Patients with chronic obstructive pulmonary disease (COPD) have a reduced quality of life (QoL) and exacerbations that drive health service utilization (HSU). A majority of patients with COPD are managed in primary care. Our objective was to evaluate an integrated disease management, self-management, and structured follow-up intervention (IDM) for high-risk patients with COPD in primary care. This was a one-year multi-center randomized controlled trial. High-risk, exacerbation-prone COPD patients were randomized to IDM provided by a certified respiratory educator and physician, or usual physician care. IDM received case management, self-management education, and skills training. The primary outcome, COPD-related QoL, was measured using the COPD Assessment Test (CAT). Of 180 patients randomized from 8 sites, 81.1% completed the study. Patients were 53.6% women, mean age 68.2 years, post-bronchodilator FEV1 52.8% predicted, and 77.4% were Global Initiative for Obstructive Lung Disease Stage D. QoL-CAT scores improved in IDM patients, 22.6 to 14.8, and worsened in usual care, 19.3 to 22.0, adjusted difference 9.3 (p < 0.001). Secondary outcomes including the Clinical COPD Questionnaire, Bristol Knowledge Questionnaire, and FEV1 demonstrated differential improvements in favor of IDM of 1.29 (p < 0.001), 29.6% (p < 0.001), and 100 mL, respectively (p = 0.016). Compared to usual care, significantly fewer IDM patients had a severe exacerbation, -48.9% (p < 0.001), required an urgent primary care visit for COPD, -30.2% (p < 0.001), or had an emergency department visit, -23.6% (p = 0.001). We conclude that IDM self-management and structured follow-up substantially improved QoL, knowledge, FEV1, reduced severe exacerbations, and HSU, in a high-risk primary care COPD population. Clinicaltrials.gov NCT02343055.

中文翻译：

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综合疾病管理对初级保健中高风险COPD患者的影响。

患有慢性阻塞性肺疾病（COPD）的患者的生活质量（QoL）降低，病情加重，推动了医疗服务的利用（HSU）。大多数COPD患者在初级保健中接受治疗。我们的目标是评估针对初级保健中COPD高危患者的综合疾病管理，自我管理和结构化的后续干预（IDM）。这是一项为期一年的多中心随机对照试验。高危，易发作的COPD患者被随机分配到由认证的呼吸教育者和医师提供的IDM或常规医师的护理。IDM接受了案例管理，自我管理教育和技能培训。使用COPD评估测试（CAT）测量了主要结局，即COPD相关的QoL。从8个地点随机分配的180名患者中，有81.1％完成了研究。患者为53.6％的女性，平均年龄为68.2岁，预计支气管扩张剂后FEV1为52.8％，全球阻塞性肺疾病D期倡议为77.4％。IDM患者的QoL-CAT评分提高了，从22.6降低到14.8，在常规护理中恶化了，从19.3到22.0，调整后的差值为9.3（p <0.001）。次要结果包括临床COPD问卷，Bristol知识问卷和FEV1，分别显示IDM的差异有所改善，IDM分别为1.29（p <0.001），29.6％（p <0.001）和100 mL（p = 0.016）。与常规护理相比，严重加重病的IDM患者明显减少，为-48.9％（p <0.001），需要进行COPD的紧急初级护理就诊，为-30.2％（p <0.001），或者有急诊就诊，为-23.6 ％（p = 0.001）。我们得出的结论是，在高风险的初级保健COPD人群中，IDM的自我管理和结构化的随访大大改善了QoL，知识，FEV1，减轻了严重加重和HSU。Clinicaltrials.gov NCT02343055。