Evaluation of the Training Program for Community Pharmacists for Dispensing Emicizumab (HEMLIBRA®) in France

Study Overview
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Brief Summary
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Haemophilia A (HA) is a rare constitutional haemorrhagic disease whose drug management is based on the use of chronic lifelong replacement therapy. The occurrence of an inhibitor is a dreaded complication that impacts conventional management, consisting in using factor VIII (FVIII)-based replacement therapy, most often for prophylaxis. Although effective, these treatments can only be administered intravenously, leading to accessibility constraints and significant mental burden for patients and their relatives. Before June 15, 2021 in France, the emicizumab (HEMLIBRA®) was available only in hospital pharmacies for the prevention or reduction of bleedings. The introduction of the dual dispensing circuit in hospital or community pharmacies, left to patient's choice, is effective from this date. These changes have important organizational consequences for patients and health professionals alongside the pathway of care. Therefore, the effectiveness of this new organization requires to be evaluated with a national French study, called PASO DOBLE DEMI. The aims of this study are twofold : I. To evaluate the direct impact of the training programs provided to the new placeholders of the dispensing circuit ; the community pharmacists, II. To evaluate satisfaction of patients or their relatives regarding the emicizumab treatment whether they chose dispensing in the community pharmacy, or kept the dispensing at the hospital pharmacy. The methodology was based on the 4-level of the Kirkpatrick's evaluation model; 1) the immediate reaction of community pharmacists following the trainings (Reaction), 2) their knowledge acquisition (Learning), 3) their professional practice (Behavior) and 4 ) the patients' satisfaction related to their treatment whether dispensing in hospital or in community pharmacies (Results). The PASO DOBLE DEMI I was based on the first three levels of the evaluation model.

Official Title
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Evaluation of the Evolution of the Patient Care Pathway in the Context of the Implementation of the DOuBLE EMIcizumab Dispensing Circuit in France

Conditions
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Hemophilia A

Intervention / Treatment
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* Other: HEMOPHAR e-learning program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pharmacists practicing in a pharmacy in metropolitan France Working in a pharmacy chosen by the patient with haemophilia type A And who have agreed to dispense Emicizumab (Hemlibra®) Exclusion Criteria: Other pharmacy staff (including pharmacy technician, biologist, pharmacy students) Retired pharmacists at the date of the study Pharmacists who no longer practice in a community pharmacy dispensing Emicizumab (HEMLIBRA®) Pharmacists who expressed opposition to participating in the study

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Community pharmacists chosen by the patient with haemophilia A for dispensing Emicizumab<br> | Other: HEMOPHAR e-learning program<br>* training on professional practice by following HEMOPHAR e-learning program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies |  | 6 months. | 
| Number of non-trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies |  | 6 months. | 
| Satisfaction of community pharmacists following the HEMOPHAR training program assessed by a likert scale | levels of satisfaction (very satisfied,satisified, dissatisfied,very dissatisfied) | 6 months. | 
| Professional practices of community pharmacists in dispensing emicizumab (HEMLIBRA (R)) assessed by a specific questionnaire | specific questionnaire developed for the study | 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemophilia A, Accessibility, Emicizumab (HEMLIBRA®), Training evaluation