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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05449197
Acronym
PASODOBLEDEMI1
Enrollment
363
Registered
2022-07-08
Start date
2022-07-01
Completion date
2023-01-05
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

Haemophilia A, Accessibility, Emicizumab (HEMLIBRA®), Training evaluation

Brief summary

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.

Interventions

OTHERHEMOPHAR e-learning program

training on professional practice by following HEMOPHAR e-learning program

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies6 months.
Number of non-trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies6 months.
Satisfaction of community pharmacists following the HEMOPHAR training program assessed by a likert scale6 months.levels of satisfaction (very satisfied,satisified, dissatisfied,very dissatisfied)
Professional practices of community pharmacists in dispensing emicizumab (HEMLIBRA (R)) assessed by a specific questionnaire6 months.specific questionnaire developed for the study

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026