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

Abstract

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% confidence interval [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 predefined 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% versus 30.8%, P = 0.003). Conclusion: Mailed outreach invitations and navigation significantly increased HCC surveillance versus usual care in patients with cirrhosis.

Trial registration: ClinicalTrials.gov NCT02312817.

Figure 1

Study Consort Diagram

Figure 2

HCC surveillance^a completion over 18-month study period by intervention group ^aHCC surveillance was defined as receipt of abdominal imaging during each 6-month period after randomization. Legend: Compared to usual care, HCC surveillance was significantly higher in the outreach-alone (+10.5%; 95%CI 6.8 – 14.2%) and outreach/navigation (+16.0%; 95%CI 12.0 – 20.0%) groups (p<0.001 for both). Adding navigation to outreach increased the surveillance proportion by 5.5% (95%CI 0.9 – 10.1%; p=0.02).