The CAPTURE Study: Validating a unique COPD screening tool in primary care

CAPTURE 研究：在初级保健中验证独特的慢性阻塞性肺病筛查工具

• 批准号: 9981799
• 负责人: MeiLan K Han
• 金额: $ 205.69万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9981799
• 关键词: Acute; Address; Advocate; Ambulatory Care; Behavior; Caring; Characteristics; Chronic Obstructive Airway Disease; Clinic; Clinical; Clinical Trials; Cohort Studies; Data; Deterioration; Diagnostic; Education; Exhibits; Focus Groups; Gender; Goals; Gold; Guidelines; Health; Health Personnel; Health Status; Healthcare Systems; Human Resources; Impaired health; Individual; Knowledge; Label; Logic; Lung diseases; Measurement; Methodology; Mission; Modeling; Morbidity - disease rate; Online Systems; Outcome; Patient Care; Patients; Peak Expiratory Flow; Population; Predictive Value; Primary Health Care; Process; Public Health; Pulmonary Function Test/Forced Expiratory Volume 1; Questionnaires; Recommendation; Research; Risk; Screening procedure; Self Efficacy; Sensitivity and Specificity; Severities; Site; Spirometry; Surveys; Telephone; Testing; Therapeutic; United States; United States National Institutes of Health; Work; base; case finding; clinical care; clinical practice; clinical translation; clinically relevant; clinically significant; disease diagnosis; experience; health care service utilization; improved; innovation; mortality; novel; patient population; patient subsets; primary care setting; prospective; respiratory; screening; socioeconomics; tool

PROJECT SUMMARY/ABSTRACT Most COPD patients remain unrecognized and undertreated; these individuals experience impaired health status, acute respiratory deteriorations, increased mortality and high health care utilization. Targeted case finding to date has generally identified patients without reference to spirometric severity or exacerbation (ECOPD) risk. We have developed a simple case finding tool using five questions combined with selective peak expiratory flow measurement (CAPTURE) that identifies individuals with “clinically significant COPD,” those most likely to benefit from currently available therapies. Our long-term goal is to effectively identify these individuals so therapy can improve health status, reduce ECOPD, and decrease morbidity. The overall objectives of this proposal are to validate the sensitivity, specificity, and predictive value of CAPTURE to identify undiagnosed, clinically significant COPD in a diverse primary care population; to confirm that this methodological approach can be integrated into a variety of primary clinical care settings; and explore whether identifying these patients results in improved COPD specific care and health status. Our central hypothesis is that CAPTURE can effectively and efficiently identify primary care patients with undiagnosed, clinically significant COPD. The rationale for the proposed research is that the answer to three simple questions will change the paradigm for COPD diagnosis in primary care: 1) Is CAPTURE effective in identifying patients with clinically significant COPD; 2) Does CAPTURE work in primary care settings; and 3) does CAPTURE make a difference in the lives of patients with previously undiagnosed, clinically significant COPD. Guided by strong preliminary data we will pursue three specific aims: 1) We will determine the sensitivity and specificity of CAPTURE in identifying clinically significant COPD in a broad range of primary care outpatient practices; 2) We will define the feasibility of using CAPTURE in 10 practices representing a wide range of primary care clinical settings across the US; 3) We will explore the impact of our case finding approach in a broad range of primary care outpatient practices and evaluate practice and patient level characteristics that are associated with COPD related care implementation and clinical outcomes. These aims will be accomplished in a 5,000 subject cohort study in 75 primary care practices affiliated with five primary care based research networks that provide access to previously undiagnosed patients who exhibit ethnic, racial, socioeconomic and regional diversity. In a subset of these clinical practices we will complete a detailed feasibility analysis of CAPTURE implementation. Our approach is highly innovative and clinically relevant as it applies a rigorously developed, novel COPD case finding approach to identifying COPD patients most likely to benefit from available therapy. The proposed research is significant, as the results will change the paradigm for COPD diagnosis in primary care and change COPD recommendations globally.

项目概要/摘要 大多数慢性阻塞性肺病患者仍未得到识别和治疗；这些人的健康状况受损 状况、急性呼吸系统恶化、死亡率增加和医疗保健利用率高。有针对性的案件发现 迄今为止，通常在不考虑肺活量严重程度或恶化（ECOPD）风险的情况下识别患者。 我们开发了一个简单的病例查找工具，使用五个问题并结合选择性呼气峰流量 测量（CAPTURE）可识别患有“临床显着慢性阻塞性肺病”的个体，即最有可能受益的个体 从目前可用的疗法来看。我们的长期目标是有效识别这些人，以便治疗能够 改善健康状况，减少ECOPD，并降低发病率。该提案的总体目标是 验证 CAPTURE 的敏感性、特异性和预测价值，以识别未确诊的、具有临床意义的疾病 不同初级保健人群中的慢性阻塞性肺病；确认该方法可以整合到 各种初级临床护理机构；并探讨识别这些患者是否会导致改善 COPD 特定护理和健康状况。我们的中心假设是 CAPTURE 可以有效且高效地 识别患有未确诊、有临床意义的 COPD 的初级保健患者。拟议的理由 研究表明，三个简单问题的答案将改变初级慢性阻塞性肺病的诊断范式 护理： 1) CAPTURE 能否有效识别患有临床显着慢性阻塞性肺病的患者； 2) CAPTURE 是否有效 在初级保健机构； 3) CAPTURE 是否会对既往患有此病的患者的生活产生影响？ 未确诊的、有临床意义的慢性阻塞性肺病。在强有力的初步数据的指导下，我们将追求三个具体目标： 1) 我们将确定 CAPTURE 在识别具有临床意义的 COPD 方面的敏感性和特异性 广泛的初级保健门诊实践； 2）我们将在10年内定义使用CAPTURE的可行性 代表美国各地初级保健临床环境的实践； 3）我们将探讨影响 我们在广泛的初级保健门诊实践中的病例发现方法，并评估实践和 与慢性阻塞性肺病相关护理实施和临床结果相关的患者水平特征。 这些目标将通过一项涉及 5,000 名受试者的队列研究来实现，该研究涉及 75 个初级保健机构，隶属于 5 个机构。 基于初级保健的研究网络，为以前未确诊的患者提供访问途径 民族、种族、社会经济和地区多样性。在这些临床实践的一部分中，我们将完成 CAPTURE实施的详细可行性分析。我们的方法具有高度创新性和临床意义 相关性，因为它采用了严格开发的新型慢性阻塞性肺病病例发现方法来识别慢性阻塞性肺病患者 最有可能从现有治疗中受益。拟议的研究意义重大，因为其结果将改变 初级保健中慢性阻塞性肺病诊断的范例并改变全球慢性阻塞性肺病的建议。