Satisfaction Regarding the Dispensing of Emicizumab (HEMLIBRA®) for Patients With Haemophilia A in France

Completed

• Conditions: Hemophilia A
• Interventions: Other: satisfaction survey

• Registration Number: NCT05450640
• Lead Sponsor: Hospices Civils de Lyon

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 II study was based on the fourth level of the evaluation model and particularly to evaluate to what extent the dispensing of Emicizumab (HEMLIBRA ®) treatment in community pharmacies has contributed to the improvement of the satisfaction of patients with HA.

The availability of the treatment in community pharmacy assumes an improvement of the treatment accessibility for the patient at several levels :

* Global accessibility: what choice has the patient expressed to access his treatment from a practical point of view?

* Adaptation: Has the patient adapted to the new treatment delivery organization?

* Availability of resources: are the special needs of the patients taken into consideration?

* Social acceptability: is the patient willing to follow the proposed care pathway? The issue of treatment cost is not considered in this study because the cost of antihemophilic treatments is totally covered by the French government for all patients regardless of their insurance coverage

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-05
• Study First Posted: 2022-07-11
• Study Start: 2023-01-09
• Primary Completion: 2023-01-09
• Study Completion: 2023-01-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• Patient with hemophilia type A with or without inhibitors
• Patients treated with Emicizumab (Hemlibra®)
• Age over 18 years old or legal representative of a minor haemophilia type A patient or his/her relative/caregiver for a non-autonomous adult patient

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Exclusion Criteria

• Patient under guardianship / curatorship
• Opposition expressed to use personal data

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with haemophilia A with dispensing Emicizumab (HEMLIBRA®) in community pharmacy	satisfaction survey	This group of patients have chosen the dispensing of Emicizumab (HEMLIBRA®) in community pharmacy. This choice involves the contribution of the community pharmacist in the dispensing circuit who does not replace the hospital pharmacist but interact together for prescriptions renewals, emergency treatment or sharing information if necessary.
Patients with haemophilia A with dispensing Emicizumab (HEMLIBRA®) in hospital pharmacy	satisfaction survey	This group of patients have kept the dispensing of Emicizumab (HEMLIBRA®) in hospital pharmacy

Primary Outcome Measures

Name	Time	Method
satisfaction levels reported through a specific questionnaire	6 months	This questionnaire is composed of 40 questions for an estimated time to fulfil not exceeding 8 minutes. The overall satisfaction levels consists in collecting the patient's perception based on the 4-item of the Likert-scale (strongly dissatisfied, rather not satisfied, rather satisfied, strongly satisfied) taking into account the 4 dimensions of accessibility (global accessibility, adaptation, availability of resources, social acceptability).

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Bron, France