Clinical trial NCT05449197: Evaluation of the Training Program for Community Pharmacists for Dispensing Emicizumab (HEMLIBRA®) in France
Official title: Evaluation of the Evolution of the Patient Care Pathway in the Context of the Implementation of the DOuBLE EMIcizumab Dispensing Circuit in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Keywords: Haemophilia A
Accessibility
Emicizumab (HEMLIBRA®)
Training evaluation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 363
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In March 2022, 300 community pharmacists have already followed-up the HEMOPHAR e-learning program, and the Laboratory Roche-Chugai counted approximately 450 community pharmacies which have ordered at least one time the treatment. We assumed that at least one pharmacist per community pharmacy followed the HEMOPHAR e-learning program, so with 2.5 pharmacists per community pharmacy, we estimated that 950 community pharmacists were concerned by dispensing Emicizumab (HEMLIBRA®) and potentially eligible for inclusion. This population was threefold depending on the training program followed-up (HEMOPHAR, Roche-Chugai) or absence of training program.

With more than 2,500 hospital pharmacies throughout the metropolitan French territory, the hospital pharmacies met the pharmaceutical needs of people treated in health structures, medical and social structures. The eligible hospital pharmacists concerned all pharmacists practicing in hospital pharmacy on the date of the study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies
timeFrame: 6 months.
measure: Number of non-trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies
timeFrame: 6 months.
measure: Satisfaction of community pharmacists following the HEMOPHAR training program assessed by a likert scale
timeFrame: 6 months.
measure: Professional practices of community pharmacists in dispensing emicizumab (HEMLIBRA (R)) assessed by a specific questionnaire
timeFrame: 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Valérie CHAMOUARD
role: PRINCIPAL_INVESTIGATOR
References: