Colorectal Cancer Screening Through Proactive Outreach and Navigation in a Federally Qualified Health Care Center in Brooklyn
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months
研究概览
简要总结
The proposed study is a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice.
详细描述
The proposed study is a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice, which provides free and subsidized health services to underrepresented minorities. The investigators will randomize patients to the proactive screening outreach arm which will include mailed letters providing patients with information regarding their eligibility for and instructions for performing colorectal cancer screening with FIT testing or colonoscopy. Colorectal cancer screening rates via FIT testing or colonoscopy will be compared in the proactive outreach group and the usual care group. The investigators hypothesize that rates of colorectal cancer screening will improve in underserved populations with the implementation of a proactive approach that incorporates a mailed outreach invitation to screen, followed by active assistance to a colonoscopy completion if preferred or indicated.
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
- 是
入选标准
- •Receiving medical care at Flatbush FHC
- •Due or overdue for CRC screening
排除标准
- •Age younger than 45 years old or greater than 75 years old
- •Up-to-date with colorectal cancer screening (FIT within 1 year or colonoscopy within 10 years)
- •History of colorectal cancer, inflammatory bowel disease or colorectal polyps
- •No address or phone number on file
- •FIT test ordered within 6 months
研究组 & 干预措施
Proactive Screening Outreach
Participants will receive a letter from their clinic explaining CRC screening options (fecal immunochemical test (FIT) vs colonoscopy) including a FIT kit with completion and return instructions. The letter will also include information for navigation to a screening colonoscopy instead of FIT testing, if deemed to be the participant's preference.
Approximately 10-14 days after mailing the FIT kit, participants who have not completed screening will receive a telephone call (with voice message left) and text message, querying whether the FIT kit was received and reminding the participant to complete the test or request a new kit, if needed.
If the FIT kit has not been submitted after about two weeks from the reminder call/text message, the study team will mail a final letter to the participant on behalf of the clinic, reminding them to complete and return the FIT kit.
干预措施: Proactive CRC Screening Outreach (Behavioral)
Usual Care
Individuals in the usual care group will not be approached or notified of their enrollment in the study.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months
时间窗: Up to Month 6
Number of Participants who completed CRC screening via FIT by 6 months past the start of intervention
Number of Participants Who Completed Colonoscopy at 6 Months
时间窗: Up to Month 6
Number of Participants who underwent colonoscopy by 6 months past the start of intervention
次要结局
- Number of Participants With Positive FIT Test Who Complete Colonoscopy at 6 Months(Up to Month 6)