Optimal Implementation of Antimicrobial Stewardship in General Practice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Antimicrobial stewardship activities delivered through Virtual Network, Antimicrobial stewardship activities delivered through Integrated Network activities.
- Who it may be relevant to
- Registry conditions: The Use of Antimicrobial Stewardship in in General Practice (Family Medicine), Respiratory Tract Infections (RTI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimal Implementation of Antimicrobial Stewardship in General Practice (OPTIMAS-GP) Study: A Hybrid Type 3 Implementation Trial
Overview
This trial aims to increase the use of antimicrobial stewardship resources when treating patients with respiratory tract infections. This trial is set in Australian general practices (family medicine or primary care). The main question it aims to answer is which type of implementation activities increase the use of antimicrobial stewardship resources. Researchers will compare doctors who receive face-to-face implementation activities (the Integrated Network group) to those who received virtual or online activities (the Virtual Network group). The primary hypothesis is that there will be a difference in how often interventions are used Participating doctors will be asked to record how often they use antimicrobial stewardship resources and which interventions they prefer. Participating practices will also provide researchers data on how many patients the doctors see. Patients with respiratory tract infections who saw a participating doctor will be asked to give feedback on their experience using surveys. A subgroup of doctors, practice staff, and patients will interviewed about their experience in the study.
Detailed description
SUMMARY The OptimasGP study is a two-arm superiority cluster-randomised Hybrid type 3 pragmatic implementation trial to promote the use of antimicrobial stewardship (AMS) interventions by doctors in general practice treating adults with respiratory tract infections.
The implementation strategies used in the trial will be delivered using a Virtual Network (arm 1) and Integrated Network (arm 2) approach. Data collection will collected for five months during winter for the baseline period, followed by implementation activities, and five months in the following winter post-activities.
The primary study outcome is AMS intervention use per 100 consultations. Secondary objectives are based on the RE-AIM framework for reach, efficacy, implementation, adoption, and maintenance of the implementation.
SETTING The study sites for the implementation study comprise 40 general practices across New South Wales, Queensland, Tasmania, and Victoria in Australia.
PARTICIPANTS Participants include 120 general practice (family practice) doctors, 40 practice staff, and patients with respiratory tract infections. Informed consent will be obtained from participating doctors and practice staff in written form by members of the research team. Approximately half of participants will be recruited in 2025, with the remainder recruited in 2026.
Patients will be sent invitations to participate in the study by practice staff via SMS. For patient surveys, completion of surveys will constitute tacit consent. For patients in the case-studies sub-group, informed consent will be obtained in written form by members of the research team.
There are two subgroups. In the first subgroup, three sites from each arm will be elected for the nested case-study (individual semi-structured interviews). For each site, interviewers will construct case studies consisting of 6-8 participants (e.g., 2 doctors, 1-2 practice nurses, 1 practice manager, and 4 ARI patients per case).
In the second subgroup, 3 sites per arm (6-9 doctors) will be provided with FebriDx point of care tests to identify if respiratory tract infections are bacterial or viral in origin. These tests have been approved by the USA FDA (K230917) and by the Australian Therapeutic Goods Administration (ref 346636).
Recruitment and retention will be facilitated by payments to participants.
INTERVENTION RESOURCES Participating doctors will be provided AMS interventions in an online AMS Toolbox (see the latest version at https://redcap.uow.edu.au/redcap/surveys/?s=37HKC3KFMLED7PY7) which they may use when treating eligible patients. The Toolbox will contain AMS interventions resource for shared decision-making between doctors and patients, delayed prescribing, and clinical decision support (including guidance for using FebriDx point of care devices for relevant members of the subgroup).
IMPLEMENTATION ACTIVITIES Both arms will complete \~7 hours of implementation activities. These activities will be provided by MedCast, an established provider of ongoing health professional education in Australia.
Participants in the Virtual arm will receive online self-paced education modules, guided self-audit and reflection regarding antimicrobial stewardship and use of AMS Toolbox components, and reinforcement podcasts.
Participants randomised to the Integrated Network arm will receive education delivered by live interactive online webinar-based sessions, peer-group audit and reflection, and reinforcement online forum participation.
