Multidisciplinary Management of Severe COPD

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Longitudinal, Open Label, Clinical Trial Evaluating the Effectiveness of Detailed Phenotyping and Subsequent Multidisciplinary Management of Both COPD and Multimorbidity in Patients With COPD After a Hospitalization Due to Acute Exacerbation of COPD.

Conditions
-----------------
Copd, COPD Exacerbation

Intervention / Treatment
-----------------
* Procedure: Multidisciplinary patient care
* Other: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients, aged ≥40 years. Smokers or ex-smokers (≥10 pack-year). 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. Signed informed concent form. Exclusion Criteria: 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). Already enrolled in other studies perceived to interfere with this protocol. In whom spirometry test is contraindicated (e.g., hemoptysis, detached retina, active tuberculosis). 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). Acute myocardial infarction and unstable angina pectoris or arrhythmias requiring specific cardiology ICU. Diagnosed stroke, dementia, degenerative neurological disorders or psychiatry disorders requiring specialized care. At the discretion of the recruiting clinician would not be able to be considered for the study.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective, open label, cohort study using design of intervention and registries data. Eligible patients for intervention group will be recruited consecutively from patients referred to the COPD-Center at the Sahlgrenska University Hospital, after a hospital admission because of acute or progressive worsening dyspnea. The control group will be recruited from the Swedish Airway Register and selection will be based on propensity score matching. A total of 110 patients will be included in the intervention group and 220 in the control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidisciplinary, holistic and patient-centered care<br>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 (total 5 visits). | Procedure: Multidisciplinary patient care<br>* A holistic, multidisciplinary, patient-centered care.<br>|
| Active Comparator: Standard care<br>The control group will be recruited from the Swedish Airway Register at the end of the study. Selection will be based on propensity score matching to the intervention group. | Other: Standard care<br>* Standard care in Sweden<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of hospitalizations | The aim is to investigate whether comprehensive care according to an individual plan (accurate diagnosis, assessment of severity, and multidisciplinary management of COPD patients referred to the COPD center after hospitalization caused by hospitalization due to acute exacerbation of COPD) will be associated with a decreased number of hospitalizations from all causes compared to a standard care. Change in number of hospitalizations will be calculated by total number of hospitalizations from all causes per year. | Baseline and 3 years after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospitalizations for COPD diagnosis | Change will be calculated by number of hospitalizations for COPD and compared to a total number of hospitalizations from other causes. | Baseline and 3 years after baseline | 
| Length of hospitalization | Change in mean hospitalization time will be calculated by number of hospitalization days per year and in total study period. | Baseline and 3 years after baseline | 
| Mortality | Change in all cause mortality will be measured by time to death (days, months or years). | Baseline and up to 3 years after baseline | 
| Impact of COPD on patient's health | Change in disease-specific impact on health will be assessed by using a COPD Assessment Test (CAT) questionnaire. CAT measures COPD symptoms with scores from 0 to 5 points (0 indicating no impact or symptoms, 5- worst possible impact or symptoms) summing up to a total CAT score range of 0-40 points. | Baseline and 3 years after baseline | 
| Dyspnea | Change in dyspnea will be measured by Modified Medical Research Council Dyspnea Scale (mMRC). The scale ranges 0 to 4 points, higher score indicating higher degree of disability that breathlessness poses on day-to-day activities. | Baseline and 3 years after baseline | 
| Anxiety and depression | Change in anxiety and depression will be assessed by using the Hospital Anxiety and Depression Scale (HADS). HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >10 denotes anxiety or depression. | Baseline and 3 years after baseline | 
| Sleepiness | Change in sleepiness will be measured by the Epworth Sleepiness Scale (ESS). The result is a sum of 8 item scores (0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life or their 'daytime sleepiness'. | Baseline and 3 years after baseline | 
| Physical activity | Change in physical activity will be measured by 6-Minute Walking Test. | Baseline and 3 years after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Multidisciplinary management, COPD exacerbation