Randomized Controlled Trial of Outreach Strategies to improve Hepatocellular Carcinoma Screening Rates
AASLD LiverLearning®. Singal A. Nov 14, 2016; 144623
Dr. Amit Singal
Dr. Amit Singal
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TITLE: Randomized Controlled Trial of Outreach Strategies to improve Hepatocellular Carcinoma Screening Rates

This study was conducted as part of the Center for Patient-Centered Outcomes Research with support from AHRQ Grant R24 HS022418 and NIH/NCI Cancer Center Support Grant P30 CA142543. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or AHRQ.

Background: Hepatocellular carcinoma (HCC) surveillance is associated with early tumor detection and improved survival in patients with cirrhosis, but its effectiveness is limited by underuse, particularly among racial/ethnic minorities and socioeconomically disadvantaged patients.
Aim: Conduct a pragmatic randomized controlled trial to compare the clinical effectiveness of mailed outreach and patient navigation strategies to increase HCC surveillance rates in a racially diverse and socioeconomically disadvantaged cohort of patients with cirrhosis.
Methods: Patients with documented or suspected cirrhosis at an urban safety-net health system were randomized in a 1:1:1 fashion to receive mailed outreach invitations for screening ultrasound, mailed outreach plus patient navigation, or usual care with opportunistic, visit-based screening. Patients who did not respond to outreach invitations within 2 weeks received up to 3 reminder telephone calls. All 3 arms continued to receive visit-based screening as ordered by outpatient clinic providers. The primary study outcome was completion of abdominal imaging within 6 months of randomization. We used an intent- to-screen principle for analyses. Our study had 80% power to detect a difference of 9% in screening rates, assuming a baseline rate of 20% and alpha of 0.05.
Results: Baseline characteristics (n=1800) across the 3 groups were similar. Mean age was 55 years, and 59% were men. The cohort was racially diverse: 38% Hispanic, 32% Black, and 28% White. Cirrhosis was 51% hepatitis C, 18% alcohol, and 17% NASH. Cirrhosis was documented by ICD-9 codes in 79.6% and suspected by non-invasive markers of fibrosis in 21.4% of patients. Imaging-based HCC screening rates were significantly higher in the outreach/patient navigation (48.2%) and outreach alone arms (44.8%) than usual care (24.2%) (p<0.001 for both); however, screening rates did not differ between outreach arms (p=0.25). The intervention effect was consistent across pre-defined subgroups including Caucasian vs. non-Caucasian race, insured vs. uninsured status, documented vs. suspected cirrhosis, Child Pugh A vs. B cirrhosis, degree of primary care contact, and receipt of GI subspecialty care. In addition to the outreach strategy, screening participation was positively associated in multivariate analysis with female gender, older age, racial/ethnic minority status, primary care contact in year prior to randomization, and receipt of GI subspecialty care in year prior to randomization.
Conclusion: Outreach strategies doubled HCC screening rates in patients with cirrhosis. Adding patient navigation to telephone reminders provided no significant additional benefit.
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