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Trial registered on ANZCTR


Registration number
ACTRN12614001209684
Ethics application status
Approved
Date submitted
2/08/2014
Date registered
17/11/2014
Date last updated
17/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changing the Antibiotic Prescribing of General Practice Registrars through better adherence to antibiotic guidelines
Scientific title
The effect of an educational intervention on general practice vocational trainees compared to the usual educational program on prescribing antibiotics in upper respiratory tract infections and acute bronchitis/bronchiolitis
Secondary ID [1] 285097 0
Nil
Universal Trial Number (UTN)
Trial acronym
The ChAP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antibiotic prescribing for upper respiratory tract infections (URTI)
292650 0
Antibiotic prescribing for acute bronchitis/bronchiolitis 292684 0
Condition category
Condition code
Respiratory 292959 292959 0 0
Other respiratory disorders / diseases
Public Health 293728 293728 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in the ChAP study consists of three components: 1) access to two online learning modules, 2) a face-to-face interactive workshop, and 3) engagement of the registrar's supervisor.
1. The first component is a predisposing activity consisting of access to two of the three INternet TRaining for AntibiOtic use (INTRO) electronic modules (developed within the European Union funded GRACE study) adapted for the Australian context. The first module contains information about the epidemiology of respiratory infections in primary care, antibiotic use in Australia and worldwide, information about antimicrobial resistance, and evidence supporting the recommendations from clinical guidelines, with a special focus on the electronic Therapeutics Guidelines: Australia (Antibiotics) 2013 version (eTG:A). This module will take 10-30 minutes to complete depending on the level of perusal of the materials provided in the module.
INTRO module 2 will not be used as it concerns CRP-testing which is currently not recommended in the Australian Therapeutic Guidelines.
INTRO module 3 focuses on communication skills training through videos showing how a GP can use communication skills to elicit patient concerns and expectations, discuss the pros and cons of antibiotic treatment and the natural course of respiratory infections. The communication training takes 25-30 minutes to complete and is supported by a patient booklet that can be used in the consultation.
The online modules will be made available to registrars to work through individually at a time prior to the face-to-face session. They will be given a time frame of 2 weeks in which to complete the modules. The face-to-face session will occur after completion of the electronic modules in order to maximise the potential for effectiveness.
2. The face-to-face component consists of a 1.5 hour workshop in group settings with approximately 100 registrars scheduled as part of the standard training program for GP registrars delivered at their Regional Training Provider (RTP, geographically-based providers of general practice vocational training in Australia). It is usual for not all eligible registrars to attend a given workshop, therefore this number is somewhat less than the number of registrars who will receive access to the online modules and be included in the Intention to Treat analysis, as outlined below. Prescribing data from the Registrars’ Clinical Encounters in Training (ReCEnT) study that reflects prescribing by the cohorts of registrars in the participating RTPs will be used in the educational session to personalise and reinforce the practical relevance and importance of the educational message. During these sessions, registrars will be asked to reflect on their group’s prescribing data and by means of clinical cases work through the main principles of rational prescribing of antibiotics for acute bronchitis/bronchiolitis and upper respiratory tract infections (URTIs) as outlined in eTG:A. Barriers to, and facilitators of, appropriate prescribing by registrars will be addressed. During the workshop there will be room for practising of the communication skills presented in the online modules.
3. Engagement of the supervisor is the focus of the third component of the intervention. For logistic reasons this engagement will be different in the two participating Regional Training Providers: in RTP 1 – supervisors will participate in face-to-face interactive workshops similar to those delivered to registrars; in RTP 2 – where these workshops are not practicable (because of the geographical distances between practices where registrars are located), each registrar will have a reinforcing one-on-one session with their clinical supervisor.
The reinforcing activity in the second RTP consists of 3 to 4 structured cases that will be made available to the registrars and their supervisors for discussion in their routinely scheduled weekly one-on-one in-practice sessions over the following 4-6 weeks. These sessions usually take approximately 1 hour weekly. Supervisors will be given access to the online modules prior to these sessions in RTP2 and prior to the supervisor workshop in RTP1.
The intervention will be delivered at different times in the participating RTPs, starting in November 2014 and expected to be completed by March 2015. The intervention period in RTP2 will be 6-8 weeks (from start of predisposing activity to completion of the reinforcing activity) and 2 weeks (from access to predisposing activity to face-to-face workshop) in RTP1.
Participation in the online predisposing activity modules (INTRO 1 and 3) will be monitored by surveying registrars and supervisors. Presence at the face to face workshop is monitored by participants signing the attendance sheet. Reinforcing activity participation by RTP2 registrars and their supervisors will be surveyed after the intervention period.

