Active (CDSS) Control Blinded Multicenter, Cluster-randomized Trial of the Adherence to Clinical Practice Guidelines Using the Clinical Decision Support System in Patients With Hypertension and Atrial Fibrillation (INTELLECT II Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Compliance with AF/hypertension clinical practice guidelines
研究概览
简要总结
The Clinical Decision Support Systems (CDSS) based on real clinical data and its own algorithms can help to make the right choice according to guidelines. The goal of the INTELLECT II study is to investigate treatment adherence to guidelines/science-based medicine and its impact on patient outcomes into two groups of doctors, clinical centers with standard care of treatment (control), and clinical centers using CDSS (active).
详细描述
Hypertension and atrial fibrillation are 2 important public health priorities. There is a gap between evidence-based best management and actual clinical practice. To decrease this gap, clinical practice guidelines (CPGs), based on available evidence are employed. Clinical decision support system ("MedicBK") is a computer-based program that analyzes published evidence and provides prompts and reminders to assist health care providers in implementing clinical guidelines and science-based medicine at the point of care. The INTELLECT II trial is designed as a multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment. Approximately 10 centers from Russia will be enrolled. Centers managing patients with symptomatic atrial fibrillation and/or hypertension will be randomized to either patient management with aid of CDSS ("MedicBK") or standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Patients diagnosed with nonvalvular atrial fibrillation and hypertension and indications for therapy according to European guidelines.
排除标准
- •Inability to adhere to study procedures
- •Severe heart-valve disorder
- •Stroke within 14 days or severe stroke within 6 months before screening
- •Active bleedings
- •Thyroid dysfunction
- •Pregnancy
- •Secondary hypertension
研究组 & 干预措施
CDSS
patient management with aid of CDSS
干预措施: CDSS ("MedicBK") (Other)
standart care
patient management with standard care according to guidelines
结局指标
主要结局
Compliance with AF/hypertension clinical practice guidelines
时间窗: 1 month
number of patients treated in accordance with current ESC clinical guidelines for management atrial fibrillation evaluated by independent professionals compared with Clinical decision support system MedicBK
次要结局
- Total cardiovascular events(6 months)
- Total mortality(6 months)
- total number of non-planing visits and hospitalization(6 months)
研究者
Prof. Dmitry Duplyakov FESC
Ass. Prof. Dmitry Duplyakov M.D.,Ph.D.
Samara Regional Cardiology Dispensary