- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03969186
Telehealth Intervention in Cirrhotics
Use of A Telehealth Intervention to Decrease Readmissions in Cirrhosis: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- The Hospital of the University of Pennslyvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Telehealth intervention monitoring weight and medication adherence accompanied by a weekly phone call to monitor symptoms.
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No Intervention: Standard of care follow-up
Standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
90 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
90 Days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vandana Khungar, MD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 828183
- chbgaidc (Other Identifier: University of Pennsylvania Institutional Review Board)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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