Colonoscopy Outreach for Rural Communities Aim 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 527
- 试验地点
- 2
- 主要终点
- Number of participants who complete colonoscopy within 1 year of the colonoscopy referral
研究概览
简要总结
This study aims to test the effectiveness of a remotely-delivered patient navigation program for increasing colonoscopy completion for colorectal cancer screening, among rural populations. The study will partner with geographically disparate primary care organizations to recruit patients aged 45-75 to the study. The patient navigation program will be delivered through a community organization. This project is critical in advancing our knowledge of the effectiveness of patient navigation for increasing colonoscopy in this patient population as well as for understanding factors that can support long term implementation and sustainability of effective interventions.
详细描述
Colorectal cancer (CRC) is a leading cause of cancer death in the United States and its burden is greater in rural and low-income communities. Failure to complete recommended colonoscopy contributes to later-stage CRC diagnosis and worse CRC outcomes, which means timely and successful colonoscopy is a key opportunity to reduce CRC mortality. Using a Type 1 Hybrid Implementation-Effectiveness design, we will randomize 480-600 subjects from 6-8 primary care clinical organizations in a randomized controlled trial (RCT) to accomplish the following:
- Test the effectiveness of a patient navigation program, remotely-delivered by a community-based organization, for increasing colonoscopy completion rates for colorectal cancer screening among rural patients.
- Assess implementation and sustainability of the patient navigation program from the perspectives of both community and clinical stakeholders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 915 Months（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 45-76.25 on the date of their referral for colonoscopy
- •Referred for colonoscopy as part of colorectal cancer screening in the last 3 months. This includes patients referred for colonoscopy after an abnormal stool screening test (e.g., FIT/FOBT/Cologuard) and patients referred for colonoscopy as a primary screening test for colorectal cancer.
排除标准
- •Colonoscopy procedure since colonoscopy referral
- •Colonoscopy procedure scheduled less than or equal to 7 days from study enrollment date
- •Colonoscopy procedure scheduled more than 9 months from colonoscopy referral date (if known at enrollment)
- •Have diagnosis or past history of total colectomy or colorectal cancer (malignant neoplasm) at any time
- •Has hospice
- •Aged 66 and older living long-term in an institution for more than 90 consecutive days during the year prior to the query
研究组 & 干预措施
Standard of Care Control
Participants randomized to this arm will receive an educational brochure about the importance of colonoscopy to screen for colorectal cancer.
干预措施: Usual Care Control (Behavioral)
Patient Navigation Intervention
Patients randomized to this arm will receive language-concordant patient navigation from a trained navigator, over the phone and via text and email, to assist patients to complete colonoscopy to screen for colorectal cancer.
干预措施: Patient Navigation (Behavioral)
结局指标
主要结局
Number of participants who complete colonoscopy within 1 year of the colonoscopy referral
时间窗: 1 year
次要结局
- Number of participants who complete colonoscopy within 6 months of the colonoscopy referral(6 months)
- Time to completion of colonoscopy or end of follow-up after the colonoscopy referral(1 year)
- Number of participants who have colonoscopies with cecal intubation(1 year)
- Number of participants who complete colonoscopy within 9 months of the colonoscopy referral(9 months)
- Number of participants who have completed colonoscopies with adequate preparation(1 year)
研究者
Alison Cole
Professor, School of Medicine
University of Washington