transitional care after hospital discharge improves survival in cirrhotic patients. [2020]

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

Treatment of patients with cirrhosis and ascites. [2005]

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

Outpatient interventions for hepatology patients with fluid retention: a review and synthesis of the literature. [2018]

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

Nurse-assisted and multidisciplinary outpatient follow-up among patients with decompensated liver cirrhosis: A systematic review. [2023]

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

Strategies to Improve Delivery of Cirrhosis Care. [2022]

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

Portal pressure predicts outcome and safety of antiviral therapy in cirrhotic patients with hepatitis C virus infection. [2023]

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

Hepatic Encephalopathy-Related Hospitalizations in Cirrhosis: Transition of Care and Closing the Revolving Door. [2022]

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

Ritonavir-boosted danoprevir-based regimens in treatment-naive and prior null responders with HCV genotype 1 or 4 and compensated cirrhosis. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Patient quality of life in the Mayo Clinic Care Transitions program: a survey study. [2020]

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

Safety net hospital, community providers collaborate to improve transitions. [2016]

11. Thailand pubmed.ncbi.nlm.nih.gov

Transitional Cancer Care Program from Hospital to Home in the Health Care System of Iran. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Effectiveness of facility-based transition care on health-related outcomes for older adults: A systematic review and meta-analysis. [2021]

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

Implementation and Evaluation of a Team-Based Approach to Hospital Discharge Transition of Care. [2022]