Abstract
BackgroundCOPD is a progressive lung disorder with rates of mortality between 36–50%, within 2 years after admission for an acute exacerbation. While treatment with inhaled bronchodilators and steroids may partially relieve symptoms and oxygen therapy may prolong life, for many patients the course of the disease is one of inexorable decline. Very few palliative care intervention studies are available for this population. This trial seeks to determine the effectiveness of the introduction of specialized palliative care on hospital, intensive care unit and emergency admissions of patients with severe and very severe COPD.Methods/DesignThe study is a three year single centre, randomized controlled trial using a 2 arms parallel groups design conducted in a tertiary center (University Hospitals; Geneva). For the intervention group, an early palliative care consultation is added to standard care; the control group benefits from standard care only. Patients with COPD defined according to GOLD criteria with a stage III or IV disease and/or long term treatment with domiciliary oxygen and/or home mechanical ventilation and/or one or more hospital admissions in the previous year for an acute exacerbation are eligible to participate. Allocation concealment is achieved using randomisation by sealed envelopes. Our sample size of 90 patients/group gives the study a 80% power to detect a 20% decrease in intensive care unit and emergency admissions – the primary endpoint. All data regarding participants will be analysed by a researcher blinded to treatment allocation, according to the "Intention to treat" principle.DiscussionGiven the trends toward aggressive and costly care near end-of-life among patients with COPD, a timely introduction of palliative care may limit unnecessary and burdensome personal and societal costs, and invasive approaches. The results of this study may provide directions for future palliative care interventions in this particular population.Trial registrationThis trial has been registered at clinicaltrials.gov under NCT02223780
Highlights
Chronic obstructive pulmonary disease (COPD) is a progressive lung disorder with rates of mortality between 36–50%, within 2 years after admission for an acute exacerbation
No randomised early palliative care intervention studies are available for this particular population, it has been shown that it is feasible to provide palliative care interventions in this population [11,12,13,14,15] A study conducted in the UK found that patients with COPD are much less likely to die at home and to receive palliative care services than patients with lung cancer [7]
In a retrospective cohort study conducted in Canada, of 1098 patients who died in 2004, very few patients who died with COPD used the palliative care services that were available in acute care hospitals (5.1%) or home care settings (2.8%) compared to those with lung cancer [20]
Summary
COPD is a progressive lung disorder with rates of mortality between 36–50%, within 2 years after admission for an acute exacerbation. While treatment with inhaled bronchodilators and steroids may partially relieve symptoms and Noninvasive Positive Pressure Ventilation (NIV) and long term oxygen therapy (LTOT) may prolong life, for many patients the course of the disease is one of inexorable decline with a prolonged period of disabling dyspnea and increasingly frequent hospital admissions reflecting deteriorating lung function and usually presaging a premature death [5]. In the Nocturnal Oxygen Therapy trial of LTOT, disturbances in emotional and social functioning were common and there was a marked impairment in activities of daily living [6] Despite these issues, the needs of these patients are typically poorly addressed, and many patients have limited access to specialists in palliative care services [7,8,9,10]. In a retrospective cohort study conducted in Canada, of 1098 patients who died in 2004, very few patients who died with COPD used the palliative care services that were available in acute care hospitals (5.1%) or home care settings (2.8%) compared to those with lung cancer (acute care 47.6%; home care 37.4%) [20]
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