Clinical Utility of Methylation-based Prognostic Assay for Barrett's Esophagus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Clinical performance change in physician behavior.
研究概览
简要总结
Capsulomics has developed a prognostic assay for patients with diagnosed Barrett's esophagus (BE). This study will measure how gastroenterologists make surveillance and treatment management decisions when presented with different clinical and prognostic assay information.
详细描述
Capsulomics has developed a prognostic assay for patients with diagnosed Barrett's esophagus (BE). This study will measure how gastroenterologists make surveillance and treatment management decisions for virtual patient cases when presented with different clinical and prognostic assay information. The data from this study will be published in a peer-review scientific journal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be currently practicing board-certified gastroenterologist practicing in the United States
- •Have practiced (as a board-certified gastroenterologist) for greater than 2
- •Be English-speaking
- •Have ≥ 50 Barrett's esophagus patients under care annually
- •Have Internet access
- •Have no prior experience with the methylation assay test
- •Provide voluntary informed consent to participate in the study.
排除标准
- •Non-practicing gastroenterologists
- •Less than two years of gastroenterology practice
- •Non-English speaking
- •Does not have access to the internet
- •Does not consent to participate in study
结局指标
主要结局
Clinical performance change in physician behavior.
时间窗: 1 year
Change in the overall and the diagnostic and treatment in patient simulations: difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of risk progression in patients with Barrett's esophagus, as measured by the participants' diagnostic and treatment scores. In each category, participants' care recommendations are evaluated, ranging from 0 to a high potential score of up to 10, where higher scores mean increased intensity in surveillance and treatment, to measure the impact of the methylation assay on care decision making.
The impact of methylation assay on physician confidence in clinical care decision-making.
时间窗: 1 year
Measure the confidence in care decisions based on patient's methylation test result: Once the intervention group is exposed to the intervention, education materials on the methylation assay (a validated molecular test for risk stratifying patients with Barrett's esophagus), the scores are measured, on a scale of 0 to 10 from round 1 (pre-exposure) to round 2 (post-exposure) and observe how the assay impacts confidence in the physician following evidence-based patient care.
次要结局
未报告次要终点