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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 63,001
- 试验地点
- 2
- 主要终点
- Adequacy of anticoagulant treatment
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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).
排除标准
- •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.
研究组 & 干预措施
CDS-NVAF benefiting group
CDS-NVAF = Clinical decision support (CDS) tool for improving the adequacy of the anticoagulant therapy adequacy in non-valvular atrial fibrillation (NVAF)
干预措施: CDS-NVAF (Device)
CDS-NVAF not-benefiting group
结局指标
主要结局
Adequacy of anticoagulant treatment
时间窗: one year after the beginning of the intervention
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
Incidence rate of mortality
时间窗: Two years after the beginning of the intervention
All-cause mortality
Incidence rate of Thromboembolic events
时间窗: Two years after the beginning of the intervention
Thromboembolic events: acute myocardial infarction or angina, ischemic stroke, peripheral embolism or transient ischemic attack (TIA)
Incidence rate of Hemorrhagic events
时间窗: Two years after the beginning of the intervention
Hemorrhagic events: intracranial hemorrhage and gastrointestinal hemorrhage
次要结局
- Characteristics of the professional: PCC(at the beginning of the intervention)
- Primary Care Center (PCC) characteristics: teaching center(at the beginning of the intervention)
- Sociodemographic characteristics of the patients(at the beginning of the intervention)
- Primary Care Center (PCC) characteristics: Standard of Health Care Quality (SHCQ)(at the beginning of the intervention)
- Characteristics of the professional: sex(at the beginning of the intervention)
- Characteristics of the professional: Standard of Health Care Quality (SHCQ)(at the beginning of the intervention)
- Treatment by direct-acting oral antagonists(at the beginning of the intervention and one year after the beginning of the intervention)
- Treatment by Vitamin K antagonists(at the beginning of the intervention and one year after the beginning of the intervention)
- Primary Care Center (PCC) characteristics: urban/rural(at the beginning of the intervention)
- Primary Care Center (PCC) characteristics: socioeconomic deprivation index (MEDEA)(at the beginning of the intervention)
- Characteristics of the professional: age(at the beginning of the intervention)
- Characteristics of the professional: type of work contract(at the beginning of the intervention)
- Primary Care Center (PCC) characteristics: Standard of Quality of Pharmaceutical Prescription (SQPP)(at the beginning of the intervention)
- Characteristics of the professional: Standard of Quality of Pharmaceutical Prescription (SQPP)(at the beginning of the intervention)
- Treatment by heparin(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(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(at the beginning of the intervention and one year after the beginning of the intervention)