Condition category
Not Applicable
Date applied
08/10/2020
Date assigned
13/10/2020
Last edited
12/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
China makes a major contribution to the global burden of antimicrobial resistance. The major underlying cause is misuse of antibiotics. In many areas of China there has been recent progress in reducing antibiotic misuse at secondary and tertiary levels in healthcare, but there has been very little progress in primary care or in the pharmacy sector. The overall goal of the project therefore is to develop replicable models to improve antimicrobial stewardship in primary care facilities and pharmacies in urban and rural settings in China.

Who can participate?
Doctors at primary care facilities in urban and rural Zhejiang Province (China)

What does the study involve?
The intervention will be multi-faceted using quality improvement and educational approaches. All primary care doctors will be trained in rational prescribing, antimicrobial stewardship and infection control measure, using an innovative mobile application combined with local on-site training. Through social media, a system of transparency will be introduced to share prescribing behaviours within and between primary care facilities. This will be combined with a knowledge sharing and mutual support system. Patients will be educated at the time of consultation and through an entertaining mobile application. The primary outcome measures will be percentage reduction in antibiotic prescribing by doctors, and in sales by pharmacists, compared both with baseline measures and with control facilities in the same areas.

What are the possible benefits and risks of participating?
Primary doctors can learn and consolidate their knowledge of antibiotics and their ability to diagnose and treat infectious diseases. For primary hospitals, it can solve the problem of the implementation of training on the right to prescribe antibacterial drugs. For society, the researchers propose a scientific management practice and overall solution for antimicrobial drugs.

Where is the study run from?
Primary health care hospitals in Hangzhou city and Kaihua County, Zhejiang Province (China)

When is the study starting and how long is it expected to run for?
January 2019 to October 2022

Who is funding the study?
Pfizer Pharmaceutical Co. Ltd

Who is the main contact?
Jie Chen
med_chenjie@zju.edu.cn

Trial website

Contact information

Type

Scientific

Primary contact

Prof Therese Hesketh

ORCID ID

Contact details

Centre for Global Health
Zhejiang University School of Medicine
866 Yuhangtang Road
Hangzhou
310058
China
+86 (0)13754318244
t.hesketh@ucl.ac.uk

Type

Public

Additional contact

Dr Jie Chen

ORCID ID

http://orcid.org/0000-0002-4029-4192

Contact details

Centre for Global Health
Zhejiang University School of Medicine
866 Yuhangtang Road
Hangzhou
310058
China
+86 (0)17764519560
med_chenjie@zju.edu.cn

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ZGL201901-3

Study information

Scientific title

Regulating the rational use of antibiotics by grassroots doctors through mobile apps: a randomized controlled trial

Acronym

ZJAMR

Study hypothesis

Mobile application training can enhance the infection diagnosis and treatment skills of grass-roots doctors, help them understand antibiotic stewardship, and reduce the antibiotic prescription rate in primary care facilities.

Ethics approval

Approved 29/01/2019, Medical Ethics Committee, School of Public Health, Zhejiang University (866 Yuhangtang Road, Hangzhou 310058, China; +86 (0)571 88981368; zjusph@zju.edu.cn), ref: ZGL201901-3

Study design

Multi-center randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Antimicrobial stewardship in primary care facilities

Intervention

A computer program is used to randomly select more than 20 hospitals in Quzhou City Kailua county and Hangzhou city, Zhejiang province and allocate them to the intervention group and control group in a 1:1 ratio.

Interventions will be multifaceted, using quality improvement and educational approaches. In this study, questionnaire surveys, individual interviews and behavioral interventions are combined to collect data from the perspective of health service providers through an electronic medical record system plug-in, to study the types, degree and influencing factors of antibiotic use in primary medical institutions, and to summarize the actual obstacles and shortcomings in the management of primary antibiotics. All primary care physicians will be trained in rational prescribing, antimicrobial management and infection control measures, using an innovative mobile application, combined with local on-site training. Through social media, a transparent system will be introduced to share prescribing behaviour within and between primary health-care institutions. At the same time, the mobile application ("Antimicrobial drug treatment right Training System") is used to evaluate and strengthen the knowledge level of antibacterial drugs and the ability of infection diagnosis and treatment of grassroots doctors, so as to reduce the unreasonable use of antibiotics to the greatest extent. Pharmacists will be trained in the same way and their sales records will be spot-checked. Patients will be educated through a fun mobile app at the time of consultation. In order to promote rational drug use, improve health level, explore the establishment of primary medical institutions antibiotic use monitoring and evaluation system to provide ideas and scientific evidence.

The researchers do not conduct any intervention for the control group, and will invite the control group for relevant training free of charge after the completion of the project.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Antibiotic prescription rate measured from electronic medical records using the proportion of prescriptions for upper respiratory infections and gastrointestinal infection containing at least one antibiotic (prescribers and physicians) at baseline and 12 months

Secondary outcome measures

1. Attitudes and behaviours of doctors and the general public in relation to antibiotic use, AMS and infection control at all levels, measured using a repeat questionnaire survey at baseline and 12 months
2. Multi-antibiotic prescription rate measured from electronic medical records using the proportion of antibiotic prescriptions containing two or more antibiotics at baseline and 12 months
3. Broad-spectrum antibiotic prescription rate measured from electronic medical records using the proportion of antibiotic prescriptions containing at least one broad-spectrum antibiotic at baseline and 12 months
4. Intravenous antibiotic prescription rate is measured from electronic medical records using the proportion of antibiotic prescriptions containing at least one intravenous antibiotic at baseline and 12 months

Overall trial start date

01/01/2019

Overall trial end date

01/10/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Primary care doctors from primary care facilities who have an antibiotic prescription qualification

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

More than 20 primary health care centers and all doctors from the target hospitals (about 500)

Participant exclusion criteria

1. Primary care doctors not from primary care facilities
2. Primary care doctors who do not have an antibiotic prescription qualification

Recruitment start date

01/10/2020

Recruitment end date

01/04/2021

Locations

Countries of recruitment

China

Trial participating centre

Health Committee of Kaihua County
5 Fenghuang South Road Kailua County
Quzhou
324304
China

Trial participating centre

Hangzhou Municipal Health Commission
Block D, Civic Center 18 Jiefang East Road
Hangzhou
310016
China

Sponsor information

Organisation

Joint Commission

Sponsor details

One Renaissance Blvd
Oakbrook Terrace
Illinois
60181
United States of America
+1 (0)630 792 5800
aaliaga@jointcommission.org

Sponsor type

Other

Website

http://www.jointcommission.org/

Funders

Funder type

Industry

Funder name

Pfizer

Alternative name(s)

Pfizer Inc., Pfizer Consumer Healthcare

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

United States of America

Results and Publications

Publication and dissemination plan

The researchers plan to publish one to three papers in SCI journals or international academic conferences. At the same time, the results will be reported to the relevant government agencies to provide theoretical guidance for solving the problem of antibiotic abuse, which is of great practical significance. Additional related documents (e.g., study protocol, statistical analysis plan, etc) will not be available.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Jie Chen (med_chenjie@zju.edu.cn). Data will be available after the paper is published for one year (Attribution (BY) - Noncommercial (NC)).

Intention to publish date

01/04/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/10/2020: Trial's existence confirmed by the Medical Ethics Committee, School of Public Health, Zhejiang University.