Strategies and Opportunities to STOP Colon Cancer in Priority Populations: Design of a cluster-randomized pragmatic trial

Strategies and Opportunities to STOP Colon Cancer in Priority Populations: Design of a cluster-randomized pragmatic trial
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DOI:
10.1016/j.cct.2014.06.006
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发表时间:
2014-07-01
影响因子:
2.2
通讯作者:
Green, Beverly B.
Green, Beverly B.
中科院分区:
医学4区
文献类型:
--
作者:
Coronado, Gloria D.;Vollmer, William M.;Green, Beverly B.

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背景:在美国,结直肠癌是癌症死亡的第二大原因。在优先人群中阻止结直肠癌的战略和机会(STOP CRC)研究是一项务实的试验,是两个研究机构和200多个安全网诊所网络之间的合作。这项研究将评估一项基于系统的干预措施的有效性,该干预措施旨在利用粪便免疫化学测试(FIT)在俄勒冈州和加利福尼亚州北部的联邦合格卫生中心提高结直肠癌筛查率。材料和方法:Stop CRC是一项整群随机的比较有效性务实试验,招募了26家诊所。诊所将被随机分配到两个部门中的一个。干预部门的诊所(1)将使用自动化的、数据驱动的、嵌入电子健康记录的程序来识别应进行结直肠筛查的患者,并向他们邮寄合适的试剂盒(带有象形文字说明);(2)将进行改进过程(例如,计划-做-研究-法案),以提高该计划的采用率、覆盖面和有效性。控制部门的诊所将在就诊时为患者提供机会性结直肠癌筛查。主要结果是:符合年龄和筛查条件的患者在12个月内完成匹配的比例;以及干预措施的成本、成本效益和投资回报。结论:这项大规模的务实试验将利用电子健康记录信息和现有的诊所工作人员来招募广泛的患者,包括许多结直肠癌筛查率创历史新低的患者。如果成功,该计划将为提高结直肠癌筛查率的成本效益和可扩展方法提供一个模式。(C)2014 Elsevier Inc.保留所有权利。
Background: Colorectal cancer is the second-leading cause of cancer deaths in the United States. The Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) in Priority Populations study is a pragmatic trial and a collaboration between two research institutions and a network of more than 200 safety net clinics. The study will assess the effectiveness of a system-based intervention designed to improve the rates of colorectal-cancer screening using fecal immunochemical testing (FIT) in federally qualified health centers in Oregon and Northern California.Material and methods: STOP CRC is a cluster-randomized comparative-effectiveness pragmatic trial enrolling 26 clinics. Clinics will be randomized to one of two arms. Clinics in the intervention arm (1) will use an automated, data-driven, electronic health record-embedded program to identify patients due for colorectal screening and mail FIT kits (with pictographic instructions) to them; (2) will conduct an improvement process (e.g. Plan-Do-Study-Act) to enhance the adoption, reach, and effectiveness of the program. Clinics in the control arm will provide opportunistic colorectal-cancer screening to patients at clinic visits. The primary outcomes are: proportion of age- and screening-eligible patients completing a FIT within 12 months; and cost, cost-effectiveness, and return on investment of the intervention.Conclusions: This large-scale pragmatic trial will leverage electronic health record information and existing clinic staff to enroll a broad range of patients, including many with historically low colorectal-cancer screening rates. If successful, the program will provide a model for a cost-effective and scalable method to raise colorectal-cancer screening rates. (C) 2014 Elsevier Inc. All rights reserved.