A Real World, Observational Registry of Diabetic Foot Ulcers and Quality of Care in Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Wound healing
研究概览
简要总结
This is an observational, longitudinal real world registry of diabetic foot ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR.
详细描述
This is an observational, longitudinal real world registry of diabetic foot ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR. No secondary data entry are required and all data are obtained via structured language from data entered in the EHR. Data from quality measures designed as electronic clinical quality measures (eCQMs) standardize the quality of care provided to patients and their clinical outcomes which are risk stratified using the Wound Healing Index (WHI). The eCQMs enable standardized data collection and the ability to transmit data electronically obviates the possibility of transcription errors. National benchmarking is possible since data are available from thousands of participants across the USA. While an independent IRB oversees this project, the data are collected for the purpose of measuring and improving the quality of care delivered to diabetic patients with foot ulcers and understanding their outcomes in relation to level of risk. Quality performance is reported as part of PQRS. These functions are exempt from the requirements of informed consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with diabetic foot ulcers seen by the practitioner
排除标准
- 未提供
结局指标
主要结局
Wound healing
时间窗: 6 months
wound closure
Death
时间窗: 6 months
death without wound closure
major amputation
时间窗: 6 months
above the knee, below the knee
minor amputation with preservation of ambulation
时间窗: 6 months
toe amputation, transmetatarsal
次要结局
- Patient Quality of life(12 weeks)
- Patient Reported Outcome(12 months)
