Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home

Study Overview
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Brief Summary
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The implementation of pharmaceutical consultations in the city or at the hospital could modify the occurrence of exacerbations related to chronic obstructive pulmonary disease after return of the patient to his home.

Official Title
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Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Pharmaceutical consultation at the hospital
* Other: Pharmaceutical consultation at the pharmacy
* Other: Follow-up pharmaceutical consultation at the pharmacy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has signed the consent form. The patient is affiliated to a health insurance programme The patient is at least 18 years old (≥). The patient is admitted to complete hospitalization (for patients in the Hospital and Control groups). The patient is diagnosed with stage 2 to 4 Chronic Obstructive Pulmonary Disease. The diagnosis as well as the stage of the disease are validated by a pulmonologist at the facility. The patient has one or more inhaler devices to treat Chronic Obstructive Pulmonary Disease. The patient returns to his / her home when discharged from hospital (for patients in the Hospital and Control groups). The patient is available for a follow-up of 12 months. Exclusion Criteria: The subject participates in another interventional study. The subject is in an exclusion period determined by a previous study. The patient is under safeguard of justice. The subject refuses to sign the consent. It is not possible to give the patient (or his/her trusted-person) informed information.

Ages Eligible for Study
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Minimum Age: 18 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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | |
| Experimental: Experimental group from the hospital<br> | Other: Pharmaceutical consultation at the hospital<br>* During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.<br>|
| Experimental: Experimental group from the city<br> | Other: Pharmaceutical consultation at the pharmacy<br>* During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.<br>Other: Follow-up pharmaceutical consultation at the pharmacy<br>* During 10 minutes, the patient will get more information about his chronic obstructive pulmonary disease treatments and their use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of exacerbation events | Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence. | Month 3 | 
| Number of exacerbation events | Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence. | Month 6 | 
| Number of exacerbation events | Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence. | Month 9 | 
| Number of exacerbation events | Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence. | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of visits to the attending physician |  | Month 3 | 
| Number of visits to the attending physician |  | Month 6 | 
| Number of visits to the attending physician |  | Month 9 | 
| Number of visits to the attending physician |  | Month 12 | 
| Number of visits to the pulmonologist |  | Month 3 | 
| Number of visits to the pulmonologist |  | Month 6 | 
| Number of visits to the pulmonologist |  | Month 9 | 
| Number of visits to the pulmonologist |  | Month 12 | 
| Number of visits to the hospital emergency service |  | Month 3 | 
| Number of visits to the hospital emergency service |  | Month 6 | 
| Number of visits to the hospital emergency service |  | Month 9 | 
| Number of visits to the hospital emergency service |  | Month 12 | 
| Number of hospitalisation events |  | Month 3 | 
| Number of hospitalisation events |  | Month 6 | 
| Number of hospitalisation events |  | Month 9 | 
| Number of hospitalisation events |  | Month 12 | 
| Medication Possession Ratio | unit = percent | 12 months | 
| Usability score of devices | Score between 0 and 3 | Month 3 | 
| Usability score of devices | Score between 0 and 3 | Month 6 | 
| Usability score of devices | Score between 0 and 3 | Month 9 | 
| Usability score of devices | Score between 0 and 3 | Month 12 | 
| Quality of life questionnaire | The quality of life questionnaire BPCO-VQ11 is composed of 11 items. Each item is scored in a 5 point scale. | Month 1 | 
| Quality of life questionnaire | The quality of life questionnaire BPCO-VQ11 is composed of 11 items. Each item is scored in a 5 point scale. | Month 6 | 
| Quality of life questionnaire | The quality of life questionnaire BPCO-VQ11 is composed with11 items. Each item is scored in a 5 point scale. | Month 12 | 
| device usage learning curve |  | 12 months | 
| satisfaction questionnaire | This questionnaire is composed with 4 questions. Each item is scored in a 4 point scale. | Month 12 |