Clinical trial NCT02457988: The Cirrhosis Outpatient Optimization, Readmission & Safety Study
Official title: COORS: The Cirrhosis Outpatient Optimization, Readmission & Safety Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Cirrhosis
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of 30-day readmissions between intervention and control group
timeFrame: 30 days
Secondary outcomes:
measure: Number of emergency room visits between the two study groups for ED visits within 30 days post discharge. (composite measure)
timeFrame: 30 days
measure: Blood pressure control
timeFrame: 30 days
measure: Weight compliance
timeFrame: 30 days
measure: Medication compliance
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Inflammatory Bowel Diseases
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Daniel W Hommes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.