Plain English Summary
Background and study aims
Antibiotics are over-prescribed for patients with respiratory-tract infections (RTIs, coughs & colds) in primary care, especially in the rural areas of China. This study is aimed to evaluate an intervention to improve antibiotic prescribing by doctors and reduce unnecessary antibiotic consumption for coughs and colds (respiratory infections).
Who can participate?
One village clinic each from 64 areas overseen by a township hospital will be selected. All the village healthcare professionals who see patients with RTI in the selected village clinics will be invited to participate in this study; and all the patients with URTIs who are present to seek consultation in their clinics will be also invited to participant in this study.
What does the study involve?
Village clinician: a researcher from Anhui Medical University will contact you, and may arrange a bespoke training about appropriate antibiotics prescribing in clinical practice, a computer-based decision support system and access to a wechat peer support group.
Patient: a researcher from Anhui Medical University will contact and also observe your consultation with the doctor. A researcher will also contact you by phone to ask you a few questions about your recovery at 3 days, 7 days, 14 days and 21 days after your initial consultation. Each phone call will take about 10 minutes.
What are the possible benefits and risks of participating?
Village clinician: the main burden for you is the time it will take to participate in the training, the WeChat group, completing the short interviews during your consultation with patients in your clinic. However, you will receive a training in the current National Guidelines and research for treat respiratory infections; and you will also receive a computer programme to help you follow the guidelines.
Patient: there is no risks from taking part in the study. You will receive treatment for your illness that follows the National Chinese guidelines for treating this type of illness. You will not benefit from taking part in this study, but you will help us improve treatment for future patients
Where is the study run from?
1. Anhui Medical University (China)
2. University of Bristol (UK)
When is the study starting and how long is it expected to run for?
February 2019 to December 2022.
Who is funding the study?
This project is jointly funded by National Natural Science Foundation of China and Medical Research Council of the UK. The RCT ethics has been reviewed by the Biomedical Research Ethics Committee of Anhui Medical University and registered within Research Governance Team at the University of Bristol (UK).
Who is the main contact?
Prof Linhai Zhao, zhao700110@126.com
Prof Debin Wang, dbwang@vip.sina.cn
Trial website
Contact information
Type
Scientific
Primary contact
Prof Debin Wang
ORCID ID
http://orcid.org/0000-0002-5106-6427
Contact details
81 Meishan Rd
School of Health Services Management
Anhui Medical University
Hefei
230032
China
+86 55165116395
dbwang@vip.sina.com
Type
Public
Additional contact
Prof Linhai Zhao
ORCID ID
Contact details
81 Meishan Rd
School of Health Services Management
Anhui Medical University
Hefei
230032
China
+86 15955134608
zhao700110@126.com
Type
Public
Additional contact
Dr Wenjuan Cong
ORCID ID
http://orcid.org/0000-0002-5034-8182
Contact details
Population Health Sciences
Bristol Medical School
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
+44 (0)1173314528
wenjuan.cong@bristol.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
STAR-CHINA RCT Trial protocol 27May20
Study information
Scientific title
Evaluation of effectiveness and cost-effectiveness of a Training, decision Aid and Peer Support (TAPS) intervention aimed at village healthcare professionals and patients to improve antibiotic prescribing for upper respiratory-tract infections (URTIs)
Acronym
TAPS
Study hypothesis
The training, decision aid and peer support (TAPS) intervention will reduce unnecessary antibiotic prescriptions for patients with respiratory-tract infections (RTI) in village clinics in rural China.
Ethics approval
Approved 24/09/2020, Biomedical Research Ethics Committee of Anhui Medical University (81 Meishan Rd, Hefei, 230032, China; +86 (0)55165161057; chengfan@ahmu.edu.cn), ref: 20180259
Study design
Interventional mixed-methods study
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Other
Patient information sheet
See additional files for patients (ISRCTN30652037_PIS_patients) and clinicians (ISRCTN30652037_PIS_clinicians) (added 02/12/2020)
Condition
Reduction of unnecessary antibiotic prescribing for adult patients with suspected respiratory tract infections
Intervention
This is a 12-month, cluster randomised controlled trial and a total of 64 village clinics from different townships (one village clinic per township) within 6-8 cities, Anhui Province, China will be recruited. A baseline audit of 2000 URTI patients across the village clinics will be conducted. Then all the village clinics will be simply randomised at a 1:1 ratio to usual care group vs intervention group. Each group will have 32 village clinics. After 9-12 months, a follow-up visit will be made for both study arms.
