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

IF 23 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Gut Pub Date : 2024-11-11 DOI:10.1136/gutjnl-2024-332508
Amit G Singal, Manasa Narasimman, Darine Daher, Sruthi Yekkaluri, Yan Liu, MinJae Lee, Vanessa Cerda, Aisha Khan, Karim Seif El Dahan, Jennifer Kramer, Purva Gopal, Caitlin Murphy, Ruben Hernaez
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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.

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促进完成 HCC 筛查流程的邮寄宣传和患者指导的有效性:一项多中心实用随机临床试验。
背景:肝细胞癌(HCC)因癌症治疗过程中的失败而备受困扰,导致晚期诊断率和死亡率居高不下。我们评估了邮寄外展邀请函加患者导航对促进肝硬化患者完成 HCC 筛查流程的有效性:2018年4月至2021年9月期间,我们在美国三个医疗系统的肝硬化患者中开展了一项多中心实用随机临床试验,比较了HCC筛查的邮寄外展加患者导航(1436人)与基于就诊筛查的常规护理(1436人)。我们的主要结果是在 36 个月内完成筛查过程,次要结果是筛查覆盖的时间比例(PTC)。所有患者均纳入意向筛查分析:所有 2872 名参与者(中位年龄 61.3 岁;32.3% 为女性)均纳入了意向筛查分析。在随机接受外展治疗的患者中,6.6%(95% CI:5.3% 至 7.9%)的患者完成了筛查过程;在随机接受常规治疗的患者中,3.3%(95% CI:2.4% 至 4.3%)的患者完成了筛查过程(OR 2.05,95% CI:1.44 至 2.92)。在年龄、性别、种族和民族、Child-Turcotte-Pugh 等级和医疗系统等大多数亚群中,干预措施提高了 HCC 筛查流程的完成率。外展治疗组的 PTC 也明显高于常规治疗组(平均 37.5% vs 28.2%;RR 1.33,95% CI:1.31 至 1.35)。尽管筛查使用不足,但两组中的大多数 HCC 都在早期阶段被发现:结论:与常规护理相比,邮寄外展加导航服务大大提高了肝硬化患者HCC筛查过程的完成率,在大多数受检亚组中效果一致。然而,两组患者的筛查完成率仍未达到最佳水平,这说明有必要采取更深入的干预措施:试验注册号:NCT02582918。
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来源期刊
Gut
Gut 医学-胃肠肝病学
CiteScore
45.70
自引率
2.40%
发文量
284
审稿时长
1.5 months
期刊介绍: Gut is a renowned international journal specializing in gastroenterology and hepatology, known for its high-quality clinical research covering the alimentary tract, liver, biliary tree, and pancreas. It offers authoritative and current coverage across all aspects of gastroenterology and hepatology, featuring articles on emerging disease mechanisms and innovative diagnostic and therapeutic approaches authored by leading experts. As the flagship journal of BMJ's gastroenterology portfolio, Gut is accompanied by two companion journals: Frontline Gastroenterology, focusing on education and practice-oriented papers, and BMJ Open Gastroenterology for open access original research.
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