Cirrhosis Readmission Telehealth Project

NCT02313896 | Terminated

• 1 other identifier: 1403013528
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Hospital Readmission

  Time to hospital readmission after discharge during the 3 month study period for hepatic encephalopathy

  up to 3 months

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Phone calls

EXPERIMENTAL

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

Interventions

Phone calls BEHAVIORAL

Phone calls from medical staff assess confusion of the patient, and recommend immediate changes to dosage of lactulose.

Phone calls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guadalupe Garcia-Tsao, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

US (1)