Patients with cirrhosis are prone to clinical and psycho-social issues that manifest as patient-reported outcomes (PRO), which can independently predict hospitalization, re-hospitalizations and death. Our group has studied the impact of these PRO extensively. With the increasing spread of health-related electronic devices, the relevance of health IT in the management of chronic diseases such as cirrhosis is paramount. The team has already developed and used several health IT advances to educate patients and their caregivers in inpatient and outpatient settings. These tools include Patient Buddy to prevent avoidable readmissions and EncephalApp Stroop to detect and guide therapy for cognitive dysfunction in cirrhosis. However the evaluation of these tools in a multi-center study that adapts to the status of the patients and their caregivers is required. The central hypothesis is that cirrhotic patients randomized to health IT interventions that elicit PROs in a structured outpatient setting will have a significantly greater reduction in hospital readmissions because of improved communication with their medical teams compared to standard of care regardless of scheduled return outpatient visits. This will be tested using the following two specific aims in three centers (Virginia Commonwealth University, Richmond VA Medical Center and Mayo Clinic).
Specific Aim 1 : To evaluate in a multi-center, randomized trial the effectiveness of PROs elicited using PatientBuddy and EncephalApp with and without scheduled outpatients return visits on the prevention of avoidable 30 day readmissions in patients with cirrhosis and their caregivers compared to standard of care. We will include 450 total cirrhotic patients and 450 caregivers (150 patients and 150 caregivers per center), who will be followed for 30 days post-discharge. The groups will be randomized 1:1:1 into a standard of care group, a group receiving health IT interventions who will receive PatientBuddy and EncephalApp with as-needed follow-up and another group that receives the same health IT interventions along with scheduled outpatient visits and calls within 30 days of discharge. Avoidable readmissions will be adjudged using a blinded adjudication committee and the differences between the three groups will be compared.
Specific aim 2 : To incorporate the opinion of key stakeholders (patients, caregivers and nurse managers) towards improving the Patient Buddy App in the prevention of readmission in cirrhosis. As part of this trial, we will also elicit feedback regarding the ease, safety and personal effectiveness of these interventions as well as their personal comfort and educational value of the App with and without the scheduled outpatient follow-up, from the patients, caregivers and administering staff. This will be compared between centers and used to enhance the Patient Buddy App in collaboration with our technology partners. The updated App will then be available for future studies in larger cirrhosis populations.

Public Health Relevance

Patients with cirrhosis have a high likelihood of being hospitalized and readmitted post hospital dismissal, which could be preventable by greater communication between patients, their family members and treating teams. We plan to follow three groups of cirrhotic patients from the time of hospital dismissal randomly divided into either receiving standard of care, using devices through which they can communicate with the clinical teams and using devices and structured follow-up over thirty days. Our aim is to develop these devices so as to learn quickly about issues that patients and their caregivers are facing so that we can intervene to stop unnecessary and re-hospitalizations in this population.

National Institute of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)
Research Project (R01)
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Healthcare Effectiveness and Outcomes Research (HEOR)
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Hsiao, Janey
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Virginia Commonwealth University
Internal Medicine/Medicine
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United States
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