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临床试验/NCT01519999
NCT01519999已完成不适用

Colorectal Cancer Screening With Improved Shared Decision Making (CRCS-WISDM)

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 206,721 人开始时间: 2012年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
206,721
试验地点
2
主要终点
Change in colorectal cancer screening adherence

研究概览

简要总结

The purpose of this study is to increase colorectal cancer screening by implementing a community-wide shared decision-making (SDM) intervention, which embeds shared decision making within clinical practice and also uses an extensive community engagement campaign. The investigators hypothesize that colorectal cancer screening adherence will be higher in the intervention group (participating communities) compared to the usual care control group (non-participating comparison communities).

详细描述

Clinical practice: All patients 50-75 years seen in the participating primary care clinics during the study period who are non-adherent to CRCS recommendation. This sample is anticipated to be N~50,000 patients.

Community engagement: Includes mailed questionnaires to age-eligible adults residing in intervention and comparison (control) communities (N=2150).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50 to 75 years of age
  • Lives in or receives care in the selected intervention or comparison (control) communities
  • Average-risk for colorectal cancer
  • Non-adherent to CRCS recommendation
  • English-speaking
  • People who consent to participate

排除标准

  • <50 years of age or >75 years of age
  • Not living in or receiving care in the selected intervention or comparison communities
  • High-risk for colorectal cancer
  • Adherent to CRCS recommendation
  • Non-English speaking
  • People who do not consent to participate

研究组 & 干预措施

Shared Decision Making

Experimental

干预措施: Shared Decision Making for Colorectal Cancer Screening (Behavioral)

Comparison (control)

No Intervention

结局指标

主要结局

Change in colorectal cancer screening adherence

时间窗: Baseline up to 24 months post intervention initiation

Colorectal cancer screening adherence will be defined as having screening according to the recommendations of the United States Preventive Services Task Force. Participants will be classified as screened per recommendations if they have had fecal occult blood testing in the last year, flexible sigmoidoscopy in the last five years, or colonoscopy in the last ten years. Participants will be classified as non-adherent if they have not had any of the modalities within the recommended timeframe.

次要结局

  • Decisional conflict(Baseline up to 24 months post intervention initiation)
  • Modality-specific colorectal cancer screening barriers(Baseline up to 24 months post intervention initiation)
  • Colorectal cancer screening-related confusion(Baseline up to 24 months post intervention initiation)
  • Patients' shared decision-making experience(Baseline up to 12 months post intervention initiation)
  • Providers'/staff shared decision-making experience(Baseline up to 24 months post intervention initiation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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