Cirrhosis Readmission Telehealth Project

Yale University

Status: Terminated

Conditions: Cirrhosis

Treatments: Behavioral: Phone calls

Study type: Interventional

Funder types: Other

Identifiers

NCT02313896

1403013528

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Phone calls