Family Medicine and Epidemiology, Alpert Medical School of Brown University, Providence, RI 02912, USA.
BMC Fam Pract. 2013 May 6;14:56. doi: 10.1186/1471-2296-14-56.
Chronic obstructive pulmonary disease (COPD) is a progressive, debilitating disease associated with significant clinical burden and is estimated to affect 15 million individuals in the US. Although a large number of individuals are diagnosed with COPD, many individuals still remain undiagnosed due to the slow progression of the disorder and lack of recognition of early symptoms. Not only is there under-diagnosis but there is also evidence of sub-optimal evidence-based treatment of those who have COPD. Despite the development of international COPD guidelines, many primary care physicians who care for the majority of patients with COPD are not translating this evidence into effective clinical practice.
METHOD/DESIGN: This paper describes the design and rationale for a randomized, cluster design trial (RCT) aimed at translating the COPD evidence-based guidelines into clinical care in primary care practices. During Phase 1, a needs assessment evaluated barriers and facilitators to implementation of COPD guidelines into clinical practice through focus groups of primary care patients and providers. Using formative evaluation and feedback from focus groups, three tools were developed. These include a computerized patient activation tool (an interactive iPad with wireless data transfer to the spirometer); a web-based COPD guideline tool to be used by primary care providers as a decision support tool; and a COPD patient education toolkit to be used by the practice team. During phase II, an RCT will be performed with one year of intervention within 30 primary care practices. The effectiveness of the materials developed in Phase I are being tested in Phase II regarding physician performance of COPD guideline implementation and the improvement in the clinically relevant outcomes (appropriate diagnosis and management of COPD) compared to usual care. We will also examine the use of a patient activation tool - 'MyLungAge' - to prompt patients at risk for or who have COPD to request spirometry confirmation and to request support for smoking cessation if a smoker.
Using a multi-modal intervention of patient activation and a technology-supported health care provider team, we are testing the effectiveness of this intervention in activating patients and improving physician performance around COPD guideline implementation.
ClinicalTrials.gov, NCT01237561.
慢性阻塞性肺疾病（COPD）是一种进行性、使人虚弱的疾病，与巨大的临床负担相关，据估计影响美国 1500 万人。尽管大量患者被诊断为 COPD，但由于该疾病进展缓慢且早期症状缺乏认知，许多患者仍未被诊断。不仅诊断不足，而且对于那些患有 COPD 的患者，也存在证据表明其接受的治疗未达到基于最佳证据的标准。尽管制定了国际 COPD 指南，但大多数 COPD 患者的初级保健医生并未将这些证据转化为有效的临床实践。
方法/设计：本文介绍了一项随机、群组设计试验（RCT）的设计和原理，旨在将 COPD 基于证据的指南转化为初级保健实践中的临床护理。在第一阶段，通过对初级保健患者和提供者的焦点小组进行评估，了解实施 COPD 指南进入临床实践的障碍和促进因素，从而进行需求评估。使用形成性评估和焦点小组的反馈，开发了三种工具。这些工具包括一个计算机化的患者激活工具（带有无线数据传输到肺量计的交互式 iPad）；一个供初级保健提供者使用的基于网络的 COPD 指南工具，作为决策支持工具；以及一个 COPD 患者教育工具包，供实践团队使用。在第二阶段，将在 30 个初级保健实践中进行为期一年的干预的 RCT。正在第二阶段测试第一阶段开发的材料的有效性，以评估其对医生实施 COPD 指南的效果和改善与临床相关的结果（适当诊断和管理 COPD），与常规护理相比。我们还将检查使用患者激活工具 - 'MyLungAge' - 来提示有风险或患有 COPD 的患者要求进行肺功能检查确认，并在吸烟者要求支持戒烟时提供支持。
通过使用多模式干预手段（患者激活和技术支持的医疗保健提供者团队），我们正在测试这种干预措施在激活患者和改善 COPD 指南实施方面医生表现的有效性。
ClinicalTrials.gov，NCT01237561。
