Disease management added to recommended care for ambulatory patients with chronic obstructive pulmonary disease (COPD) may not be a superior treatment compared with recommended care alone, according to a study published in the American Journal of Respiratory and Critical Care Medicine.
Researchers in Israel conducted a multicenter, open-label randomized trial of parallel group design research study to evaluate whether the addition of a disease management component by a nurse to the current recommended care for ambulatory COPD management (study intervention) would be more effective than recommended care alone (control group).
A total of 1202 individuals ≥40 years of age diagnosed with COPD with moderate to very severe airflow limitation were recruited and randomly assigned 1:1 to 1 of 2 treatment groups: a disease management group (n=600) and a control group (n=602). Assessments occurred every 6 months and included a patient history, questionnaires, 6-minute walk-test, and postbronchodilator spirometry. The primary outcome observed in this study was the time to first hospital admission for acute exacerbation of COPD, or death resulting from any cause.
Individuals in the study intervention group were assigned to a trained COPD nurse, who, during the course of the study, monitored COPD disease signs and symptoms and provided advice in case of acute disease exacerbation based on designated protocols and guidance from pulmonologists, as well as motivated and encouraged individuals to adhere to medical therapy and maintain a healthy lifestyle (including smoking cessation). They also coordinated care vis-á-vis other healthcare professional caregivers.
Recommended care given to both the control and study intervention groups included pulmonology follow-up, long-acting bronchodilator treatment, corticosteroids, long-term oxygen treatment if necessary, psychological support and dietary advice as necessary. Individuals noted to be current smokers were referred to smoking cessation groups, as well as given prescriptions for smoking cessation medications.
According to the results, 284 (47.2%) individuals in the control group and 264 (44.0%) individuals in the experimental group had either reported a first hospital admission for COPD or had died from any cause. The median time to either of these primary outcome events was 1.0 (range, 0-4.0) and 1.1 (range, 0-4.1) years in individuals in the experimental group and the control group, respectively (hazard ratio [HR], 0.91; 95% CI, 0.77-1.08).
There was still no statistical significance or superiority of the experimental group over the control group observed after adjusting for age, sex, study center, baseline GOLD classification, and smoking status (adjusted HR, 0.92; 95% CI, 0.77-1.08). In addition, the individual components of the study, which included the time to first hospital admission for COPD (adjusted HR, 0.93; 95% CI, 0.78-1.11) and time to death (adjusted HR, 0.82; 95% CI, 0.60-1.12), were also not found to be more superior for those in the experimental group compared with the control group.
Regarding secondary outcomes, there were no differences between groups noted for total number of hospital admissions, in-hospital days, mean number of acute exacerbations of COPD that did not end with hospital admission (P =.20), or likelihood of attaining clinically important changes in health-related quality of life, depression, 6-minute walk-test, forced expiratory volume in 1 second, and severity of respiratory symptoms during follow-up. However, individuals in the experimental group compared with the control group were more likely to report clinically important improvement in their health status (adjusted OR, 1.32; 95% CI, 1.01-1.73; P =.046), and those actively smoking (n=410) were more likely to report cessation of smoking at their last follow-up visit (57/221 [25.8%] vs 32/189 [16.9%]), respectively; OR, 1.72; 95% CI, 1.05-2.82; P =.031].
Researchers concluded that disease management added to standard recommended care was not found to be superior in the treatment of ambulatory individuals with COPD in reducing the number of or time to first hospital admission for COPD or death from any cause. It was also not a superior treatment for the majority of secondary outcomes. However, individuals in the disease management course were more likely to report clinically important improvements in disease status, and they were more likely to quit smoking by the end of the follow-up period. Clinicians may consider the use of this type of intervention program for individuals with COPD who are currently smoking, as it was shown to have an effect on smoking cessation.
Kalter-Leibovici O, Benderly M, Freedman LS, et al. Disease management plus recommended care versus recommended care alone for ambulatory COPD patients [published online March 1, 2018]. Am J Respir Crit Care Med. doi:10.1164/rccm.201711-2182OC