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Hepatology
Original research
Effectiveness of mailed outreach and patient navigation to promote HCC screening process completion: a multicentre pragmatic randomised clinical trial
  1. Amit G Singal1,
  2. Manasa Narasimman1,
  3. Darine Daher1,
  4. Sruthi Yekkaluri1,
  5. Yan Liu2,
  6. MinJae Lee3,
  7. Vanessa Cerda1,
  8. Aisha Khan4,
  9. Karim Seif El Dahan1,
  10. Jennifer Kramer4,
  11. Purva Gopal1,
  12. Caitlin Murphy5,
  13. Ruben Hernaez2,6
  1. 1Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA
  2. 2Gastroenterology and Hepatology, Baylor College of Medicine, Houston, Texas, USA
  3. 3Population and Data Sciences, UT Southwestern Medical, Dallas, Texas, USA
  4. 4Michael E. DeBakey Veterans Affairs Medical Center, Center for Innovations in Quality, Effectiveness and Safety and Baylor College of Medicine, Houston, Texas, USA
  5. 5School of Public Health, The University of Texas Health Science Center at Houston, Houston, Texas, USA
  6. 6Gastroenterology and Hepatology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA
  1. Correspondence to Dr Amit G Singal, Internal Medicine, University of Texas Southwestern, Dallas, TX 75390-8887, USA; amit.singal{at}utsouthwestern.edu

Abstract

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.

  • SCREENING
  • CIRRHOSIS
  • HEPATOCELLULAR CARCINOMA
  • HEALTH SERVICE RESEARCH

Data availability statement

Data are available on reasonable request.

https://doi.org/10.1136/gutjnl-2024-332508

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    Data availability statement

    Data are available on reasonable request.

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    Footnotes

    • X @docamitgs, @darinedaher, @purvgo, @caitlincmurphy, @ruben_hernaez

    • Contributors AGS: Study concept and design, drafting of the manuscript, obtained funding and study supervision. AGS, MN, DD, YL, VC, AK and RH: Acquisition of data. SY and ML: Analysis of data. All authors: Interpretation of the data. All authors: Critical revision of the manuscript for intellectual content. AGS is the guarantor of the article and takes responsibility for the integrity of the research; no important aspects of the study have been omitted.

    • Funding This work was conducted with support from National Cancer Institute R01 CA212008, U01 CA230694 and Cancer Prevention Research Institute of Texas (CPRIT) RP150587. The work is also supported in part by the Center for Innovations in Quality, Effectiveness and Safety (CIN 13-413), Michael E. DeBakey VA Medical Center, Houston, Texas, USA. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Health, Cancer Prevention Research Institute of Texas or the US government.

    • Competing interests AGS has served as a consultant or on advisory boards for Bayer, FujiFilm Medical Sciences, Exact Sciences, Universal Dx, Glycotest, Roche, Freenome, DELFI, GRAIL, Genentech, AstraZeneca, Eisai, Exelixis, Merck, Boston Scientific, Sirtex and HistoSonics. CM has served as a consultant for Freenome. None of the other authors have any relevant conflicts of interest to disclose.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.