Skip to main content
OpenTrials
Completed

NCT Number: NCT03969186

Telehealth Intervention in Cirrhotics

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cirrhosis, Liver Ascites Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fibrosis Hepatic Encephalopathy Hepatic Insufficiency Liver Cirrhosis Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital of the University of Pennslyvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Behavioral

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

Primary outcomes

  1. A change in readmission rates of cirrhotic patients

    Time frame: 90 Days

    Number of hospital readmissions during the 90 day intervention compared to control arm

Secondary outcomes

  1. A difference in patient or caregiver satisfaction post-discharge.

    Time frame: 90 Days

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2023
First posted
May 31, 2019
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.