Intervention code [1] 289944 0
Behaviour
Intervention code [2] 289945 0
Treatment: Drugs
Comparator / control treatment
The ‘control group’ will receive “standard education” during the study period. Standard education comprises topics as scheduled by the RTP that are not related to antibiotic prescribing in URTI or acute bronchitis/bronchiolitis. The standard sessions will not include any online INTRO training component nor will the additional cases be available as reinforcing activity.
Control group
Active

Outcomes
Primary outcome [1] 292816 0
The proportion of consultations for URTI (International Classification of Primary Care version 2 PLUS chapter R74) in which antibiotics are prescribed. Antibiotic prescription derived from ReCEnT study recording of registrars’ prescribing.
Timepoint [1] 292816 0
Pre-intervention and at 4 months post-intervention
Secondary outcome [1] 309737 0
Proportion of consultations for URTI and bronchitis/bronchiolitis (International Classification of Primary Care version 2 PLUS chapters R74 and R78) in which antibiotics are prescribed. Antibiotic prescription derived from ReCEnT study recording of registrars’ prescribing.
Timepoint [1] 309737 0
Pre-intervention and at 4 months post-intervention
Secondary outcome [2] 309738 0
Proportion of consultations for sore throat (International Classification of Primary Care version 2 PLUS chapter R76) in which antibiotics are prescribed. Antibiotic prescription derived from ReCEnT study recording of registrars’ prescribing.
Timepoint [2] 309738 0
Pre-intervention and at 4 months post-intervention
Secondary outcome [3] 309739 0
Proportion of consultations for acute sinusitis (International Classification of Primary Care version 2 PLUS chapter R75) in which antibiotics are prescribed. Antibiotic prescription derived from ReCEnT study recording of registrars’ prescribing.
Timepoint [3] 309739 0
Pre-intervention and at 4 months post-intervention
Secondary outcome [4] 309740 0
Proportion of consultations for acute otitis media (International Classification of Primary Care version 2 PLUS chapter H71) in which antibiotics are prescribed. Antibiotic prescription derived from ReCEnT study recording of registrars’ prescribing.
Timepoint [4] 309740 0
Pre-intervention and at 4 months post-intervention

Eligibility
Key inclusion criteria
Intervention group: Registrars in Terms 1 and 2 of their vocational training program at two RTPs (General Practice Training Valley to Coast – GPTVTC – and Adelaide to Outback General Practice Training – AOGP) who provide consent for the data they collect as part of the ReCEnT project to be used for research purposes.
Control group: Registrars in Terms 1 and 2 of their vocational training program at three RTPs (General Practice Tasmania – GPTT – and Victorian Metropolitan Alliance – VMA – and Tropical Medicine Training –TMT) who provide consent for the data they collect as part of the ReCEnT project to be used for research purposes.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Intervention group: Registrars in Terms 1 and 2 of their vocational training program at two RTPs (General Practice Training Valley to Coast – GPTVTC – and Adelaide to Outback General Practice Training – AOGP) who do not provide consent for the data they collect as part of the ReCEnT project to be used for research purposes.
Control group: Registrars in Terms 1 and 2 of their vocational training program at three RTPs (General Practice Tasmania – GPTT – and Victorian Metropolitan Alliance – VMA – and Tropical Medicine Training –TMT) who do not provide consent for the data they collect as part of the ReCEnT project to be used for research purposes.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The principle analysis will be logistic regression within a Generalised Estimating Equation framework to adjust for clustering of observations within registrars. The unit of analysis will be consultations involving an RTI and the dependent variable will be antibiotics prescribed (dichotomous). Independent variables in the model will be treatment group (intervention/control), time (before/after) and an interaction term of treatment group by time. The p-value of the interaction term will be used to determine statistical significance.
For the primary outcome analyses, the dependent variables in regression models will be consultations in which antibiotics are prescribed for: R74 and R78 (separately). For secondary outcome analyses, the dependent variables in regression models will be: both categories combined (R74+R78), R75, R76 and H71.
The independent variable of interest will be intervention RTP/control RTP.
Primary analyses will be by Intention to Treat (data of all GPTVTC and AOGP registrars will be analysed irrespective of whether they attended the intervention workshop). We will also analyse the per protocol data (as this reflects a pragmatic approach) and compare these with the ITT analysis. We will also explore effects on specific groups of registrars by means of subgroup analysis (overseas trained versus Australian trained, male versus female).

Sample size
It is expected that the intervention group will consist of approximately 130 registrars sourced from two intervention RTPs and the control group of approximately 160 registrars from the control RTPs. Each of these registrars will provide data on an average of 4 URTI consultations before the intervention and 4 URTI consultations after the intervention. This will provide the study with approximately 80% power to find an absolute reduction of 10% in antibiotic prescribing for URTIs in the intervention group compared with the control group. This sample size calculation takes into account an inflation factor of 1.9 derived from an intracluster correlation of 0.27 from a similar study by investigator van Driel and an anticipated proportion of consultations for URTI of 7.3% and
expected pre-intervention rate of antibiotic prescribing of 26% as shown in the ReCEnT study.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC

