Developing a model to address antimicrobial stewardship in primary care facilities in Zhejiang Province, China
| ISRCTN | ISRCTN38590135 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38590135 |
| Secondary identifying numbers | ZGL201901-3 |
- Submission date
- 08/10/2020
- Registration date
- 13/10/2020
- Last edited
- 12/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
Centre for Global Health
Zhejiang University School of Medicine
866 Yuhangtang Road
Hangzhou
310058
China
| Phone | +86 (0)13754318244 |
|---|---|
| t.hesketh@ucl.ac.uk |
Public
Centre for Global Health
Zhejiang University School of Medicine
866 Yuhangtang Road
Hangzhou
310058
China
 ORCID ID |
0000-0002-4029-4192 |
|---|---|
| Phone | +86 (0)17764519560 |
| med_chenjie@zju.edu.cn |
Study information
| Study design | Multi-center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Regulating the rational use of antibiotics by grassroots doctors through mobile apps: a randomized controlled trial |
| Study acronym | ZJAMR |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2019 |
| Completion date | 01/10/2022 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | More than 20 primary health care centers and all doctors from the target hospitals (about 500) |
| Key inclusion criteria | Primary care doctors from primary care facilities who have an antibiotic prescription qualification |
| Key exclusion criteria | 1. Primary care doctors not from primary care facilities 2. Primary care doctors who do not have an antibiotic prescription qualification |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 01/04/2021 |
Locations
Countries of recruitment
- China
Study participating centres
Kailua County
Quzhou
324304
China
18 Jiefang East Road
Hangzhou
310016
China
Sponsor information
Other
One Renaissance Blvd
Oakbrook Terrace
Illinois
60181
United States of America
| Phone | +1 (0)630 792 5800 |
|---|---|
| aaliaga@jointcommission.org | |
| Website | http://www.jointcommission.org/ |
"ROR" |
https://ror.org/03skrcz21 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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)). |
Editorial Notes
12/10/2020: Trial's existence confirmed by the Medical Ethics Committee, School of Public Health, Zhejiang University.
