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 (EDUC-AOD)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Deep Vein Thrombosis; Pulmonary Embolism
• Intervention / Treatment: Other: Phone interview

• Study Type: Observational
• Enrollment (Anticipated): 154

Contacts and Locations

• Study Contact: Name: Samuel COHEN; Phone Number: +33 635192704; Email: samuel.cohen4@aphp.fr

Study Locations

• France
  • Montreuil, France, 93100
    • Recruiting
    • Centre Hospitalier Intercommunal de Montreuil
    • Contact: Albert BOCCARA, MD; Phone Number: +33 951706247; Email: albert.boccara@gmail.com
  • Saint-Mandé, France, 94160
    • Recruiting
    • Hopital d'Instruction des Armees BEGIN
    • Contact: François BOUVIER, MD; Email: francois-rene.bouvier@intradef.gouv.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of patients hospitalized in a cardiology department with a discharge prescription for direct oral anticoagulants.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pharmaceutical interview; This group will benefit from a pharmaceutical interview, accordingly with the common practice in the department in which they are treated.	Other: Phone interview; The participant will have 2 phone interview in which they will be asked about their knowledge of direct oral anticoagulants.
No pharmaceutical interview; This group will not benefit from a pharmaceutical interview, accordingly with the common practice in the department in which they are treated.	Other: Phone interview; The participant will have 2 phone interview in which they will be asked about their knowledge of direct oral anticoagulants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Direct oral anticoagulants
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Embolism; Atrial Fibrillation; Thrombosis; Venous Thrombosis; Pulmonary Embolism
• Other Study ID Numbers: 2020PPRC08; 2020-A02285-34 (Other Identifier: IDRCB)

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