Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up

描述（由申请人提供）：结直肠癌筛查（CRCS）降低结直肠癌（CRC）的发病率和死亡率，但仍未得到充分利用。支持增加结直肠癌筛查和随访的系统（SOS）是一项为期2年的随机对照试验，旨在增加：(1)结直肠癌筛查和(2)阳性筛查试验的随访。慢性护理模式和预防健康模式为研究设计提供了信息。对于这一竞争性修订，我们提出了两个新的辅助目标来解决以下问题：1)医疗之家模式是否修改（即增强或降低）SOS干预的有效性？主要目的1：比较SOS系统水平的干预效果，在诊所之前和之后的MH实施。我们假设SOS系统级别的CRCS率在第2年将继续高于UC（单独MH），但CRCS率将根据诊所的特点及其MH组件的实施而改变（减少或提高）。为了验证这一假设，我们将收集与实施MH和临床特征相关的过程措施相关的协变量数据。主要结局将包括CRCS和FOBT率在多大程度上受到MH实施和临床因素的影响。2)对于那些选择每年FOBT的患者，是否需要持续的系统级干预来维持CRCS的增加？主要目标2：随着时间的推移，确定SOS系统级自动干预措施的持久性和长期影响。我们假设，随着时间的推移，患者需要持续的SOS自动干预来保持当前的FOBT筛查。我们还假设，与没有接受SOS自动干预的个体相比，之前完成1-2年的个体仍然更有可能完成CRCS。为了验证这些假设，我们建议在第3年将仍有资格接受CRCS（未接受结肠镜检查或乙状结肠镜检查）的积极干预组（自动、辅助和护理管理）患者随机分为以下两组：主要结果包括第3年的CRCS和FOBT率，分类（是/否），以及第1-3年适当的CRCS和FOBT覆盖率的个人评估。本研究将利用现有的研究队列有效地解决这些问题。

DESCRIPTION (provided by applicant): Colorectal cancer screening (CRCS) decreases colorectal cancer (CRC) morbidity and mortality, yet remains underutilized. Systems of Support to Increase Colorectal Cancer Screening and Follow-up (SOS) is a 2-year randomized controlled trial designed to increase: (1) CRC screening and (2) follow-up of positive screening tests. The Chronic Care Model and the Preventive Health Model inform study design. For this Competitive Revision we propose two new ancillary aims to address the following questions: 1) Does the medical home model modify (i.e. enhance or reduce) the effectiveness of the SOS intervention? Primary Aim #1: To compare SOS systems-level intervention effect in clinics before and after MH implementation. We hypothesize that SOS systems-level CRCS rates will continue be higher than UC (MH alone) in year 2, but CRCS rates will be modified (lessoned or enhanced) by characteristics of clinics and their implementation of MH components. To test this hypothesis we will collect data on covariates related to process measures related to implementation of the MH and clinic characteristics. 7 Primary outcomes will include to what degree CRCS and FOBT rates are modified by MH implementation and clinic factors. 2) Is a continued systems-level intervention required to maintain increases in CRCS for those choosing annual FOBT? Primary Aim #2: To determine the durability and long-term impact of SOS systems-level automated interventions over time. We hypothesize that continued SOS automated interventions are needed for patients to remain current for FOBT screening over time. We also hypothesize that individuals who have previously completed in years 1-2, will still be more likely to complete CRCS, than those not receiving SOS automated interventions. To test these hypotheses we propose in year 3 to randomize patients in the active intervention groups (auto, assist, and care managed) who are still eligible for CRCS (have not had a colonoscopy or flexible sigmoidoscopy) to either: A. Stopped Auto or B. Continued Auto systems-level FOBT interventions 7 Primary outcomes include CRCS and FOBT rates, categorically (yes/no) in year 3 and as person-time assessments of appropriate CRCS and FOBT coverage in years 1-3 This study will efficiently address these questions by taking advantage of an existing study cohort. PUBLIC HEALTH RELEVANCE: Screening people age 50 to 75 prevents colon cancer from starting and dying from it, but almost half have not been screened. This study is testing how much help patients need to get colon cancer screening done. In the second year of the study, the health plan made changes to how clinics deliver health care. This change is called the "Medical Home" and doctors are given more time to see patients and medical assistants check to see if patients are due for screening tests, such as colon cancer screening, and help at visits or mail letters. We will study whether "Medical Home" care increases colon cancer screening. A second aim of this study will to be to find out if people who choose to do stool cards at home, need to receive these in the mail every year to stay current for screening.