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| Name | Class |
|---|---|
| Institut Català de la Salut | OTHER |
| Department of Health, Generalitat de Catalunya | OTHER_GOV |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDS-NVAF benefiting group | Experimental | CDS-NVAF = Clinical decision support (CDS) tool for improving the adequacy of the anticoagulant therapy adequacy in non-valvular atrial fibrillation (NVAF) |
|
| CDS-NVAF not-benefiting group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDS-NVAF | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria (all criteria must be met):
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol) | Barcelona | 08007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38056770 | Derived | Dalmau Llorca MR, Aguilar Martin C, Carrasco-Querol N, Hernandez Rojas Z, Rodriguez Cumplido D, Castro Blanco E, Queiroga Goncalves A, Fernandez-Saez J, Perez-Villacastin J. Clinical value of a tool for managing oral anticoagulation in nonvalvular atrial fibrillation in primary health care. Randomized clinical trial. Rev Esp Cardiol (Engl Ed). 2024 Jun;77(6):471-480. doi: 10.1016/j.rec.2023.11.009. Epub 2023 Dec 4. English, Spanish. | |
| 29504981 |
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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 |
| Derived |
| Dalmau Llorca MR, Goncalves AQ, Forcadell Drago E, Fernandez-Saez J, Hernandez Rojas Z, Pepio Vilaubi JM, Rodriguez Cumplido D, Morral Parente RM, Aguilar Martin C. A new clinical decision support tool for improving the adequacy of anticoagulant therapy and reducing the incidence of stroke in nonvalvular atrial fibrillation: A randomized clinical trial in primary care. Medicine (Baltimore). 2018 Jan;97(3):e9578. doi: 10.1097/MD.0000000000009578. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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