Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001128583
Ethics application status
Approved
Date submitted
21/08/2015
Date registered
26/10/2015
Date last updated
29/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and efficacy of an antimicrobial stewardship program in general practices in Queensland
Scientific title
Feasibility and efficacy of an antimicrobial stewardship program versus standard protocol in reducing antibiotic prescription rates and preventing infection in general practices in Queensland
Secondary ID [1] 287326 0
Nil known
Universal Trial Number (UTN)
U1111-1173-4698
Trial acronym
GAPS (General Practitioner Antimicrobial Stewardship Programme Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antimicrobial resistance 295964 0
Condition category
Condition code
Infection 296242 296242 0 0
Studies of infection and infectious agents
Public Health 296829 296829 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twenty-four urban general practices in Queensland (16 in Brisbane and 8 in the Gold Coast) will be identified and asked to participate: 12 will be intervention practices; their performance in antibiotic prescribing will be compared with 12 control practices. The rate of antimicrobial prescribing will be compared with the preceding year’s rates, in the same time period, as an internal control/comparison.

The interventions will be implemented within the first month of the 6 month intervention period by research coordinators and consist of: a delayed prescribing protocol; patient decision aids; communication training; a ‘poster’ on practice prescribing policy for antibiotics, the patient information leaflet and the near patient testing with C-reactive protein. The GP practice staff will be educated about the interventions by the research coordinators at the practice site during the implementation phase and will receive follow up monthly visits plus reminders via emails of the interventions
1. Delayed prescribing
Patients who present with Acute Respiratory Infections (ARIs) will be evaluated by the GP. The GP will negotiate with the patient about management decisions for ARIs describing that very few people prescribed antibiotics will receive any benefit, and that benefit is of limited clinical relevance. If antibiotics are not needed immediately the patient will be offered a delayed prescription which is in concordance with the Therapeutic Guidelines: Antibiotics. A sticker will be applied to the prescription labeling it as a delayed prescription.

2. Patient decision aids
Patient Decision Aids are brief summaries of evidence for the management of a number of ARI conditions. The decision aids have been developed to assist the patient to make an appropriate decision about their condition in conjunction with the GP.

The Patient Decision Aids are laminated cards which are utilised by the GP in the consultation room to aid when discussing the management of ARIs with the patient. The Patient Decision Aids will also be made available on the GPs computers so that a printed copy can be provided to the patient.
3. Communicating training
Clinicians will be trained in communication strategies. The interventions will be targeted at GPs rather than patients, and have been developed to be sensitive to cultural and national differences. Training in enhanced communication skills to facilitate the appropriate management of the patient’s illness during consultation will be provided. This will enable the clinician and patient to participate jointly in making a health decision, having discussed the options and their benefits and harms, and having considered the patient’s values, preferences and circumstances.

The communication training package will be offered in combination with background information on the problem of antimicrobial resistance in primary care and the effectiveness of antibiotics for most commonly presenting ARIs as web-based online modules and be provided as a Continuing Professional Development (CPD) activity to GPs.

4. Poster on Practice Antibiotic Prescribing Policy ‘Nudge’ Intervention
A ‘nudge’ intervention is one in which the object of the intervention (in this case GPs) is provided with a minimal driver which has a large behavioural effect. Clinicians in the practice would agree on an antibiotic prescribing policy for ARIs which is concordant with Therapeutic Guidelines:Antibiotic.

This intervention will consist of displaying a poster-sized commitment letter in the GPs waiting room and/or examination room. Each GPs photograph and signature will be required as endorsement on the letters. The poster(s) will be delivered by the research co-ordinators to the GP practices. All GPs will be asked to sign the poster(s) before displaying them in their waiting room and /or examination rooms.

The posted commitment letter, written at the eighth grade reading level and displayed in English emphasises GP commitment to guidelines, i.e. Therapeutic Guidelines: Antibiotic, for appropriate antibiotic prescribing and explains why antibiotics are not appropriate in many cases.
5. Patient information leaflet
The leaflet provides information to the patient about inappropriate use of antibiotics for ARIs and the potential harmful effects of antibiotics. It complements the poster in the GPs waiting room and/or examination room.
6. Near patient testing with C-reactive protein.
The CRP test is widely used in some European primary care settings and has been shown to significantly reduce antibiotic prescribing for patients with ARIs.
The intervention practices will each have access to a CRP testing machine for three months (with 50 CRP tests per practice provided free of charge) to determine the feasibility and uptake of this type of near patient testing.
Tests will be performed using the QuikRead CRP kits (Orion Diagnostica). The research co-ordinator, in conjunction with the distribution company (ABACUS ALS), will train the GPs and practice staff in the use and interpretation of the tests. In addition GPs will have access to an online training module on CRP testing (http://gaps.uq.edu.au).
The following instructions will be provided regarding CRP testing:
a) CRP testing should only be used within ARI consultations for lower respiratory tract infections and acute rhinosinusitis.
b) the GP can decide to perform a CRP test as a complement to the routine consultation (including history and physical examination).
c) the CRP test is performed on a finger prick blood sample and the result will be available within a few minutes.
d) the CRP test result can be used in addition to the clinical assessment to decide whether to prescribe an antibiotic.
Two sub-studies are nested in the main study: (1) point prevalence estimation carriage of bacterial upper respiratory pathogens in practice staff and asymptomatic patients; (2) feasibility of direct measures of antibiotic resistance by nose/throat swabbing.
Intervention code [1] 292645 0
Prevention
Comparator / control treatment
The control practices will function as normal with no interventions implemented at the practice sites.
The research team will obtain, by prescriber number, the number of prescriptions reimbursed under the J01 code (systemic antibiotics) for the control practices for the 6 month intervention period which will be compared to the intervention practices for the same time period. In addition, data on antibiotic prescribing in the comparable period in the preceding year for all GPs which be collected and this will serve as an internal comparison.
Control group
Active

