Effectiveness of mailed outreach and patient navigation to promote HCC screening process completion: a multicentre pragmatic randomised clinical trial

Background
Hepatocellular carcinoma (HCC) is plagued by failures across the cancer care continuum, leading to frequent late-stage diagnoses and high mortality. We evaluated the effectiveness of mailed outreach invitations plus patient navigation to promote HCC screening process completion in patients with cirrhosis.

Methods
Between April 2018 and September 2021, we conducted a multicentre pragmatic randomised clinical trial comparing mailed outreach plus patient navigation for HCC screening (n=1436) versus usual care with visit-based screening (n=1436) among patients with cirrhosis at three US health systems. Our primary outcome was screening process completion over a 36-month period, and our secondary outcome was the proportion of time covered (PTC) by screening. All patients were included in intention-to-screen analyses.

Results
All 2872 participants (median age 61.3 years; 32.3% women) were included in intention-to-screen analyses. Screening process completion was observed in 6.6% (95% CI: 5.3% to 7.9%) of patients randomised to outreach and 3.3% (95% CI: 2.4% to 4.3%) of those randomised to usual care (OR 2.05, 95% CI: 1.44 to 2.92). The intervention increased HCC screening process completion across most subgroups including age, sex, race and ethnicity, Child-Turcotte-Pugh class and health system. PTC was also significantly higher in the outreach arm than usual care (mean 37.5% vs 28.2%; RR 1.33, 95% CI: 1.31 to 1.35). Despite screening underuse, most HCC in both arms were detected at an early stage.

Conclusion
Mailed outreach plus navigation significantly increased HCC screening process completion versus usual care in patients with cirrhosis, with a consistent effect across most examined subgroups. However, screening completion remained suboptimal in both arms, underscoring a need for more intensive interventions.

Trial registration number
NCT02582918.

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Novembre 2024

Is mailed outreach and patient navigation a perfect solution to improve HCC screening?

Hepatocellular carcinoma (HCC) is a significant global health problem, and its incidence is expected to exceed 1 million new HCC annually by 2025.1 The reported 3-year survival rate for advanced-stage HCC is less than 17%, while 70% of patients diagnosed with early-stage HCC can achieve 5-year survival.2 Despite well-established guidelines and the clear benefits of early detection, the meta-analysis results (29 papers, 1 18 799 patients) showed that only 24% of individuals at risk for developing HCC were screened.3 Efforts to surmount barriers at patient, provider and healthcare levels have shown a minimal screening rate increase over time.3 4 One of the reasons for the disappointing results might be the fact that authors focused on individual barriers, rather than considering the screening failure the result of the interplay of different factors. Additionally, the published studies have the following limitations, detailed reasons for…

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Novembre 2024