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 Cabral; Lucy Yardley; Guiqing Lily Yao; Tingting Zhang; Jing Cheng; Xing Rong Shen; Rong Liu; Paul Little; Beth Stuart; Xiaowen Hu; Ye Huan Sun; Isabel Oliver; Bo Zheng; Helen Lambert; De Bin Wang

doi:10.1136/bmjopen-2020-048267

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 Cabral, Lucy Yardley, Guiqing Lily Yao, Tingting Zhang, Jing Cheng, Xing Rong Shen, Rong Liu, Paul Little, Beth Stuart, Xiaowen Hu, Ye Huan Sun, Isabel Oliver, Bo Zheng, Helen Lambert, De Bin Wang^*

^*Corresponding author for this work

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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 language	English
Article number	e048267
Journal	BMJ Open
Volume	12
Issue number	1
DOIs	https://doi.org/10.1136/bmjopen-2020-048267
Publication status	Published - 3 Jan 2022

Bibliographical note

Funding Information: 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).

Open Access: This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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

Citation: Cong W, Chai J, Zhao L, et al. Cluster randomised controlled trial to assess a tailored intervention to reduce antibiotic prescribing in rural China: study protocol. BMJ Open 2022;12:e048267.

DOI: 10.1136/bmjopen-2020-048267

Keywords

General medicine (see internal medicine)
Primary care
Respiratory infections

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Cong2022ClusterRandomisedControlledTrialToAssessATailoredInterventionBMJOpenFinal published version, 700 KBLicence: CC BY

Cite this

Cong, W., Chai, J., Zhao, L., Cabral, C., Yardley, L., Yao, G. L., Zhang, T., Cheng, J., Shen, X. R., Liu, R., Little, P., Stuart, B., Hu, X., Sun, Y. H., Oliver, I., Zheng, B., Lambert, H., & Wang, D. B. (2022). Cluster randomised controlled trial to assess a tailored intervention to reduce antibiotic prescribing in rural China: study protocol. BMJ Open, 12(1), Article e048267. https://doi.org/10.1136/bmjopen-2020-048267

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

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.",

keywords = "General medicine (see internal medicine), Primary care, Respiratory infections",

author = "Wenjuan Cong and Jing Chai and Linhai Zhao and Christie Cabral and Lucy Yardley and Yao, {Guiqing Lily} and Tingting Zhang and Jing Cheng and Shen, {Xing Rong} and Rong Liu and Paul Little and Beth Stuart and Xiaowen Hu and Sun, {Ye Huan} and Isabel Oliver and Bo Zheng and Helen Lambert and Wang, {De Bin}",

note = "Funding Information: 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). Open Access: This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. Citation: Cong W, Chai J, Zhao L, et al. Cluster randomised controlled trial to assess a tailored intervention to reduce antibiotic prescribing in rural China: study protocol. BMJ Open 2022;12:e048267. DOI: 10.1136/bmjopen-2020-048267 ",

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Cong, W, Chai, J, Zhao, L, Cabral, C, Yardley, L, Yao, GL, Zhang, T, Cheng, J, Shen, XR, Liu, R, Little, P, Stuart, B, Hu, X, Sun, YH, Oliver, I, Zheng, B, Lambert, H & Wang, DB 2022, 'Cluster randomised controlled trial to assess a tailored intervention to reduce antibiotic prescribing in rural China: study protocol', BMJ Open, vol. 12, no. 1, e048267. https://doi.org/10.1136/bmjopen-2020-048267

TY - JOUR

T1 - Cluster randomised controlled trial to assess a tailored intervention to reduce antibiotic prescribing in rural China

T2 - study protocol

AU - Cong, Wenjuan

AU - Chai, Jing

AU - Zhao, Linhai

AU - Cabral, Christie

AU - Yardley, Lucy

AU - Yao, Guiqing Lily

AU - Zhang, Tingting

AU - Cheng, Jing

AU - Shen, Xing Rong

AU - Liu, Rong

AU - Little, Paul

AU - Stuart, Beth

AU - Hu, Xiaowen

AU - Sun, Ye Huan

AU - Oliver, Isabel

AU - Zheng, Bo

AU - Lambert, Helen

AU - Wang, De Bin

N1 - Funding Information: 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). Open Access: This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. Citation: Cong W, Chai J, Zhao L, et al. Cluster randomised controlled trial to assess a tailored intervention to reduce antibiotic prescribing in rural China: study protocol. BMJ Open 2022;12:e048267. DOI: 10.1136/bmjopen-2020-048267

PY - 2022/1/3

Y1 - 2022/1/3

N2 - 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.

AB - 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.

KW - General medicine (see internal medicine)

KW - Primary care

KW - Respiratory infections

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DO - 10.1136/bmjopen-2020-048267

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ER -

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

Abstract

Bibliographical note

Keywords

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