CRC-HUB-SPOKE: A ColoRectal Cancer screening Hub for Southern California community health centers.

摘要 结直肠癌(CRC)筛查和适当的随访可以降低发病率和死亡率。美国 预防服务工作组(USPSTF)建议通过各种侵袭性和非侵入性 对年龄在50岁到75岁之间的人进行侵入性测试。循证干预(EBI)和其他战略 存在促进儿童权利委员会筛查的办法，但采用和实施这些办法受到限制，特别是在儿童保健中心。 我们的假设是，中心辐射式多层次干预将优于通常的护理。枢纽将是 南加州健康质量合作伙伴(HQP)，一个由16个CHC系统组成的非营利性组织 (辐条)，服务于135个农村和城市诊所站点。我们建议分两个阶段进行试验和优化(第一阶段) 并严格测试(第二阶段)中心辐射式方法及其对CRC筛查、后续和 照常照看。UG3规划/探索阶段目标：试行测试可行性、可接受性和初步 使用混合方案对结直肠癌筛查、随访和转诊至护理的多水平干预结果 方法：研究方法。干预措施包括基于HQP集线器的集中邮寄FIT给患者的交付 由个别社区卫生中心提供服务，外加免费提供者和诊所级别的干预服务，以及 协调CHC提供的标准化导航策略，以进行异常匹配跟踪。UH3 实施阶段。我们将进行一项双臂务实随机试验，以评估 区域制定的多层次干预措施，以增加结直肠癌筛查、随访和转诊至护理 在慢性丙型肝炎患者中。试验将以务实、稳健的实施和可持续发展为指导 模型(PRISM)，其中包括REACH、有效性、采用、实施、 维护(RE-AIM)框架，并使用上下文构造对其进行扩展。目标1.评估有效性 多层次干预的基础是：1)在3年后进行筛查，改善了最新比例 实施；2)在6个月内完成诊断结肠镜检查的异常匹配比例；以及3) 完成首次治疗评估的患者比例。目标2.评估实施、可伸缩性和 多层次实施战略的可持续性。实施情况将采用混合方法进行评估 使用REACH、采用和实施以及PRISM的RE-AIM成果的方法 从多个利益相关者的角度构建干预特征和对象(即 患者、一线工作人员和运营领导)。我们还将计算复制成本。可扩展性和 将使用维护的RE-AIM结果和PRISM结构来评估可持续性 实施与可持续基础设施和外部环境。我们的研究将有助于加快 通过确定多层次干预策略，在服务不足的人群中预防结直肠癌的进展 可扩展到该地区更多的社区卫生中心，具有更大规模实施的潜力。

ABSTRACT Colorectal cancer (CRC) screening and appropriate follow-up can reduce incidence and mortality. The US Preventive Services Task Force (USPSTF) recommends CRC screening through a variety of invasive and non- invasive tests for individuals aged 50 to 75 years. Evidence-based interventions (EBIs) and other strategies exist to promote CRC screening, but adoption and implementation of these are limited, especially in CHCs. Our hypothesis is that a Hub and Spoke multilevel intervention will be superior to usual care. The hub will be Health Quality Partners of Southern California (HQP), a non-profit organization comprised of 16 CHC systems (spokes), serving 135 rural and urban clinic sites. We propose a 2-phase study to pilot and optimize (Phase I) and rigorously test (Phase II) the Hub and Spoke approach and its impact on CRC screening, follow-up, and usual care. UG3 Planning/Exploratory Phase AIM: Pilot test the feasibility, acceptability, and preliminary outcomes of a multilevel intervention for CRC screening, follow-up, and referral-to-care using a mixed methods approach. The intervention includes HQP hub-based delivery of centralized mailed FIT to patients served by individual CHCs-spokes plus complimentary provider and clinic-level interventions at CHCs, and coordination of a standardized navigation strategy delivered by CHCs for abnormal FIT follow-up. UH3 Implementation Phase. We will conduct a 2-arm pragmatic randomized trial to assess impact of a regionally-developed multilevel intervention to increase CRC screening, follow-up, and referral-to-care among CHC patients. The trial will be guided by the Pragmatic, Robust Implementation and Sustainability Model (PRISM), which includes outcomes from the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework and expands them with contextual constructs. Aim 1. Assess effectiveness of the multilevel intervention based on: 1) improvement in proportion up-to-date with screening 3 years post implementation; 2) proportion with abnormal FIT who complete diagnostic colonoscopy within 6 months; and 3) proportion with CRC completing first treatment evaluation. Aim 2. Evaluate the implementation, scalability, and sustainability of a multilevel implementation strategy. Implementation will be evaluated with a mixed methods approach using the RE-AIM outcomes of Reach, Adoption, and Implementation as well as the PRISM constructs of Intervention Characteristics and Recipients from perspective of multiple stakeholders (i.e. patients, front-line staff, and operational leaders). We will also calculate replication costs. Scalability and Sustainability will be evaluated using the RE-AIM outcome of Maintenance and the PRISM constructs of Implementation & Sustainability Infrastructure and External Environment. Our study will help accelerate progress in CRC prevention in underserved populations by identifying multilevel intervention strategies that are scalable to additional CHCs in the region, with potential for larger scale implementation.