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将教育计划提高结直肠癌筛查效果(EPICS)的疗效转化为效果的研究方案:一项群组随机对照试验。

Efficacy to effectiveness transition of an Educational Program to Increase Colorectal Cancer Screening (EPICS): study protocol of a cluster randomized controlled trial.

机构信息

Department of Community Health and Preventive Medicine, Morehouse School of Medicine, Atlanta, GA, USA.

出版信息

Implement Sci. 2013 Aug 7;8:86. doi: 10.1186/1748-5908-8-86.

DOI:10.1186/1748-5908-8-86
PMID:23924263
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3750535/
Abstract

BACKGROUND

African Americans have the highest incidence and mortality and are less likely than whites to have been screened for colorectal cancer (CRC). Many interventions have been shown to increase CRC screening in research settings, but few have been evaluated specifically for use in African-American communities in real world settings. This study aims to identify the most efficacious approach to disseminate an evidence-based intervention in promoting colorectal screening in African Americans and to identify the factors associated with its efficacy.

METHODS/DESIGN: In this study, investigators will recruit 20 community coalitions and 7,200 African-Americans age 50 to 74 to test passive and active approaches to disseminating the Educational Program to Increase Colorectal Cancer Screening (EPICS); to measure the extent to which EPICS is accepted and the fidelity of implementation in various settings and to estimate the potential translatability and public health impact of EPICS. This four-arm cluster randomized trial compares the following implementation strategies: passive arms, (web access to facilitator training materials and toolkits without technical assistance (TA) and (web access, but with technical assistance (TA); active arms, (in-person access to facilitator training materials and toolkits without TA and (in-person access with TA). Primary outcome measures are the reach (the proportion of representative community coalitions and individuals participating) and efficacy (post-intervention changes in CRC screening rates). Secondary outcomes include adoption (percentage of community coalitions implementing the EPICS sessions) and implementation (quality and consistency of the intervention delivery). The extent to which community coalitions continue to implement EPICS post-implementation (maintenance) will also be measured. Cost-effectiveness analysis will be conducted.

DISCUSSION

Implementing EPICS in partnership with community coalitions, we hypothesized, will result in more rapid adoption than traditional top-down approaches, and resulting changes in community CRC screening practices are more likely to be sustainable over time. With its national reach, this study has the potential to enhance our understanding of barriers and enablers to the uptake of educational programs aimed at eliminating cancer disparities.

TRIAL REGISTRATION

http://www.ClinicalTrials.gov NCT01805622.

摘要

背景

非裔美国人的结直肠癌(CRC)发病率和死亡率最高,且接受 CRC 筛查的比例低于白人。许多干预措施已被证明可在研究环境中增加 CRC 筛查,但很少有专门针对非裔美国人社区在真实环境中使用的干预措施进行评估。本研究旨在确定最有效的方法来传播基于证据的干预措施,以促进非裔美国人的结直肠筛查,并确定与干预效果相关的因素。

方法/设计:在这项研究中,研究人员将招募 20 个社区联盟和 7200 名年龄在 50 至 74 岁的非裔美国人,以测试被动和主动方法来传播《增加结直肠癌筛查教育计划》(EPICS);衡量 EPICS 的接受程度及其在各种环境中的实施保真度,并估计 EPICS 的潜在可翻译性和公共卫生影响。这项四臂聚类随机试验比较了以下实施策略:被动组(访问网络以获取 facilitator 培训材料和工具包,但没有技术援助(TA);访问网络,但有技术援助(TA);主动组(亲自访问 facilitator 培训材料和工具包,但没有 TA 和(亲自访问,有 TA)。主要结局指标是覆盖率(代表性社区联盟和个人参与的比例)和效果(干预后 CRC 筛查率的变化)。次要结局包括采用(实施 EPICS 课程的社区联盟的百分比)和实施(干预提供的质量和一致性)。社区联盟在实施后(维护)继续实施 EPICS 的程度也将被衡量。将进行成本效益分析。

讨论

与社区联盟合作实施 EPICS,我们假设这将比传统的自上而下的方法更快地被采用,并且社区 CRC 筛查实践的变化更有可能随着时间的推移而持续。该研究具有全国性的影响力,有潜力增强我们对消除癌症差异的教育计划采用的障碍和促进因素的理解。

试验注册

http://www.ClinicalTrials.gov NCT01805622。

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