Funding & Sponsors
Funding source category [1] 289704 0
Charities/Societies/Foundations
Name [1] 289704 0
The Royal Australian College of General Practitioners
Address [1] 289704 0
RACGP House, 100 Wellington Parade, East Melbourne, Victoria 3002
Country [1] 289704 0
Australia
Primary sponsor type
Individual
Name
Professor Mieke van Driel
Address
School of Medicine, The University of Queensland, Level 8, Health Sciences Building 16/910 Royal Brisbane & Women’s Hospital Campus, Butterfield St, Brisbane QLD 4006
Country
Australia
Secondary sponsor category [1] 288396 0
Individual
Name [1] 288396 0
Dr Anthea Dallas
Address [1] 288396 0
School of Medicine, The University of Queensland, Level 8, Health Sciences Building 16/910 Royal Brisbane & Women’s Hospital Campus, Butterfield St, Brisbane QLD 4006
Country [1] 288396 0
Australia
Secondary sponsor category [2] 288397 0
Individual
Name [2] 288397 0
Dr Simon Morgan
Address [2] 288397 0
General Practice Training Valley To Coast, Newbolds Building, Corner of Gavey and Frith Streets, Mayfield, NSW 2304
Country [2] 288397 0
Australia
Secondary sponsor category [3] 288398 0
Individual
Name [3] 288398 0
Dr Lawrie McArthur
Address [3] 288398 0
Adelaide to Outback GP Training, Lower Level, 183 Melbourne Street, North Adelaide, SA 5006
Country [3] 288398 0
Australia
Secondary sponsor category [4] 288399 0
Individual
Name [4] 288399 0
Associate Professor Patrick McElduff
Address [4] 288399 0
School of Medicine and Public Health, University of Newcastle, HMRI Building, Lookout Road, New Lambton, NSW 2305
Country [4] 288399 0
Australia
Secondary sponsor category [5] 288400 0
Individual
Name [5] 288400 0
Conjoint Professor Parker Magin
Address [5] 288400 0
General Practice Training Valley To Coast, Newbolds Building, Corner of Gavey and Frith Streets, Mayfield, NSW 2304
Country [5] 288400 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291443 0
Human Research Ethics Committee (HREC), University of Newcastle
Ethics committee address [1] 291443 0
Research Integrity Unit, Research Services, The University of Newcastle, Callaghan, NSW 2308
Ethics committee country [1] 291443 0
Australia
Date submitted for ethics approval [1] 291443 0
Approval date [1] 291443 0
12/05/2014
Ethics approval number [1] 291443 0
H-2009-0323
Ethics committee name [2] 291444 0
Medical Research Ethics Committee, University of Queensland
Ethics committee address [2] 291444 0
The University of Queensland, Cumbrae-Stewart Building, Research Road, Brisbane Qld 4072
Ethics committee country [2] 291444 0
Australia
Date submitted for ethics approval [2] 291444 0
Approval date [2] 291444 0
05/06/2014
Ethics approval number [2] 291444 0
2014000743

Summary
Brief summary
The primary purpose of the ChAP Study is to assess the impact of an intervention based on online modules, a face to face workshop and one-on-one supervisor contact, on antibiotic prescribing by GP registrars, specifically for acute upper respiratory tract infections (URTIs) and acute bronchitis/bronchiolitis.
We hypothesise that an appropriately targeted educational intervention will improve adherence to evidence-based guidelines regarding antibiotic prescribing for respiratory infections by GP registrars participating in a vocational training program.
Trial website
Trial related presentations / publications
Public notes
The ChAP study is embedded within the ReCEnT study which commenced in February 2009. Ethics approval has been obtained for the ReCEnT study in 2009 (ref no: H-2009-0323). Additional ethics approval was sought for the ChAP study under the umbrella of the ReCEnT study. This additional request was approved on 5 June 2014.

Contacts
Principal investigator
Name 50402 0
Prof Mieke L van Driel
Address 50402 0
School of Medicine, The University of Queensland, Level 8, Health Science Building 16/910, Royal Brisbane & Women’s Hospital Campus, Butterfield St, Brisbane QLD 4006
Country 50402 0
Australia
Phone 50402 0
+61 7 3345 5144
Fax 50402 0
+61 7 3346 5178
Email 50402 0
m.vandriel@uq.edu.au
Contact person for public queries
Name 50403 0
Prof Mieke L van Driel
Address 50403 0
School of Medicine, The University of Queensland, Level 8, Health Science Building 16/910, Royal Brisbane & Women’s Hospital Campus, Butterfield St, Brisbane QLD 4006
Country 50403 0
Australia
Phone 50403 0
+61 7 3345 5144
Fax 50403 0
+61 7 3346 5178
Email 50403 0
m.vandriel@uq.edu.au
Contact person for scientific queries
Name 50404 0
Prof Mieke L van Driel
Address 50404 0
School of Medicine, The University of Queensland, Level 8, Health Science Building 16/910, Royal Brisbane & Women’s Hospital Campus, 100 Butterfield St, Brisbane QLD 4006
Country 50404 0
Australia
Phone 50404 0
+61 7 3345 5144
Fax 50404 0
+61 7 3346 5178
Email 50404 0
m.vandriel@uq.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary