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

Study Overview
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Brief Summary
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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).

Official Title
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A New Clinical Decision Support Tool for Improving the Adequacy of Anticoagulant Therapy and Reduce Stroke Incidence in Non-valvular Atrial Fibrillation: a Randomized Clinical Trial in Primary Care

Conditions
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Atrial Fibrillation, Anticoagulants, Clinical Decision Support Systems

Intervention / Treatment
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* Device: CDS-NVAF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDS-NVAF benefiting group<br>CDS-NVAF = Clinical decision support (CDS) tool for improving the adequacy of the anticoagulant therapy adequacy in non-valvular atrial fibrillation (NVAF) | Device: CDS-NVAF<br>* 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.<br>|
| No Intervention: CDS-NVAF not-benefiting group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of Thromboembolic events | Thromboembolic events: acute myocardial infarction or angina, ischemic stroke, peripheral embolism or transient ischemic attack (TIA) | Two years after the beginning of the intervention | 
| Incidence rate of Hemorrhagic events | Hemorrhagic events: intracranial hemorrhage and gastrointestinal hemorrhage | Two years after the beginning of the intervention | 
| Incidence rate of mortality | All-cause mortality | 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 | one year after the beginning of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic characteristics of the patients | age, sex, primary care area assigned, physician assigned | 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 | 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 | 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 | 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 | 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 | at the beginning of the intervention | 
| Characteristics of the professional: age | This variable encompasses the age of the professional | at the beginning of the intervention | 
| Characteristics of the professional: sex | This variable encompasses the sex of the professional | at the beginning of the intervention | 
| Characteristics of the professional: PCC | This variable identifies the PCC of the professional | 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 | 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 | 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 | at the beginning of the intervention | 
| Treatment by direct-acting oral antagonists | Direct-acting oral antagonists: dabigatran, apixaban or rivaroxaban | 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 | at the beginning of the intervention and one year after the beginning of the intervention | 
| Treatment by heparin | presence / absence of heparin treatment | 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). | 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 | at the beginning of the intervention and one year after the beginning of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-valvular atrial fibrillation, time in therapeutic range, primary care