Evaluation of the Training Program for Community Pharmacists for Dispensing Emicizumab (HEMLIBRA®) in France (PASODOBLEDEMI1)

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

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.

Study Overview

• Status: Completed
• Conditions: Hemophilia A
• Intervention / Treatment: Other: HEMOPHAR e-learning program

• Study Type: Observational
• Enrollment (Actual): 363

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Community pharmacists chosen by the patient with haemophilia A for dispensing Emicizumab	Other: HEMOPHAR e-learning program; training on professional practice by following HEMOPHAR e-learning program

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2022
• Primary Completion (ACTUAL): December 30, 2022
• Study Completion (ACTUAL): January 5, 2023

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (ACTUAL): July 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Haemophilia A; Accessibility; Emicizumab (HEMLIBRA®); Training evaluation
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID Numbers: 69HCL21_1391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No