Clinical Utility of a Non Endoscopic Device EsoCheck and Biomarker EsoGuard as Alternative to Endoscopy for Screening for Barrett's Esophagus in At Risk Population (ASBE) A Randomized Controlled, Virtual Patient Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral
研究概览
简要总结
This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.
The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes).
After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.
详细描述
This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.
Around 200 US physicians will be asked to participate in this study and at least 100 will be enrolled. Physicians eligible for participation are those whose scope of practice includes preventative care and disease screening - namely screening of BE, such as primary care physicians, family medicine physicians, and general practitioners; physicians whose scope of practice include diagnosis and management of esophageal disease may also participate.
The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes). Per round, there will be 3 different questionnaires consisting of 6 clinical vignettes (A/B/C). Participants will be randomized to questionnaire A, B or C according to the randomization scheme. After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Board-certified physicians whose scope of practice includes preventative care and disease screening, and/or those whose scope of practice include diagnosis and management of esophageal disease (examples include but are not limited to primary care physicians/ general practitioners, family medicine physicians, gastroenterologists, and foregut surgeons);
- •Have between 1 to 40 years of post-residency clinical experience within their field of practice;
- •Have an active panel (whether as part of a group practice, or individually) of over 1000 patients with an adult patient load of more than 50%.
排除标准
- 未提供
结局指标
主要结局
The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral
时间窗: 1 month
The change in the percentage/rate of intervention cases who will be referred for endoscopy compared to the control cases.
次要结局
- The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral for EsoGuard Positive Cases(1 month)