Health professionals working in village clinics will receive training on AMR and URTI symptoms treatment, latest national prescribing guideline, address key concerns and misapprehensions, communication skills with patients during the consultation. Training will be delivered by a senior clinician from a tertiary hospital in the region. Village doctors will be required to sign a public declaration letter stating that they are committed to reducing unnecessary antibiotic prescribing and display this in their clinics.
A computer-based decision aid tool will be installed in the village clinics of the intervention group to facilitate appropriate antibiotic prescribing in the clinical practice. A WeChat peer support group will be established to enable village healthcare professionals to support each other's learning and practice. Health professionals will be provided with a leaflet to give to patients to support no-antibiotic treatment decisions.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
The prescribing rate of antibiotic (oral and intravenous) for RTI patients during the consultations at baseline and follow-up audit (9-12 months after intervention) using patient records
Secondary outcome measures
1. Patient symptom severity and duration will be assessed through follow-up telephone interview at 3, 7, 14, 21 days after consultation
2. Patient satisfaction will be assessed during the initial consultation
3. Patient recovery situation will be assessed through follow-up telephone interview at 7, 14 days after consultation
4. Patient consumption of prescribed antibiotics will be recorded through follow-up telephone interview at 21 days after consultation
5. Patient attitude, knowledge of the patient leaflet and beliefs will be assessed through follow-up telephone interview at 3 days after consultation
6. Patient cost-effectiveness evaluation will be assessed through follow-up telephone interview at 21 days after consultation
7. Patient EQ5D-5L (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) will be assessed through follow-up telephone interview at 3, 7, 14, 21 days after consultation
Overall trial start date
01/02/2019
Overall trial end date
31/12/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Village Healthcare Professionals:
1. All the village healthcare professionals working in the village clinics with URTI patients
Patients:
2. All the patients with URTIs who are present to seek consultation in the recruited practices
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
All healthcare professionals working at 64 village clinics; Patients with URTIs (n=2,000)
Participant exclusion criteria
Village healthcare professionals:
1. Healthcare professionals who are not computer literate
2. Healthcare professionals who are not involved in the clinical diagnosis and medicine prescribing
Patients:
1. Patient has sought repeat consultation for this illness will be excluded.
2. Patients who is unable to provide consent form (eg, dementia, psychosis, or severe depression)
3. Patient who is pregnant
4. Patient with immunological deficiencies
5. Patient with non-infective disorder (eg, pulmonary embolus, heart failure, oesophageal reflux, or allergy)
6. Patient use of antibiotics in the previous month
Recruitment start date
01/12/2020
Recruitment end date
31/12/2021
Locations
Countries of recruitment
China
Trial participating centre
School of Health Services Management Anhui Medical University
81 Meishan Rd, Hefei, China
Hefei
230032
China
Sponsor information
Organisation
Anhui Medical University
Sponsor details
81 Meishan Rd
School of Health Services Management
Hefei
230032
China
+86 (0) 551 65161057
chengfan@ahmu.edu.cn
Sponsor type
University/education
Website
http://www.ahmu.edu.cn/english/
Organisation
University of Bristol
Sponsor details
Research & Enterprise Development (RED)
One Cathedral Square
Bristol
BS1 5DD
United Kingdom
+44 (0)117 428 4011
research-governance@bristol.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Natural Science Foundation of China, Grant Ref: 81861138049
Alternative name(s)
Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, The National Natural Science Foundation of China, NSFC, NNSF, NNSFC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
China
Funder name
Medical Research Council, Grant Ref: MR/S013717/1
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal. The study protocol will be submitted to BMJ open soon.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
31/12/2023
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN30652037_PIS_patients.pdf Uploaded 02/12/2020
- ISRCTN30652037_PIS_clinicians.pdf Uploaded 02/12/2020