Strategies and Opportunities to Stop Colon Cancer in Priority Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62,155
- 试验地点
- 16
- 主要终点
- FIT Completion
研究概览
简要总结
Only an estimated 50 million US adults aged 50-75 are up-to-date on colorectal cancer (CRC) screening according to guidelines set by the federal government. CRC is 90% curable with timely detection and appropriate treatment of precancerous polyps; increased screening could reduce incidence by up to 50%. Groups least likely to undergo screening, those with minimal education, low income, low access to health care, recent immigrants or Hispanics, are the same people who frequently receive care at Federally Qualified Healthcare Center's (FQHCs). The use of fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) is exceedingly low in FQHCs (7-9% of patients in the past year) and far below national averages and target rates. Our results will provide valuable information on how to use electronic health record (EHR) resources to optimize guideline-based screening in FQHC clinics whose patient populations have disproportionately low CRC screening rates.
This project, in conjunction with the research team, will use an advisory panel to direct the research activities. The advisory panel will be made up of clinicians, leaders, researchers, and patients. The panel and team will guide the development of materials, the outreach to patients, and the research protocol to best reach FQHC patients who are due for colorectal cancer screening.
This project will be conducted in two phases, Phase I is conducting a pilot at two FQHC's, and Phase II is rolling out the intervention to between 20-30 clinics.
详细描述
Phase I (Pilot Aims)
- Aim 1 Conduct preliminary analyses of EHR data at two pilot clinics.
- Aim 2: Use codes and methods developed in Aim 1 to test the feasibility, reach, effectiveness, and cost of an EHR-based CRC screening intervention using a subset of 100 patients at each of two pilot clinics. We will use codes defined in Aim 1 to create a Solutions-based, Epic-integrated system to track CRC screening, mail FIT kits, and track patient test results and receipt of follow-up care. The system will be pilot-tested in two clinics.
- Aim 3: Use results from the pilot intervention to prepare for a large-scale, cluster-randomized pragmatic trial across 18 OCHIN clinics (see Phase II).
Transition from Phase I to Phase II
-Changes to our original proposal include going from a three arm to a two-arm pragmatic cluster trial with revised evaluation and power calculation and refinements to the intervention components for both usual care (now described as enhanced usual care) and the intervention (now described as enhanced auto).
Phase II (Full trial Aims)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 50-74 with no evidence of a colonoscopy within 9 years or fecal testing within 11 months, and no history of colorectal disease will be eligible to receive a mailed FIT.
排除标准
- •End Stage Renal Disease (ESRD)
- •Hospice/Nursing Home
结局指标
主要结局
FIT Completion
时间窗: Completed FIT kits sent back within 12 months
Binary indication of FIT completion within 12 months or through August 3, 2015 (when usual care clinics received access to study tools). Proportion of completed FIT is represented below with a confidence interval of the difference in completed FIT.
次要结局
- Any CRC Screening(Any CRC screening complete within 12 months)