The Cirrhosis Outpatient Optimization, Readmission & Safety Study

NCT ID: NCT02457988

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-10-31

Brief Summary

A prospective series comparing care incorporating home monitoring and liver care coordination to conventional care for patients with cirrhosis.

Detailed Description

Telemonitoring has been suggested to have potential benefits in patients with cirrhosis. However, to date, no prospective studies exist to support this idea. Hence, the investigators study would like to explore the use of home telemonitoring devices with vital sign capturing capabilities in recently-discharged patients with cirrhosis to decrease 30-day readmissions, mortality and costs.

This is prospective, randomized controlled trial comparing two strategies of post-discharged care in patients with cirrhosis-related hospitalizations.

First treatment arm will incorporate the Vivify home monitoring device into post hospital care.Home monitoring kits include a tablet with wireless internet and vital sign monitoring capabilities (temperature, blood pressure, heart rate, weight and pulse oximetry if needed) and the device has the ability to trigger an alert to the "liver care coordinator."

Second treatment arm will continue the standard of care therapy that all post- hospitalized patients receive upon discharge, i.e. return to clinic appointments, education regarding any signs or worsening symptoms to watch for, as well as contact numbers to connect with their doctor or nurse.

Conditions

Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Vivify Kit

Patients with cirrhosis will undergo home monitoring for 30 days post-discharge through the use of the Vivify kit which contains a wireless tablet with daily medication/diet/symptom questionnaires and vital sign monitoring.

Group Type: EXPERIMENTAL

Vivify Kit

Intervention Type: DEVICE

home telemonitoring devices with vital sign capturing capabilities, i.e. blood pressure, weight, pulse, and specific questionnaires targeted to the cirrhosis diagnosis.

Standard of Care

Patients with cirrhosis will undergo standard of care, which includes a post-discharge lab check and follow-up clinic appointment. Otherwise, no day-to-day monitoring of these patients will occur.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vivify Kit

home telemonitoring devices with vital sign capturing capabilities, i.e. blood pressure, weight, pulse, and specific questionnaires targeted to the cirrhosis diagnosis.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Ascites requiring paracentesis during the hospitalization

2. Hepatic encephalopathy defined as altered mental status that improves after treatment with lactulose

3. Variceal hemorrhage, defined as clinically significant gastrointestinal bleed (tachycardia, hypotension, requirement for blood transfusion, or >2g drop in hemoglobin) and varices seen on endoscopy

4. Spontaneous bacterial peritonitis defined as >250 polymorphonuclear cells per high-power field and/or monomicrobial culture in the ascetic fluid

5. Renal failure in the presence of ascites, defined as a rise in the serum creatinine by 0.5mg/dl (to >1.5mg/dl), with ascites documented on physical exam or ultrasound, or admitted on diuretics for the treatment of ascites

6. Hyponatremia, defined by serum sodium <130 on admission labs

7. Hepatocellular carcinoma as seen on arterial phase MRI or liver biopsy, if tumor is treated and fits within Milan criteria

Exclusion Criteria

• Admissions for scheduled or elective procedures
• Patients with a comorbid conditions with a life expectancy of less than 12 months or ones that may confound a patient's clinical course

• Hepatocellular carcinoma
• Hepatorenal syndrome
• Hepatopulmonary syndrome
• Metastatic cancer
• Chronic kidney disease (pre-dialysis, dialysis)
• Congestive heart failure
• Diagnosed dementia
• HIV/AIDS
• Pregnancy or planned pregnancy during the study
• Those managed by palliative care
• Patients with liver transplants prior to or during the index hospitalization
• Patients unable to understand study procedures/instructions/use of the home monitoring device
• Patients unable to stand for <1 minute
• Patients living in nursing homes or similar institutions

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel W Hommes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Center for Inflammatory Bowel Diseases

Los Angeles, California, United States

Countries

United States

References

Volk ML, Tocco RS, Bazick J, Rakoski MO, Lok AS. Hospital readmissions among patients with decompensated cirrhosis. Am J Gastroenterol. 2012 Feb;107(2):247-52. doi: 10.1038/ajg.2011.314. Epub 2011 Sep 20.

Reference Type: BACKGROUND

PMID: 21931378 (View on PubMed)

Berman K, Tandra S, Forssell K, Vuppalanchi R, Burton JR Jr, Nguyen J, Mullis D, Kwo P, Chalasani N. Incidence and predictors of 30-day readmission among patients hospitalized for advanced liver disease. Clin Gastroenterol Hepatol. 2011 Mar;9(3):254-9. doi: 10.1016/j.cgh.2010.10.035. Epub 2010 Nov 17.

Reference Type: BACKGROUND

PMID: 21092762 (View on PubMed)

Other Identifiers

COORS

Identifier Type: -

Identifier Source: org_study_id