Effectiveness of Informative and/or Educational Interventions Aimed at Improving the Appropriate Use of Drugs Designed for General Practitioners and Their Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 4,840
- 试验地点
- 1
- 主要终点
- Inappropriate drug prescription and use indicators
研究概览
简要总结
Pharmacological intervention is an essential step in health promotion. However, lots of drugs are often used in inappropriate ways, especially in elderly patients. This study is aiming at evaluating the effectiveness of educational and/or informative interventions addressed to general practitioners and their adult patients in Italy, in order to improve appropriateness of prescribing in primary care.
详细描述
EDU.RE.DRUG project is a prospective, multicentre, open-label, parallel-arm, controlled, pragmatic trial directed to general practitioners (GPs) and their patients from two Italian regions (Campania and Lombardy), with the objective of investigating the practice of prescribing among GPs to highlight the most frequent events of inappropriateness and to implement ad hoc interventions for GPs and patients.
Appropriateness of prescribing in general practice will be assessed by evaluating selected prescribing, consumption and adherence indicators, using Regional administrative pharmaceutical prescription databases.
Primary care physicians and their patients will be assigned to four trial arms: informative intervention (leaflets and posters for patients), educational intervention (feedback reports and online CME courses for GPs), combined interventions, or no intervention. Intervention effectiveness will be assessed measuring the variation in rates of inappropriate prescription indicators after 1-year of follow-up.
EDU.RE.DRUG project will provide with improvements in the prescribing performance of GPs and in patients' adherence to treatment, with relevant clinical implications in terms of rational and safe use of drugs and optimized patient care, and with economic benefits (optimization of available resources use and savings in direct and indirect health costs).
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •general practitioners of the Italian National Health System (NHS) operating at December 31, 2016 belonging to the 8 Local Health Units involved in the project
排除标准
- •primary care pediatricians
研究组 & 干预措施
Control
No intervention
General practitioners and patients
Combined strategy
干预措施: Educational intervention addressed to general practitioners (Other)
General practitioners and patients
Combined strategy
干预措施: Informative intervention addressed to patients (Other)
General practitioners
Educational intervention
干预措施: Educational intervention addressed to general practitioners (Other)
Patients
Informative intervention
干预措施: Informative intervention addressed to patients (Other)
结局指标
主要结局
Inappropriate drug prescription and use indicators
时间窗: 30 months
Changes in prevalences of selected potentially inappropriate prescribing (including drug-drug interactions, duplicate therapies, inappropriate drugs in older people and drugs with high anticholinergic and sedative burden), consumption and adherence indicators between baseline and after the intervention
次要结局
- GP's satisfaction(30-36 months)
- Health Technology Assessment of intervention implemented(30-36 months)
- Predictive factors of inappropriate prescribing(30-36 months)
研究者
Elena Tragni
Researcher at Epidemiology and Preventive Pharmacology Centre
University of Milan