Evaluation of the Evolution of the Patient Care Pathway in the Context of the Implementation of the DOuBLE EMIcizumab Dispensing Circuit in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 363
- 试验地点
- 1
- 主要终点
- Satisfaction of community pharmacists following the HEMOPHAR training program assessed by a likert scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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®)
排除标准
- •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
结局指标
主要结局
Satisfaction of community pharmacists following the HEMOPHAR training program assessed by a likert scale
时间窗: 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
时间窗: 6 months.
specific questionnaire developed for the study
Number of trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies
时间窗: 6 months.
Number of non-trained pharmacists dispensing emicizumab (HEMLIBRA (R)) in community pharmacies
时间窗: 6 months.
次要结局
未报告次要终点