Transitional Care Program vs Standard of Care in Cirrhosis With Volume Overload: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of instances of weight monitoring
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Placement of a TIPS.
- •Ascites from an etiology other than cirrhosis, such as malignancy, heart failure, pancreatitis, nephrotic syndrome.
- •Non-English speaking
研究组 & 干预措施
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.
干预措施: Transitional Care Program (Behavioral)
Standard of Care
Participants will be given typical discharge and follow up instructions.
结局指标
主要结局
Number of instances of weight monitoring
时间窗: 8 weeks for each participant
at home monitoring weight
feasibility of the program
时间窗: all 8 weeks of each participant
how much time does it take to review material and complete phone calls
Number of follow up visits
时间窗: 8 weeks for each participant
lab visits, primary care visits, hepatology visits
Number of successful phone calls
时间窗: 8 weeks for each participant
weekly phone call with participant
次要结局
- 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)
研究者
Karen Krok
Professor of Medicine
Milton S. Hershey Medical Center