Condition category
Respiratory
Date applied
24/11/2020
Date assigned
01/12/2020
Last edited
08/01/2021
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://bristol.ac.uk/

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

Editorial Notes

08/01/2021: Internal review. 02/12/2020: The participant information sheets have been uploaded as additional files. 01/12/2020: Trial’s existence confirmed by Biomedical Research Ethics Committee of Anhui Medical University.