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

Thromboembolic Event Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06100380
• Other study ID #: PO20162*
• Status: Completed
• Start date: September 20, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: October 1, 2023
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Thromboembolic Event
• Thromboembolism

Intervention

Other:
• Survey
Questionnaire

Locations

Country	Name	City	State
France	Chu Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thromboembolic event in patients treated with an oral anticoagulant		1 day