The Cirrhosis Medical Home: A Pilot Randomized Trial of a Collaborative Care Model for Patients With Decompensated...

Patients with decompensated cirrhosis have a high symptom burden and poor outcomes. Collaborative care models that provide coordinated, personalized care could improve outcomes. In this pilot randomized trial, we tested a cirrhosis-centric collaborative care model: the Cirrhosis Medical Home (CMH).

A single-center pilot randomized trial enrolling 40 hospitalized adults with decompensated cirrhosis randomized 1:1 to CMH or usual care. CMH involved 6 months of postdischarge individualized care. Primary outcomes were feasibility-based (enrollment, retention, data completeness). Secondary outcomes at 3 and 6 months included quality of life (SF-36) and healthcare utilization.

Of 205 patients screened, 40 were enrolled. Of the 20 patients randomized to CMH, 13 received postdischarge CMH follow-up. At 3 months, 19 died or had a transplant, 9 were lost to follow-up, and 12 completed the SF-36. At 6 months, an additional 4 died or were lost to follow-up, and 8 completed the SF-36. In intention-to-treat analysis at 3 months, CMH did not improve quality of life. In per protocol analysis at 3 months, CMH improved physical functioning (delta +15 vs -10, P = 0.015), energy/fatigue (+20 vs -5, P = 0.02), and physical component score (+5.5 vs -5.0, P = 0.009). High mortality and readmission rates were seen in both arms but without significant differences.

Enrollment and retention in a randomized trial of the CMH for posthospitalization management of decompensated cirrhosis is challenging, and patient-reported outcome assessment is limited by high rates of mortality, transplant, and loss to follow-up. These data can be used to inform future design and testing of health services interventions for this population.