Transitional Care Program for Fluid Overload in Cirrhosis

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cirrhosis, Liver
• Intervention / Treatment: Behavioral: Transitional Care Program

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alison J Faust, MD; Phone Number: 7175311017; Email: afaust1@pennstatehealth.psu.edu
• Study Contact Backup: Name: Shannon F Dalessio; Phone Number: 320883 7175310003; Email: sdalessio@pennstatehealth.psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: edema; ascites; anasarca
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: STUDY00023071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No