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Telehealth Intervention in Cirrhotics

Primary Purpose

Cirrhosis, Liver, Liver Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cirrhosis, Liver focused on measuring Telehealth, Cirrhosis, Ascites, Hepatic encephalopathy, Readmissions, Preventable readmissions, Liver diseases, Variceal bleeding

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital of the University of Pennslyvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Daily telehealth follow-up

Standard of care follow-up

Arm Description

The intervention arm will receive a simple telehealth intervention utilizing the Way to Health Platform engineered at the University of Pennsylvania. This platform will be used to send daily SMS messages to patients for 90 days following discharge and alert the research team to changes in patients' status. In addition, the patients in the intervention arm will receive a weekly phone call administered by members of the research team to assess their overall progress and well-being.

Standard of care

Outcomes

Primary Outcome Measures

A change in readmission rates of cirrhotic patients
Number of hospital readmissions during the 90 day intervention compared to control arm

Secondary Outcome Measures

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.

Full Information

First Posted
May 22, 2019
Last Updated
July 20, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03969186
Brief Title
Telehealth Intervention in Cirrhotics
Official Title
Use of A Telehealth Intervention to Decrease Readmissions in Cirrhosis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
June 26, 2020 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver, Liver Diseases
Keywords
Telehealth, Cirrhosis, Ascites, Hepatic encephalopathy, Readmissions, Preventable readmissions, Liver diseases, Variceal bleeding

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily telehealth follow-up
Arm Type
Experimental
Arm Description
The intervention arm will receive a simple telehealth intervention utilizing the Way to Health Platform engineered at the University of Pennsylvania. This platform will be used to send daily SMS messages to patients for 90 days following discharge and alert the research team to changes in patients' status. In addition, the patients in the intervention arm will receive a weekly phone call administered by members of the research team to assess their overall progress and well-being.
Arm Title
Standard of care follow-up
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
Telehealth intervention monitoring weight and medication adherence accompanied by a weekly phone call to monitor symptoms.
Primary Outcome Measure Information:
Title
A change in readmission rates of cirrhotic patients
Description
Number of hospital readmissions during the 90 day intervention compared to control arm
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
A difference in patient or caregiver satisfaction post-discharge.
Description
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.
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vandana Khungar, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital of the University of Pennslyvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Telehealth Intervention in Cirrhotics

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