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临床试验/NCT06100380
NCT06100380已完成不适用

Elaboration of a Prioritization Score for Pharmaceutical Interviews in Patients Treated With Oral Anticoagulants

CHU de Reims1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2020年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
197
试验地点
1
主要终点
Number of thromboembolic event in patients treated with an oral anticoagulant

研究概览

简要总结

Oral anticoagulants have a prominent place in the strategy of prevention and treatment of thromboembolic diseases, especially in patients with atrial fibrillation. However, a study conducted by the National Fund for Health Insurance (Caisse primaire d'Assurance maladie, CPAM) in 2017 among nearly 35,000 patients with non-valvular atrial fibrillation showed that one in five patients stopped their oral anticoagulant without medical advice for at least 60 days during the first year of treatment.

In our establishment, patients hospitalized in the Cardiology departments and treated with oral anticoagulants benefit from pharmaceutical interviews on their treatment before they return at home. This activity, which exists since November 2014, is based on a team consisting on a pharmacy student, supervised by a pharmacist trained in therapeutic education.

In order to secure the management of patients treated by oral anticoagulants and to answer the requirements of Certification, the investigators wish to extend the pharmaceutical interviews to all of hospital's healthcare services. However, the large number of patients concerned, the shorter hospital stays and the difficulties to organize collective sessions in front of the diversity of treatments and diseases are parameters to be taken into account in the development of this activity. The provision of a targeting tool for patients with high risk of thromboembolism and / or hemorrhage is a prerequisite for organizing this institutional approach to support patients on anticoagulants.

In this context, the investigators want to establish a prioritization score to identify patients on oral anticoagulants with a higher drug risk.

详细描述

Oral anticoagulants are represented by two classes: vitamin K antagonists (VKA) and non-VKA oral anticoagulants (DOAC). They have a prominent place in the strategy of prevention and treatment of thromboembolic diseases, especially in patients with atrial fibrillation. Their prescription continues to increase in France.

However, a study conducted by the National Fund for Health Insurance (Caisse primaire d'Assurance maladie, CPAM) in 2017 among nearly 35,000 patients with non-valvular atrial fibrillation showed that one in five patients stopped their oral anticoagulant without medical advice for at least 60 days during the first year of treatment.

In our establishment, patients hospitalized in the Cardiology departments and treated with oral anticoagulants benefit from pharmaceutical interviews on their treatment before they return at home. This activity, which exists since November 2014, is based on a team consisting on a pharmacy student, supervised by a pharmacist trained in therapeutic education.

In order to secure the management of patients treated by oral anticoagulants and to answer the requirements of Certification, he investigators wish to extend the pharmaceutical interviews to all of hospital's healthcare services. However, the large number of patients concerned, the shorter hospital stays and the difficulties to organize collective sessions in front of the diversity of treatments and diseases are parameters to be taken into account in the development of this activity. The provision of a targeting tool for patients with high risk of thromboembolism and / or hemorrhage is a prerequisite for organizing this institutional approach to support patients on anticoagulants.

In this context, the investigators want to establish a prioritization score to identify patients on oral anticoagulants with a higher drug risk. Case-control study was performed at University hospital of Reims.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For the case-subjects:
  • Patient hospitalized at the Reims university hospital
  • Patient treated with an oral anticoagulant (vitamin K antagonist: VKA or non-VKA oral anticoagulant: DOAC) since at least one month
  • Patient with a serious hemorrhage or a thromboembolic event.
  • For the control-subjects:
  • Patient hospitalized at the Reims university hospital
  • Patient treated with an oral anticoagulant (vitamin K antagonist: VKA or non-VKA oral anticoagulant: DOAC) since at least one month
  • Without a serious hemorrhage or a thromboembolic event.

排除标准

  • Patient physically or mentally not able to express non-opposition or opposition to the study;
  • Patient protected by law;
  • Patient physically or mentally not able to answer the surveys;
  • Patient hospitalized in the month preceding the inclusion;
  • Patient discharged from hospital before having answering the surveys.

结局指标

主要结局

Number of thromboembolic event in patients treated with an oral anticoagulant

时间窗: 1 day

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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