Efficacy-to-Effectiveness Transition of an Educational Program to Increase Colore

描述（由申请人提供）：非裔美国人的发病率和死亡率最高，并且比白人更不可能进行结直肠癌（CRC）筛查。我们最近完成了一项为期五年的随机对照社区干预试验，该试验证明了小组教育干预（现称为EPICS或增加结直肠癌筛查的教育计划）的有效性，与对照组相比，CRC筛查率翻了一番。EPICS随后与当地卫生部门合作付诸实施，同样有效。我们现在正在整个格鲁吉亚州传播干预措施。在这项申请中，我们提出了一个国家的传播和实施研究。我们建议使用Rogers的创新扩散理论和格拉斯哥的RE-AIM（覆盖、有效性、采用、实施、维持）评估框架，以实现以下具体目标：1）测试传播EPICS的被动和主动方法，以提高非裔美国人的结直肠癌筛查率; 2）衡量EPICS被社区联盟接受的程度以及在各种环境中实施的保真度; 3）估计EPICS的潜在可译性和公共卫生影响。创新传播理论将指导EPICS传播过程，RE-AIM将用于评估这种传播及其影响。在这项研究中，我们提出了一个来自美国各地的20个社区联盟的集群随机对照试验，分配到四个条件之一：（1，被动）基于网络访问促进者培训材料和工具包，没有技术援助（TA）;（2，被动）与1相同，但有TA;（3，主动）亲自访问（IP）促进者培训材料和工具包 没有助教和（4，主动）IP访问辅导员培训材料和工具包与助教。每个社区联盟将与三个实施场所合作：教堂、诊所和社区场所。非裔美国人，50-74岁，目前没有接受CRC筛查，有资格参加研究（每个社区联盟n= 7，200或n=360名合格个体）。这假设每个研究组的样本量为1800，显著性水平为5%（即α = 0.05），比例的双侧两组卡方检验。假设我们在我们的研究中观察到，与被动组参与者的筛查率相比，主动组参与者的结直肠癌筛查率有所增加，我们将有99%以上的把握度检测到比例的统计学显著差异。本研究拟定的所有统计检验均为双侧检验，并将使用5%的显著性水平（即，α =0.05）。 公共卫生相关性：结直肠癌（CRC）是癌症死亡的最重要原因之一（仅次于肺癌），根据种族/民族记录的持续差异。该项目旨在证明在非裔美国人中被证明有效的干预措施的有效性，并通过描述其从研究到真实的世界环境的过渡来记录其效用。成功实施干预措施的核心要素将增加非裔美国人的CRC筛查，并将有助于降低CRC的发病率和死亡率。

DESCRIPTION (provided by applicant): African Americans have the highest incidence and mortality and are less likely than whites to have screening for colorectal cancer (CRC). We recently completed a five-year randomized controlled community intervention trial that demonstrated the efficacy of a small group education intervention (now named EPICS or Educational Program to Increase Colorectal Cancer Screening) that doubled the CRC screening rate compared to the control group rate. EPICS was then put into practice in partnership with the local health department and was equally effective. We are now disseminating the intervention across the state of Georgia. In this application we propose a national dissemination and implementation study. We propose using Rogers' Diffusion of Innovation Theory and Glasgow's RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) evaluation framework to pursue the following specific aims: 1) test passive and active approaches to disseminating EPICS to increase screening rates for colorectal cancer among African Americans; 2) measure the extent to which EPICS is accepted by community coalitions and the fidelity of implementation in various settings and 3) estimate the potential translatability and public health impact of EPICS. Diffusion of Innovations Theory will guide the process of EPICS dissemination and RE-AIM will be used to assess this dissemination and its impact. For this study we propose a cluster randomized controlled trial of 20 community coalitions from across the United States, assigned to one of four conditions: (1, passive) web-based access to facilitator training materials and toolkits without technical assistance (TA); (2, passive) the sam as 1, but with TA; (3, active) in-person access (IP) to facilitator training materials and toolkits without TA and (4, active) IP access to facilitator training materials and toolkits with TA. Each community coalition will partner with three settings for implementation: a church, clinic and community site. African Americans, 50-74 years of age, who are not current on CRC screening are eligible for study participation (n=7,200 or n=360 eligible individuals per community coalition). This assumes a sample size of 1800 per study arm, a significance level of 5% (i.e. alpha = 0.05), and a two-sided two-group chi-square test of proportions. Assuming that we observe in our study an increase in screening rates of colorectal cancer among participants in active arms compared to screening rates among participants in the passive arms, we will have greater than 99% power to detect statistically significant differences in the proportions. All statistical tests proposed for this study will be two-sided and will be performed using a significance level of 5% (i.e., alpha=0.05). PUBLIC HEALTH RELEVANCE: Colorectal Cancer (CRC) is one of the most important causes of cancer deaths (second to lung cancer), with persistent disparities documented by race/ethnicity. This project seeks to demonstrate the effectiveness of an intervention proven efficacious among African Americans, and to document its utility by describing its transition from research to real world settings. Successfully implementing the core elements of the intervention will increase CRC screening among African Americans and will help reduce CRC incidence and mortality.