Hemophilia APASODOBLEDEMI1NCT05449197
Evaluation of the Training Program for Community Pharmacists for Dispensing Emicizumab (HEMLIBRA®) in France
An observational study of Hemophilia A, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemophilia A
- What is being tested?
- HEMOPHAR e-learning program
- How many people
- 363 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2022to 5 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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®)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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 :
Read more
- 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.
- Conditions
- Hemophilia A
- Being tested
- HEMOPHAR e-learning program
- Keywords
- Haemophilia A, Accessibility, Emicizumab (HEMLIBRA®), Training evaluation
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEMOPHAR e-learning programOther
training on professional practice by following HEMOPHAR e-learning program
| Study group | Role | What they receive |
|---|---|---|
| Community pharmacists chosen by the patient with haemophilia A for dispensing Emicizumab | Not described Receives: Other: HEMOPHAR e-learning program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies
Measured: 6 months.
Number of non-trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies
Measured: 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)
Measured: 6 months.
Professional practices of community pharmacists in dispensing emicizumab (HEMLIBRA (R)) assessed by a specific questionnaire
specific questionnaire developed for the study
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Jul 2022
- Primary completion30 Dec 2022
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie CHAMOUARD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449197
- Sponsor's protocol ID
- 69HCL21_1391
- Acronym
- PASODOBLEDEMI1
- Status last verified
- Jan 2023
- First submitted
- 4 Jul 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chamouard V, Freyssenge J, Clairaz-Mahiou B, Ferrera Bibas F, Fraticelli L. Evaluation of an e-Learning Program for Community Pharmacists for Dispensing Emicizumab (Hemlibra) in France: Nationwide Cross-Sectional Study. JMIR Form Res. 2024 Apr 4;8:e54656. doi: 10.2196/54656.
PubMed 38574351Fraticelli L, Freyssenge J, Prome-Combel E, Agnellet E, Dargaud Y, Chamouard V. 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. JMIR Res Protoc. 2023 Mar 8;12:e43091. doi: 10.2196/43091.
PubMed 36884286
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05449197
- Acronym / sponsor ID
- PASODOBLEDEMI1 / 69HCL21_1391
- Conditions
- Hemophilia A
- Keywords
- Haemophilia A, Accessibility, Emicizumab (HEMLIBRA®), Training evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community pharmacists chosen by the patient with haemophilia A for dispensing Emicizumab | – | Other: HEMOPHAR e-learning program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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®)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEMOPHAR e-learning programtraining on professional practice by following HEMOPHAR e-learning program | Other | Community pharmacists chosen by the patient with haemophilia A for dispensing Emicizumab |
Primary outcome
Number of trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies
Time frame: 6 months.
Number of non-trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies
Time frame: 6 months.
Satisfaction of community pharmacists following the HEMOPHAR training program assessed by a likert scale
Time frame: 6 months.
levels of satisfaction (very satisfied,satisified, dissatisfied,very dissatisfied)
Professional practices of community pharmacists in dispensing emicizumab (HEMLIBRA (R)) assessed by a specific questionnaire
Time frame: 6 months.
specific questionnaire developed for the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 38574351Chamouard V, Freyssenge J, Clairaz-Mahiou B, Ferrera Bibas F, Fraticelli L. Evaluation of an e-Learning Program for Community Pharmacists for Dispensing Emicizumab (Hemlibra) in France: Nationwide Cross-Sectional Study. JMIR Form Res. 2024 Apr 4;8:e54656. doi: 10.2196/54656.
- Derived from this study: PubMed 36884286Fraticelli L, Freyssenge J, Prome-Combel E, Agnellet E, Dargaud Y, Chamouard V. 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. JMIR Res Protoc. 2023 Mar 8;12:e43091. doi: 10.2196/43091.
- Individual participant dataSharing planned: No
Related trials for Hemophilia A
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
RecruitingPhase 3
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
Hemophilia A
Not yet recruitingPhase 1
Lentiviral FVIII Gene Therapy
Hemophilia A
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie CHAMOUARD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies (time frame: 6 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05449197, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.