The Cirrhosis Outpatient Optimization, Readmission & Safety Study (Vivify)

COORS: The Cirrhosis Outpatient Optimization, Readmission & Safety Study

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

Study Overview

• Status: Terminated
• Conditions: Cirrhosis
• Intervention / Treatment: Device: Vivify Kit

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Center for Inflammatory Bowel Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Vivify Kit; home telemonitoring devices with vital sign capturing capabilities, i.e. blood pressure, weight, pulse, and specific questionnaires targeted to the cirrhosis diagnosis.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of 30-day readmissions between intervention and control group	Compare hospital readmission rates between the intervention group (device) and control group	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of emergency room visits between the two study groups for ED visits within 30 days post discharge. (composite measure)	Number of ED visits will be measured and compared for both of the groups	30 days
Blood pressure control	Overall control of blood pressure between the two groups will be compared	30 days
Weight compliance	Weight changes will be monitored and compared between two groups	30 days
Medication compliance	Medication compliance will be monitored and compared between two groups	30 days

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Daniel W Hommes, MD, PhD, University of California, Los Angeles

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: February 25, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimated): May 29, 2015

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis
• Other Study ID Numbers: COORS