跳至主要内容
临床试验/NCT02813187
NCT02813187Enrolling By Invitation不适用

A Real World, Observational Registry of Venous Leg Ulcers and Quality of Care in Clinical Practice

U.S. Wound Registry1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
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 venous leg 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 venous leg 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 bench marking 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

入选标准

  • All patients with venous leg 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: 12 months

wound closure

次要结局

  • Patient Reported Outcome(12 months)
  • Venous Insufficiency(12 months)
  • Weeks of Therapy(12 months)
  • Adverse events during therapy(12 months)

研究者

发起方
U.S. Wound Registry
申办方类型
Other
责任方
Sponsor

研究点 (1)

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