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

NCT04674202 | Unknown

• 2 other identifiers: 2020PPRC082020-A02285-34
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atrial Fibrillation; Deep Vein Thrombosis; Pulmonary Embolism

Keywords

Direct oral anticoagulants

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Phone interview OTHER

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

No pharmaceutical interview; Pharmaceutical interview

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (2)

Centre Hospitalier Intercommunal de Montreuil

Montreuil, 93100, France

RECRUITING

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, 94160, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Central Study Contacts

Samuel COHEN

CONTACT

635192704; samuel.cohen4@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: January 18, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

FR (2)