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临床试验/NCT00251862
NCT00251862已完成不适用

Shared Decision-Making for Colorectal Cancer Screening

Agency for Healthcare Research and Quality (AHRQ)4 个研究点 分布在 1 个国家目标入组 825 人开始时间: 2005年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
825
试验地点
4
主要终点
Patient Adherence (Test Completion)

研究概览

简要总结

The overall objective of this study is to conduct a three-arm randomized controlled trial to evaluate the impact of an interactive, web-based decision aid on shared decision-making and patient adherence to colorectal cancer (CRC) screening recommendations.

详细描述

Colorectal cancer (CRC) is the second leading cause of cancer-related death and third most commonly diagnosed cancer among men and women in the United States. Screening has been shown to be a cost-effective strategy for reducing both CRC mortality through early detection and incidence through the detection and removal of precancerous adenomatous polyps (adenomas). Despite a compelling rationale and widespread endorsement by authoritative groups, screening rates remain far below those necessary to achieve significant reductions in CRC mortality or incidence. Poor patient acceptance and non-adherence to screening recommendations are partly responsible for low screening rates. Shared decision-making has been advocated as a potentially effective yet unproven strategy for addressing this problem. Implicit in this approach is the need for an unbiased decision aid that not only educates patients about the pros and cons of the different strategies so as to enable them to identify a preferred strategy but also empowers patients to take a proactive role in the decision-making process, thereby increasing satisfaction and promoting adherence. From a logistical standpoint, the decision aid must also be easy to implement in the ambulatory setting so as to maximize use but minimize demands on physician time and office resources. To address this need, we have developed an interactive, web-based decision aid and implementation strategy for use in routine clinical practice.

Comparison(s): Average risk subjects assigned to one of two intervention arms (decision aid alone versus decision aid plus personalized risk assessment with feedback) compared to a control arm(generic website that discusses lifestyle changes that can reduce overall cancer risk).

研究设计

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

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

  • Asymptomatic average-risk subjects
  • Under the direct care of one of participating site's staff (attending) physicians or physician extenders;
  • No prior screening other than fecal occult blood testing (FOBT);
  • No major co-morbidities that preclude CRC screening by any method

排除标准

  • Prior CRC screening by any method other than FOBT occult blood testing
  • High-risk condition (personal history of colorectal cancer or polyps, family history of colorectal cancer or polyps involving one or more first degree relatives, chronic inflammatory bowel disease)
  • Lack of fluency in written and spoken English (since decision aid and personalized risk assessment tool will be in English only due to funding issues);
  • Comorbidities that preclude CRC screening by any method

结局指标

主要结局

Patient Adherence (Test Completion)

时间窗: 12 months post-intervention

Completion of a screening test within 12 months of the study visit.

次要结局

  • Patient Knowledge(Immediate post-intervention study visit)
  • Patient Satisfaction With Decision Making Process(Immediate post-intervention primary care provider (PCP) visit)
  • Screening Intentions(Immediate post-intervention study visit)

研究者

发起方
Agency for Healthcare Research and Quality (AHRQ)
申办方类型
Fed
责任方
Sponsor

研究点 (4)

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