NCT03564626

Health IT Generated PROs to Improve Outcomes in Cirrhosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

SPECIFIC AIM 1: To evaluate in a multi-center, randomized trial the effectiveness of PROs elicited using PatientBuddy and EncephalApp on the prevention of avoidable 30 day readmissions in patients with cirrhosis and their caregivers compared to standard of care.

Detailed description

Cirrhosis affects more than 6 million US patients and is a major burden on patients, caregivers and the healthcare system. Patients with cirrhosis are prone to clinical and psycho-social issues that may predict hospitalization, re-hospitalizations and death. Important patient-reported outcomes (PRO) such as impaired daily functioning, sleep, cognition and pain are widely prevalent in patients with cirrhosis. These changes can independently impact hospitalizations, re-hospitalizations and death in cirrhotic patients. The investigators have studied the impact of these PRO using traditional and computerized scales such as PROMIS (Patient-reported outcomes measurement information system). 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 are Patient Buddy to define patients regarding factor preventing readmission, and EncephalApp Stroop to detect cognitive dysfunction in cirrhosis. As part of a funded AHRQ R21, PatientBuddy, which has undergone multiple refinements in response to feedback from patients, caregivers and administering staff, is being used by the study team to prevent readmissions to Virginia Commonwealth University Medical Center (VCU). However the evaluation of these tools in a multi-center study that adapts to the status of the patients and their caregivers is an important step towards improvement in cirrhosis-related outcomes. In addition, PROs that are elicited and monitored when the patients are outside the hospital will advance the field by making them integral parts of clinical management.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
OTHER	Health-IT +/- Scheduled Follow Up	* Training patient and caregiver on Patient Buddy and EncephalApp * Counseling regarding readmission * Daily contact through app * Standard of care counseling regarding readmission and discharge instructions * Follow up phone calls at Week 1 and Week 3 * In-person follow up visits at Week 2 and Week 4

Timeline

• Start date: 2018-06-22
• Primary completion: 2024-04-22
• Completion: 2024-05-22
• First posted: 2018-06-21
• Last updated: 2025-09-17
• Results posted: 2025-09-17

Locations

3 sites across 1 country: United States