Optimizing Evidence-Based Interventions to Improve Colorectal Cancer Screening Adherence in Community Health Clinics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Number of participants with scheduled or completed colorectal cancer screening.
研究概览
简要总结
This is a 4 arm pragmatic trial to test a multicomponent intervention designed to improve adherence to colorectal cancer screening.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established adult medicine patient at Cornell Scott Hill health (defined as having a CSHH primary care doctor or >1 adult medicine visits in the last year).
- •Incomplete colorectal cancer screening test defined as an outstanding order for colonoscopy or stool-based CRC screening (e.g., fecal immunochemical test (FIT) or FIT-DNA testing), but no evidence of test completion at the time of randomization. Orders must have been placed between 90-365 days prior to randomization.
- •Abnormal stool-based test without follow-up, defined as an abnormal stool-based test result (e.g., positive FIT or FIT-DNA) with no completed diagnostic colonoscopy within 90 days of the result. Patients who meet this criterion will be included in a non randomized arm of the study.
排除标准
- •Because this is a pragmatic study of a behavioral intervention to improve colorectal cancer screening adherence, any participants who otherwise meet the inclusion criteria will not be excluded.
研究组 & 干预措施
Messaging Group A
Participants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C).
干预措施: Bundled messaging intervention (Behavioral)
Control-Usual Care
Participants will receive a simple text message reminder
Messaging Group B
Participants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C).
干预措施: Bundled messaging intervention (Behavioral)
Messaging Group C
Participants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C).
干预措施: Bundled messaging intervention (Behavioral)
结局指标
主要结局
Number of participants with scheduled or completed colorectal cancer screening.
时间窗: up to 3 months from randomization
Number of participants who completed or scheduled screening (colonoscopy or stool-based test) within 3 months of randomization.
次要结局
- Number of participants with abnormal stool-based test that complete a diagnostic colonoscopy.(up to 90 days from intervention)
- Number of participants who complete screening.(up to 90 days from randomization)
- Number of participants who achieve the primary endpoint.(6 months post randomization)
- Number of participants who achieve the primary endpoint by message type.(up to 90 days from randomization)
- Number of participants who complete screening within 6 months of initial outreach.(up to 6 months from initial outreach)
- Number of participants who complete screening colonoscopy within 6 months of initial outreach.(up to 6 months from initial outreach)
- Number of participants who provide any response.(7, 14, 21, and 90 days)
- Number of participants who achieve the primary outcome from among those who did and did not respond to any text message.(6 months post randomization)
- Number of providers who respond to reminders.(6 months post randomization)