Abstract

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.

Highlights

  • Chronic obstructive pulmonary disease (COPD) is a progressive lung disease characterized by increasing symptoms, decreasing (QoL), and increasing frequency of exacerbations.[1,2,3,4] These inter-related patient outcomes are the foundational elements of the currentGlobal Initiative for Chronic Obstructive Lung Disease (GOLD) severity classification (A–D).[1]

  • Primary outcome: COPD specific quality of life (QoL)—COPD assessment test (CAT) score counseling and who have successfully completed a Canadian QoL improved in the integrated disease management (IDM) cohort with a COPD Assessment Test (CAT) score of 22.6 (SD 6.8)

  • The Clinical COPD Questionnaire (CCQ) total score and the domain scores all improved, decreasing from total score 2.58 (SD 1.15) to 1.65 (SD 0.99), symptom domain 2.97 (SD 1.23) to 2.11 (SD 1.20), function domain 2.31 (SD 1.17) to 1.53 (SD 1.04), and mental domain 2.34 (SD 1.87) to 0.94 (SD 1.20). This is the first study of a COPD IDM-selfmanagement and COPD IDM-structured follow-up intervention in primary care, to demonstrate that IDM substantially improves COPD-related QoL

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Summary

Introduction

Chronic obstructive pulmonary disease (COPD) is a progressive lung disease characterized by increasing symptoms, decreasing (QoL), and increasing frequency of exacerbations.[1,2,3,4] These inter-related patient outcomes are the foundational elements of the current. Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity classification (A–D).[1] GOLD A and B patients are low and medium-risk patients who infrequently experience exacerbations.[1] Collectively, GOLD C and D patients are high-risk patients defined by frequent exacerbations and/or a severe exacerbation requiring hospitalization.[1] The high-risk “frequent-exacerbation” COPD phenotype persists over time,[5] and accounts for one-third of the COPD patient population.[2] Exacerbations exact a substantial personal toll on COPD patients, reducing their QoL significantly.[6,7,8] In addition, COPD-related hospitalization accounts for more than half the cost of managing COPD in our health systems.[9,10] International practice guidelines recommend effective pharmacologic and nonpharmacologic interventions to address these patient and health system outcomes[1,11,12]; the impact of these recommendations on high-risk COPD patients in our communities has been limited by a substantial knowledge-to-care implementation gap. The majority of COPD patients are managed by primary care practitioners.[13,14] evidence-based management of COPD is increasingly complex, primary care providers manage high-risk

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