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临床试验/NCT01805622
NCT01805622Unknown不适用

Efficacy to Effectiveness Transition of an Educational Program to Increase Colorectal Cancer Screening

Morehouse School of Medicine2 个研究点 分布在 1 个国家目标入组 7,200 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
7,200
试验地点
2
主要终点
Reach (RE-AIM Framework)

研究概览

简要总结

  • Hypothesis 1. When compared to passive dissemination, active dissemination will result in greater participant enrollment.
  • Hypothesis 2. The intervention will be offered with equal fidelity in churches, clinics and community sites.
  • Hypothesis 3. Knowledge of CRC screening and perceived risk of CRC will be positively correlated.

详细描述

In this study, investigators aim to evaluate 20 community coalitions and 7,200 participants by: testing passive and active approaches to disseminating the Educational Program to Increase Colorectal Cancer Screening (EPICS) to increase screening rates for colorectal cancer; measuring the extent to which EPICS is accepted and the fidelity of implementation in various settings and estimating the potential translatability and public health impact of EPICS. This four-arm cluster randomized trial (five community coalitions plus 1,800 African Americans, 50-74 years of age, who are not current on colorectal cancer (CRC) screening per arm) compares the following implementation strategies: (1) web access to facilitator training materials and toolkits without technical assistance (TA); (2) web access, but with technical assistance (TA); (3) in-person access to facilitator training materials and toolkits without TA and (4) in-person access with TA. Primary outcome measures are the reach (the proportion of representative eligible community coalitions and individuals participating in the trial) and effectiveness (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 to compare passive to active dissemination costs. Investigators believe that implementing this evidence-based colorectal cancer screening intervention in partnership with community coalitions will result in more rapid adoption than traditional top-down approaches, and that 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 understanding of barriers and enablers to the uptake of educational programs aimed at eliminating cancer health disparities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
50 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • African Americans, 50-74 years of age, who are not current on CRC screening, are eligible for study participation

排除标准

  • Individuals with a personal history of CRC or inflammatory bowel disease, blindness or severe hearing impairment; dementia; or other condition with life expectancy less than two years, are ineligible for participation

结局指标

主要结局

Reach (RE-AIM Framework)

时间窗: up to 12 months

The proportion of representative eligible community coalitions and individuals participating in the trial.

Effectiveness (RE-AIM Framework)

时间窗: up to 24 months

Post-intervention changes in CRC screening rates.

次要结局

  • Adoption (RE-AIM Framework)(up to 36 months)
  • Implementation (RE-AIM Framework)(up to 36 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Selina A. Smith

Principal Investigator

Morehouse School of Medicine

研究点 (2)

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