Mailed Outreach Invitations Significantly Improve HCC Surveillance Rates in Patients with Cirrhosis: A Randomized Clinical Trial.

Hepatocellular carcinoma (HCC) surveillance is associated with early tumor detection and improved survival in patients with cirrhosis; however, effectiveness is limited by underuse. We compared the effectiveness of mailed outreach and patient navigation strategies to increase HCC surveillance in a racially diverse cohort of patients with cirrhosis. We conducted a pragmatic randomized clinical trial comparing mailed outreach for screening ultrasound (n=600), mailed outreach plus patient navigation (n=600), or usual care with visit-based screening (n=600) among 1800 patients with cirrhosis at a large safety-net health system from December 2014 to March 2017. Patients who did not respond to outreach invitations within 2 weeks received reminder telephone calls. Patient navigation included an assessment of barriers to surveillance and encouragement of surveillance participation. The primary outcome was HCC surveillance (abdominal imaging every 6 months) over an 18-month period. All 1800 patients were included in intention-to-screen analyses. HCC surveillance was performed in 23.3% of outreach/navigation patients, 17.8% of outreach-alone patients, and 7.3% of usual care patients. HCC surveillance was 16.0% (95%CI 12.0-20.0%) and 10.5% (95%CI 6.8-14.2%) higher in outreach groups than usual care (p<0.001 for both) and 5.5% (95%CI 0.9-10.1%) higher for outreach/navigation than outreach-alone (p=0.02). Both interventions increased HCC surveillance across pre-defined patient subgroups. The proportion of HCC patients detected at an early stage did not differ between groups; however, a higher proportion of patients with screen-detected HCC across groups had early stage tumors than those with HCC detected incidentally or symptomatically (83.3% vs. 30.8%, p=0.003).

CONCLUSION: Mailed outreach invitations and navigation significantly increased HCC surveillance versus usual care in patients with cirrhosis. This article is protected by copyright. All rights reserved.