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Pulmonary arterial hypertension (PAH) is a severe pulmonary vascular affection, which treatment has evolved in the last few years, improving quality of life. However, adherence to treatment has not been assessed in such patients. The investigators developed a collaborative care model involving clinical pharmacists in PAH. The objective of this work is to evaluate the impact of such model of care on medication errors and adverse events, quality of life and clinical criteria.
This randomized multicentre controlled study will include approximately 100 PAH patients (NYHA II to IV). After inclusion, patients will receive either collaborative care including consultations with specialized pharmacist and nurse, or classic follow-up. Each patient will be followed during 18 months from the date of inclusion.
The investigators hope to show the positive impact of a collaborative care model in PAH. More specifically, the investigators aim to show the interest of long-term patient education to improve patient safety related to drugs, but also their quality of life, and have preliminary data about usual clinical criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator |
| |
| Patient education | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient education | Behavioral | Pharmaceutical care of patients with PAH |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Medication-related problems | Medication errors (assessed by using the tool developped by the French Society for Clinical Pharmacy) and adverse drug reactions | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction with medication | Comparison between the SATMED-Q(R) score at 18 months between the two groups | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthieu Roustit, PharmD | Clinical Research Center - Inserm CIC03, Grenoble, France | Study Director |
| Pison Christophe, MD, PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Bordeaux | France | ||||
| CHU Brest |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32440738 | Derived | Roustit M, Chaumais MC, Chapuis C, Gairard-Dory A, Hadjadj C, Chanoine S, Allenet B, Sitbon O, Pison C, Bedouch P; ETHAP Study Group. Evaluation of a collaborative care program for pulmonary hypertension patients: a multicenter randomized trial. Int J Clin Pharm. 2020 Aug;42(4):1128-1138. doi: 10.1007/s11096-020-01047-8. Epub 2020 May 21. |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Data collection |
| Other |
Clinical and biological data, treatment, medication errors and ADEs |
|
| Brest |
| France |
| Hopital Antoine Beclere | Clamart | France |
| Clinical Research Center Inserm CIC03 - Grenoble University Hospital | Grenoble | 38043 | France |
| CHU Grenoble | Grenoble | France |
| CHU de Lille | Lille | France |
| CHU Nantes | Nantes | France |
| CHU de Nice | Nice | France |
| CHU Rouen | Rouen | France |
| CHU Strasbourg | Strasbourg | France |
| CHU Tours | Tours | France |
| D002318 |
| Cardiovascular Diseases |
| D064419 | Chemically-Induced Disorders |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |