Improving Rates of Repeat Colorectal Cancer Screening
Center for Advancing Equity in Clinical Preventive Services Project 1: Improving Rates of Repeat Colorectal Cancer Screening
The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC) screening using fecal occult blood testing (FOBT), sigmoidoscopy, or colonoscopy in adults, beginning at age 50 and continuing until age 75. However, rates of CRC screening remain inadequate. In 2006, only 60.8% of adults 50 or older reported recent CRC screening. Screening rates are even lower among Black and Hispanic populations and in areas with higher poverty rates. Annual or biennial FOBT testing over many years is essential for FOBT to be effective. Few studies have examined the rate of repeat FOBT testing; to the investigators knowledge, none have been conducted in populations with high prevalence of barriers to screening (e.g., low literacy, varied cultural norms, and transportation difficulties). The assumption that FOBT is an effective CRC screening strategy presumes it will be done at least biennially, and cost-effectiveness studies of CRC screening strategies have found that the results are sensitive to the rate of adherence. The investigators study will provide critical information for providers and policymakers as they consider optimal strategies to increase CRC screening among vulnerable populations.
Overall Study Goal: Improve colorectal cancer screening by increasing rates of repeat fecal occult blood testing (FOBT).
Aim 1: Test if a multifaceted intervention increases repeat FOBT testing adherence over a 30-month period
Hypothesis 1: Compared to usual care, the intervention will increase the proportion of patients who complete a repeat annual FOBT within 6 months of their due date.
Hypothesis 2: Compared to usual care, the intervention will increase the proportion of patients who complete 2 additional FOBTs over the 30-month intervention period.
Aim 2: Explore perceived barriers to screening among patients who received the intervention but did not complete repeat FOBT testing within 18 months
Aim 3: Assess the costs of the intervention and the costs per additional repeat screening compared to patients who received usual care.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Fecal occult blood test (FOBT) completed in the past year
- Age 51-75
- Preferred language English or Spanish
Exclusion Criteria:
- Any of the following: (1) Colonoscopy within 10 years (2) Flexible sigmoidoscopy within 5 years or (3) A clinician order or referral for FOBT prior to the due date
- Documentation of medical conditions suggesting colorectal cancer (CRC) screening through FOBT may be inappropriate including: chronic diarrhea, inflammatory bowel disease, iron deficiency, previous colonic polyp, use of medications in the previous 1 month that elevate the risk of a false-positive FOBT
学习计划
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Reminder and Outreach Intervention
Participants randomized to this arm will receive the Reminder and Outreach intervention.
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This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results.
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无干预：Usual Care Control Group
Patients assigned to this arm will receive usual care.
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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 |
|---|---|---|
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Completion of a Fecal Occult Blood Test (FOBT)
大体时间：within 6 months of randomization
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This outcome will be categorized as Completed FOBT if a participant's chart has documentation of a completed FOBT screening test.
Outcomes will be assessed by querying the electronic health record (EHR) for all participants.
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within 6 months of randomization
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合作者和调查者
调查人员
- 首席研究员：David W Baker, MD MPH、Northwestern University
出版物和有用的链接
一般刊物
- Baker DW, Brown T, Buchanan DR, Weil J, Balsley K, Ranalli L, Lee JY, Cameron KA, Ferreira MR, Stephens Q, Goldman SN, Rademaker A, Wolf MS. Comparative effectiveness of a multifaceted intervention to improve adherence to annual colorectal cancer screening in community health centers: a randomized clinical trial. JAMA Intern Med. 2014 Aug;174(8):1235-41. doi: 10.1001/jamainternmed.2014.2352.
- Baker DW, Brown T, Buchanan DR, Weil J, Cameron KA, Ranalli L, Ferreira MR, Stephens Q, Balsley K, Goldman SN, Wolf MS. Design of a randomized controlled trial to assess the comparative effectiveness of a multifaceted intervention to improve adherence to colorectal cancer screening among patients cared for in a community health center. BMC Health Serv Res. 2013 Apr 29;13:153. doi: 10.1186/1472-6963-13-153.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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