Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics
2012年12月14日 更新者：Centers for Disease Control and Prevention
This study is a three-arm randomized controlled trial to implement and evaluate the relative effects of: 1) clinic-focused intervention; 2) combined patient- and clinic-focused intervention, and 3) usual care on the provision of colorectal cancer (CRC) screening in primary care clinics.
The study will also examine the relative effects of the intervention conditions on secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening) and on intermediate outcome measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff.
The target population includes average-risk patients aged 50-75 years, clinicians, and clinical staff within the primary care setting.
The intervention will be implemented within primary care clinics in two managed care organizations (MCOs).
The intervention targets the following CRC screening modalities: fecal occult blood test (FOBT), flexible sigmoidoscopy, colonoscopy, and double contrast barium enema.
研究概览
研究类型
介入性
注册 (实际的)
5066
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
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Michigan
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Detroit、Michigan、美国、48202
- Henry Ford Health System
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New Mexico
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Albuquerque、New Mexico、美国、87106
- ABQ Health Partners/Lovelace Clinic Foundation
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Washington
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Seattle、Washington、美国、98109
- Battelle Centers for Public Health Research and Evaluation
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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
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
Inclusion Criteria for the Patient-focused Intervention
- Average risk
- Male or female
- 50-75 years
- Scheduled for non-acute ambulatory care visit at one of the study sites
- Due for CRC screening including no record of FOBT in the past year, no record of flexible sigmoidoscopy in the past 5 years, no record of colonoscopy in the past 10 years, and no record of double contrast barium enema in the past 5 years
Inclusion Criteria for the Clinic-focused Intervention
- Primary care clinicians, to include the following specialties: Family Practice/General Practice Physicians, General Internal Medicine Physicians, Nurse Practitioners in Family/General Practice, Physician Assistants who conduct non-acute ambulatory medical exams in study clinics
- Primary care clinical staff, to include nurses, medical assistants, and appointment schedulers
Exclusion Criteria (Patients):
- Prior diagnosis of CRC
- Prior diagnosis of colorectal polyps
- Prior diagnosis of ulcerative colitis
- Prior diagnosis of Crohn's Disease
- Prior diagnosis of hereditary nonpolyposis or polyposis
- Medical records contain an International Classification of Diseases (ICD-9) code for family history of CRC
- Younger than 50 years of age
- Older than 80 years of age.
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：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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其他：1个
日常护理
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No intervention will be conducted in this arm of the study.
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实验性的：2
Clinic-focused intervention: The clinicians and clinical staff in each of the clinics will be scheduled for training sessions.
The provider trainings will be designed for clinicians and clinical staff and will be conducted in at least two separate sessions of approximately 3 hours total duration.
The sessions will be scheduled to accommodate the clinic schedule, but will be held with no more than 1 month between them.
Participants in clinic training sessions will receive continuing education credit.
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The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff.
The provider training sessions will include the presentation of CRC screening statistics and information, and will be heavily interactive and skills-based.
The provider training sessions will also focus on the provision of tools for improving clinical staff- and clinician-patient interactions about CRC screening and for office system changes/improvements to identify eligible patients and to track screening.
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实验性的：3
Clinic-focused and patient focused intervention: The clinic focused-intervention as described in Arm 2 will be combined with a patient-focused intervention. Patient focused intervention: CRC education packets, based upon previously developed CDC CRC patient education materials, have been adapted for each study site. These CRC educational packets will be mailed to average-risk patients aged 50-80 years who are due for CRC screening (based on electronic records) and who schedule a non-acute ambulatory care visit in clinics assigned to the patient-focused intervention. A cover letter signed by the patient's physician will be included with each packet. The packets will be mailed approximately 1 week before the medical appointment. |
This arm will combine the clinic-focused intervention and the patient-focused intervention.
The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff as described in Arm 2. The patient-focused intervention includes sending a CRC screening education packet (CDC-developed educational text tailored for use within the study sites), accompanied by a letter from the patient's physician, to patients meeting study inclusion criteria.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Changes in colorectal cancer screening rates (4 modalities)
大体时间：One year post initiation of intervention
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One year post initiation of intervention
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次要结果测量
结果测量 |
大体时间 |
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Changes in the frequency of secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening)
大体时间：One year post initiation in intervention
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One year post initiation in intervention
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Changes in measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff.
大体时间：One year post initiation of intervention
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One year post initiation of intervention
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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：Judith Lee Smith, PhD、Centers for Disease Control and Prevention
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。
一般刊物
- Coughlin SS, Costanza ME, Fernandez ME, Glanz K, Lee JW, Smith SA, Stroud L, Tessaro I, Westfall JM, Weissfeld JL, Blumenthal DS. CDC-funded intervention research aimed at promoting colorectal cancer screening in communities. Cancer. 2006 Sep 1;107(5 Suppl):1196-204. doi: 10.1002/cncr.22017.
- Shires DA, Divine G, Schum M, Gunter MJ, Baumer DL, Kasprzyk D, Montano DE, Smith JL, Elston-Lafata J. Colorectal cancer screening use among insured primary care patients. Am J Manag Care. 2011;17(7):480-8.
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
2009年7月1日
初级完成 (实际的)
2010年6月1日
研究完成 (实际的)
2011年12月1日
研究注册日期
首次提交
2008年8月15日
首先提交符合 QC 标准的
2008年8月18日
首次发布 (估计)
2008年8月19日
研究记录更新
最后更新发布 (估计)
2012年12月17日
上次提交的符合 QC 标准的更新
2012年12月14日
最后验证
2012年12月1日
更多信息
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.
Usual care的临床试验
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The University of Texas Health Science Center,...尚未招聘
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Arizona State UniversityMayo Clinic; National Institute of Nursing Research (NINR)完全的
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Fondazione Don Carlo Gnocchi OnlusIstituto Di Ricerche Farmacologiche Mario Negri完全的
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Copenhagen University Hospital at HerlevRigshospitalet, Denmark未知
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Emory UniversityFoundation for Physical Therapy, Inc.完全的