Protocol for a pragmatic cluster randomised controlled trial for reducing irrational antibiotic prescribing among children with upper respiratory infections in rural China

Abstract Objectives This study sought to assess the effectiveness and return on investment (ROI) of a multifaceted intervention aimed at improving antibiotic prescribing for acute respiratory infections in primary care. Design Large-sized, two-arm, open-label, pragmatic, cluster-randomised controlled trial. Setting All primary care physicians working for the Spanish National Health Service (NHS) in Galicia (region in north-west Spain). Participants The seven spatial clusters were distributed by unequal randomisation (3:4) of the intervention and control groups. A total of 1217 physicians (1.30 million patients) were recruited from intervention clusters and 1393 physicians (1.46 million patients) from control clusters. Interventions One-hour educational outreach visits tailored to training needs identified in a previous study; an online course integrated in practice accreditation; and a clinical decision support system. Main outcome measures Changes in the ESAC (European Surveillance of Antimicrobial Consumption) quality indicators for outpatient antibiotic use. We used generalised linear mixed and conducted a ROI analysis to ascertain the overall cost savings. Results Median follow-up was 19 months. The adjusted effect on overall antibiotic prescribing attributable to the intervention was − 4.2% (95% CI: − 5.3% to − 3.2%), with this being more pronounced for penicillins − 6.5 (95% CI: − 7.9% to − 5.2%) and for the ratio of consumption of broad- to narrow-spectrum penicillins, cephalosporins, and macrolides − 9.0% (95% CI: − 14.0 to − 4.1%). The cost of the intervention was €87 per physician. Direct savings per physician attributable to the reduction in antibiotic prescriptions was €311 for the NHS and €573 for patient contributions, with an ROI of €2.57 and €5.59 respectively. Conclusions Interventions designed on the basis of gaps in physicians’ knowledge of and attitudes to misprescription can improve antibiotic prescribing and yield important direct cost savings. Trial registration: Current Controlled Trials ISRCTN24158380. Registered 5 February 2009.

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Cluster randomised controlled trial of an educational intervention to optimise antibiotic prescribing for acute cough

http://isrctn.org/> ◽

10.1186/isrctn09811591 ◽

2013 ◽

Author(s):

Samuel Coenen

Keyword(s):

Randomised Controlled Trial ◽

Educational Intervention ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Antibiotic Prescribing ◽

Acute Cough ◽

Cluster Randomised ◽

Randomised Controlled

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Cluster randomised controlled trial to assess a tailored intervention to reduce antibiotic prescribing in rural China: study protocol

BMJ Open ◽

10.1136/bmjopen-2020-048267 ◽

2022 ◽

Vol 12 (1) ◽

pp. e048267

Author(s):

Wenjuan Cong ◽

Jing Chai ◽

Linhai Zhao ◽

Christie Cabral ◽

Lucy Yardley ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Antibiotic Use ◽

Antibiotic Prescribing ◽

Cluster Randomised ◽

Health Centres ◽

Randomised Controlled ◽

Tract Infections

IntroductionUp to 80% of patients with respiratory tract infections (RTI) attending healthcare facilities in rural areas of China are prescribed antibiotics, many of which are unnecessary. Since 2009, China has implemented several policies to try to reduce inappropriate antibiotic use; however, antibiotic prescribing remains high in rural health facilities.Methods and analysisA cluster randomised controlled trial will be carried out to estimate the effectiveness and cost effectiveness of a complex intervention in reducing antibiotic prescribing at township health centres in Anhui Province, China. 40 Township health centres will be randomised at a 1:1 ratio to the intervention or usual care arms. In the intervention group, practitioners will receive an intervention comprising: (1) training to support appropriate antibiotic prescribing for RTI, (2) a computer-based treatment decision support system, (3) virtual peer support, (4) a leaflet for patients and (5) a letter of commitment to optimise antibiotic use to display in their clinic. The primary outcome is the percentage of antibiotics (intravenous and oral) prescribed for RTI patients. Secondary outcomes include patient symptom severity and duration, recovery status, satisfaction, antibiotic consumption. A full economic evaluation will be conducted within the trial period. Costs and savings for both clinics and patients will be considered and quality of life will be measured by EuroQoL (EQ-5D-5L). A qualitative process evaluation will explore practitioner and patient views and experiences of trial processes, intervention fidelity and acceptability, and barriers and facilitators to implementation.Ethics and disseminationEthical approval was obtained from the Biomedical Research Ethics Committee of Anhui Medical University (Ref: 20180259); the study has undergone due diligence checks and is registered at the University of Bristol (Ref: 2020-3137). Research findings will be disseminated to stakeholders through conferences and peer-reviewed journals in China, the UK and internationally.Trial registration numberISRCTN30652037.

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