Evidence-Based Colorectal Cancer Screening for the Uninsured
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,565
- 主要终点
- FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year
研究概览
简要总结
Through this program, the investigators will test a systematic colon cancer screening outreach strategy for increasing screening completion among uninsured patients, not up-to-date with screening. The intervention will consist of mailed screening invitations, with processes such as phone reminders to promote screening and evidence based follow up. All patients will be randomly assigned to receive mailed invitations to complete a home fecal immunochemical test (FIT). Some patients will be randomly assigned to receive a small financial incentive on completion of FIT testing.
详细描述
All patients meeting inclusion/exclusion criteria will receive mailed invitation and FIT kit to complete screening, with processes to promote screening completion. The list of eligible patients will be divided into 5 groups so that the expected group of 10,000 patients will receive invitations spread out in time, so as to avoid overwhelming the system. The invitation letters emphasize importance of colorectal cancer screening, encourage the patient to complete FIT screening with the enclosed FIT kit, and will be signed by John Pter Smith (JPS) investigators as representatives of JPS primary care physicians.
The invitation kit will include a 1-sample POLYMEDCO Sensor FIT, including simplified instructions on how to perform the test, as well as a return mailer with prepaid postage. Diet/medication restriction will not be required. Kits will be returned to JPS and processed per manufacturer recommendations.
Automated and "live" phone call reminders to encourage screening completion will be sent at time of invite and within week 1 of the invitation. Up to two "live" phone call reminders will be attempted 2 to 3 weeks post invitation, using English and Spanish standard scripts.
Follow up for patients with a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3 consistent with guideline recommended annual FIT for colorectal screening. Follow up for patients with an abnormal FIT will consist of navigation to complete a colonoscopy. Patients with abnormal FIT will be called by the screening team within 1 week to report the result and facilitate direct scheduling of colonoscopy or a pre-colonoscopy visit. Follow up of patients with a colorectal cancer will consist of navigation to first treatment consultation visit. A surgery or oncology clinic follow up will be scheduled for all patients with a colorectal cancer diagnosis if such follow up is not already scheduled by the colonoscopist who diagnosed the colorectal cancer. Reminder calls for these visits will be made daily for up to one week.
A group of 2,000 individuals will be randomly assigned to receive a modest financial incentive to complete screening, in addition to the organized outreach program. The incentive will consist of a gift card in one of two small dollar amounts to a local retailer. Incentives will be mailed by the JPS outreach team, in exchange for successful FIT completion, after the FIT has been returned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uninsured, but participants in John Peter Smith Health System (JPS) medical assistance program for the uninsured.
- •One or more visits to a JPS primary care clinic within a year.
- •Not up-to-date with colorectal cancer screening.
排除标准
- •Patients with a history of Colorectal Cancer or colon resection, no address and/or phone number on file, or who are incarcerated will be excluded.
结局指标
主要结局
FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year
时间窗: Each year for three years
Primary outcome was analyzed using an intent-to-screen approach where a 2-sided P-value \<0.05 was considered statistically significant. Patients were randomly assigned to one of 3 groups: outreach only, outreach + $5 incentive upon FIT return, and outreach + $10 incentive upon FIT return. For analysis, incentive groups were combined and compared to outreach alone.
次要结局
- FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive(Each year for three years)