Choice Architecture and Mailed Outreach for Colorectal Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 423
- 试验地点
- 2
- 主要终点
- CRC screening completion
研究概览
简要总结
This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy outreach only, in patients between 50-74 years old, who have received care at the University City or Valley Forge CCA (Community Care Associates) practices, are due for screening, and are asymptomatic for CRC. The three arms are: Arm 1: Direct schedule colonoscopy (Control), Arm 2: Direct schedule colonoscopy followed by mailed FIT(Fecal Immunochemical Test) (Sequential Choice), and Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).
详细描述
This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC screening outreach vs. colonoscopy outreach only. The investigators will randomize participants to one of three study arms:
Arm 1: Direct schedule colonoscopy (Control) Arm 2: Direct schedule colonoscopy followed by mailed FIT (Sequential Choice) Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).
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
- Single (Investigator)
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
- •Between 50 and 74 years old
- •Has a primary care provider who is a University City or Valley Forge Family Medicine provider
- •Has had at least 2 office visits at either practice
- •Is due for colorectal cancer screening
- •Is asymptomatic for CRC
- •Subject's zip code is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area
排除标准
- •Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, or FOBT/FIT within twelve months of chart review (we will exclude patients who self-report any of the above procedures)
- •Has a history of CRC or colonic polyps
- •Has a history of GI cancer
- •Has a history of confirmed Inflammatory Bowel Disease (IBD)
- •has a history of colitis other than Crohns disease or ulcerative colitis)
- •Has a first degree relative that has been diagnosed with CRC
- •Has had a colectomy
- •Has been diagnosed with Familial Adenomatous Polyposis (FAP)
- •Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
- •Has iron-deficiency anemia
- •Has a history of lower GI bleeding
- •Has metastatic (Stage IV) blood or solid tumor cancer
- •Has end stage renal disease
- •Has cirrhosis
- •Has heart failure
- •Has dementia
- •Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
研究组 & 干预措施
Control
Colonoscopy only outreach and follow-up
干预措施: Colonoscopy only (Behavioral)
Sequential Choice
Colonoscopy outreach + mailed FIT follow-up
干预措施: Colonoscopy outreach + mailed FIT follow-up (Behavioral)
Active Choice
Colonoscopy + mailed FIT outreach and follow-up
干预措施: Colonoscopy + Mailed FIT outreach and follow-up (Behavioral)
结局指标
主要结局
CRC screening completion
时间窗: 4 months
The percentage of participants who successfully complete FIT or colonoscopy
次要结局
- Choice of screening test(4 months)