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

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.

Study Overview

• Status: Completed
• Conditions: Thromboembolic Event
• Intervention / Treatment: Other: Survey

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 Type: Observational
• Enrollment (Actual): 197

Contacts and Locations

Study Locations

• France
  • Reims, France, 51092
    • Chu Reims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected during their hospitalization at University hospital of Reims if they are treated with an oral anticoagulant.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with Thromboembolic event and Hemorrhage group; patients who present a hemorrhage or a thromboembolic event	Other: Survey; Questionnaire
patients without Thromboembolic event and Hemorrhage; patients who don't present a hemorrhage or a thromboembolic event	Other: Survey; Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of thromboembolic event in patients treated with an oral anticoagulant	1 day

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Actual): November 17, 2021
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism
• Other Study ID Numbers: PO20162*

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No