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
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis, Liver Liver Diseases||Behavioral: Intervention||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||277 participants|
|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|
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.
No Intervention: Standard of care follow-up
Standard of care
- 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
- 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.
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
|United States, Pennsylvania|
|The Hospital of the University of Pennslyvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Vandana Khungar, MD||University of Pennsylvania|