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Trial registered on ANZCTR


Registration number
ACTRN12621001400853
Ethics application status
Approved
Date submitted
24/06/2021
Date registered
18/10/2021
Date last updated
18/10/2021
Date data sharing statement initially provided
18/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changing the Antibiotic Prescribing of General Practice Registrars through better adherence to antibiotic guidelines - II
Scientific title
The effect of an online-delivered educational intervention on general practice vocational trainees compared to the usual educational program on prescribing antibiotics in respiratory tract infections
Secondary ID [1] 303881 0
Nil
Universal Trial Number (UTN)
Trial acronym
The ChAP-II Study
Linked study record
The ChAP-II study is nested within the ReCEnT study which commenced in 2010. Ethics approval has been obtained for the ReCEnT study in 2009 (ref no: H-2009-0323). ChAP-II follows on from the experiences of ChAP-I (ACTRN12614001209684). The ChAP-I study was approved as an ethics amendment under the umbrella of the ReCEnT study on 5 June 2014. The ChAP-II study was approved as an ethics amendment on 10/02/2021.

Health condition
Health condition(s) or problem(s) studied:
Antibiotic prescribing for respiratory tract infections (RTI) 321458 0
Condition category
Condition code
Respiratory 319220 319220 0 0
Other respiratory disorders / diseases
Public Health 319221 319221 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in the ChAP study consists of four components: 1) access to two online learning modules, 2) an online webinar, 3) frameworks for case-based education sessions for the GP registrar and their supervisor, and 4) provision of posters for the registrars'/supervisors' clinics.
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 in 2015 and updated in 2021. 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) 2019 version (eTG:A). This module will take 15-30 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 the provision of a patient booklet and leaflet 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 webinar. They will be given a time frame of 2 weeks in which to complete the modules. The webinar will occur after completion of the electronic modules in order to maximise the potential for effectiveness.
2. The webinar component consists of a 70-minute online session, accessible for all registrars in the intervention group. This is scheduled to be added as part of the standard training program for GP registrars delivered at GP Synergy, their Regional Training Organisation (RTO, geographically-based providers of general practice vocational training in Australia). The webinar will be facilitated by a GP who is also part of the study team (Prof Parker Magin). It is usual for not all eligible registrars to attend a given training opportunity, therefore the number attending the webinar is anticipated to be somewhat less than the number of registrars who will receive access to the online modules. All, however, will be included in an Intention-to-treat analysis (see below). Prescribing data from the Registrars’ Clinical Encounters in Training (ReCEnT) study that includes recording of prescribing by the cohorts of registrars in the participating RTOs 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 prescribing data and by means of clinical cases work through the main principles of rational prescribing of antibiotics for non-pneumonia acute respiratory tract infections (ARTIs) using the management of acute bronchitis/bronchiolitis as outlined in eTG:A, as an exemplar. Barriers to, and facilitators of, appropriate prescribing by registrars will be addressed.
3. Engagement of the supervisor is the focus of the third component of the intervention. Supervisors will be invited to participate in a 60-minute webinar similar to that delivered to registrars and prior to the registrar webinar. The webinar will be facilitated by a GP who is also part of the study team (Prof. Parker Magin). They will also have access to the online modules 2 weeks prior to their webinar. All supervisors will be provided with a structured framework for an educational session with their registrars. This framework will be based on 3 to 4 structured cases. The education session will be delivered (at the supervisor’s discretion) for discussion in their routinely scheduled weekly one-on-one in-practice teaching sessions over the following 6 weeks. These sessions usually take approximately 1 hour weekly. Supervisors will be given access to the online modules prior to their webinar.
4. All teaching practices in the intervention RTO (GP Synergy) will be emailed an electronic copy of a waiting room/treatment room poster adapted from that used in the GAPS study of antibiotic stewardship conducted in Queensland (see Avent et al. BMC Family Practice 2016). Information booklets for use with patients are available through the electronic Therapeutic Guidelines (eTG) (all registrars and teaching practices have access to eTG).

