The Cirrhosis Outpatient Optimization, Readmission & Safety Study

Cirrhosis Clinical Trial

— Vivify  

Official title:

COORS: The Cirrhosis Outpatient Optimization, Readmission & Safety Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02457988
• Other study ID #: COORS
• Status: Terminated
• Phase: Early Phase 1
• First received: February 25, 2015
• Last updated: October 24, 2017
• Start date: April 2015
• Est. completion date: March 2018

Study information

• Verified date: October 2017
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: March 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Center for Inflammatory Bowel Diseases	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Erratum in: Clin Gastroenterol Hepatol. 2011 Jul;9(7):625. Vuppalanch, Raj [corrected to Vuppalanchi, Raj]. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Blood pressure control	Overall control of blood pressure between the two groups will be compared	30 days
Secondary	Weight compliance	Weight changes will be monitored and compared between two groups	30 days
Secondary	Medication compliance	Medication compliance will be monitored and compared between two groups	30 days