@article{d8d520772f2247fd944830f9a78500f0,
title = "Knowledge support for optimising antibiotic prescribing for common infections in general practices: evaluation of the effectiveness of periodic feedback, decision support during consultations and peer comparisons in a cluster randomised trial (BRIT2) – study protocol",
abstract = "Introduction This project applies a Learning Healthcare System (LHS) approach to antibiotic prescribing for common infections in primary care. The approach involves iterations of data analysis, feedback to clinicians and implementation of quality improvement activities by the clinicians. The main research question is, can a knowledge support system (KSS) intervention within an LHS implementation improve antibiotic prescribing without increasing the risk of complications? Methods and analysis A pragmatic cluster randomised controlled trial will be conducted, with randomisation of at least 112 general practices in North-West England. General practices participating in the trial will be randomised to the following interventions: periodic practice-level and individual prescriber feedback using dashboards; or the same dashboards plus a KSS. Data from large databases of healthcare records are used to characterise heterogeneity in antibiotic uses, and to calculate risk scores for clinical outcomes and for the effectiveness of different treatment strategies. The results provide the baseline content for the dashboards and KSS. The KSS comprises a display within the electronic health record used during the consultation; the prescriber (general practitioner or allied health professional) will answer standard questions about the patient's presentation and will then be presented with information (eg, patient's risk of complications from the infection) to guide decision making. The KSS can generate information sheets for patients, conveyed by the clinicians during consultations. The primary outcome is the practice-level rate of antibiotic prescribing (per 1000 patients) with secondary safety outcomes. The data from practices participating in the trial and the dashboard infrastructure will be held within regional shared care record systems of the National Health Service in the UK. Ethics and dissemination Approved by National Health Service Ethics Committee IRAS 290050. The research results will be published in peer-reviewed journals and also disseminated to participating clinical staff and policy and guideline developers. Trial registration number ISRCTN16230629.",
keywords = "Electronic Health Records, INFECTIOUS DISEASES, Primary Care, Randomized Controlled Trial, State Medicine, Feedback, Humans, General Practice, Referral and Consultation, Anti-Bacterial Agents/therapeutic use, Randomized Controlled Trials as Topic",
author = "Staa, {Tjeerd van} and Anita Sharma and Victoria Palin and Ali Fahmi and Harriet Cant and Xiaomin Zhong and Francine Jury and Natalie Gold and William Welfare and Darren Ashcroft and Tsang, {Jung Yin} and Elliott, {Rachel Ann} and Christopher Sutton and Chris Armitage and Philip Couch and Georgina Moulton and Edward Tempest and Buchan, {Iain Edward}",
note = "Funding Information: This work is supported by the National Institute for Health Research (HS&DR Project: NIHR130581), NIHR Manchester Biomedical Research Centre and NIHR Greater Manchester Patient Safety Research Collaboration. The views expressed in this publication are those of the authors and not necessarily those of NIHR or the Department of Health and Social Care. The ethics application (IRAS 290050) and trial registry (ISRCTN16230629) concern two funded projects including the NIHR funded cluster trial (as described in this study protocol) and an observational study funded by Health Data Research UK (HDR UK Better Care Programme for frail elderly) with data analysis and feedback for frail elderly. These two projects were combined in the same ethics research approval and study registration as they were to share the same data and dashboard infrastructure; interventions and study populations were to be different and both studies were separately described in the ethics application. Due to delays in getting data access, the frailty project did not progress to implementing the (dashboard) interventions. Sample size calculations were conducted separately for each project (including in the ethics application) although study registration reported overall target number of 300 for practice recruitment. Funding Information: This work is supported by the National Institute for Health Research (HS&DR Project: NIHR130581), NIHR Manchester Biomedical Research Centre and NIHR Greater Manchester Patient Safety Research Collaboration. The views expressed in this publication are those of the authors and not necessarily those of NIHR or the Department of Health and Social Care. The ethics application (IRAS 290050) and trial registry ( ISRCTN16230629 ) concern two funded projects including the NIHR funded cluster trial (as described in this study protocol) and an observational study funded by Health Data Research UK (HDR UK Better Care Programme for frail elderly) with data analysis and feedback for frail elderly. These two projects were combined in the same ethics research approval and study registration as they were to share the same data and dashboard infrastructure; interventions and study populations were to be different and both studies were separately described in the ethics application. Due to delays in getting data access, the frailty project did not progress to implementing the (dashboard) interventions. Sample size calculations were conducted separately for each project (including in the ethics application) although study registration reported overall target number of 300 for practice recruitment. Publisher Copyright: {\textcopyright} 2023 BMJ Publishing Group. All rights reserved.",
year = "2023",
month = aug,
day = "22",
doi = "10.1136/bmjopen-2023-076296",
language = "English",
volume = "13",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ ",
number = "8",
}