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

Completed

• Conditions: Thromboembolic Event
• Interventions: Other: Survey

• Registration Number: NCT06100380
• Lead Sponsor: CHU de Reims

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-09-20
• Study First Submitted: 2020-11-24
• Primary Completion: 2021-11-17
• Study Completion: 2023-10-01
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients without Thromboembolic event and Hemorrhage	Survey	patients who don't present a hemorrhage or a thromboembolic event
patients with Thromboembolic event and Hemorrhage group	Survey	patients who present a hemorrhage or a thromboembolic event

Primary Outcome Measures

Name	Time	Method
Number of thromboembolic event in patients treated with an oral anticoagulant	1 day

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 Reims, France