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临床试验/NCT03188211
NCT03188211已完成不适用

Simulation-based Technologies to Improve the Appropriate Use of Oral Anticoagulants in Hospitalized Elderly Patients With Atrial Fibrillation

Mario Negri Institute for Pharmacological Research20 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
247
试验地点
20
主要终点
Elderly with AF prescribed with OAC

研究概览

简要总结

Atrial Fibrillation (AF) is the most common cardiac arrhythmia and the main cause of cardioembolic stroke. Oral Anticoagulation (OAC) has been shown to significantly prevent AF-related thromboembolism, however, despite convincing evidences and current guidelines recommendations, OAC tends to be underused in clinical practice especially in the oldest. Education and training to appropriately select people suitable for OAC for stroke prevention could be pivotal in the decision making process. According to the study project, physicians working in Internal Medicine and Geriatric wards, where are mainly admitted elderly people with AF, will undergo to a program of e-learning through computer-based simulation method reproducing clinical scenarios of patients aged 65 years or older, with known or newly diagnosed AF, admitted to hospital for any medical reason and requesting that a decision about long-term antithrombotic therapy is taken.

Primary objective of the study is to investigate whether such educational intervention will improve the appropriate use and prescription rate of OAC in hospitalised elderly patients with AF, multimorbidity and polypharmacy, in comparison to the usual practice.

The study will be a cluster randomised controlled trial involving a network of Internal Medicine and Geriatrics wards. Thirty-two wards will be recruited based on voluntary participation and randomised to receive an educational intervention through computer-based simulation, (N=16) or to continue with the usual practice (N=16). Subjects receiving the intervention will be all the staff physicians of the wards randomised in the intervention arm.

The impact of the intervention compared with the usual practice will be evaluated in patients aged 65 years or older admitted to the participating centres with a known diagnosis of AF or newly diagnosed with AF during the hospitalisation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •subjects 65 years of age or older, with known or newly diagnosed AF, admitted to the Internal Medicine and Geriatric wards of the REPOSI network,
  • •consent to participate to the study.

排除标准

  • •consent denial to participate to the study,
  • •absolute contraindication to OAC,
  • •re-hospitalisation for the subject already included in the study,
  • •life expectancy less than 6 months.

研究组 & 干预措施

Intervention

Other

Clinicians allocated to intervention arm will receive an e-learning educational program based on simulation-based technologies (Dr Sim). Dr Sim provides a powerful editing system that allows to create clinical cases according to the educational need and purposes. It will be distributed on an e-learning platform, allowing the user to act in a highly interactive learning environment. Management of the virtual patients is carried out interactively and each diagnostic and or therapeutic choice will be supported by any scientific data, guidelines recommendations, drug descriptions and literature references useful to address the best choice for that specific patient as it should be in real practice.

干预措施: E-learning educational program (Other)

Control

Other

Clinicians allocated to control arm will not receive the e-learning educational program based on simulation-based technologies (Dr Sim).

干预措施: Control (Other)

结局指标

主要结局

Elderly with AF prescribed with OAC

时间窗: through study completion, up to 1 year

difference in the proportion of elderly patients with AF prescribed with OAC between the post-intervention and the pre-intervention observational phase

次要结局

  • Number of access to Dr Sim(1 month)
  • Total duration of connection to Dr Sim(1 month)
  • Elderly patients with AF prescribed with any antiplatelet agent(through study completion, up to 1 year)
  • Elderly patients with AF newly prescribed with OAC agents(through study completion, up to 1 year)
  • Patients experiencing any cerebro or cardiovascular events(6 month follow up)
  • Minor bleeding events(6 month follow up)
  • Re-hospitalization rate(6 month follow up)
  • Major bleeding event(6 month follow up)

研究者

发起方
Mario Negri Institute for Pharmacological Research
申办方类型
Other
责任方
Sponsor

研究点 (20)

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