Department of Medicine, David Geffen School of Medicine, UCLA Ronald Reagan Medical Center, University of California Los Angeles, 757 Westwood Plaza, Los Angeles, CA 90095, USA; Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, 650 S. Charles E Young Drive, Center for Health Sciences, Suite A2-125, Los Angeles, CA 90095-6900, USA; Greater Los Angeles Veterans Affairs Healthcare System, Los Angeles, CA, USA; UCLA Kaiser Permanente Center for Health Equity, Jonsson Comprehensive Cancer Center, 650 S. Charles E Young Drive, Center for Health Sciences, Suite A2-125, Los Angeles, CA 90095-6900, USA.
Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.
Contemp Clin Trials. 2024 Oct;145:107639. doi: 10.1016/j.cct.2024.107639. Epub 2024 Jul 26.
Colorectal cancer (CRC) screening utilization is low among low-income, uninsured, and minority populations that receive care in community health centers (CHCs). There is a need for evidence-based interventions to increase screening and follow-up care in these settings.
A multilevel, multi-component pragmatic cluster randomized controlled trial is being conducted at 8 CHCs in two metropolitan areas (Boston and Los Angeles), with two arms: (1) Mailed FIT outreach with text reminders, and (2) Mailed FIT-DNA with patient support. We also include an additional CHC in Rapid City (South Dakota) that follows a parallel protocol for FIT-DNA but is not randomized due to lack of a comparison group. Eligible individuals in participating clinics are primary care patients ages 45-75, at average-risk for CRC, and overdue for CRC screening. Participants with abnormal screening results are offered navigation for follow-up colonoscopy and CRC risk assessment.
The primary outcome is the completion rate of CRC screening at 90 days. Secondary outcomes include the screening completion rate at 180 days and the rate of colonoscopy completion within 6 months among participants with an abnormal result. Additional goals are to enhance our understanding of facilitators and barriers to CRC risk assessment in CHC settings.
This study assesses the effectiveness of two multilevel interventions to increase screening participation and follow-up after abnormal screening in under-resourced clinical settings, informing future efforts to address CRC disparities.
NCT05714644.
在接受社区卫生中心(CHC)护理的低收入、无保险和少数族裔人群中,结直肠癌(CRC)筛查的利用率较低。需要有循证干预措施来增加这些环境中的筛查和后续护理。
正在两个大都市(波士顿和洛杉矶)的 8 个 CHC 中进行一项多层次、多组件的实用型聚类随机对照试验,分为两组:(1)邮寄 FIT 外展和短信提醒,(2)邮寄 FIT-DNA 并提供患者支持。我们还包括拉皮德城(南达科他州)的另一个 CHC,该 CHC 遵循与 FIT-DNA 平行的方案,但由于缺乏对照组,因此未进行随机分组。参与诊所的合格个体是年龄在 45-75 岁、平均 CRC 风险且 CRC 筛查逾期的初级保健患者。有异常筛查结果的参与者可获得后续结肠镜检查和 CRC 风险评估的导航服务。
主要结果是 90 天内 CRC 筛查的完成率。次要结果包括 180 天的筛查完成率以及异常结果参与者在 6 个月内完成结肠镜检查的比率。其他目标是增强我们对 CHC 环境中 CRC 风险评估的促进因素和障碍的理解。
这项研究评估了两种多层次干预措施的有效性,以增加资源匮乏的临床环境中的筛查参与度和异常筛查后的随访,为解决 CRC 差异提供了未来的努力。
NCT05714644。