title: Electronically delivered, multicomponent intervention to reduce unnecessary antibiotic prescribing for respiratory infections in primary care: a cluster randomised trial using electronic health records-REDUCE Trial study original protocol.
abstract: 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.
authors: Department of Primary Care and Public Health Sciences, King's College London, London, UK.
authors: Dorota
authors: D
authors: Juszczyk
authors: Department of Primary Care and Public Health Sciences, King's College London, London, UK.
authors: Judith
authors: J
authors: Charlton
authors: Department of Primary Care and Public Health Sciences, King's College London, London, UK.
authors: Lisa
authors: L
authors: McDermott
authors: Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK.
authors: Jamie
authors: J
authors: Soames
authors: Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK.
authors: Kirin
authors: K
authors: Sultana
authors: Department of Primary Care and Public Health Sciences, King's College London, London, UK.
authors: Mark
authors: M
authors: Ashworth
authors: Bicester Health Centre, Bicester, UK.
authors: Robin
authors: R
authors: Fox
authors: Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors: Alastair D
authors: AD
authors: Hay
authors: Primary Care Research Group, University of Southampton, Southampton, UK.
authors: Paul
authors: P
authors: Little
authors: Primary Care Research Group, University of Southampton, Southampton, UK.
authors: Michael V
authors: MV
authors: Moore
authors: Department of Psychology, University of Southampton, Southampton, UK.
authors: Lucy
authors: L
authors: Yardley
authors: Department of Primary Care and Public Health Sciences, King's College London, London, UK.
authors: A Toby
authors: AT
authors: Prevost
authors: Department of Primary Care and Public Health Sciences, King's College London, London, UK.
authors: Martin C
authors: MC
authors: Gulliford
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D016000:Cluster Analysis; D057286:Electronic Health Records / Q000706:statistics & numerical data*; D058006:General Practice; D006801:Humans; D057970:Inappropriate Prescribing / Q000517:prevention & control / Q000706:statistics & numerical data*; D010818:Practice Patterns, Physicians'; D011320:Primary Health Care / Q000379:methods; D012017:Referral and Consultation; D012107:Research Design; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D006113:United Kingdom
chemical_list: D000900:Anti-Bacterial Agents
keywords: Anti-Bacterial Agents; Drug Resistance; Electronic Health Records; Primary Health Care; Random Allocation; Respiratory Tract Infections