Cirrhosis Readmission Telehealth Project

Not Applicable

Terminated

• Conditions: Cirrhosis
• Interventions: Behavioral: Phone calls

• Registration Number: NCT02313896
• Lead Sponsor: Yale University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-10
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phone calls	Phone calls	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.

Primary Outcome Measures

Name	Time	Method
Hospital Readmission	up to 3 months	Time to hospital readmission after discharge during the 3 month study period for hepatic encephalopathy

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States