Evidence Based Colorectal Cancer Screening for the Uninsured - Sub-study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,565
- 主要终点
- Percentage of individuals who complete FIT screening measured by return FIT kit
研究概览
简要总结
This is a sub-study nested within a previously initiated clinical study (# NCT01946282) focusing on individuals not previously randomized at baseline to the original interventions. The purpose of the sub-study is to evaluate, via a randomized controlled trial design, 3 strategies for promoting screening completion among individuals not up to date with colorectal cancer screening, but assigned to receive screening outreach.
详细描述
In the previously initiated, ongoing clinical study (# NCT01946282) investigators are testing a systematic colon cancer screening outreach strategy for increasing screening completion among uninsured patients, not up-to-date with screening. This is a Sub-study to #NCT01946282 (IRB # 082012-086).
Sub-study description:
The goal of the sub-study is to identify strategies that may further increase rates of 1) initial participation in colorectal cancer screening, and 2) follow up of abnormal colorectal cancer screening tests with colonoscopy.
At the time of the sub-study, all patients randomly assigned to receive gift card incentives have been enrolled. At this time only standard, non-incentive invitations continue to be mailed to eligible patients.
The sub-study involves 2 parts:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Participants in John Peter (JPS) Health System 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 with JPS
- •Incarcerated
结局指标
主要结局
Percentage of individuals who complete FIT screening measured by return FIT kit
时间窗: Within 3 months of invitation
The primary outcome will be analyzed using an intention to treat approach. An "a priori" estimated sample size is 2,124; assigned 1:1:1 via simple randomization, stratified by round of invitation to each of the three intervention groups. Sample size was constrained by the number of individuals eligible for screening outreach; all eligible individuals during study period will be included in one of the intervention groups. Assuming a standard intervention group FIT completion rate of 36%, and two-sided alpha=0.125 for each comparison, an estimated 80% power to detect a \>8% difference between Condition 1 (standard mailed invitation, n=708) and Condition 2 (n=708), as well as 80% power to detect a \>8% difference between Condition 1 (n=708) and Condition 3 (n=708).
次要结局
- Percentage of individuals who schedule a pre-operative clinic visit (if recommended).(Within 6 months of mailed FIT results letter)
- Percentage of individuals who complete a colonoscopy (if recommended).(Within 6 months of mailed FIT results letter)
- Pre-post analysis of current results reporting strategy (which will utilize a white envelope for normal results, and a red envelope for abnormal results) to prior generic envelope for FIT result reporting for both normal and abnormal results.(Within 6 months of mailed FIT results letter)
- Percentage of individuals who receive a positive (abnormal) FIT result that then call to receive additional information about potential follow-up test.(Within 6 months of mailed FIT results letter)