Cirrhosis Readmission Telehealth Project

Cirrhosis Clinical Trial

Official title:

Cirrhosis Readmission Telehealth Project

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02313896
• Other study ID #: 1403013528
• Status: Terminated
• Phase: N/A
• First received: December 8, 2014
• Last updated: October 13, 2016
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Readmission	Time to hospital readmission after discharge during the 3 month study period for hepatic encephalopathy	up to 3 months	No