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

Primary Purpose

Cirrhosis

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vivify Kit
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Center for Inflammatory Bowel Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vivify Kit

Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Blood pressure control
Overall control of blood pressure between the two groups will be compared
Weight compliance
Weight changes will be monitored and compared between two groups
Medication compliance
Medication compliance will be monitored and compared between two groups

Full Information

First Posted
February 25, 2015
Last Updated
October 24, 2017
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02457988
Brief Title
The Cirrhosis Outpatient Optimization, Readmission & Safety Study
Acronym
Vivify
Official Title
COORS: The Cirrhosis Outpatient Optimization, Readmission & Safety Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Increased recruitment difficulties
Study Start Date
April 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vivify Kit
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vivify Kit
Intervention Description
home telemonitoring devices with vital sign capturing capabilities, i.e. blood pressure, weight, pulse, and specific questionnaires targeted to the cirrhosis diagnosis.
Primary Outcome Measure Information:
Title
Number of 30-day readmissions between intervention and control group
Description
Compare hospital readmission rates between the intervention group (device) and control group
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of emergency room visits between the two study groups for ED visits within 30 days post discharge. (composite measure)
Description
Number of ED visits will be measured and compared for both of the groups
Time Frame
30 days
Title
Blood pressure control
Description
Overall control of blood pressure between the two groups will be compared
Time Frame
30 days
Title
Weight compliance
Description
Weight changes will be monitored and compared between two groups
Time Frame
30 days
Title
Medication compliance
Description
Medication compliance will be monitored and compared between two groups
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ascites requiring paracentesis during the hospitalization Hepatic encephalopathy defined as altered mental status that improves after treatment with lactulose Variceal hemorrhage, defined as clinically significant gastrointestinal bleed (tachycardia, hypotension, requirement for blood transfusion, or >2g drop in hemoglobin) and varices seen on endoscopy Spontaneous bacterial peritonitis defined as >250 polymorphonuclear cells per high-power field and/or monomicrobial culture in the ascetic fluid 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 Hyponatremia, defined by serum sodium <130 on admission labs 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel W Hommes, MD, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Center for Inflammatory Bowel Diseases
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21931378
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.
Results Reference
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PubMed Identifier
21092762
Citation
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].
Results Reference
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The Cirrhosis Outpatient Optimization, Readmission & Safety Study

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