Transitional Care Program for Fluid Overload in Cirrhosis

Penn State Health

Status: Enrolling

Conditions: Cirrhosis, Liver

Treatments: Behavioral: Transitional Care Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06174272

STUDY00023071

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Transitional Care Program

Experimental group

Description:

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.

Treatment:

Behavioral: Transitional Care Program

Standard of Care

No Intervention group

Description:

Participants will be given typical discharge and follow up instructions.