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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
63,001
The CDS-NVAF is intended for patients diagnosed with NVAF and treated with VKA. This tool calculates the time in the therapeutic range (TTR) using the Rosendaal method considering the last International Normalized Ratio (INR) data. The INR data are found in the clinical history of NVAF patients. The CDS-NVAF will be activated when the physician introduces the last INR value. At this time the TTR will be calculated automatically. If the TTR value is \< 65%, a pop up screen with a warning text will open suggesting a change to DOAC therapy. The physician can decide whether to change or not the previous prescription. If the TTR value in \> 65% the pop up screen will not appear. The TTR value will remain registered on the screen of the follow up of oral anticoagulant use and can be consulted in future queries. The diffusion of the CDS-NVAF will be made by an announcement on the first day of the intervention when the health care professional opens the electronic clinical history.
Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)
Barcelona, Spain
Incidence rate of Thromboembolic events
Thromboembolic events: acute myocardial infarction or angina, ischemic stroke, peripheral embolism or transient ischemic attack (TIA)
Time frame: Two years after the beginning of the intervention
Incidence rate of Hemorrhagic events
Hemorrhagic events: intracranial hemorrhage and gastrointestinal hemorrhage
Time frame: Two years after the beginning of the intervention
Incidence rate of mortality
All-cause mortality
Time frame: Two years after the beginning of the intervention
Adequacy of anticoagulant treatment
This variable encompasses the adequacy of the anticoagulant treatment, taking into account if an adequate change has occurred or not. 0 = No adequate change (when an inadequate change has been produced or when an inadequate treatment has been maintained) 1 = adequate change (when an adequate change has been produced or when an adequate treatment has been maintained) The adequacy of the anticoagulant therapy in patients with NVAF will be based on the fulfillment of the criteria of the Ministry of Health, Social Services and Equality of Spain, 2016\* \* Ministry of Health, Social Services and Equality. Criteria and recommendations for the use of direct oral anticoagulants (ACOD) in the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. 2016. available in: https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/criterios-anticoagulantes-orales.pdf
Time frame: one year after the beginning of the intervention
Sociodemographic characteristics of the patients
age, sex, primary care area assigned, physician assigned
Time frame: at the beginning of the intervention
Primary Care Center (PCC) characteristics: teaching center
This variable encompasses if a PCC is a teaching center or not
Time frame: at the beginning of the intervention
Primary Care Center (PCC) characteristics: urban/rural
This variable encompasses if a PCC is located at urban o rural area
Time frame: at the beginning of the intervention
Primary Care Center (PCC) characteristics: socioeconomic deprivation index (MEDEA)
This variable encompasses the socioeconomic deprivation index (MEDEA) of each PCC
Time frame: at the beginning of the intervention
Primary Care Center (PCC) characteristics: Standard of Health Care Quality (SHCQ)
This variable encompasses the Standard of Health Care Quality of each PCC
Time frame: at the beginning of the intervention
Primary Care Center (PCC) characteristics: Standard of Quality of Pharmaceutical Prescription (SQPP)
This variable encompasses the Standard of Quality of Pharmaceutical Prescription of each PCC
Time frame: at the beginning of the intervention
Characteristics of the professional: age
This variable encompasses the age of the professional
Time frame: at the beginning of the intervention
Characteristics of the professional: sex
This variable encompasses the sex of the professional
Time frame: at the beginning of the intervention
Characteristics of the professional: PCC
This variable identifies the PCC of the professional
Time frame: at the beginning of the intervention
Characteristics of the professional: type of work contract
This variable encompasses the type of work contract of the professional
Time frame: at the beginning of the intervention
Characteristics of the professional: Standard of Health Care Quality (SHCQ)
This variable encompasses the Standard of Health Care Quality of the professional
Time frame: at the beginning of the intervention
Characteristics of the professional: Standard of Quality of Pharmaceutical Prescription (SQPP)
This variable encompasses the Standard of Quality of Pharmaceutical Prescription of the professional
Time frame: at the beginning of the intervention
Treatment by direct-acting oral antagonists
Direct-acting oral antagonists: dabigatran, apixaban or rivaroxaban
Time frame: at the beginning of the intervention and one year after the beginning of the intervention
Treatment by Vitamin K antagonists
Vitamin K antagonists: acenocoumarol or warfarin
Time frame: at the beginning of the intervention and one year after the beginning of the intervention
Treatment by heparin
presence / absence of heparin treatment
Time frame: at the beginning of the intervention and one year after the beginning of the intervention
Thromboembolic risk CHA2DS2-VASC (congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, age 65 to 74 years, female) score
The score indicates the risk of a patient with non-valvular atrial fibrillation of suffering a stroke in one year. The score goes from 0 (absence of risk) to 10 (greater risk).
Time frame: at the beginning of the intervention and one year after the beginning of the intervention
Bleeding risk HAS-BLED (Hypertension, Abnormal liver/renal function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), and Drugs/alcohol) score
The score allows the calculation of the risk of bleeding in patients with non-valvular atrial fibrillation receiving oral anticoagulant treatment based on the risk factors associated with the probability of bleeding. 0 = low risk; 1 = intermediate risk; 2 = intermediate risk; ≥3 = high risk
Time frame: at the beginning of the intervention and one year after the beginning of the intervention
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