减少诊断错误以提高 COPD 和哮喘患者的安全(REDEFINE 研究) (REDEFINE)
研究概览
详细说明
哮喘和慢性阻塞性肺病 (COPD) 是常见的慢性肺病,在美国有超过 3000 万成年人被确诊。 然而,诊断错误 (DE) 被医学研究所认为是最常见和最有害的患者安全问题之一,经常发生在哮喘和/或 COPD 中,并且对少数族裔和服务不足的人群影响尤为严重。 DE 导致失去识别其他慢性病的机会、可避免的发病率和死亡率、患者和卫生系统不必要的成本以及低质量的护理。 呼吸急促或呼吸困难是哮喘和慢性阻塞性肺病的常见症状,对于心血管疾病和肥胖症等许多其他慢性疾病也很常见。 更好地了解 DE 的影响和干预措施以提高哮喘和 COPD 的诊断准确性,对于少数民族和服务不足的人群尤其重要,因为他们会受到导致呼吸困难的疾病的影响。
肺活量测定法是一种简单、可移动且必不可少的测试,所有主要的国家和国际哮喘和慢性阻塞性肺病诊断指南均推荐使用。 然而,众所周知,在门诊初级保健环境中并没有常规使用肺活量测定法,少数民族和服务不足的人群不太可能进行肺活量测定,从而导致 DE 的患病率更高。 据估计,在诊断为哮喘和慢性阻塞性肺病的人群中,有 30-50% 被发现被误诊。 许多被误诊为哮喘和/或慢性阻塞性肺病的患者接受了不必要的呼吸系统药物治疗,这可能会带来严重的风险,包括肺炎、心血管事件和死亡。 在 DE 的情况下,这些被认为是少数民族可以避免和不必要的呼吸药物治疗使用,而已经受到心血管疾病不成比例影响的服务不足增加了较差结果的风险。 哮喘与 COPD 的诊断中也存在 DE,因为这两种呼吸系统疾病在临床上截然不同,治疗建议也存在细微差别。 据报道,非洲裔美国人被认为具有增加的 COPD 死亡率,并且受哮喘死亡率的影响不成比例。 然而,由于肺活量测定不是常规进行的,并且 DE 在哮喘和 COPD 中很普遍,这些不良结果的一个组成部分可能是由于其他慢性疾病的漏诊或延迟诊断或哮喘和 COPD 的误诊。
在提供者和卫生系统层面存在在初级保健中使用肺量计的障碍。 以前的研究表明,初级保健提供者 (PCP) 缺乏对现有指南和在初级保健诊所实施肺活量测定法的了解。 除了这些障碍之外,PCP 还要应对后勤方面的挑战,例如时间和工作流程限制,以及对患有多种慢性疾病的患者进行持续 15 分钟或更短时间的门诊就诊。 这些诱发因素和促成因素解释了为什么先前的研究(包括干预措施以教育 PCP 和纳入初级保健诊所培训人员的肺活量测定)结果有限。
需要一种新的范例来改进基于指南的哮喘和 COPD 护理,其中包括肺活量测定法,并且可以更好地理解 DE 并改善患者安全和以患者为中心的结果。 健康促进者或社区卫生工作者 (CHW) 一直在通过为服务不足的少数群体传播适当的医疗保健实践来补充医疗保健。 然而,尚未进行包括使用肺活量测定法对哮喘和 COPD 进行诊断评估的研究。 REDEFINE 计划(减少诊断错误以提高 COPD 和哮喘患者的安全性)将纳入健康促进者与 PCP 的合作,以解决已确定的基于指南的护理障碍,其中包括用于诊断有 DE 风险的哮喘和 COPD 患者的肺活量测定法。 我们提出了一项比较有效性研究,以更好地了解 DE 的流行病学,并评估向被诊断患有哮喘和/或 COPD 且有 DE 风险的服务不足、主要是少数民族人群提供 REDEFINE 计划的有效性和经济影响。
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60612
- CCHHS
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Chicago、Illinois、美国、60612
- UI Health
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 1.年龄>40岁
- 2. 在过去一年中使用维持呼吸药物和以下情况之一:
- 3. 哮喘和/或 COPD 的诊断
- 4. 近 3 年未进行肺活量测定
- 5. 过去或现在吸烟者或接触过烟草
排除标准:
- 无法进行足够的肺活量测定
- 不会说英语
- 怀孕
- 计划明年搬离芝加哥地区
- 过去 3 年由肺科专家看过
- 任何预期寿命小于 6 个月的绝症
- 危及生命(例如 重症监护入院和/或使用机械通气)过去一年发生呼吸衰竭事件。
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较:患者的日常护理
在门诊就诊当天,将建议受试者在就诊前 90 分钟到达。 将执行以下操作。
将建议受试者前往其诊所并由其 PCP 进行管理。 在 1 年随访结束时,患者将被安排进行 BD 前后肺量测定,并接受与干预组相同的肺量测定方案。 |
支气管扩张器后肺活量测定法测试将在使用称为沙丁胺醇的呼吸药物后进行。
沙丁胺醇用于 COPD 的标准实践中,并且常用于肺活量测定。
其他名称:
在 1 年随访结束时,将安排患者进行 BD 前后肺量测定测试,并接受与干预组相同的肺量测定方案。
其他名称:
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实验性的:患者-受试者干预
在门诊就诊当天,将建议受试者在就诊前 90 分钟到达与诊所地点相同的大楼。 将收集以下信息并执行程序:
|
支气管扩张器后肺活量测定法测试将在使用称为沙丁胺醇的呼吸药物后进行。
沙丁胺醇用于 COPD 的标准实践中,并且常用于肺活量测定。
其他名称:
干预组的初次访问、初始人口统计表和健康问卷。
为了评估呼吸,将进行前后支气管扩张器以及肺活量测试。
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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就诊总次数
大体时间:1年
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确定医疗保健就诊的差异,包括全因和呼吸相关、急诊门诊就诊、急诊就诊以及组间住院
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1年
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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COPD 和/或哮喘的诊断与肺活量测定结果一致
大体时间:1年
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确定组间诊断准确性的差异
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1年
|
合作者和调查者
调查人员
- 首席研究员:Min Joo, MD MPH、University of Illinois at Chicago
出版物和有用的链接
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (估计的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2016-1209
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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