The intervention will be delivered in July 2021. The intervention period will be 6 weeks (from the start of the predisposing activity to completion of the reinforcing activity, including attendance at the webinar).
Registrar participation in the online predisposing activity modules (INTRO 1 and 3) will be monitored by surveying registrars and supervisors with a short questionnaire on completion of INTRO module 3. Presence at the webinar is monitored by the webinar host electronically.
Intervention code [1] 320187 0
Behaviour
Comparator / control treatment
The ‘control group’ (RTOs Eastern Victoria General Practice Training (EVGPT) and General Practice Training Tasmania (GPTT)) will receive “standard education” during the study period. Standard education comprises topics as scheduled by the RTO. This may include education on RTIs or antibiotic stewardship, but it will not include any of the elements of the educational package designed for and delivered in the intervention RTO (GP Synergy) as part of the ChAP II study.
Control group
Active

Outcomes
Primary outcome [1] 327091 0
The proportion of consultations for bronchitis/bronchiolitis (International Classification of Primary Care version 2-PLUS chapter R78) in which antibiotics are prescribed. Antibiotic prescription data are derived from the ReCEnT study recording of registrars’ prescribing over the period 4 years pre-intervention up to 10 months post-intervention.
Timepoint [1] 327091 0
Four years pre-intervention and at 10 months post completion of the intervention
Secondary outcome [1] 393753 0
The proportion of consultations for URTI (International Classification of Primary Care version 2 PLUS chapter R74) in which antibiotics are prescribed. Antibiotic prescription data are derived from the ReCEnT study recording of registrars’ prescribing over the period 4 years pre-intervention up to 10 months post-intervention.
Timepoint [1] 393753 0
Four years pre-intervention and at 10 months post completion of the intervention
Secondary outcome [2] 393755 0
The proportion of consultations for acute sore throat (International Classification of Primary Care version 2 PLUS chapter R76) in which antibiotics are prescribed. Antibiotic prescription data are derived from the ReCEnT study recording of registrars’ prescribing over the period 4 years pre-intervention up to 10 months post-intervention.
Timepoint [2] 393755 0
Four years pre-intervention and at 10 months post completion of the intervention
Secondary outcome [3] 393756 0
The proportion of consultations for acute sinusitis (International Classification of Primary Care version 2 PLUS chapter R75) in which antibiotics are prescribed. Antibiotic prescription data are derived from the ReCEnT study recording of registrars’ prescribing over the period 4 years pre-intervention up to 10 months post-intervention.
Timepoint [3] 393756 0
Four years pre-intervention and at 10 months post completion of the intervention
Secondary outcome [4] 393757 0
The proportion of consultations for acute otitis media (International Classification of Primary Care version 2 PLUS chapter H71) in which antibiotics are prescribed. Antibiotic prescription data are derived from the ReCEnT study recording of registrars’ prescribing over the period 4 years pre-intervention up to 10 months post-intervention.
Timepoint [4] 393757 0
Four years pre-intervention and at 10 months post completion of the intervention
Secondary outcome [5] 396731 0
The proportion of consultations for the composite outcome of bronchitis/bronchiolitis (International Classification of Primary Care version 2-PLUS chapter R78) AND URTI (International Classification of Primary Care version 2 PLUS chapters R74) AND acute sore throat (International Classification of Primary Care version 2 PLUS chapter R76) AND acute sinusitis (International Classification of Primary Care version 2 PLUS chapter R75) AND acute otitis media (International Classification of Primary Care version 2 PLUS chapter H71) in which antibiotics are prescribed. Antibiotic prescription data are derived from the ReCEnT study recording of registrars’ prescribing over the period 4 years pre-intervention up to 10 months post-intervention.
Timepoint [5] 396731 0
Four years pre-intervention and at 10 months post completion of the intervention

Eligibility
Key inclusion criteria
Intervention group: Registrars in Terms 1 and 2 of their vocational training program at one RTO (GP Synergy) 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 two RTOs (General Practice Training Tasmania (GPTT) and Eastern Victoria General Practice Training (EV GP Training)) who provide consent for the data they collect as part of the ReCEnT project to be used for research purposes.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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
This non-randomised trial is nested within the Registrar Clinical Encounters in Training (ReCEnT) ongoing inception cohort study of the in-consultation clinical experience of GP registrars with the analyses using data from RecEnT.
The principal 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 problems diagnosed by the participating registrar as 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 R78. For secondary outcome analyses, the dependent variables in regression models will be: R74, R75, R76, H71, and all five categories combined (R74+R78+R75+R76+H71)
The independent variable of interest will be intervention RTO/control RTOs.
Primary analyses will be by Intention to Treat (data of all GPSynergy registrars will be analysed irrespective of whether they attended the intervention webinar). We will also explore effects on specific groups of registrars by means of subgroup analysis (overseas trained versus Australian trained, male versus female).

