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临床试验/NCT00134589
NCT00134589已完成4 期

Increasing CRC Screening in Health Plan Members

Centers for Disease Control and Prevention2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2005年4月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
450
试验地点
2
主要终点
Completion of colorectal cancer screening

研究概览

简要总结

The purpose of this study is to determine the effectiveness of a two-component intervention, that combines academic detailing at the medical practice level and distribution of decision aids at the patient level, on adherence to colorectal cancer screening guidelines.

详细描述

Colorectal cancer is the second most common cause of cancer death in the United States. Early detection and intervention can significantly reduce morbidity and mortality from colorectal cancer (CRC), and current guidelines recommend that asymptomatic adults over age 50 periodically obtain screening by one of several modalities (FOBT, sigmoidoscopy, colonoscopy, or double contrast barium enema). However, CRC screening remains substantially underutilized in the U.S., and more than half of all adults do not adhere to these recommendations. This study was designed to increase CRC screening among health plan members, and involves the collaboration of a major health insurer.

We are conducting a cluster-randomized trial in health practices in Georgia and Florida, to test the effectiveness of a decision aid (video + brochures) for increasing adherence to CRC screening guidelines. Thirty-two large group practices were recruited and randomized to receive usual care (routine reminders) or an evidence-based decision aid intervention. In each practice, patients between the ages of 52 and 75, without current CRC screening history, were enrolled into the study.

In early 2007, we received a full HIPAA waiver that permitted us to send the decision aid intervention to long-term non-responders in the intervention group, and to access claims data for this group and the long-term non-responders in the usual care group. This procedure will make it possible for us to learn more about the real-world impact of the intervention.

The intervention will continue for up to 2 years for still-unscreened participants. The main outcome is receipt of an evidence-based modality of CRC screening according to the US Preventive Services Task Force Guidelines (FOBT, flexible sigmoidoscopy, colonoscopy, or double contrast barium enema).

Unique features of the proposed study include its potential to establish systems to increase screening uptake that will help fulfill HEDIS requirements; improving our understanding of how screening promotion interventions work in both White and Black populations; collaboration with a community partner of the Emory Prevention Research Center, and forging collaborative relationships between public health and health care researchers, and the affected communities of health plans and health care providers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
盲法
Single

入排标准

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

入选标准

  • Ages 52-75
  • Aetna Health Plan member
  • Average risk for colorectal cancer
  • Did not have colorectal cancer screening within guideline time frame (1 to 10 years, depending on individual's age and type of screening)

排除标准

  • History of colorectal cancer, polyps, inflammatory bowel disease, upper or lower gastrointestinal bleeding, cirrhosis, chronic obstructive pulmonary disease, cancer, blindness, uncorrectable hearing loss, severe dementia, severe heart failure, severe coronary artery disease
  • Family history of colorectal cancer/polyps

结局指标

主要结局

Completion of colorectal cancer screening

次要结局

  • Patient's intention to ask/patient asking medical provider for colorectal cancer screening

研究者

研究点 (2)

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