Evaluation of a Prescription Support-tool for Chronic Management of Oral Antithrombotic Combinations in Adults: Protocol of a Randomized Controlled Trial Using Clinical Vignettes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 478
- 主要终点
- The primary outcome measure is the rate of the "right prescription of oral ATs" as defined according to the guidelines in terms of number, class, duration and dosage between the two groups.
研究概览
简要总结
From a systematic review of international guidelines (2012-2018), a prescription support-tool synthesizing national and international guidelines on chronic management (≥ 1 month) of oral AT agents without considering in-hospital management and bridging therapy will be developed. Guidelines dealing with the use of oral ATs for non-valvular atrial fibrillation, coronary artery disease, ischemic stroke, valvular heart disease, peripheral artery disease and venous thromboembolism in adults will be included. These pathologies were selected because most prescriptions of ATs are related to neuro-cardiovascular diseases and because this study would provide a synthesis relevant for clinicians in charge of the follow-up of patients with oral AT combinations. Studies are needed to assess the impact of this tool on appropriate prescribing.
详细描述
Oral antithrombotic (AT) drugs are widely implicated in serious and preventable bleeding events, which justifies the implementation of risk minimization actions. Avoiding inappropriate oral AT combinations is a major concern, particularly for patients with multiple chronic conditions. The first step is to provide fast and easy access to the latest recommendations. From a systematic review of international guidelines (2012-2018), a prescription support-tool synthesizing national and international guidelines on chronic management (≥ 1 month) of oral AT agents without considering in-hospital management and bridging therapy will be developed. Our main objective in this study is to evaluate the accuracy of this tool by measuring the appropriateness of oral AT prescriptions according to the most recent guidelines.
Methods and analysis: In this web-based randomized controlled trial, participating French general practitioners and cardiologists in the outpatient setting will be randomized by use or not of the prescription support-tool. They will be asked to provide the number of drugs, drug class, duration and dosage of ATs, within a time window of 10 minutes, for 3 different clinical situations presented as clinical vignettes (multiple-choice questions). The scientific committee has created and validated 30 clinical vignettes illustrating outpatient clinical situations for which the use of oral ATs (single, dual or triple therapy) is recommended or not according to the guidelines. All data will be treated anonymously.
Ethics and dissemination: If the prescription support-tool is associated with more appropriate prescription of AT combinations, its dissemination to further evaluate outcome data including haemorrhage, ischemic events, and death will be considered.
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
- None
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
- •French practicing physicians who are involved in outpatient settings, including general practitioners and cardiologists.
排除标准
- •Physicians with an exclusive hospital practice.
结局指标
主要结局
The primary outcome measure is the rate of the "right prescription of oral ATs" as defined according to the guidelines in terms of number, class, duration and dosage between the two groups.
时间窗: Day one
How will be defined the "right prescription of oral ATs" : From a systematic review of international guidelines (2012-2018), has been developed, a prescription support-tool synthesizing 70 national and international guidelines on chronic management (≥ 1 month) of oral AT agents without considering in-hospital management and bridging therapy. The scientific committee of this study (cardiologist, internist-geriatricians, general practitioner and epidemiologists) created and validated 30 clinical vignettes. The expert committee of this study had to review all clinical vignettes with the prescription support-tool (external validation) to confirm their agreement with clinical practice and their readability. Thus, the "right prescription of oral ATs" was defined a priori (right or false) thanks to the prescription support tool and validated by the expert committee and the scientific committee.
次要结局
- The difference between the control and intervention groups in the degree of confidence physicians have in their AT prescriptions in line with the guidelines.(Day one)
- The rate of the "right prescription of oral ATs" performed by physicians' specialty.(Day one)