Transitional Care Program for Fluid Overload in Cirrhosis
- Conditions
- Cirrhosis, Liver
- Interventions
- Behavioral: Transitional Care Program
- Registration Number
- NCT06174272
- Lead Sponsor
- Milton S. Hershey Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- Placement of a TIPS.
- Ascites from an etiology other than cirrhosis, such as malignancy, heart failure, pancreatitis, nephrotic syndrome.
- Non-English speaking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transitional Care Program 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.
- Primary Outcome Measures
Name Time Method Number of instances of weight monitoring 8 weeks for each participant at home monitoring weight
feasibility of the program all 8 weeks of each participant how much time does it take to review material and complete phone calls
Number of follow up visits 8 weeks for each participant lab visits, primary care visits, hepatology visits
Number of successful phone calls 8 weeks for each participant weekly phone call with participant
- Secondary Outcome Measures
Name Time Method Number of subjects that develop Acute Kidney Injury 12 months Creatinine increase of \>0.3g/dL
Number of Hospitalizations per participant 12 months number of admissions to the hospital
Number of subjects that continue to have volume overload 12 months persistent weight above dry weight and/or ongoing ascites/lower extremity edema/pleural effusion
Number of subjects that expire 12 months subject death
Trial Locations
- Locations (1)
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States