Cirrhosis Readmission Telehealth Project

NCT ID: NCT02313896

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-06-30

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.

Conditions

Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Phone calls

Intervention Type: BEHAVIORAL

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

Interventions

Phone calls

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guadalupe Garcia-Tsao, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1403013528

Identifier Type: -

Identifier Source: org_study_id