Effectiveness of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6,500
- 试验地点
- 4
- 主要终点
- Effectiveness of mPATH-CRC
研究概览
简要总结
mPATH-CRC (mobile Patient Technology for Health) is an automated direct-to-patient digital health program about colorectal cancer screening. The goal of this project is to test a cloud-based version of mPATH that patients can use at home independent of a scheduled medical visit. Patients will access mPATH on their own devices using a hyperlink sent via text message. The cloud version of mPATH will have the proven effective content of the tablet version, including the ability to request a screening test directly via the program. mPATH will then share this information with the patient's healthcare organization so screening can be arranged. This cloud-based version will be highly scalable, have broad reach, and be easy to support, making it a commercially viable product. This project will (1) test the reach and effectiveness of the mPATH web app in two different healthcare settings: a Fee-for-Service setting, and a value-based care setting; and (2) determine the value generated by mPATH in each healthcare setting.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 45-74 years
- •Be identified in the electronic health record as due for routine CRC screening, defined as
- •No colonoscopy in prior 10 years
- •No flexible sigmoidoscopy in prior 5 years
- •No CT colography in prior 5 years
- •No FIT-DNA test (Cologuard) within prior 3 years
- •No Fecal Occult Blood Test within prior 1 year
- •Have a cell phone number listed in the EHR
- •Have a preferred language of English or Spanish in the EHR
- •Upcoming appointment within 9 to 16 days
- •Georgia Market Only: Insurance type is listed as Medicare Advantage.
排除标准
- •Prior diagnosis of colorectal cancer
- •Prior history of total colectomy
- •Currently enrolled in palliative care or Hospice
- •Age over 65 AND currently enrolled in an Institutional SNP (I-SNP) or living in Long Term Care
- •Age over 65 with frailty and advanced illness (as defined by the health system's My Panel metric which mirrors the HEDIS COL-E quality metric for CRC screening)
结局指标
主要结局
Effectiveness of mPATH-CRC
时间窗: 180 Days
The proportion of individuals who complete a CRC screening test (colonoscopy, FIT, or FIT-DNA) within 180 days of randomization in both arms
次要结局
- Mean revenue generated in a Fee-for-Service setting(365 Days)
- Reach of mPATH-CRC(30 Days)
- Reporting current CRC screening(30 Days)
- CRC screening ordered(180 Days)
- Colorectal Neoplasia(180 days)
- Quality gaps closed in a value-based care setting(180 Days)
研究者
David P. Miller, Jr.
CEO
Digital Health Navigation Solutions, Inc