Detection of COPD in Primary Care

Study Overview
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Brief Summary
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Chronic obstructive pulmonary disease (COPD) is a common chronic disease with a significant medical and economic impact. Its prevalence is increasing and is estimated at 7.5% of people over 40 in France. COPD is responsible for a significant impairment of quality of life and was the 3rd leading cause of death in the world in 2010 when it was 4th place 20 years ago. However, about 75% of patients with COPD are not diagnosed. Spirometry is the only examination for the diagnosis of COPD. Patients identified at risk for COPD are insufficiently using spirometry and general practitioners (GPs) underestimate the severity of COPD when they do not practice spirometry in their patients. COPD is often diagnosed too late, the disease being discovered at the stage of complications requiring hospitalization. The underdiagnosis is mainly due to poor knowledge of patients, their difficulty in accessing a specialist performing spirometry, their reluctance to perform spirometry, and the insufficient involvement of general practitioners. Currently in France, targeted screening for COPD and diagnosis in primary care is a major challenge. The international (GOLD 2014) and French (HAS 2014) recommendations do not indicate a systematic screening in the general population for COPD but advocate targeted screening of patients by five questions to identify risk factors and symptoms of COPD. The presence of at least one of these factors in an adult over the age of 40 requires spirometry. Recent studies suggest the relevance of finding primary care variables for smoking and respiratory symptoms in order to identify new cases of COPD. However, the impact of the use of these questionnaires on the prevalence of diagnoses of COPD in general practice has not been demonstrated. Moreover, the heterogeneity of the provision of care according to the territories limits a fast or easy access (distance) to the spirometry. It is therefore necessary to evaluate in primary care the interest of a targeted screening of COPD and the interest of a coordination of care for the realization of a spirometry, in order to improve the rate of diagnosis of the disease.

Official Title
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Detection of COPD in Primary Care

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Questionnaire
* Other: Coordination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with health insurance Non-opposition to participation in the study Exclusion Criteria: COPD known and confirmed by spirometry Asthma known and confirmed by spirometry Patient not having the physical or mental ability to perform spirometry Pregnant woman Patient under protection Patient already included in the study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Questionnaire<br> | Other: Questionnaire<br>* Targeted screening of COPD by GPs via the GOLD / HAS questionnaire. The questionnaire includes 4 questions for patients over 40. At least one positive response is an indication to perform a spirometry.<br>|
| Experimental: Coordination<br> | Other: Coordination<br>* Information of the GPs of the existence of a coordination of the care of proximity to facilitate the access to the spirometry (identification of a referent specialist, making appointments).<br>|
| Experimental: Questionnaire + coordination<br> | Other: Questionnaire<br>* Targeted screening of COPD by GPs via the GOLD / HAS questionnaire. The questionnaire includes 4 questions for patients over 40. At least one positive response is an indication to perform a spirometry.<br>Other: Coordination<br>* Information of the GPs of the existence of a coordination of the care of proximity to facilitate the access to the spirometry (identification of a referent specialist, making appointments).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of COPD in each of the study's 4 arms, to assess the relevance of each intervention and the interaction between these interventions. | Prevalence is defined as the number of patients with positive spirometry (i.e FEV1 / post-bronchodilator CVF <0.70) in relation to the number of patients included. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of the severity stages of COPD | Severity stage will be evaluated with FEV1 in each arm | 6 months | 
| Time to diagnosis of COPD according to the GOLD / HAS score |  | 6 months | 
| Prevalence of COPD according to the GOLD / HAS score |  | 6 months | 
| Severity of COPD according to the GOLD / HAS score |  | 6 months | 
| Time to spirometry | Delay between consultation with GP and realization of a spirometry when applicable in each arm | 6 months | 
| Number of spirometries performed in each arm |  | 6 months |