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Cirrhosis Readmission Telehealth Project

Cirrhosis Readmission Telehealth Project

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02313896
Enrollment
10
Registered
2014-12-10
Start date
2014-07-31
Completion date
2016-06-30
Last updated
2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

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.

Interventions

BEHAVIORALPhone calls

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

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hospital Readmissionup to 3 monthsTime to hospital readmission after discharge during the 3 month study period for hepatic encephalopathy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026