Condition category
Respiratory
Date applied
17/06/2015
Date assigned
23/06/2015
Last edited
06/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Over-prescribing antibiotics is a serious issue globally. It is also very common among children with acute upper respiratory tract infections. It has left many children suffering from bacterial resistance due to irrational use of antibiotics, especially in less developed rural areas. Antibiotics are widely abused in China, especially in rural areas. However, few studies have focused on this area in developing countries including China. The aim is to carry out a study in rural Guangxi, China to test an effective approach of reducing over-prescribing antibiotics for upper respiratory infections (URTIs) among children.

Who can participate?
Parents/caregivers and doctors who have been taking care of children between 2-14 years old

What does the study involve?
The 25 participating township hospitals in two counties of Guangxi province, China, are randomly allocated into one of two groups. The hospitals in the control group continue usual management according to the current national guidelines. The hospitals in the intervention group receive an educational intervention for both clinicians and parents. Clinicians receive antibiotic use guidelines, training on antibiotic use, and an antibiotics use appraisal in the monthly hospital staff meeting. Parents receive specific short messages and printed educational material describing rational antibiotic use during clinical consultations, and videos about rational antibiotic use play in the education area at the hospitals. A questionnaire survey is conducted to see the changes in clinicians' knowledge, attitude and practice before and after the intervention in each group. Interviews and group discussions take place to see if this study is feasible and acceptable with the intervention package. Effectiveness is assessed through the difference in the antibiotic prescription rate before and after the intervention and between the intervention and control groups.

What are the possible benefits and risks of participating?
This study may help to reduce irrational antibiotic use among clinician, increase knowledge on antibiotic use among rural caregivers/parents, improve the management of antibiotic use for policy makers, and change prescription behaviours of health providers. No risks are expected.

Where is the study run from?
China Global Health Research and Development, as the leading centre, is in collaboration with Guangxi Provincial Center for Disease Control, the University of Leeds, the Chinese University of Hong Kong and Shandong University.

When is the study starting and how long is it expected to run for?
June 2015 to March 2016

Who is funding the study?
China Programme, COMDIS Health Services Delivery Research Consortium

Who is the main contact?
Prof. Xiaolin Wei
xiaolin.wei@utoronto.ca

Trial website

Contact information

Type

Scientific

Primary contact

Prof Xiaolin Wei

ORCID ID

http://orcid.org/0000-0002-3076-2650

Contact details

Division of Clinical Public Health
Institute for Health Policy
Management and Evaluation
Dalla Lana School of Public Health
University of Toronto
155 College Street
Toronto
M5T 3M7
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Educational interventions on reducing antibiotic over-prescribing among children with upper respiratory infections (URIs): a clustered randomized controlled trial in rural Guangxi, China

Acronym

Study hypothesis

Current hypothesis as of 03/07/2017:
Educational interventions on both clinicians and parents are effective on reducing over-prescribing antibiotics for childhood upper respiratory infections (URIs).

Previous hypothesis:
Educational interventions on both clinicians and parents are effective on reducing over-prescribing antibiotics for childhood upper respiratory infections (URIs) and acute bronchitis.

Ethics approval

1. Ethics Committee of Guangxi Provincial Centre for Disease Control and Prevention, 13/09/2014, ref: GXIRB2014-0036
2. University of Leeds, School of Medicine, Research Ethics Committee, 11/02/2016, ref: MREC15-016

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

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

Condition

Upper respiratory infections (URIs) among children, which includes: acute URIs, common cold, acute tonsillitis and acute pharyngitis

Intervention

Current interventions as of 03/07/2017:
The township hospitals randomly allocated into the intervention group will receive the educational intervention for both clinicians and parents.

For clinicians:
1. Operational guidelines (based on Chinese antibiotic use guidelines, IMCI, and the NICE guideline, we will focus on but not limit to URIs)
2. Systematic training for clinicians in township hospitals on rational antibiotic use
3. Antibiotics use appraisal in the monthly hospital staff meeting

For parents:
1. Specific short messages to be given during clinical consultations by doctors.
2. Printed educational material describing rational antibiotic use for childhood URIs
3. Videos to play in the education area at township hospitals, describing rational antibiotic use for childhood URIs

The control group will continue usual management according to the current national guidelines. Treatment is provided according to existing knowledge and antibiotics are given at the individual clinician’s discretion, while no systematic health education is provided.

Previous interventions:
The township hospitals randomly allocated into the intervention group will receive the educational intervention for both clinicians and parents.