Outcomes
Primary outcome [1] 295906 0
The principle study outcome is GP antibiotic prescribing rates.
The research team will obtain, by prescriber number, the number of prescriptions reimbursed under the J01 code (systemic antibiotics). The study team will also collect data on antibiotic prescribing in the comparable period in the preceding year for all GPs in all 24 practices.
Timepoint [1] 295906 0
6 month period
Secondary outcome [1] 316906 0
The study will assess the general practice environment for antibiotic-resistant organisms and any consequent need for more intense infection control measures (antibiotic resistance in bacteria sampled by throat and nasal swabs among practice patients and practice staff).
Timepoint [1] 316906 0
6 months
Secondary outcome [2] 318350 0
The study will establish the costs incurred to implement the package; and by economic modelling, calculate the potential cost-effectiveness of the package to reduce the economic burden of antibiotic resistance in Australia will also be determined.
Timepoint [2] 318350 0
6 months
Secondary outcome [3] 318351 0
Semi-structured interviews will be conducted with the general practitioners and practice staff (practice nurse and/or practice manager) from the intervention practices on conclusion of the intervention phase to assess the feasibility and uptake of the interventions.
Timepoint [3] 318351 0
6 months

Eligibility
Key inclusion criteria
1. Urban general practices in S.E. Queensland (16 Brisbane and 8 in the Gold Coast)
2. A minimum of 2 GPs per practice
3. Prescribers will be asked to consent to the investigators accessing their Medicare (MBS) and Pharmaceutical Benefits Scheme (PBS) Information
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Prescribers who do not consent to having their Medicare (MBS) and Pharmaceutical Benefits Scheme (PBS) Information accessed by the investigators

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation generated by a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation generated by a computerized blocked randomisation list. according to geographical location
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 main outcome measure for the pilot study is the change in proportion of patients who have been prescribed and supplied antibiotics before and after the intervention period in the intervention and control groups.
With standard parameters (significance level 5% and power 80%), 12 intervention practices compared with 12 control practices will be able to detect a 24 percentage point change in prescribing rates.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
21/08/2015
Date of last participant enrolment
Anticipated
26/02/2016
Actual
26/02/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291891 0
Government body
Name [1] 291891 0
Department of Health
Country [1] 291891 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Public Health
Faculty of Medicine + Biomedical Sciences
Level 4, Mayne Medical Building
The University of Queensland
Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 290557 0
None
Name [1] 290557 0
Address [1] 290557 0
Country [1] 290557 0
Other collaborator category [1] 278585 0
University
Name [1] 278585 0
Bond University
Address [1] 278585 0
Centre for Research Excellence in Minimising Antibiotic Resistance from Acute Respiratory Infections (CREMARA) Centre for Research in Evidence-Based Practice Faculty of Health Sciences and Medicine Bond University Robina, Queensland 4229
Country [1] 278585 0
Australia
Other collaborator category [2] 278586 0
University
Name [2] 278586 0
Queensland University of Technology
Address [2] 278586 0
Centre of Research Excellence in Reducing Healthcare Associated Infections
Institute of Health and Biomedical Innovation, School of Public Health and Social Work
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD 4059 , Australia
Country [2] 278586 0
Australia
Other collaborator category [3] 278587 0
University
Name [3] 278587 0
The Australian Sentinel Practices Research Network (ASPREN)The University of Adelaide
Address [3] 278587 0
Discipline of General Practice
School of Population Health
The University of Adelaide
Level 11, 178 North Terrace ADELAIDE South Australia 5005
Country [3] 278587 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293400 0
University of Queensland
Ethics committee address [1] 293400 0
Ethics committee country [1] 293400 0
Australia
Date submitted for ethics approval [1] 293400 0
19/06/2015
Approval date [1] 293400 0
05/08/2015
Ethics approval number [1] 293400 0
2015000988

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

Contacts
Principal investigator
Name 59654 0
Prof Charles Gilks
Address 59654 0
School of Public Health
Faculty of Medicine + Biomedical Sciences
Level 4, Mayne Medical Building
The University of Queensland
Herston QLD 4006
Country 59654 0
Australia
Phone 59654 0
+61 7 3365 5280
Fax 59654 0
Email 59654 0
[email protected]
Contact person for public queries
Name 59655 0
Minyon Avent
Address 59655 0
School of Public Health
Faculty of Medicine + Biomedical Sciences
Level 4, Mayne Medical Building
The University of Queensland
Herston QLD 4006
Country 59655 0
Australia
Phone 59655 0
+61 7 3365 5280
Fax 59655 0
Email 59655 0
[email protected]
Contact person for scientific queries
Name 59656 0
Minyon Avent
Address 59656 0
School of Public Health
Faculty of Medicine + Biomedical Sciences
Level 4, Mayne Medical Building
The University of Queensland
Herston QLD 4006
Country 59656 0
Australia
Phone 59656 0
+61 7 3365 5280
Fax 59656 0
Email 59656 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseGeneral Practitioner Antimicrobial Stewardship Programme Study (GAPS): protocol for a cluster randomised controlled trial.2016https://dx.doi.org/10.1186/s12875-016-0446-7
N.B. These documents automatically identified may not have been verified by the study sponsor.