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

• DOI: 10.1002/hep.30129
• Publication Date: 2018-08-06T22:06:40Z
• Authors: Amit G. Singal; Jasmin A. Tiro; Caitlin C. Murphy; Jorge A. Marrero; Katharine McCalli...; Hannah Fullington; Caroline Mejias; Akbar K. Waljee; Wendy Pechero Bishop; Noel O. Santini; Ethan A. Halm
• Keywords: Adult; Aged, 80 and over; Liver Cirrhosis; Male; 0303 health sciences; Carcinoma, Hepatocellular; Liver Neoplasms; Middle Aged; 3. Good health; Young Adult; 03 medical and health sciences; Double-Blind Method; Population Surveillance; Internal Medicine and Specialties; Health Sciences; Humans; Female; Postal Service; Early Detection of Cancer; Aged; Ultrasonography

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.