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Telehealth Intervention in Cirrhotics

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ClinicalTrials.gov Identifier: NCT03969186
Recruitment Status : Active, not recruiting
First Posted : May 31, 2019
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Cirrhosis, Liver Liver Diseases Behavioral: Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of A Telehealth Intervention to Decrease Readmissions in Cirrhosis: A Randomized Controlled Trial
Actual Study Start Date : October 11, 2017
Actual Primary Completion Date : June 26, 2020
Estimated Study Completion Date : July 31, 2021


Arm Intervention/treatment
Experimental: Daily telehealth follow-up
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.
Behavioral: Intervention
Telehealth intervention monitoring weight and medication adherence accompanied by a weekly phone call to monitor symptoms.

No Intervention: Standard of care follow-up
Standard of care



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969186


Locations
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United States, Pennsylvania
The Hospital of the University of Pennslyvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Vandana Khungar, MD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Study Protocol  [PDF] September 26, 2018
Informed Consent Form  [PDF] June 20, 2019

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03969186    
Other Study ID Numbers: 828183
chbgaidc ( Other Identifier: University of Pennsylvania Institutional Review Board )
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
Telehealth
Cirrhosis
Ascites
Hepatic encephalopathy
Readmissions
Preventable readmissions
Liver diseases
Variceal bleeding
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Fibrosis
Pathologic Processes
Digestive System Diseases