Back to resultsCirrhosis Readmission Telehealth Project
Primary Purpose
Cirrhosis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phone calls
Sponsored by
About this trial
This is an interventional prevention trial for Cirrhosis
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
Sites / Locations
- Yale New Haven Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
Phone calls
Arm 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.
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.
Outcomes
Primary Outcome Measures
Hospital Readmission
Time to hospital readmission after discharge during the 3 month study period for hepatic encephalopathy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02313896
Brief Title
Cirrhosis Readmission Telehealth Project
Official Title
Cirrhosis Readmission Telehealth Project
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm 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.
Arm Title
Phone calls
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Phone calls
Intervention Description
Phone calls from medical staff assess confusion of the patient, and recommend immediate changes to dosage of lactulose.
Primary Outcome Measure Information:
Title
Hospital Readmission
Description
Time to hospital readmission after discharge during the 3 month study period for hepatic encephalopathy
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guadalupe Garcia-Tsao, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cirrhosis Readmission Telehealth Project
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