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Increased recruitment difficulties
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A prospective series comparing care incorporating home monitoring and liver care coordination to conventional care for patients with cirrhosis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivify Kit | Experimental | 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. |
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| Standard of Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivify Kit | Device | home telemonitoring devices with vital sign capturing capabilities, i.e. blood pressure, weight, pulse, and specific questionnaires targeted to the cirrhosis diagnosis. |
| 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 |
| 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 |
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Inclusion 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
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| Name | Affiliation | Role |
|---|---|---|
| Daniel W Hommes, MD, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Center for Inflammatory Bowel Diseases | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21931378 | Background | 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. | |
| 21092762 | Background | 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. |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |