Cirrhosis Readmission Telehealth Project

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.

Study Overview

• Status: Terminated
• Conditions: Cirrhosis
• Intervention / Treatment: Behavioral: Phone calls

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; 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; 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; Phone calls from medical staff assess confusion of the patient, and recommend immediate changes to dosage of lactulose.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Guadalupe Garcia-Tsao, MD, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 8, 2014
• First Posted (Estimate): December 10, 2014

Study Record Updates

• Last Update Posted (Estimate): October 14, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 1403013528