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

Hemophilia A Clinical Trial

— PASODOBLEDEMI1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05449197
• Other study ID #: 69HCL21_1391
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: January 5, 2023

Study information

• Verified date: January 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: January 5, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Other:
• HEMOPHAR e-learning program
training on professional practice by following HEMOPHAR e-learning program

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies		6 months.
Primary	Number of non-trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies		6 months.
Primary	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.
Primary	Professional practices of community pharmacists in dispensing emicizumab (HEMLIBRA (R)) assessed by a specific questionnaire	specific questionnaire developed for the study	6 months.