Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH)

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Multidisciplinary Collaboration Care Program in Pulmonary Arterial Hypertension

Conditions
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Hypertension, Pulmonary

Intervention / Treatment
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* Behavioral: Patient education
* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18; Pulmonary arterial hypertension (NYHA II to IV); Any specific PAH treatment or oral anticoagulant. Exclusion Criteria: Patients under 18 or protected by law; Patients who do not speak/understand French; Pregnancy; Patients enrolled in other clinical trials.

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br> | Other: Data collection<br>* Clinical and biological data, treatment, medication errors and ADEs<br>|
| Active Comparator: Patient education<br> | Behavioral: Patient education<br>* Pharmaceutical care of patients with PAH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction with medication | Comparison between the SATMED-Q(R) score at 18 months between the two groups | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Education, Drug Toxicity