Frerichs Leah, Zhang Zhang, Moore Alexis A, Falk Isabelle, Tan Xianming, Randazzo Aliza, Brenner Alison T, S Reuland Daniel, Dharod Ajay, Miller David P
Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
BMC Health Serv Res. 2025 Aug 8;25(1):1047. doi: 10.1186/s12913-025-13262-y.
Over the past decade, many well-resourced health plans and systems surpassed the 80% colorectal cancer screening rate goal, while lower resource environments such as federally qualified health centers (FQHCs) lag behind. FQHCs in rural areas are especially challenged with limited resources to reach diverse patients who often lack consistent engagement with clinical care. mHealth solutions, like mPATHCRC, can address these challenges by automating tasks and expanding patient outreach. This platform identifies patients due for CRC screening, educates them on the commonly used screening tests, and helps them select their best option. This paper describes protocols for a study that will implement mPATHCRC in FQHCs using a novel outreach strategy that engages patients outside of regular appointments.
Following a type 1 hybrid effectiveness-implementation design, we will conduct a patient-level randomized controlled trial (RCT) to assess the effectiveness of mPATH-CRC over a three-year period. Embedded within the RCT, we will utilize a convergent, mixed methods design for evaluation of the implementation process. The planned trial sample will include 1000 patients who are at average CRC risk and due for screening. Participants will be randomized 1:1 to receive either usual care or outreach through mPATH-CRC that includes text messages about screening, multi-media education on screening options, and either mailed FIT or assistance to schedule a colonoscopy. The primary outcome is completion of any CRC screening test within six months of randomization. We will also use surveys and interviews with FQHC personnel to explore integration of mPATH-CRC into clinical workflows and sustainability challenges.
This trial will generate insights into the effectiveness and implementation of a digital CRC screening intervention in resource-limited FQHCs. Findings will inform strategies for optimizing outreach components and scaling implementation in similar settings.
This trial was registered on June 4, 2024, at ClinicalTrials.gov (identifier NCT06441487).
在过去十年中，许多资源充足的医疗计划和系统超过了80%的结直肠癌筛查率目标，而诸如联邦合格医疗中心（FQHCs）等资源较少的环境则落后了。农村地区的FQHCs尤其面临挑战，因为资源有限，难以覆盖经常缺乏持续临床护理参与的多样化患者。移动健康解决方案，如mPATHCRC，可以通过自动化任务和扩大患者外展服务来应对这些挑战。该平台识别应进行结直肠癌筛查的患者，对他们进行常用筛查测试的教育，并帮助他们选择最佳方案。本文描述了一项研究的方案，该研究将使用一种新颖的外展策略在FQHCs中实施mPATHCRC，该策略使患者在常规预约之外也能参与进来。
遵循1型混合有效性-实施设计，我们将进行一项患者层面的随机对照试验（RCT），以评估mPATH-CRC在三年期间的有效性。在RCT中，我们将采用收敛性混合方法设计来评估实施过程。计划的试验样本将包括1000名平均有结直肠癌风险且应进行筛查的患者。参与者将按1:1随机分组，分别接受常规护理或通过mPATH-CRC进行外展服务，其中包括关于筛查的短信、筛查选项的多媒体教育，以及邮寄粪便免疫化学试验（FIT）或协助安排结肠镜检查。主要结局是在随机分组后六个月内完成任何结直肠癌筛查测试。我们还将对FQHC工作人员进行调查和访谈，以探讨将mPATH-CRC整合到临床工作流程中以及可持续性挑战。
该试验将深入了解在资源有限的FQHCs中数字结直肠癌筛查干预的有效性和实施情况。研究结果将为优化外展组成部分和在类似环境中扩大实施规模的策略提供信息。
该试验于2024年6月4日在ClinicalTrials.gov注册（标识符NCT06441487）。
