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Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

2015年4月14日 更新者:Kenzie Cameron、Northwestern University
The purpose of this study is to evaluate the effectiveness of a low literacy, physician and patient-directed intervention to promote colorectal cancer (CRC) screening among the medically underserved.

研究概览

详细说明

This study will test the separate and combined effect of two of these interventions: 1) a provider communication skills training using a continuous quality improvement (CQI) framework, and 2) a brief, multimedia Patient Education Program (PEP) that incorporates plain language, graphic design, and audio voice-over to overcome literacy limitations. Our provider intervention has demonstrated efficacy to significantly improve CRC screening recommendation rates. Our multimedia program has also been field tested among patients with limited literacy and was able to improve patient knowledge and intention to receive screening.

We will implement both provider-only and combined provider-patient strategies within a federally qualified health center network to determine the most effective and efficient approach to promote CRC screening in these settings. Results from the study, supplemented by cost analyses and the process evaluation will directly inform translational strategies for cancer prevention within difficult community-based healthcare settings.

研究类型

介入性

注册 (实际的)

569

阶段

  • 阶段2
  • 第三阶段

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

    • Illinois
      • Chicago、Illinois、美国、60606
        • Access Community Health Network
      • Chicago、Illinois、美国、60612
        • University of Illinois Hospital & Health Sciences System

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 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients aged 50-75 years of age (in month 1 of the study)
  • Patients have had two or more visits to the clinic during the past two years
  • ACCESS Community Health Network patients
  • University of Illinois Hospital & Health Sciences System patients
  • Patients ages 50 - 75 as of the start of the intervention study
  • English or Spanish-Speaking

Exclusion Criteria:

  • Patients <50 or > 75 years of age
  • Patients who have had fewer than two or more visits to the clinic during the past two years
  • Personal history of CRC or colorectal polyps, or of inflammatory bowel disease and a family history with a first-degree relative with CRC or colorectal polyps.
  • Unable to speak English or Spanish
  • Compliant with CRC screening (FOBT or FIT within the past year; flexible sigmoidoscopy within past 5 years; colonoscopy within past 10 years)

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:卫生服务研究
  • 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
无干预:Control
Participants will complete interviewer-administered pre- and post-test
实验性的:Physician Intervention
Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training
Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
实验性的:Physician and Patient Intervention
Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Colorectal Cancer (CRC) Screening Completion
大体时间:within 6 months of provider recommendation
CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy
within 6 months of provider recommendation
Colorectal Cancer (CRC) Screening Completion
大体时间:within 6 months of provider recommendation
CRC screening completion via FOBT, FIT or Colonoscopy
within 6 months of provider recommendation

次要结果测量

结果测量
措施说明
大体时间
Provider Recommendation of CRC Screening
大体时间:6 months following patient enrollment into study
Provider recommendation of CRC Screening based on chart review
6 months following patient enrollment into study

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:Kenzie A Cameron, PhD、Northwestern University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2010年4月1日

初级完成 (实际的)

2013年7月1日

研究完成 (实际的)

2013年9月1日

研究注册日期

首次提交

2010年4月12日

首先提交符合 QC 标准的

2010年4月13日

首次发布 (估计)

2010年4月14日

研究记录更新

最后更新发布 (估计)

2015年5月6日

上次提交的符合 QC 标准的更新

2015年4月14日

最后验证

2015年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • R01CA140177-01 (美国 NIH 拨款/合同)
  • R01CA140177 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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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