Health IT-Generated PROs to Improve Outcomes in Cirrhosis

Cirrhosis affects more than six million U.S. patients and is a major burden on patients, caregivers, and the healthcare system. Individuals with cirrhosis are prone to clinical and psychosocial issues that may predict hospitalization, re-hospitalizations, and death. Important patient-reported outcomes (PROs), such as impaired daily functioning, sleep, cognition, and pain, are prevalent in patients with cirrhosis. Changes in these PROs can independently predict a decline in patient health status.

Researchers at Virginia Commonwealth University Medical Center, along with Creative Information Technology Inc. (CITI), developed and refined two tools that aim to improve health outcomes for patients with cirrhosis. Patient Buddy is a mobile health application (app) designed to prevent readmissions by providing HIPAA-compliant and secure patient communications, monitoring medication adherence, and data analysis to keep case managers and clinicians informed of a patient’s status. EncephalApp was designed to detect and guide therapy for cognitive dysfunction among patients with cirrhosis. Patient Buddy integrates data from the electronic health record and EncephalApp to enable reporting on compliance, alert the patient when assessments are required, and notify the healthcare team when an abnormality has occurred.

The specific aims of the project are as follows:

• To evaluate in a multi-center, randomized trial the effectiveness of PROs elicited using Patient Buddy and EncephalApp with and without scheduled outpatient return visits on  preventing avoidable 30-day readmissions in patients with cirrhosis and their caregivers compared to standard of care. 
• To incorporate the opinion of key stakeholders (patients, caregivers, and nurse managers) toward improving the Patient Buddy App in preventing readmission in cirrhosis. 

The trial will be conducted with 450 patients with cirrhosis and their caregivers, who will be followed for 30 days post-discharge. Sites participating in the trial are the Virginia Commonwealth University Medical Center, Richmond Virginia Medical Center, and Mayo Clinic in Rochester. The groups will be randomized into three study arms: 1) a standard of care group, 2) a group receiving Patient Buddy and EncephalApp with as-needed followup, and 3) a group receiving Patient Buddy and EncephalApp along with scheduled outpatient visits and calls within 30 days of discharge. Additionally, the research team will elicit feedback regarding the ease, safety, effectiveness, and value of these interventions. The feedback will be used to update the Patient Buddy App, which will then be available for future studies in larger populations of patients with cirrhosis. The research team hypothesizes that the patients randomized to the Patient Buddy and EncephalApp study arm 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.