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Clinical Trials/NCT03969186
NCT03969186CompletedNot Applicable

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

University of Pennsylvania1 site in 1 country277 target enrollmentStarted: October 11, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
277
Locations
1
Primary Endpoint
A change in readmission rates of cirrhotic patients

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Daily telehealth follow-up

Experimental

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.

Intervention: Intervention (Behavioral)

Standard of care follow-up

No Intervention

Standard of care

Outcomes

Primary Outcomes

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

  • A difference in patient or caregiver satisfaction post-discharge.(90 Days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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