Ofra Kalter-Leibovici1,2, Michal Benderly1,2, Laurence S Freedman3, Galit Kaufman4, Tchiya Molcho Falkenberg Luft5, Havi Murad3, Liraz Olmer3, Meri Gluch6, David Segev7, Avi Gilad8, Said Elkrinawi9, Tali Cukierman-Yaffe2,10, Baruch Chen11, Orit Jacobson12, Calanit Key5, Mordechai Shani13, Gershon Fink14. 1. Cardiovascular Epidemiology Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel-Hashomer, Israel. 2. Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. 3. Biostatistics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel-Hashomer, Israel. 4. Northern District, Maccabi Health Care Services, Haifa, Israel. 5. Community Division, Clalit Health Services, Tel-Aviv, Israel. 6. Tel-Aviv District, Clalit Health Services, Tel-Aviv, Israel. 7. Sharon-Shomron District, Clalit Health Services, Hadera, Israel. 8. Central District, Clalit Health Services, Tel-Aviv, Israel. 9. Pulmonary Institute, Soroka Medical Center, Beer-Sheva, Israel. 10. Endocrinology Institute, Chaim Sheba Medical Center, Tel-Hashomer, Israel. 11. Department of Pulmonology, Meir Medical Center, Kfar-Saba, Israel. 12. MOR Institute for Medical Data, Bnei Brak, Israel. 13. Medical Research Infrastructure Development and Health Services Fund, Chaim Sheba Medical Center, Tel-Hashomer, Israel; and. 14. Clinical Research Institute, Kaplan Medical Center, Rechovot, Israel.
Abstract
Rationale: The efficacy of disease management programs in the treatment of patients with chronic obstructive pulmonary disease (COPD) remains uncertain. Objectives: To study the effect of disease management (DM) added to recommended care (RC) in ambulatory patients with COPD.Measurements and Main Results: In this trial, 1,202 patients with COPD (age, ≥40 yr), with moderate to very severe airflow limitation were randomly assigned either to DM plus RC (study intervention) or to RC alone (control intervention). RC included follow-up by pulmonologists, inhaled long-acting bronchodilators and corticosteroids, smoking cessation intervention, nutritional advice and psychosocial support when indicated, and supervised physical activity sessions. DM, delivered by trained nurses during patients' visits to the designated COPD centers and by remote contacts with the patients between these visits, included patient self-care education, monitoring patients' symptoms and adherence to treatment, provision of advice in case of acute disease exacerbation, and coordination of care vis-à-vis other healthcare providers. The primary composite endpoint was first hospital admission for respiratory symptoms or death from any cause. During 3,537 patient-years, 284 patients (47.2%) in the control group and 264 (44.0%) in the study intervention group had a primary endpoint event. The median (range) time elapsed until a primary endpoint event was 1.0 (0-4.0) years among patients assigned to the study intervention and 1.1 (0-4.1) years among patients assigned to the control intervention; adjusted hazard ratio, 0.92 (95% confidence interval, 0.77-1.08).Conclusions: DM added to RC was not superior to RC alone in delaying first hospital admission or death among ambulatory patients with COPD.
RCT Entities:
Rationale: The efficacy of disease management programs in the treatment of patients with chronic obstructive pulmonary disease (COPD) remains uncertain. Objectives: To study the effect of disease management (DM) added to recommended care (RC) in ambulatory patients with COPD.Measurements and Main Results: In this trial, 1,202 patients with COPD (age, ≥40 yr), with moderate to very severe airflow limitation were randomly assigned either to DM plus RC (study intervention) or to RC alone (control intervention). RC included follow-up by pulmonologists, inhaled long-acting bronchodilators and corticosteroids, smoking cessation intervention, nutritional advice and psychosocial support when indicated, and supervised physical activity sessions. DM, delivered by trained nurses during patients' visits to the designated COPD centers and by remote contacts with the patients between these visits, included patient self-care education, monitoring patients' symptoms and adherence to treatment, provision of advice in case of acute disease exacerbation, and coordination of care vis-à-vis other healthcare providers. The primary composite endpoint was first hospital admission for respiratory symptoms or death from any cause. During 3,537 patient-years, 284 patients (47.2%) in the control group and 264 (44.0%) in the study intervention group had a primary endpoint event. The median (range) time elapsed until a primary endpoint event was 1.0 (0-4.0) years among patients assigned to the study intervention and 1.1 (0-4.1) years among patients assigned to the control intervention; adjusted hazard ratio, 0.92 (95% confidence interval, 0.77-1.08).Conclusions: DM added to RC was not superior to RC alone in delaying first hospital admission or death among ambulatory patients with COPD.
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