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

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

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.

general medicine (see internal medicine), primary care, respiratory infections
2044-6055
Cong, Wenjuan
d22a5677-789e-4571-8b1d-dd455d28eea3
Chai, Jing
fe49eaf3-1e1c-412e-a3dc-082f37964865
Zhao, Linhai
eb249985-6e12-42a9-8526-d7d9735a56c8
Cabral, Christie
e45df99c-4e9a-4d55-b9f0-923ee4b2a506
Yardley, Lucy
64be42c4-511d-484d-abaa-f8813452a22e
Yao, Guiqing Lily
93c8b843-35ee-4a63-8486-98efa85cb7f5
Zhang, Tingting
dc40ceb4-ffc0-4457-a688-98177d239ba4
Cheng, Jing
285726c4-1556-4fdf-8cb8-110b7fb08d81
Shen, XingRong
537d225f-5c97-49f2-8233-d88eadce498d
Liu, Rong
c30d45dd-68bc-4410-9e9a-7dc5598eb89e
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Hu, Xiaowen
584c0963-dc80-4121-a494-195a5679c0e7
Sun, Ye-Huan
1019bc70-4ac6-4d00-96e3-41081f087047
Oliver, Isabel
8cd29c59-d46a-4b7f-97ee-ad66a48cf0ff
Zheng, Bo
e8628bf8-4f5a-442e-b6cd-5334c6307003
Lambert, Helen
efd371f7-fb37-43b7-98e8-e9d012c6920d
Wang, DeBin
55d3645e-f668-4109-8c53-d42af21e1007
Cong, Wenjuan
d22a5677-789e-4571-8b1d-dd455d28eea3
Chai, Jing
fe49eaf3-1e1c-412e-a3dc-082f37964865
Zhao, Linhai
eb249985-6e12-42a9-8526-d7d9735a56c8
Cabral, Christie
e45df99c-4e9a-4d55-b9f0-923ee4b2a506
Yardley, Lucy
64be42c4-511d-484d-abaa-f8813452a22e
Yao, Guiqing Lily
93c8b843-35ee-4a63-8486-98efa85cb7f5
Zhang, Tingting
dc40ceb4-ffc0-4457-a688-98177d239ba4
Cheng, Jing
285726c4-1556-4fdf-8cb8-110b7fb08d81
Shen, XingRong
537d225f-5c97-49f2-8233-d88eadce498d
Liu, Rong
c30d45dd-68bc-4410-9e9a-7dc5598eb89e
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Hu, Xiaowen
584c0963-dc80-4121-a494-195a5679c0e7
Sun, Ye-Huan
1019bc70-4ac6-4d00-96e3-41081f087047
Oliver, Isabel
8cd29c59-d46a-4b7f-97ee-ad66a48cf0ff
Zheng, Bo
e8628bf8-4f5a-442e-b6cd-5334c6307003
Lambert, Helen
efd371f7-fb37-43b7-98e8-e9d012c6920d
Wang, DeBin
55d3645e-f668-4109-8c53-d42af21e1007

Cong, Wenjuan, Chai, Jing, Zhao, Linhai, Cabral, Christie, Yardley, Lucy, Yao, Guiqing Lily, Zhang, Tingting, Cheng, Jing, Shen, XingRong, Liu, Rong, Little, Paul, Stuart, Beth, Hu, Xiaowen, Sun, Ye-Huan, Oliver, Isabel, Zheng, Bo, Lambert, Helen and Wang, DeBin (2022) Cluster randomised controlled trial to assess a tailored intervention to reduce antibiotic prescribing in rural China: study protocol. BMJ Open, 12 (1), [e048267]. (doi:10.1136/bmjopen-2020-048267).

Record type: Article

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 dissemination.

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.

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Accepted/In Press date: 8 December 2021
e-pub ahead of print date: 3 January 2022
Keywords: general medicine (see internal medicine), primary care, respiratory infections

Identifiers

Local EPrints ID: 453327
URI: http://eprints.soton.ac.uk/id/eprint/453327
ISSN: 2044-6055
PURE UUID: c6b00cc3-321b-4e9d-887f-a522ab9a0cd2
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X
ORCID for Beth Stuart: ORCID iD orcid.org/0000-0001-5432-7437

Catalogue record

Date deposited: 13 Jan 2022 17:31
Last modified: 28 Apr 2022 01:56

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Contributors

Author: Wenjuan Cong
Author: Jing Chai
Author: Linhai Zhao
Author: Christie Cabral
Author: Lucy Yardley ORCID iD
Author: Guiqing Lily Yao
Author: Tingting Zhang
Author: Jing Cheng
Author: XingRong Shen
Author: Rong Liu
Author: Paul Little
Author: Beth Stuart ORCID iD
Author: Xiaowen Hu
Author: Ye-Huan Sun
Author: Isabel Oliver
Author: Bo Zheng
Author: Helen Lambert
Author: DeBin Wang

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