Exacerbation action plans for patients with COPD and comorbidities: a randomised controlled trial

Abstract

This international randomised controlled trial evaluated whether COPD patients with comorbidities, trained in using patient-tailored multidisease exacerbation action plans, had fewer COPD exacerbation days than usual care (UC).COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification II–IV) with ≥1 comorbidity (ischaemic heart disease, heart failure, diabetes, anxiety, depression) were randomised to a patient-tailored self-management intervention (n=102) or UC (n=99). Daily symptom diaries were completed for 12 months. The primary outcome “COPD exacerbation days per patient per year” was assessed using intention-to-treat analyses.No significant difference was observed in the number of COPD exacerbation days per patient per year (self-management: median 9.6 (interquartile range (IQR) 0.7–31.1); UC: median 15.6 (IQR 3.0–40.3); incidence rate ratio (IRR) 0.87 (95% CI 0.54; 1.39); p=0.546). There was a significantly shorter duration per COPD exacerbation for self-management (self-management: median 8.1 (IQR 4.8–10.1) days; UC: median 9.5 (IQR 7.0–15.1) days; p=0.021), with no between-group differences in the total number of respiratory hospitalisations (IRR 0.76 (95% CI 0.42; 1.35); p=0.348), but a lower probability of ≥1 for respiratory-related hospitalisation compared to UC (relative risk 0.55 (95% CI 0.35; 0.87); p=0.008). No between-group differences were observed in all-cause hospitalisations (IRR 1.07 (95% CI 0.66; 1.72)) or mortality (self-management: n=4 (3.9%); UC: n=7 (7.1%); relative risk 0.55 (95% CI 0.17; 1.84)).Patient-tailored exacerbation action plans for COPD patients with comorbidities did not significantly reduce exacerbation days, but reduced the duration per COPD exacerbation and the risk of having at least one respiratory-related hospitalisation during follow-up, without excess all-cause mortality.

Self-management interventions in COPD patients with multimorbidity

“…Unfortunately, the effect of the self-management plan was arithmetically superior to usual care, but the difference was not statistically significant. These results, taken together with similar trends in the primary outcome (number of COPD exacerbation days and severity per exacerbation day), further suggest that this study [10] might have been underpowered. In fact, according to the protocol [13], 150 patients per arm were expected, but only 102 and 99 in the self-management arm and the usual care arm, respectively, were recruited.…”

“…In this issue of the European Respiratory Journal, LENFERINK et al [10] report the results of an international randomised controlled trial intended to evaluate whether COPD patients with multimorbidities who had been trained in using a patient-tailored multidisease exacerbation action plan (figure 1) had fewer days of COPD exacerbations. Unfortunately, the study was negative for the primary outcome (number of COPD exacerbation days per patient per year) but showed a significant reduction of some relevant predefined secondary outcomes, i.e.…”

“…A recent Cochrane review [2] of the efficacy and safety of self-management plans for COPD, written by some of the authors of the LENFERINK et al [10] study, underlined the consistent effect of self-management plans on health status. Both COPD Assessment Test and the Chronic Respiratory Disease Questionnaire were administered [13], and quality of life was a secondary outcome.…”

“…Patients recruited to the study after hospitalisation due to a COPD exacerbation have a reduced frequency of rehospitalisation when following an action plan, such as one with video-assisted telehealth rehabilitation [15]. Thus, LENFERINK et al [10] might consider conducting an even shorter study with patients discharged after hospitalisation due to an exacerbation of COPD or one of the concomitant chronic diseases, and powering the study on hospital readmission. Furthermore, the self-management plan could be revised to include a case manager for each patient.…”

“…Patient-tailored action plan for COPD and some of its concomitant chronic diseases. Adapted from the supplementary material of LENFERINK et al[10]. The action plan included a final safety check, which is not in the figure, advising patients to contact the general practitioner in case of high fever but without change in the evaluated symptoms.…”