For clinicians:
1. Operational guidelines (based on Chinese antibiotic use guidelines, IMCI, and the NICE guideline, we will focus on but not limit to URIs)
2. Systematic training for clinicians in township hospitals on rational antibiotic use
3. Antibiotic prescription rate (APR) reminder - social media message reminders once a month by pharmacist
4. Antibiotics use appraisal in the monthly hospital staff meeting
5. Health education to patient caregivers: specific short messages to be given during clinical consultations

For parents:
1. Printed educational material describing rational antibiotic use for childhood URIs
2. Videos to play in the education area at township hospitals, describing rational antibiotic use for childhood URIs

The control group will continue usual management according to the current national guidelines. Treatment is provided according to existing knowledge and antibiotics are given at the individual clinician’s discretion, while no systematic health education is provided.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Current primary outcome measures as of 03/07/2017:
Antibiotics prescription rate (APR) of outpatient childhood URIs between 2-14 years old, measured at baseline (3 months prior to the intervention) and endline (last 3 months during intervention period)

Previous primary outcome measures:
Antibiotics prescription rate (APR) of outpatient childhood URIs between 2-14 years old, measured at baseline (3 months prior to the intervention), 3 months after the intervention and 6 months after the intervention

Secondary outcome measures

Current secondary outcome measures as of 03/07/2017:
Measured at baseline (3 months prior to the intervention) and endline (last 3 months during intervention period):
1. Two and more than two antibiotic combination prescription rate
2. Broad-spectrum antibiotic use rate of outpatient prescriptions
3. Injectable antibiotic prescription rate
4. Quinolones use rate
5. Average cost of a prescription

Previous secondary outcome measures:
Measured at baseline (3 months prior to the intervention), 3 months after the intervention and 6 months after the intervention:
1. Two and more than two antibiotic combination prescription rate
2. Broad-spectrum antibiotic use rate of outpatient prescriptions
3. Quinolones use rate
4. Average cost of a prescription
5. Antibiotics prescription rate of inpatient childhood URIs
6. Appropriateness of antibiotics use among inpatient childhood URIs

Overall trial start date

15/06/2015

Overall trial end date

30/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 03/07/2017:
All eligible township hospitals from the two selected counties of Guangxi who agree to participate in the study will be included. The two counties should have implemented the Essential Medicine List and Zero-markup policy in 2012.

Intervention:
1. Township hospitals: 25 township hospitals in two selected counties
2. Parents/caregivers: who have been taking care of children between 2 and 14 years old
3. Doctors: pedestrian or internal medicine clinician who is seeing children between 2 and 14 years old

Research:
1. Parents/caregivers: 2 parents/caregivers per township hospital in 6 township hospitals selected for process evaluation.
2. Doctors: 1 township hospital director and 3 clinicians per township hospital in 6 township hospitals selected for process evaluation.
3. Prescriptions: 200/township hospital (before and after intervention respectively)

Previous inclusion criteria:
All eligible township hospitals from the two selected counties of Guangxi who agree to participate in the study will be included. The two counties should have implemented the Essential Medicine List and Zero-markup policy in 2012.

Intervention:
1. Township hospitals: 25 township hospitals in two selected counties
2. Parents/caregivers: who have been taking care of children between 2 and 14 years old
3. Doctors: pedestrian or internal medicine clinician who is seeing children between 2 and 14 years old

Research:
1. Parents/caregivers: 6-8 parents/caregivers in each focus group discussion
2. Doctors: 1 township hospital director and 2 clinicians in each township
3. Prescriptions: outpatients: 40/township (before and after intervention), inpatients: 200/township (before and after intervention)

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

25 clusters, each cluster requires at least 200 prescriptions at baseline and endline period respectively

Participant exclusion criteria

1. Prescriptions for children diagnosed with diseases such as tuberculosis, HIV/AIDS or other immunodeficiency disease, any form of cancer, dyslipidaemia, chronic heart diseases, and pneumonia, who need long-term antibiotic treatment or prophylaxis
2. Children ≤2 years old and >14 years old will be excluded

Recruitment start date

25/06/2015

Recruitment end date

25/09/2015

Locations

Countries of recruitment

China

Trial participating centre

25 township hospitals
Rong county and Liujiang
-
China

Sponsor information

Organisation

China Programme, COMDIS Health Services Delivery Research Consortium

Sponsor details

Rm 403
1032 Dongmen Bei Rd
Shenzhen
518003
China

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

COMDIS Health Services Delivery Research Consortium

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publications in high-impact peer reviewed journals including:
1. Main outcomes of the trial
2. Trial process evaluation
3. Cost-effectiveness of the trial
Expected to be published by the end of 2017.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Xiaolin Wei (xiaolin.wei@utoronto.ca).

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27235297
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/29102353

Publication citations

Additional files

Editorial Notes

06/11/2017: Publication reference added. 04/07/2017: Publication and dissemination plan and IPD sharing statement added. 03/07/2017: The following changes were made to the trial record: 1. The recruitment start date was changed from 15/06/2015 to 25/06/2015. 2. The recruitment end date was changed from 01/08/2015 to 25/09/2015. 3. The title was changed from 'Educational interventions on reducing antibiotic over-prescribing among children with upper respiratory infections (URIs) and acute bronchitis' to 'Educational interventions on reducing antibiotic over-prescribing among children with upper respiratory infections (URIs)'. 4. The condition field was changed from 'Upper respiratory infections (URIs) and acute bronchitis among children, which includes: acute URIs, common cold, acute tonsillitis and acute pharyngitis' to 'Upper respiratory infections (URIs) among children, which includes: acute URIs, common cold, acute tonsillitis and acute pharyngitis' 31/05/2016: Publication reference added.