Telehealth Intervention in Cirrhotics

Liver Diseases Clinical Trial

Official title:

Use of A Telehealth Intervention to Decrease Readmissions in Cirrhosis: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969186
• Other study ID #: 828183
• Secondary ID: chbgaidc
• Status: Completed
• Phase: N/A
• Start date: October 11, 2017
• Est. completion date: August 31, 2023

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized controlled trial comparing a simple telehealth intervention implemented after hospital discharge to standard of care, specifically looking at the number of hospital readmissions throughout the course of the study. All cirrhotic patients admitted to the Hepatology service at The Hospital of the University of Pennsylvania will be approached and consenting patients will be randomized to one of the two arms as outlined below. Patients will be followed for 90 days with daily texts and weekly phone calls. The rates of 30 and 90 day readmission as well as the days to readmission will be compared between the two study groups.

Description:

Patients with cirrhosis and ascites comprise a large percentage of hospital admissions. As a large transplant center, the University of Pennsylvania sees an average of 54-65 cirrhotic patients admitted to the hepatology service every month. Many of these admissions are preventable and can be attributed to poor medication adherence and late detection of clinical deterioration. By introducing a telehealth intervention following hospital discharge, investigators seek to decrease the number of readmissions for these patients by encouraging and assisting with improved adherence and by regularly tracking the progression of symptoms.

This interventional study will serve a dual purpose of helping both the patient and their provider. Patients will obtain an extra line of communication to their providers that eases their ability to access resources and alert their providers to new symptoms. Similarly, by instituting a triaged system of communication with the patient, their health team is able to offer more individualized treatment while also providing more immediate attention at the first signs of clinical deterioration. This study will determine rates of 30 and 90-day readmissions in both cohorts as a way to examine the impact of a simple telehealth intervention compared to standard of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: August 31, 2023
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of cirrhosis of the liver

• Admitted to the Hospital of the University of Pennsylvania

• Ability to read and provide informed consent in English

• Ability to read and provide informed consent or surrogate present who can provide consent

• Possess a cell phone and willing to receive text messages.

• Has a surrogate who with a cell phone who is willing to receive and sent text messages for patient

Exclusion Criteria:

• Inability to provide informed consent in English

• Inability to provide informed consent or lack of surrogate who can provide consent

• Non-Cirrhotic

• Has received a liver transplant

• Discharged to hospice or has a disease process other than cirrhosis (i.e. severe heart disease or cancer) accounting for a high chance of mortality in the next 6 months.

• Advance symptoms of other disease process or too medically complex

• Actively using illicit substances or alcohol

• No access to cell phone with texting capability

• Not followed at the Hospital of the University of Pennsylvania

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis
• Liver Diseases

Intervention

Behavioral:
• Intervention
Telehealth intervention monitoring weight and medication adherence accompanied by a weekly phone call to monitor symptoms.

Locations

Country	Name	City	State
United States	The Hospital of the University of Pennslyvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A change in readmission rates of cirrhotic patients	Number of hospital readmissions during the 90 day intervention compared to control arm	90 Days
Secondary	A difference in patient or caregiver satisfaction post-discharge.	Self-reported patient satisfaction in surveys at 30 and 90 days looking at the research team's effectiveness, as well as provider communication. Satisfaction will be scored on a sliding scale and statistically analyzed to provide a quantifiable difference in satisfaction post-discharge for patients based on several aspects of their care.	90 Days