The Cirrhosis Outpatient Optimization, Readmission & Safety Study

Early Phase 1

Terminated

• Conditions: Cirrhosis
• Interventions: Device: Vivify Kit

• Registration Number: NCT02457988
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2015-02-25
• Study Start: 2015-04
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-29
• Status Verified: 2017-10
• Primary Completion: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vivify Kit	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.

Primary Outcome Measures

Name	Time	Method
Number of 30-day readmissions between intervention and control group	30 days	Compare hospital readmission rates between the intervention group (device) and control group

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UCLA Center for Inflammatory Bowel Diseases; 🇺🇸 Los Angeles, California, United States