Transitional Care Program for Fluid Overload in Cirrhosis

Study Overview
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Brief Summary
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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.

Official Title
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Transitional Care Program vs Standard of Care in Cirrhosis With Volume Overload: A Pilot Study

Conditions
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Cirrhosis, Liver

Intervention / Treatment
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* Behavioral: Transitional Care Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 18 years of age. Inpatient at Penn State Health, Milton S. Hershey Medical Center. Diagnosis of cirrhosis. Hospitalized with fluid overload (ascites and/or significant anasarca/edema) requiring diuretic therapy. English speaking Exclusion Criteria: Placement of a TIPS. Ascites from an etiology other than cirrhosis, such as malignancy, heart failure, pancreatitis, nephrotic syndrome. Non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transitional Care Program<br>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. | Behavioral: Transitional Care Program<br>* Intensive monitoring post discharge for cirrhosis and fluid overload<br>|
| No Intervention: Standard of Care<br>Participants will be given typical discharge and follow up instructions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of the program | how much time does it take to review material and complete phone calls | all 8 weeks of each participant | 
| Number of instances of weight monitoring | at home monitoring weight | 8 weeks for each participant | 
| Number of successful phone calls | weekly phone call with participant | 8 weeks for each participant | 
| Number of follow up visits | lab visits, primary care visits, hepatology visits | 8 weeks for each participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Hospitalizations per participant | number of admissions to the hospital | 12 months | 
| Number of subjects that develop Acute Kidney Injury | Creatinine increase of >0.3g/dL | 12 months | 
| Number of subjects that continue to have volume overload | persistent weight above dry weight and/or ongoing ascites/lower extremity edema/pleural effusion | 12 months | 
| Number of subjects that expire | subject death | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ascites, anasarca, edema