Clinical trial NCT04932603: Multidisciplinary Team Approach to Prescribe Antithrombotic Therapy in Older People With Atrial Fibrillation
Official title: Impact of Multidisciplinary Team Approach on the Utilization and Risks Related to Antithrombotic Drugs in Older Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Frail Elderly
Anticoagulants
Platelet Aggregation Inhibitors
Multidisciplinary team
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 820
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite outcome of all-cause mortality, ischemic event or bleeding event
timeFrame: 3 months after inclusion
Secondary outcomes:
measure: All-cause mortality
timeFrame: 3 months after inclusion
measure: Ischemic event
timeFrame: 3 months after inclusion
measure: Ischemic event
timeFrame: 6 months after inclusion
measure: Bleeding event
timeFrame: 3 months after inclusion
measure: Bleeding event
timeFrame: 6 months after inclusion
measure: Composite outcome of all-cause mortality, ischemic event or bleeding event
timeFrame: 6 months after inclusion
measure: All-cause mortality
timeFrame: 6 months after inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Unité de gériatrie aiguë, hôpital Pitié-Salpêtrière (Pr Marc Verny)
Study officials:
References: