Cirrhosis Readmission Telehealth Project

Study Overview
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Brief Summary
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This is a 2 year research study to study if post discharge phone calls can help lengthen time to hospital readmissions for patients with encephalopathy.

Detailed Description
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The purpose of this randomized prospective pilot study is to decrease hospital readmissions for patients with hepatic encephalopathy. Patients who were admitted at YNHH with hepatic encephalopathy will be enrolled. Patients will then be randomized to one of two groups upon discharge. The control group will receive usual standard of care for hepatic encephalopathy (encephalopathy education, cirrhosis brochure, stool chart, and routine follow up with their primary care provider and hepatologist). The intervention group will receive usual standard of care as discussed above and phone calls for a 3-month period after their hospitalization.

Official Title
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Cirrhosis Readmission Telehealth Project

Conditions
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Cirrhosis

Intervention / Treatment
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* Behavioral: Phone calls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of at least 18 Patients with known cirrhosis Current hospitalization for overt hepatic encephalopathy as categorized by West Haven encephalopathy score of 2 or more Current hospitalization found no precipitants triggering encephalopathy as determined by the primary team Encephalopathy resolved at time of enrollment Has a telephone Able to obtain medications Exclusion Criteria: Altered mental status unrelated to cirrhosis Acute liver failure Expectation of liver transplant within 1 month after enrollment Chronic kidney disease with Cr > 2 mg/dL Respiratory insufficiency:moderate to sever COPD on pulmonary function test Electrolyte imbalances not corrected at enrollment Sodium less than 125 mmol/L Calcium greater than 10mg/dL Potassium < 2.5mmol/L Unable to give legal consent Deafness Infection, spontaneous bacterial peritonitis, gastrointestinal bleeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Patients recieve standard care. On discharge they receive an information packet about cirrhosis and hepatic encephalopathy. They will continue to follow with their doctor as usual. | |
| Experimental: Phone calls<br>On discharge, patients will receive an information package about cirrhosis and hepatic encephalopathy. In addition to regular visits with the doctor, they will receive phone calls from one of our research providers who will be a nurse practitioner, doctor, or physician assistant. In the first 2 weeks after discharge, they will receive phone calls every other day. For the following 10 weeks, they will receive phone calls once a week. | Behavioral: Phone calls<br>* Phone calls from medical staff assess confusion of the patient, and recommend immediate changes to dosage of lactulose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Readmission | Time to hospital readmission after discharge during the 3 month study period for hepatic encephalopathy | up to 3 months |