Note: the trial is nested within an ongoing cohort study in which data collection occurs six-monthly for registrars in each of their six-monthly training terms. The educational package will be delivered only to intervention group (GP Synergy) registrars in Training Terms 1 and 2.
There will be an issue for registrars at GP Synergy who are in Term 1 in the second half of 2021 and in Term 2 in the first half of 2022. These registrars will not have received the educational package at the time of their data collection for the second half of 2021 and for the first half of 2022. But including these registrars in the control group will risk contamination (they will be working under the supervision of supervisors who have received the intervention). We will, therefore, exclude these registrars from analysis until they have received the intervention.
Our main analysis will be conducted following ReCEnT collection of data for the second half of 2022.
(Our study design and the scheduling of our educational intervention and ReCEnT data collection means there will be no Term 1 registrars in the post-intervention data. Thus we will do a sensitivity analysis where we exclude Term 1 registrars from the pre-intervention data).
We plan to conduct an interim analysis following ReCEnT data collection for the first half of 2022 and a further follow-up analysis following ReCEnT data collection for the second half of 2023.

Sample size
It is expected that the intervention group will consist of approximately 490 registrars sourced from the intervention RTO and the control group of approximately 160 registrars from the two control RTOs. Each of these registrars will provide data on an average of 2 acute bronchitis/bronchiolitis diagnoses before the intervention and 2 bronchitis/bronchiolitis diagnoses after the intervention. This will provide the study with approximately 80% power to find an absolute reduction of 6% (from 64% to 58%) in antibiotic prescribing for bronchitis/bronchiolitis in the intervention group, compared to the control group. This sample size calculation allows for a reduced effective sample size given repeated measures on registrars, based on an assumed intracluster correlation coefficient (ICC) of 0.27, representing the proportion of total correlation in response values accounted for by within-registrar correlation (within and across time). This ICC was estimated in a similar study by investigator van Driel. The projected sample size is based on an anticipated proportion of consultations for bronchitis/bronchiolitis of 1.3% and an expected pre-intervention rate of antibiotic prescribing of 64% (based on preliminary exploration of the existing database).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/04/2021
Date of last participant enrolment
Anticipated
Actual
22/07/2021
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
650
Accrual to date
Final
650
Recruitment in Australia
Recruitment state(s)
ACT,NSW,TAS,VIC

Funding & Sponsors
Funding source category [1] 308274 0
Other
Name [1] 308274 0
GP Synergy
Country [1] 308274 0
Australia
Primary sponsor type
Individual
Name
Emeritus Professor Mieke van Driel
Address
Primary Care Clinical Unit, Faculty 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] 309071 0
Individual
Name [1] 309071 0
Conjoint Professor Parker Magin
Address [1] 309071 0
Discipline of General Practice, School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan NSW 2308
Country [1] 309071 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308250 0
Human Research Ethics Committee (HREC), University of Newcastle
Ethics committee address [1] 308250 0
Ethics committee country [1] 308250 0
Australia
Date submitted for ethics approval [1] 308250 0
Approval date [1] 308250 0
10/02/2021
Ethics approval number [1] 308250 0
H-2009-0323

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110074 0
Prof Mieke van Driel
Address 110074 0
Primary Care Clinical Unit, Faculty of Medicine, The University of Queensland, Level 8, Health Science Building 16/910, Campus Royal Brisbane & Women’s Hospital Campus, Butterfield St, Brisbane QLD 4006
Country 110074 0
Australia
Phone 110074 0
+61 405485154
Fax 110074 0
Email 110074 0
[email protected]
Contact person for public queries
Name 110075 0
Mieke van Driel
Address 110075 0
Primary Care Clinical Unit, Faculty of Medicine, The University of Queensland, Level 8, Health Science Building 16/910, Campus Royal Brisbane & Women’s Hospital Campus, Butterfield St, Brisbane QLD 4006
Country 110075 0
Australia
Phone 110075 0
+61 405485154
Fax 110075 0
Email 110075 0
[email protected]
Contact person for scientific queries
Name 110076 0
Mieke van Driel
Address 110076 0
Primary Care Clinical Unit, Faculty of Medicine, The University of Queensland, Level 8, Health Science Building 16/910, Campus Royal Brisbane & Women’s Hospital Campus, Butterfield St, Brisbane QLD 4006
Country 110076 0
Australia
Phone 110076 0
+61 405485154
Fax 110076 0
Email 110076 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per the advice of the Human Research Ethics Committee overseeing the project.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.