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

Wenjuan Cong, Jing Chai, Linhai Zhao, Christie L Cabral, Lucy Yardley, Guiqing Yao, Tingting Zhang, Jing Cheng, Xingrong Shen, Rong Liu, Paul Little, Beth Stuart, Xiaowen Hu, Yehuan Sun, Isabel Oliver, Bo Zheng, Helen S Lambert, Debin Wang*

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

8 Downloads (Pure)

Abstract

Introduction
Up 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 analysis
A 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 dissemination
Ethical 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 number ISRCTN30652037.
Original languageEnglish
Article numbere048267
Number of pages8
JournalBMJ Open
Volume12
Issue number1
DOIs
Publication statusPublished - 3 Jan 2022

Bibliographical note

Funding Information:
Funding The authors acknowledge MRC and Newton Fund through a UK-China AMR Partnership Hub award (MR/S013717/1), and National Natural Science Foundation of China award (81861138049).

Funding Information:
Ethical 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 (Case No: 2020-3137). This project is one of the three work packages in the UK-China AMR Centre Partnerships 2018 (Strategies to reduce the burden of antibiotic resistance in China) supported by UKRI (UK Research and Innovation) Medical Research Council (Grant Ref: MR/S013717/1)) and National Natural Science Foundation of China (Grant Ref: 81861138049). The protocol is rooted in a multidisciplinary collaboration between institutions in the UK and China.

Publisher Copyright:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Fingerprint

Dive into the research topics of 'Cluster randomised controlled trial to assess a tailored intervention to reduce antibiotic prescribing in rural China: study protocol'. Together they form a unique fingerprint.

Cite this