A pragmatic controlled trial to improve the appropriate prescription of drugs in adult outpatients: design and rationale of the EDU.RE.DRUG study
A pragmatic controlled trial to improve the appropriate prescription of drugs in adult outpatients: design and rationale of the EDU.RE.DRUG study
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DOI：
10.1017/s1463423620000249
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发表时间：
2020-07-09
影响因子：
1.6
通讯作者：
Tragni E
中科院分区：
文献类型：
--
作者：
Casula M;Menditto E;Galimberti F;Russo V;Olmastroni E;Scotti L;Orlando V;Corrao G;Catapano AL;Tragni E
药物干预是患者护理的重要组成部分。然而，药物经常被不适当地使用。各国有必要实施改善药物合理使用的战略，包括向保健专业人员和公众提供独立的信息，这些信息必须得到训练有素的工作人员的支持。EDU.RE.DRUG的主要目的（旨在改善为全科医生及其患者设计的药物的适当使用的信息和/或教育干预措施的有效性）研究是对适当处方指标（API）的比率进行回顾性评价，并评估针对全科医生（GP）及其患者的信息和/或教育干预措施的有效性，旨在提高处方质量和促进正确使用药物。这是一项针对意大利两个地区（坎帕尼亚和伦巴第）的全科医生及其患者的前瞻性、多中心、开放标签、平行组、对照、实用性试验。研究数据从行政数据库（人口统计学、药物再填充和住院数据库）中检索，其中包含相关地方卫生单位（LHU）的国家卫生服务所有受益人的医疗保健信息。根据LHU，全科医生/患者将被分配到以下四个干预组之一：（1）对全科医生和患者进行干预;（2）对全科医生进行干预;（3）对患者进行干预;以及（4）不进行干预（对照）。为全科医生设计的干预措施包括根据基线和两个在线持续医学教育（CME）课程确定的API报告其患者的状态。为患者设计的干预措施包括在全科医生门诊和社区药房分发传单和海报，重点是正确使用药物。已经定义了一组适应意大利环境的指标（如潜在的药物相互作用、不必要的重复处方和老年人的不适当处方），以确定基线和干预阶段后的不适当处方。主要结局是复合API。本研究于2017年6月7日获得米兰大学伦理委员会批准（代码15/17）。研究者将通过适当的演示文稿和出版物向利益相关者、合作者和参与者传达试验结果。注册详情：NCT 04030468。EudraCT编号2017-002622-21
Pharmacological intervention is an important component of patient care. However, drugs are often inappropriately used. It is necessary for countries to implement strategies to improve the rational use of drugs, including independent information for healthcare professionals and the public, which must be supported by well-trained staff. The primary objectives of the EDU.RE.DRUG (Effectiveness of informative and/or educational interventions aimed at improving the appropriate use of drugs designed for general practitioners and their patients) study are the retrospective evaluation of rates of appropriate prescribing indicators (APIs) and the assessment of the effectiveness of informative and/or educational interventions addressed to general practitioners (GPs) and their patients, aimed at improving prescribing quality and promoting proper drug use. This is a prospective, multicentre, open-label, parallel-arm, controlled, pragmatic trial directed to GPs and their patients in two Italian regions (Campania and Lombardy). The study data are retrieved from administrative databases (Demographic, Pharmacy-refill, and Hospitalization databases) containing healthcare information of all beneficiaries of the National Health Service in the Local Health Units (LHUs) involved. According to LHU, the GPs/patients will be assigned to one of the following four intervention arms: (1) intervention on GPs and patients; (2) intervention on GPs; (3) intervention on patients; and (4) no intervention (control). The intervention designed for GPs consists of reports regarding the status of their patients according to the APIs determined at baseline and in two on-line Continuous Medical Education (CME) courses. The intervention designed for patients consists in flyers and posters distributed in GPs ambulatories and community pharmacies, focusing on correct drug use. A set of indicators (such as potential drug–drug interactions, unnecessary duplicate prescriptions, and inappropriate prescriptions in the elderly), adapted to the Italian setting, has been defined to determine inappropriate prescription at baseline and after the intervention phase. The primary outcome was a composite API. The study was approved by the Ethics Committee of the University of Milan on 7th June 2017 (code 15/17). The investigators will communicate trial results to stakeholders, collaborators, and participants via appropriate presentations and publications. Registration details: NCT04030468. EudraCT number 2017-002622-21