Can early introduction of specialized palliative care limit intensive care, emergency and hospital admissions in patients with severe and very severe COPD? a randomized study.
BACKGROUND
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 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
The 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.


CONCLUSIONS
Given 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.


BACKGROUND
This trial has been registered at clinicaltrials.gov under NCT02223780.
Department of Community Medicine, Primary Care and Emergency Medicine, Geneva University Hospitals and University of Geneva, Geneva University Hospitals 4 rue Gabrielle-Perret-Gentil, Genève, 14 1211, Suisse. catherine.weber@hcuge.ch.
Catherine
C
Weber
Department of Internal Medicine, Geriatrics and Rehabilitation, Geneva University Hospitals and University of Geneva, Geneva University Hospitals 4, rue Gabrielle-Perret-Gentil, Genève, 14 1211, Suisse. Jerome.stirnemann@hcuge.ch.
Jerome
J
Stirnemann
Department of Internal Medicine, Geriatrics and Rehabilitation, Geneva University Hospitals and University of Geneva, Geneva University Hospitals 4, rue Gabrielle-Perret-Gentil, Genève, 14 1211, Suisse. francois.herrmann@hcuge.ch.
François R
FR
Herrmann
Department of Community Medicine, Primary Care and Emergency Medicine, Geneva University Hospitals and University of Geneva, Geneva University Hospitals 4 rue Gabrielle-Perret-Gentil, Genève, 14 1211, Suisse. sophie.pautex@hcuge.ch.
Sophie
S
Pautex
Department of Medical Specialties, Division of pulmonary diseases, Geneva University Hospitals and University of Geneva, Geneva University Hospitals 4, rue Gabrielle-Perret-Gentil, Genève, 14 1211, Suisse. Jean-Paul.Janssens@hcuge.ch.
Jean-Paul
JP
Janssens
D003422:Critical Care / Q000379:methods* / Q000523:psychology; D020000:Decision Support Systems, Clinical; D018450:Disease Progression; D004635:Emergency Medicine / Q000379:methods*; D006760:Hospitalization; D006801:Humans; D010102:Oxygen Inhalation Therapy / Q000295:instrumentation* / Q000523:psychology; D010166:Palliative Care / Q000379:methods* / Q000523:psychology / Q000639:trends; D018579:Patient Selection; D010817:Physician-Patient Relations; D029424:Pulmonary Disease, Chronic Obstructive / Q000401:mortality / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life / Q000523:psychology*