DATA COLLECTION Doctors complete data entry using the AMS Toolbox by selecting if they used an intervention, which intervention was used, and whether an antibiotic was prescribed for immediate use, delayed use, or not prescribed. In addition, the number of patients seen by each doctor will be collected based on a fortnightly record of practice records using surveys.
Demographic data will be collected using online surveys.
Patients will completed patient-reported outcome measures and patient reported experience measures using online surveys. Interviews of the nested-case study sub-group will be qualitative in nature.
All surveys will using REDCap (Research Electronic Data Capture) forms hosted at the University of Wollongong.
RISKS As this study has a low risk of harm or death, and as no interim analyses are planned, the study will not have a Data Safety Monitoring Board. Harms will be recorded through PROMs and direct reports from participating doctors. Harms such as re-consultations and hospitalizations reported to the research team will be discussed with an independent data monitor. This monitor can cease the study at any time if concerns arise. No interim analysis is planned and thus no stopping guidelines are provided.
Interventions
- Other Antimicrobial stewardship activities delivered through Virtual Network
Participants will receive online self-paced education modules regarding antimicrobial interventions, guided self-audit and reflection regarding intervention use, and reinforcement podcasts (\~7 hours). Participants in the Virtual Newtwork arm will primarily receive these interventions online. - Other Antimicrobial stewardship activities delivered through Integrated Network activities
Participants will receive online self-paced education modules regarding antimicrobial interventions, guided self-audit and reflection regarding intervention use, and reinforcement podcasts (\~7 hours). Participants in the Integrated Network arm will primarily receive these interventions face-to-face and active online activities.
Primary outcome measures
- Change in use of antimicrobial interventions per 100 consults [Time frame: From baseline for 5 months, from post intervention for 5 months]
Secondary outcome measures (12)
- Reach: Number enrolled - Doctors [Time frame: Enrolment]
- Reach: Representativeness of practices [Time frame: Baseline]
- Reach: Completions - Doctors [Time frame: 5 months post intervention]
- Reach: Representativeness of participating doctors and staff [Time frame: Baseline.]
- Reach: Representativeness of patients [Time frame: From baseline up to 5 months, from post intervention up 5 months]
- Effectiveness: Change in intervention use per 100 RTI consults [Time frame: From baseline for 5 months, from post intervention for 5 months]
- Effectiveness: Change in antibiotics prescribed per 100 RTI consults [Time frame: From baseline for 5 months, from post intervention for 5 months]
- Effectiveness: Change in antibiotic prescriptions given for RTIs (self-report) [Time frame: From baseline for 5 months, from post intervention for 5 months]
- Effectiveness: Total antibiotics prescribed per 100 consults [Time frame: From baseline for 5 months, from post intervention for 5 months]
- Effectiveness: Adverse events [Time frame: From baseline up to 5 months, from post intervention up 5 months]
- Implementation: Fidelity to protocol during the study [Time frame: 5 months post-intervention]
- Implementation: Doctor experiences of interventions and implementation strategies [Time frame: 5 months post baseline, 5 months post intervention]
Eligibility criteria
Study sites
Inclusion criteria
- New South Wales, Queensland, Tasmania, or Victoria
- at least two GPs per practice consent to be in the study,
- that at least one member of practice staff consents to be in the study
- that a staff member from the site will be available to provide 90 minutes per fortnight of administrative support for the study. There are no exclusion criteria in addition to this.
Exclusion Criteria: None
Participating doctors and healthcare workers
Inclusion criteria
1\) Working at a participating practice for at least three days a week. Exclusion criteria : None
Patients completing patient reported outcome measure survey
Inclusion criteria
- patients consulted with a participating GP for a RTI,
- patients re-consulted with a GP or was hospitalized. Exclusion criteria: None
Patient reported experience measures survey
Inclusion criteria
1\) patient consulted with a participating GP for an RTI. Exclusion criteria: None
Patients participating in interviews as part of the nested case studies
Inclusion criteria
- consulted with a participating GP for a RTI,
- completed a patient survey,
- able to read and speak English Exclusion criteria: None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
Australia · 4 centers
- University of Wollogongong — Wollongong
- Bond University — Gold Coast
- University of Tasmania — Hobart
- Monash University — Melbourne
Identifiers
NCT: NCT06953804 · 2024/337 · MRFF project 2029531 · U1111-1319-2201