中心辐射式集中干预优化结直肠癌筛查及随访：一项实用、群组随机对照试验方案。
Hub-and-Spoke centralized intervention to optimize colorectal cancer screening and follow-up: A pragmatic, cluster-randomized controlled trial protocol.
机构信息
Department of Psychology, San Diego State University, San Diego, CA, United States of America.
UC San Diego Moores Cancer Center, University of California San Diego, La Jolla, CA, United States of America.
出版信息
Contemp Clin Trials. 2023 Nov;134:107353. doi: 10.1016/j.cct.2023.107353. Epub 2023 Oct 5.
BACKGROUND
Guidelines recommend screening for colorectal cancer (CRC), but participation and abnormal test follow up rates are suboptimal, with disparities by demography. Evidence-based interventions exist to promote screening, but community adoption and implementation are limited.
METHODS
The San Diego Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) program is an academic-community partnership testing regional implementation of a Hub-and-Spoke model for increasing CRC screening and follow-up. The "hub" is a non-academic, non-profit organization that includes 17 community health center (CHC) systems, serving over 190 rural and urban clinic sites. The "spokes" are 3 CHC systems that oversee 11-28 clinics each, totaling over 60 clinics. Using a cluster-randomized trial design, 9 clinics were randomized to intervention and 16 to usual care. Within intervention clinics, approximately 5000 eligible patients not up-to-date with CRC screening per year were identified for intervention. Interventions include an invitation primer, a mailed fecal immunochemical test with completion instructions, and phone and text-based reminders (hub) and patient navigation protocol to promote colonoscopy completion after abnormal FIT (spoke). Outcomes include: 1) proportion of patients up-to-date with screening after three years in intervention versus non-intervention clinics; 2) proportion of patients with abnormal FIT completing colonoscopy within six months of the abnormal result. Implementation science measures are collected to assess acceptability, intervention and usual care adaptations, and sustainability of the intervention strategies.
CONCLUSION
This large-scale, regional cluster randomized trial among CHCs serving diverse populations is anticipated to accelerate progress in CRC prevention in underserved populations.
TRIAL REGISTRATION
NCT04941300.
背景
指南建议筛查结直肠癌（CRC），但参与率和异常检测随访率不理想，且存在人口统计学差异。存在促进筛查的循证干预措施，但社区采用和实施有限。
方法
圣地亚哥加速结直肠癌筛查和通过实施科学（ACCSIS）计划是一个学术-社区合作项目，旨在测试通过实施科学增加 CRC 筛查和随访的区域实施Hub-and-Spoke 模型。“Hub”是非学术性的非营利组织，包括 17 个社区卫生中心（CHC）系统，服务于 190 多个农村和城市诊所。“Spokes”是 3 个 CHC 系统，每个系统监督 11-28 个诊所，总计超过 60 个诊所。使用集群随机试验设计，将 9 个诊所随机分配到干预组和 16 个对照组。在干预诊所中，每年大约有 5000 名不符合 CRC 筛查条件的患者被确定接受干预。干预措施包括邀请入门、邮寄带有完成说明的粪便免疫化学检测以及电话和基于文本的提醒（Hub）和患者导航协议，以促进异常 FIT 后的结肠镜检查完成（Spoke）。结果包括：1）干预组和非干预组患者在三年内完成筛查的比例；2）异常 FIT 的患者在异常结果后六个月内完成结肠镜检查的比例。正在收集实施科学措施，以评估可接受性、干预和常规护理的适应性以及干预策略的可持续性。
结论
这项针对不同人群的 CHC 的大规模区域性集群随机试验有望加速为服务不足人群预防 CRC 的进展。
试验注册
NCT04941300。
Zotero 插件