Transitional Care Program vs Standard of Care in Cirrhosis With Volume Overload: A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Transitional Care Program
- Conditions
- Cirrhosis, Liver
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of instances of weight monitoring
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
Karen Krok
Professor of Medicine
Milton S. Hershey Medical Center
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
Arms & Interventions
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.
Intervention: Transitional Care Program
Standard of Care
Participants will be given typical discharge and follow up instructions.
Outcomes
Primary Outcomes
Number of instances of weight monitoring
Time Frame: 8 weeks for each participant
at home monitoring weight
feasibility of the program
Time Frame: all 8 weeks of each participant
how much time does it take to review material and complete phone calls
Number of follow up visits
Time Frame: 8 weeks for each participant
lab visits, primary care visits, hepatology visits
Number of successful phone calls
Time Frame: 8 weeks for each participant
weekly phone call with participant
Secondary Outcomes
- Number of subjects that develop Acute Kidney Injury(12 months)
- Number of Hospitalizations per participant(12 months)
- Number of subjects that continue to have volume overload(12 months)
- Number of subjects that expire(12 months)