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Implementation Intentions to Promote Colon Cancer Screening in Rural Primary Care Practice

2013年9月6日 更新者:Kimberly Engelman, PhD
To assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions.

研究概览

详细说明

Although colorectal cancer (CRC) is preventable and curable if detected early, a large portion of the population is not current with screening recommendations. Many unscreened individuals 50 years of age and older do not receive health care system prompts to promote adherence to test preparation or completion. This study will assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions". The intervention will be delivered through a partnership between patients, rural primary care physicians, and trained CRC information specialists (CRC-IS) and will focus on the 'recalcitrant' primary care population. A randomized design will test a comparison condition of a "no-partnership" system with generic information versus a "partnership" intervention system that specifically addresses each participants' CRC screening "implementation intentions" (the "when," "where" and "how" screening details). The study will be conducted with 600 patients eligible for CRC screening and recruited while presenting for care in a set of Research Network affiliated primary care clinics, or patient contact information gathered from in-house chart reviews. All participants who are not up-to-date on CRC screening, or not at high risk for CRC, will receive a baseline tablet PC-administered CRC assessment, or a letter of invitation from their PC physician to go online to the Healthy Living Kansas patient portal to complete the assessment. Completion of CRC screening at 60 days post index visit will be assessed through follow-up phone calls. Those not completing CRC screening after taking the assessment,(i.e., recalcitrant participants) then will be randomized to either C (comparison group-"no-partnership") or CPI2 (active intervention-CRC-IS/ physician/patient partnership and implementation intentions-based communication concepts). Physicians will receive informational fax sheets summarizing all participant phone calls. A 120-day post randomization follow-up telephone call will assess the effects of implementation intentions communications and perceived CRC screening barriers encountered. The primary outcome will be CRC screening adherence at 120 days. Secondary outcomes will assess 120-day perceived barriers and advancement in screening decisional stage. This intervention will provide information on the utility of embedding an "implementation intentions" based behavioral intervention for promoting CRC screening among initially non-adherent primary care patients.

研究类型

介入性

注册 (实际的)

373

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Kansas
      • Kansas City、Kansas、美国、66160
        • University of Kansas Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 50 years of age or older
  • at average risk for colorectal cancer
  • not up to date with colorectal cancer screening

Exclusion Criteria:

  • Younger than 50 years of age
  • at high risk for colorectal cancer
  • up to date with colorectal cancer screening

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:1
Implementation Intentions-based telephone counseling. Partnership intervention between rural Primary Care Physicians, their patients, and CRC Information Specialists using an implementation intentions based approach.
Implementation Intentions-based telephone counseling
无干预:2
Healthy Living information on Physical Activity and Nutrition

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Follow up survey to assess participant compliance with CRC screening. For those non compliant participants, randomized to either Control group or CPI2 group - active intervention with implementation intentions-based communication concepts
大体时间:60 days
60 days

次要结果测量

结果测量
大体时间
120 day followup survey to assess perceived barriers and screening decisional stage
大体时间:120 Days
120 Days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Kimberly K. Engelman, PhD、University of Kansas Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年9月1日

初级完成 (实际的)

2011年12月1日

研究完成 (实际的)

2012年6月1日

研究注册日期

首次提交

2007年12月31日

首先提交符合 QC 标准的

2008年1月10日

首次发布 (估计)

2008年1月23日

研究记录更新

最后更新发布 (估计)

2013年9月10日

上次提交的符合 QC 标准的更新

2013年9月6日

最后验证

2013年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 11018
  • 1R01CA121016-01A2 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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