Pilot Study: Comparison of Patients' Knowledge of Direct Oral Anticoagulants in Post-hospitalization Between 2 Cardiology Departments Offering or Not a Pharmaceutical Interview During Hospitalization

Atrial Fibrillation Clinical Trial

— EDUC-AOD  

Official title:

Pilot Study: Comparison of Patients' Knowledge of Direct Oral Anticoagulants in Post-hospitalization Between 2 Cardiology Departments Offering or Not a Pharmaceutical Interview During Hospitalization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04674202
• Other study ID #: 2020PPRC08
• Secondary ID: 2020-A02285-34
• Status: Recruiting
• Start date: January 18, 2021
• Est. completion date: January 2024

Study information

• Verified date: September 2022
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Samuel COHEN
• Phone: 635192704
• Email: samuel.cohen4[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Direct oral anticoagulants (Rivaroxaban, Apixaban and Dabigatran) are an alternative to anti-vitamin K drugs and low molecular weight heparins in many cardiovascular diseases.

This new class of anticoagulants represents a particular and very promising advance: they are administered orally, their mechanism of action is rapid and direct on coagulation and their predictable pharmacological action allows for administration at fixed doses. In contrast to anti-vitamin K, there is no need for routine biological monitoring.

However, their therapeutic range is narrow and there is no routine biological monitoring. Rigorous compliance is therefore necessary. In addition, there are no official validated recommendations either for the measurement of anticoagulant activity in certain emergency situations, or for the management of severe bleeding (except recently for Pradaxa®).

Their correct use requires the training and involvement of health professionals as well as information and support for patients.

Pharmaceutical interviews are one of the main ways in which pharmacists can ensure this security through personalized and optimal patient care.

The purpose of these interviews is to:

• Reinforce the pharmacist's advisory, educational and preventive roles with patients;

• To enhance the pharmacist's expertise in the area of medication;

• To evaluate the patient's knowledge of his or her treatment;

• To assess the patient's knowledge of his or her treatment; To seek the patient's therapeutic adherence and help him or her to take ownership of his or her treatment;

• To evaluate, in the long term, the patient's appropriation of his or her treatment.

In this way, they enable involvement with patients while providing a link between healthcare professionals, which is essential for optimal patient care.

In recent years, numerous studies have been conducted on pharmaceutical interviews in the United Kingdom and the Netherlands.

On the other hand, few studies have been conducted in France to evaluate the clinical impact of pharmaceutical interviewing in medical services.

The aim of this study is to compare patients' knowledge of direct oral anticoagulants between 2 cardiology departments offering or not a pharmaceutical interview.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient hospitalized for more than 48 hours in a cardiology department with a discharge prescription for curative anticoagulation.

• Indication for a direct oral anticoagulant for atrial fibrillation, deep vein thrombosis or pulmonary embolism

Exclusion Criteria:

• Patients treated for the prevention of venous thromboembolic disease who have undergone scheduled total hip replacement or total knee replacement surgery.

• Patient with cognitive impairment

• Patients with a previous prescription for a direct oral anticoagulant

Related Conditions & MeSH terms

• Atrial Fibrillation
• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• Phone interview
The participant will have 2 phone interview in which they will be asked about their knowledge of direct oral anticoagulants.

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Montreuil	Montreuil
France	Hôpital d'Instruction des Armées Bégin	Saint-Mandé

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a "satisfactory" knowledge score 3 months after hospital discharge	Knowledge of direct oral anticoagulants will be assessed with a 4 item questionnaire. The score ranges from 0 "no knowledge" to = 3 "satisfactory knowledge".	3 months after hospital discharge