Juszczyk Dorota, Charlton Judith, McDermott Lisa, Soames Jamie, Sultana Kirin, Ashworth Mark, Fox Robin, Hay Alastair D, Little Paul, Moore Michael V, Yardley Lucy, Prevost A Toby, Gulliford Martin C
Department of Primary Care and Public Health Sciences, King's College London, London, UK.
Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK.
BMJ Open. 2016 Aug 4;6(8):e010892. doi: 10.1136/bmjopen-2015-010892.
Respiratory tract infections (RTIs) account for about 60% of antibiotics prescribed in primary care. This study aims to test the effectiveness, in a cluster randomised controlled trial, of electronically delivered, multicomponent interventions to reduce unnecessary antibiotic prescribing when patients consult for RTIs in primary care. The research will specifically evaluate the effectiveness of feeding back electronic health records (EHRs) data to general practices.
2-arm cluster randomised trial using the EHRs of the Clinical Practice Research Datalink (CPRD). General practices in England, Scotland, Wales and Northern Ireland are being recruited and the general population of all ages represents the target population. Control trial arm practices will continue with usual care. Practices in the intervention arm will receive complex multicomponent interventions, delivered remotely to information systems, including (1) feedback of each practice's antibiotic prescribing through monthly antibiotic prescribing reports estimated from CPRD data; (2) delivery of educational and decision support tools; (3) a webinar to explain and promote effective usage of the intervention. The intervention will continue for 12 months. Outcomes will be evaluated from CPRD EHRs. The primary outcome will be the number of antibiotic prescriptions for RTIs per 1000 patient years. Secondary outcomes will be: the RTI consultation rate; the proportion of consultations for RTI with an antibiotic prescribed; subgroups of age; different categories of RTI and quartiles of intervention usage. There will be more than 80% power to detect an absolute reduction in antibiotic prescription for RTI of 12 per 1000 registered patient years. Total healthcare usage will be estimated from CPRD data and compared between trial arms.
Trial protocol was approved by the National Research Ethics Service Committee (14/LO/1730). The pragmatic design of the trial will enable subsequent translation of effective interventions at scale in order to achieve population impact.
ISRCTN95232781; Pre-results.
呼吸道感染（RTIs）约占基层医疗中抗生素处方量的60%。本研究旨在通过一项整群随机对照试验，检验在基层医疗中，当患者因呼吸道感染就诊时，以电子方式提供的多成分干预措施减少不必要抗生素处方的有效性。该研究将特别评估向全科医疗反馈电子健康记录（EHRs）数据的有效性。
采用两臂整群随机试验，利用临床实践研究数据链（CPRD）的电子健康记录。正在招募英格兰、苏格兰、威尔士和北爱尔兰的全科医疗，所有年龄段的普通人群为目标人群。对照试验组的医疗实践将继续常规治疗。干预组的医疗实践将接受通过信息系统远程提供的复杂多成分干预措施，包括：（1）通过根据CPRD数据估算的每月抗生素处方报告，反馈各医疗实践的抗生素处方情况；（2）提供教育和决策支持工具；（3）举办网络研讨会，解释并推广干预措施的有效使用。干预措施将持续12个月。将从CPRD电子健康记录中评估结果。主要结局将是每1000患者年中呼吸道感染的抗生素处方数量。次要结局将包括：呼吸道感染咨询率；开具抗生素的呼吸道感染咨询比例；年龄亚组；不同类型的呼吸道感染以及干预措施使用的四分位数。检测每1000注册患者年中呼吸道感染抗生素处方绝对减少12例的功效将超过80%。将根据CPRD数据估算总医疗保健使用情况，并在试验组之间进行比较。
试验方案已获国家研究伦理服务委员会批准（14/LO/1730）。该试验的务实设计将使有效的干预措施能够随后大规模转化，以实现人群影响。
ISRCTN95232781；预结果。
