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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

363 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-01-05

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.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Community pharmacists chosen by the patient with haemophilia A for dispensing Emicizumab

HEMOPHAR e-learning program

Intervention Type OTHER

training on professional practice by following HEMOPHAR e-learning program

Interventions

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HEMOPHAR e-learning program

training on professional practice by following HEMOPHAR e-learning program

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes