Clinical Decision Support Tool for Improving the Adequacy of Anticoagulant Therapy in Non-valvular Atrial Fibrillation (NACOs)

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Unknown

Conditions: Atrial Fibrillation; Clinical Decision Support Systems; Anticoagulants

Treatments: Device: CDS-NVAF

Study type: Interventional

Funder types: Other

Identifiers

NCT03367325

SLT002/16/00146

Details and patient eligibility

About

Atrial fibrillation (AF) is the most common cardiac arrhythmia and increases the risk of ischemic stroke 4-5-fold. The prevention of complications is based on oral or antiplatelet anticoagulant treatment. The first choice of anticoagulant therapy (AT) is the vitamin K antagonist (VKA). Contraindication to VKA or poor control of the International Normalized Ratio leads to the administration of direct-acting oral anticoagulants (DOACs). There is a trend towards inadequate AT in non-valvular AF (NVAF) patients.

The Objective of the study is evaluate the impact of the implementation of a decision support tool linked to digital clinical history on the adequacy of AT, the incidence of complications and the mortality in patients with NVAF in primary health care of the Catalan Institute of Health (ICS).

Enrollment: 63,001 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (all criteria must be met):

• Patients diagnosed with NVAF one year prior to the implementation of the computerized tool;
• Patients receiving anticoagulant treatment with DOACs or VKAs;
• Patients followed in primary care (with at least 6 INR controls during the year prior to the intervention).

Exclusion Criteria:

• Patients with INR control in the reference hospital;
• patients with valvular AF (mitral stenosis);
• patients with a prosthetic heart valve;
• change to another primary care center.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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63,001 participants in 2 patient groups

CDS-NVAF benefiting group

Experimental group

Description:

CDS-NVAF = Clinical decision support (CDS) tool for improving the adequacy of the anticoagulant therapy adequacy in non-valvular atrial fibrillation (NVAF)

Treatment:

Device: CDS-NVAF

CDS-NVAF not-benefiting group

No Intervention group