Transitional Care Program for Fluid Overload in Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transitional Care Program.
- Who it may be relevant to
- Registry conditions: Cirrhosis, Liver. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transitional Care Program vs Standard of Care in Cirrhosis With Volume Overload: A Pilot Study
Overview
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.
Interventions
- Behavioral Transitional Care Program
Intensive monitoring post discharge for cirrhosis and fluid overload
Primary outcome measures
- feasibility of the program [Time frame: all 8 weeks of each participant]
- Number of instances of weight monitoring [Time frame: 8 weeks for each participant]
- Number of successful phone calls [Time frame: 8 weeks for each participant]
- Number of follow up visits [Time frame: 8 weeks for each participant]
Secondary outcome measures (4)
- Number of Hospitalizations per participant [Time frame: 12 months]
- Number of subjects that develop Acute Kidney Injury [Time frame: 12 months]
- Number of subjects that continue to have volume overload [Time frame: 12 months]
- Number of subjects that expire [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Penn State Milton S. Hershey Medical Center — Hershey
Identifiers
NCT: NCT06174272 · STUDY00023071