Multidisciplinary Team Approach to Prescribe Antithrombotic Therapy in Older People With Atrial Fibrillation (ANTITHROMBOTEA)

Impact of Multidisciplinary Team Approach on the Utilization and Risks Related to Antithrombotic Drugs in Older Patients With Atrial Fibrillation

Antithrombotic drugs, which include antiplatelet and anticoagulant therapies, are used to prevent and treat many cardiovascular disorders. With the increase in prevalence of cardiovascular diseases and medical progress, these treatments are increasingly being prescribed, particularly in older patients. One of the main indications of antithrombotic drugs is atrial fibrillation (AF), a disease highly prevalent in older people, a population at high risk of adverse drug events. Notably, antithrombotic drugs are the first involved in serious adverse drug events, among which 40-70% may be preventable. In this context, six units of the hospital group "Assistance Publique - Hôpitaux de Paris" have created a multidisciplinary team which assesses antithrombotic prescriptions in older patients with AF. This team, gathering geriatricians, cardiologists, neurologists and haematologist specialized in haemostasis, evaluates the patient medical profile and suggests the most appropriate antithrombotic treatment based on their expertise and the available recommendations. Here we want to look at patients outcomes in light of the intervention of this multidisciplinary team.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Standard of care, with intervention of the multidisciplinary team

Detailed Description

The primary objective of this study is to evaluate the impact of the multidisciplinary team on the composite outcome of all-cause mortality, ischemic event or bleeding event at 3 months. Secondary objectives are to evaluate this composite outcome at 6 months and all-cause mortality, occurrence of ischemic event, occurrence of bleeding event, at 3 and 6 months.

• Study Type: Observational
• Enrollment (Estimated): 820

Contacts and Locations

• Study Contact: Name: Lorène Zerah, MD, PhD; Phone Number: 01 42 16 03 36; Email: lorene.zerah@aphp.fr
• Study Contact Backup: Name: Noémie Simon-Tillaux, MD, MPH; Phone Number: 01 42 16 03 36; Email: noemie.simon@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Unité de gériatrie aiguë, hôpital Pitié-Salpêtrière (Pr Marc Verny)
    • Contact: Lorène Zerah, MD, PhD; Email: lorene.zerah@aphp.fr
    • Contact: Noémie Simon-Tillaux, MD, MPH; Email: noemie.simon@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in 6 geriatrics units in the Greater Paris area and / or whose clinical file is reviewed by the multidisciplinary team PAtiet

Description

Inclusion Criteria:

• 75 years old patients or more
• Diagnosis of AF
• Hospitalized in one of the 6 geriatrics unit participating in the study and / or whose clinical file is reviewed by the multidisciplinary team

Exclusion Criteria:

• opposition to data collection for research purposes

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard of care
experimental; Patients with AF, hospitalized in one of the 6 geriatrics units participating in the study, aged 75 years or over, without evaluation of their antithrombotic treatment by the multidisciplinary team. The lack of review of patient's file by the multidisciplinary team is based on physician decision.	Other: Standard of care, with intervention of the multidisciplinary team; Patients with AF, aged of 75 years or more, with evaluation of their antithrombotic treatment by the multidisciplinary team. The review of patient's file by the multidisciplinary team is based on physician decision. These patients are hospitalized in one of the 6 geriatrics units participating in the study and / or are hospitalized in another ward but their clinical file is reviewed by the multidisciplinary team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite outcome of all-cause mortality, ischemic event or bleeding event	All-cause mortality will be assess using patient's medical record or reported death by the referent general practitioner. Ischemic events include acute coronary syndrome, transient ischemic stroke or permanent ischemic stroke, arterial embolism, deep vein thrombosis and pulmonary embolism. Bleeding events include any bleeding event requiring a medical consult or a hospitalization	3 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality will be assess using patient's medical record or reported death by the referent general practitioner.	3 months after inclusion
Ischemic event	Ischemic events include acute coronary syndrome, transient ischemic stroke or permanent ischemic stroke, arterial embolism, deep vein thrombosis	3 months after inclusion
Ischemic event	Ischemic events include acute coronary syndrome, transient ischemic stroke or permanent ischemic stroke, arterial embolism, deep vein thrombosis	6 months after inclusion
Bleeding event	Bleeding events include any bleeding event requiring a medical consult or a hospitalization.	3 months after inclusion
Bleeding event	Bleeding events include any bleeding event requiring a medical consult or a hospitalization.	6 months after inclusion
Composite outcome of all-cause mortality, ischemic event or bleeding event	All-cause mortality will be assess by patient's medical record or reported death by the referent general practitioner. Ischemic events include transient ischemic attack or ischemic stroke, arterial embolism, deep vein thrombosis and pulmonary embolism. Bleeding events include any bleeding event requiring a medical consult or a hospitalization.	6 months after inclusion
All-cause mortality	All-cause mortality will be assess by patient's medical record or reported death by the referent general practitioner.	6 months after inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Estimated): August 14, 2024
• Study Completion (Estimated): August 14, 2024

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Multidisciplinary team; Platelet Aggregation Inhibitors; Anticoagulants; Frail Elderly
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: APHP210392

Drug and device information, study documents

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