Does the Use of Point of Care Ultrasound During Inflammatory Bowel Disease Clinic Appointments Change Management, Speed up Treatment Decisions and Save Money: a Feasibility and Service Development Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Compare time to definitive IBD-related treatment initiation with the use of POCUS compared to standard of care
研究概览
简要总结
Study to determine whether the use of an ultrasound completed during an inflammatory bowel disease (IBD) clinic will speed up diagnosis, treatment initiation, reduce complications, save money and reduce investigations compared with our current standard of care.
详细描述
After being provided with study information and providing written informed consent, participants attending the inflammatory bowel disease clinic will be randomised to standard of care or to receiving an ultrasound during the clinic appointment. This ultrasound result will be used to determine treatment decisions. Participants will have a 6 month follow-up to capture outcome data and further medical record review will be conducted at one year.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 years or above
- •Attending IBD clinic face-to-face
- •Able to give informed consent.
- •Belonging to one of the following groups:
- •New patients with high clinical suspicion of IBD
- •Known UC/IBD-U and possible flare
- •Known Crohn's and possible flare
- •Known IBD and assessing response to a new medication or following surgery
- •Known IBD and clinician planning endoscopic or radiological investigations
排除标准
- •Inflammatory bowel disease limited to proctitis with no clinical suspicion of extension
结局指标
主要结局
Compare time to definitive IBD-related treatment initiation with the use of POCUS compared to standard of care
时间窗: 6 months
Time in days for when a new medication is started, dose changed, medication stopped, or surgery performed following the clinic appointment
次要结局
- Compare sensitivity and specificity of POCUS to identify active disease with standard of care investigations (MRI, ultrasound, endoscopy)(6 months)
- Compare findings at POCUS when performed by a gastroenterologist or a radiologist(6 months)
- Compare healthcare resource utilisation including outpatient appointments, need for further investigations and admissions in patients receiving POCUS or standard of care(1 year)
- Compare use of steroids with POCUS compared with standard of care(1 year)
- Does point of care ultrasound change clinical decision making in the IBD clinic(Immediate)
- Compare haemaglobin levels when POCUS is used compared with standard of care(6 months)
- Compare CRP levels when POCUS is used compared with standard of care(6 months)
- Compare Platelets when POCUS is used compared with standard of care(6 months)
- Compare clinical disease activity scores when POCUS is used compared with standard of care(6 months)