Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia and increases the risk of ischemic stroke. The first choice of anticoagulant therapy (AT) is the vitamin K antagonist (VKA). The contraindication of VKA or poor control of the International Normalized Ratio leads to the direct-acting anticoagulants (DOACs) indication. There is a trend towards inadequate AT in non-valvular AF patients.
Objective: To evaluate the implementation of a decision support tool linked to digital clinical history for improving treatment adequacy in patients with non-valvular AF from the primary health care of the Catalan Institute of Health (ICS).
Methods and Design: Randomized non-blinded clinical trial in 287 primary care teams (PCT). A restrictive block randomization method will be performed at PCT level. The study will be carried out between 2017-2018. Only professionals of the intervention group will dispose of the Time in Therapeutic Range (TRT) according to the Rosendaal method in the computerized medical history. The SIDIAP database will be used for the extraction of data and analysis will be done at the year of the implementation and according to characteristics of the patients and the professionals. Multilevel logistic regression models will be used to estimate the effect of the intervention.
Discussion: A tool that reports real-time control of VKA anticoagulation is not available in the primary care computer system of ICS. We intend to demonstrate that its inclusion can improve the decision making in the consultation, adjusting the treatment and reducing the thromboembolic complications and the mortality of non-valvular AF patients.