Multidisciplinary Management of Severe COPD
Multidisciplinary Management of Severe COPD
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic disease that is
 characterized by persistent airflow limitation, that is due to airway and/or alveolar
 abnormalities usually caused by significant exposure to noxious particles or gases,
 particularly cigarette smoking. Latest updates of the Global Burden of Disease emphasize the
 dramatic size of the problem. In 2015, 3,2 million people died from COPD worldwide, an
 increase of 11,6% compared with 1990. The overall prevalence of COPD increased by 44,2% and
 was associated with a significant increase of disability-adjusted life years. In Sweden the
 prevalence of COPD is approximately 8% bringing the annual total estimated cost for society
 of 9.1 billion SEK. About 1/3 of patients with COPD undergo periods of acute worsening of
 respiratory symptoms, particularly dyspnea. Acute worsening of respiratory symptoms is
 associated with increased in-hospital mortality (up to 20%), short term- (up to 60% at 1
 year) and long-term mortality (> 50% at 5 years) and high risk of re-hospitalization. Because
 patients with COPD often suffer concomitant disorders that significantly worsen their health
 status and vital prognosis, the management of the patients is not only the management of COPD
 but must include identification and treatment of other concomitant chronic diseases.

 Accurate diagnosis, assessment of severity, and long-term interdisciplinary management of
 both COPD and concomitant chronic diseases in patients with COPD could be associated with a
 decreased number of hospitalizations and deaths, improved quality of life and decreased
 health care utilization in the following 3 years. This longitudinal study will evaluate the
 effectiveness of detailed phenotyping and comprehensive multidisciplinary management of COPD
 and multimorbidity in patients.

 This is a prospective, open label, cohort study using design of intervention and registries
 data. The anticipated study time is 5 years, with 3 years of intervention (including 2 years
 of recruitment period) and 1-year data collection from the National Registries. The study
 will compare number of rehospitalizations from all causes of patient recruited after a
 hospitalization due to acute exacerbations of COPD to control patients included from the
 Swedish Airway Register (SAR). The selection of the control population within the SAR is
 based on risk score matching. At the first visit a thorough individual's assessment will be
 performed. The assessment includes information about demographics, COPD and exacerbations,
 medical history, comorbidities, vital parameters, blood and sputum tests and assessment of
 quality of life. Based on the outcome from the assessment and disease phenotype, personalized
 care plans will be prepared and given to the patients, including dietary program, adjusted
 exercise program, psychological counselling, treatment of comorbidities etc. Patients will
 come for planned follow-up visits, according to the protocol. The last visit will take place
 at 5th year after the study start. The "end of study" is defined as last visit of the last
 subject or if the effectiveness of the intervention is shown before. Data collected at eCRFs
 will be combined with the data from SAR and complemented with data from Swedish National
 Registries.
Inclusion Criteria:

 1. Male or female patients, aged ≥40 years.

 2. Smokers or ex-smokers (≥10 pack-year).

 3. Prior hospitalization because of progressively worsening dyspnea (associated or not
 with increased cough and sputum, and or sputum purulence), with a clinically suspected
 diagnosis of exacerbations of COPD that prompt the discharging physician to refer the
 patient to the COPD Center.

 4. Signed informed concent form.

 Exclusion Criteria:

 1. Presenting to the hospital for similar symptoms, which are not defined by the
 clinicians as suspected exacerbations of COPD, because of alternative diagnoses not
 related to patients with COPD (e.g., chest wall trauma, neurological disorders,
 sepsis, cancer and anemia).

 2. Already enrolled in other studies perceived to interfere with this protocol.

 3. In whom spirometry test is contraindicated (e.g., hemoptysis, detached retina, active
 tuberculosis).

 4. Unable to comply with study procedures and follow-ups in the opinion of the
 Investigator (e.g., other severe diseases with short life expectancy or who make it
 impossible for the patients to participate into the study, evidence of alcohol or drug
 abuse, dementia, severe psychiatric disorder).

 5. Acute myocardial infarction and unstable angina pectoris or arrhythmias requiring
 specific cardiology ICU.

 6. Diagnosed stroke, dementia, degenerative neurological disorders or psychiatry
 disorders requiring specialized care.

 7. At the discretion of the recruiting clinician would not be able to be considered for
 the study.