NCT05450640: PASODOBLEDEMI2

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

Completed Last updated 3 March 2023

What this trial tests

trial testing satisfaction survey in Hemophilia A in 176 participants. Completed in 9 January 2023.

Timeline

9 January 2023

Primary endpoint
9 January 2023

9 January 2023

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Completed
Study type	OBSERVATIONAL
Enrollment	176
Start date	9 January 2023
Primary completion	9 January 2023
Estimated completion	9 January 2023
Sites	1 location across France

Drugs / interventions tested

• satisfaction survey

Conditions studied

• Hemophilia A — all drugs for Hemophilia A →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

0 and older, any sex, with Hemophilia A. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluation of the Care Pathway in the Context of the Dispensing of Emicizumab (Hemlibra) in Community Pharmacies in France: Protocol for a Cross-sectional Study Based on the Kirkpatrick Model.
   Fraticelli L, Freyssenge J, Promé-Combel E, Agnellet E, et al · · 2023 · cited 5× · PMID 36884286 · DOI 10.2196/43091
2. Evaluation of an e-Learning Program for Community Pharmacists for Dispensing Emicizumab (Hemlibra) in France: Nationwide Cross-Sectional Study.
   Chamouard V, Freyssenge J, Clairaz-Mahiou B, Ferrera Bibas F, et al · · 2024 · cited 1× · PMID 38574351 · DOI 10.2196/54656
3. Comparative evaluation of access to emicizumab (Hemlibra®) for people with haemophilia A in community and hospital pharmacies in France.
   Cabon M, Chamouard V, Freyssenge J, Fraticelli L. · · 2024 · PMID 39209530 · DOI 10.1093/eurpub/ckae131