Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001011572
Ethics application status
Approved
Date submitted
30/07/2024
Date registered
20/08/2024
Date last updated
20/08/2024
Date data sharing statement initially provided
20/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Optimal Implementation of Antimicrobial Stewardship In General Practice Study (OptimasGP) - Pilot study
Scientific title
The Optimal Implementation of Antimicrobial Stewardship In General Practice Study (OptimasGP) - Pilot study
Secondary ID [1] 312650 0
MRFF project 2029531
Universal Trial Number (UTN)
U1111-1311-3260
Trial acronym
OptimasGP Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antimicrobial stewardship 334611 0
Condition category
Condition code
Public Health 331197 331197 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention
GPs will use the online AMS Toolbox to support them to provide standard of care when consulting adult patients with acute respiratory infections who would normally seek treatment from their GP. Patients with acute respiratory tract infections will attend their GP as they normally would e.g. booking in, paying the normal amount for a consultation if required.

Examples of the resources included in the AMS Toolbox include the CDC Delayed Prescribing tool, the Australian Commission on Safety and Quality in Healthcare's Decision Aid for acute bronchitis, the National Institute for Health and Care Excellence's Cough (Acute): Antimicrobial Prescribing tool, and a treatment plan developed by University of Wollongong researchers through co-design.

During consultations, GPs will use the AMS Toolbox to record having seen an adult patient with a respiratory infection (no patient details are collected) and whether or not they prescribed an antibiotic. If the GP considers it clinically appropriate, they can choose one of the AMS Toolbox resources to support their standard clinical care. The AMS Toolbox will include resources for shared decision making, clinical decision-making support with the addition of point-of-care testing if appropriate, and delayed prescription. These resources will be available online and in hard copy. GPs are able to share these resources with patients if desired. GPs will decide which resource to use, if any, during the consultation. Use of the AMS Toolbox is expected to take 5-10 minutes per consultation depending on which AMS resources are used. The decision to prescribe an antibiotic or not is completely up to the GP and patient.

Patients may be offered a point-of-care testing to inform clinical decision making. The decision to conduct a point-of-care test will be made by the GP and the patient together using a clinical decision making guide. This test will require a finger prick test – this is entirely voluntary and is a standard method used to obtain blood for routine tests in general practice such as blood glucose tests. Approximately 3 drops of blood will be removed by finger stick. Blood will be tested using a point of care testing device using standard procedures. Results from this test are not recorded as part of the trial, and are only used as part of the clinical decision making process. There will be no additional charge to the patient for the test.

Point-of-care testing will be for C-reactive protein (CRP). A CRP level of <20mg/l indicates that bacterial infection is unlikely and provides support for not prescribing an antibiotic. A CRP level of 20-100mg/l suggests a bacterial infection may be possible and an antibiotic could be prescribed in consideration with other factors, while a CRP rating above 100mg/l suggests the infection is bacterial and an antibiotic should be prescribed.

Two point-of-care testing devices will be piloted: an Affinion 2 analyser and a Quikread Go. Both devices are approved by the Australian Therapeutic Goods Agency and are currently available to GPs who wish to buy them. Each device will be used by one of the six practices for a month after which time it will be moved on to the next practice i.e. each of the six practices will use a POCT device for a month. Training on the use of the devices will be included as part of the GP pre-trial training.

Adherence will be monitored using 1) qualitative interviews at the end of the study, 2) a comparison of the rates of data entry into the AMS Toolbox vs an audit of practice data.

The implementation support offered to GPs
- Change in workflow: the AMS Toolbox will centralise intervention resources to make them more accessible
- Reminder: A small post-card sized card will be given to each GP to remind them to complete their data analysis.
- Training: Two hours of online videos will be provided by members of the research team. This will recorded videos and are expected to be viewed in 1-2 sessions.
Intervention code [1] 329166 0
Behaviour
Intervention code [2] 329167 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338964 0
Acceptability of implementation resources
Timepoint [1] 338964 0
At conclusion of 3 month trial
Secondary outcome [1] 438042 0
To measure rates of recruitment
Timepoint [1] 438042 0
Finalized at conclusion of the study
Secondary outcome [2] 438049 0
Patient acceptability of Pateint reported outcome measures survey (PROMs) and Patient reported experience (PREMs) survey - this will be assessed as a composite measure
Timepoint [2] 438049 0
Throughout study
Secondary outcome [3] 438283 0
Retention rates
Timepoint [3] 438283 0
Finalized at conclusion of the study

Eligibility
Key inclusion criteria
For participating practices:
- Medical practices in NSW

For participating general practitioners:
- Working in general practice for at least three days a week at participating location

For participating patients:
- 18 or older
- Attended a GP for a respiratory tract infection
- Was provided with a study information card
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/09/2024
Actual
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317080 0
Government body
Name [1] 317080 0
Department of Health and Aged Care - MRFF Clinical Trials Activity [Stream 2] 2023
Country [1] 317080 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Country
Australia
Secondary sponsor category [1] 319337 0
None
Name [1] 319337 0
Address [1] 319337 0
Country [1] 319337 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315833 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 315833 0
Ethics committee country [1] 315833 0
Australia
Date submitted for ethics approval [1] 315833 0
24/05/2024
Approval date [1] 315833 0
23/07/2024
Ethics approval number [1] 315833 0
2024/171

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

Contacts
Principal investigator
Name 135942 0
Prof Andrew Bonney
Address 135942 0
University of Wollongong, Graduate School of Medicine, George Evans Rd, West Nowra, NSW 2541
Country 135942 0
Australia
Phone 135942 0
+61 02 42215473
Fax 135942 0
Email 135942 0
[email protected]
Contact person for public queries
Name 135943 0
Colin Cortie
Address 135943 0
University of Wollongong, Graduate School of Medicine, George Evans Rd, West Nowra, NSW 2541
Country 135943 0
Australia
Phone 135943 0
+61 02 42215610
Fax 135943 0
Email 135943 0
[email protected]
Contact person for scientific queries
Name 135944 0
Colin Cortie
Address 135944 0
University of Wollongong, Graduate School of Medicine, George Evans Rd, West Nowra, NSW 2541
Country 135944 0
Australia
Phone 135944 0
+61 02 4221 5610
Fax 135944 0
Email 135944 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data collected will be available in de-identified form.
When will data be available (start and end dates)?
Data will be available from 30 July 2025 for 15 years.
Available to whom?
Data will be available to researchers who provide a methodologically sound proposal and are willing to be added to the existing ethics application.
Available for what types of analyses?
Data will be available only to achieve the aims in the approved proposal due to ethical considerations.
How or where can data be obtained?
Access subject to approvals by Principal Investigator, Professor Andrew Bonney ([email protected])


What supporting documents are/will be available?




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.