The Transitional Liver Clinic: Study protocol for a stepped-wedge cluster randomized trial

Background: Patients with complications of advanced liver disease experience high rates of hospital readmission after discharge. Transitional care models have improved outcomes in other chronic conditions, but their efficacy in liver disease care remains uncertain. This randomized trial evaluates the effectiveness of a tailored transitional care model—the Transitional Liver Clinic (TLC)—in reducing readmissions, improving quality of life, and enhancing patient satisfaction for patients with advanced liver disease. Methods: This is a 45-month, stepped-wedge cluster randomized trial enrolling up to 1000 patients with advanced liver disease across 4 academic medical centers. Each site transitions from usual care to the TLC intervention on a randomized schedule at 9-month intervals. The TLC includes a post-discharge phone call within 2 business days and a hepatology advanced practice provider (APP) visit within 14 days. The primary outcome is 30-day hospital readmission. Secondary outcomes include 90-day readmission, emergency room visits, mortality, days alive out of hospital, quality of life, and patient satisfaction. Quality of life is measured with the PROMIS-29+2 Profile, and patient satisfaction is measured with the Patient Satisfaction Questionnaire-18. Follow-up occurs at 30 and 90 days post-discharge. Conclusion: This multicenter randomized trial will determine whether a structured, APP-led transitional care model can improve outcomes for patients with advanced liver disease. If successful, the TLC could serve as a scalable model for post-discharge care in hepatology.