Optimal Implementation of Antimicrobial Stewardship in General Practice: Protocol for a feasibility study

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In Australia, antibiotics are frequently prescribed in general practice (primary care) settings for acute respiratory infections (ARIs) despite these infections most commonly being caused by viruses. The Optimal Implementation of Antimicrobial Stewardship in General Practice (OptimasGP) study aims to provide implementation support for effective antimicrobial stewardship (AMS) interventions for ARIs. The current study will examine if a redesigned workflow, and an AMS Toolbox containing AMS resources, is an acceptable way to access AMS interventions and clinical data collected in general practice settings. Methods : A mixed methods approach will be applied using a single-arm, pragmatic feasibility study. Data will be collected for a period of 3 months. Data collection from general practice settings in New South Wales, Australia will involve the participation of four to six practices, twelve General Practitioners (GPs), and six to eight practice staff. We also aim to recruit 50-100 patients to complete surveys and twelve patients to participate in focus group discussions. Participating GPs and practice staff will be provided with an online AMS Toolbox to facilitate access to AMS resources. Two hours of online training and a reminder card will also be provided. The AMS Toolbox will contain AMS resources for shared decision-making, clinical decision support (including point-of-care testing), and delayed antibiotic prescribing in patients with ARIs. The primary outcome of the study will be the acceptability of the AMS Toolbox to GPs, practice staff and patients. Secondary outcomes will include recruitment and completion rates, qualitative findings from the focus group discussions, resource use and antibiotic prescription rates, patient-reported outcome measures (PROMs), and patient-reported experience measures (PREMS). Discussion: AMS interventions are needed to help reduce inappropriate antibiotic prescribing for ARIs in general practice settings. The findings of this study will inform a Hybrid Type 3 implementation trial. Trial registration: Registered prospectively with the Australian and New Zealand Clinical Trial Registry (ACTRN12624001011572) on 20/08/2024. Figures Figure 1 Figure 2 Introduction The World Health Organization considers antimicrobial resistance as one of the top 10 threats to global health [1]. Of particular concern is antibiotic resistance, which is fueled by inappropriate use of antibiotics [2]. The majority of antibiotics in the developed world are prescribed in primary care (general practice) settings, with over half used to treat acute respiratory infections (ARIs) [3, 4]. Most ARIs in otherwise healthy adults are caused by viruses and do not respond to antibiotic treatment - for example, viruses cause 90% of acute bronchitis cases [5]. An Australia-wide audit of routinely collected data found that 81.5% of patients with acute bronchitis received antibiotics, despite no evidence that antibiotics are beneficial in these cases [4]. Community antibiotic prescribing rates in Australia were more than double those of the Netherlands [4] and Sweden [6] and four to nine-times higher than Australia’s own national guideline recommendations [7]. One of the strategies which can be used to address the inappropriate prescribing of antibiotics is through anti-microbial stewardship (AMS) interventions. AMS interventions aim to measure and improve both clinician prescribing and patient use of antibiotics [8]. There is robust evidence that AMS interventions effectively reduce inappropriate antibiotic prescribing in general practice during face-to face consultations for ARIs [9, 10]. For example, shared decision-making, which involves discussion and collaboration between patients and their healthcare provider [11-13] is estimated to reduce antibiotic use by 36% [14]. Other AMS interventions which improve the appropriate prescribing of antibiotics in ARIs include clinical decision support resources [10, 11], which may include guideline-based algorithms or the use of biomarker point-of-care testing for C-reactive protein [10, 14]. Both computerized and paper-based clinical decision support have been shown to reduce antibiotic prescribing for ARIs in primary care and hospital settings [15], and biomarker point-of-care testing is estimated to reduce antibiotic use for ARIs by 32% [16, 17]. Another approach to AMS is using delayed prescribing, where patients are not prescribed antibiotics at the time of the consultation but have a mechanism for access to a prescription for antibiotics, if symptoms fail to improve or worsen over a defined timeframe. Delayed prescribing is estimated to reduce antibiotic use for ARIs in primary care by 34-76% [10]. The challenges in effectively implementing AMS interventions in general practice in Australia are complex and multifaceted. Key factors include perceptions of patient expectations for antibiotic prescriptions, GPs’ consultation time pressures, clinical uncertainty, and concerns about adverse outcomes from not prescribing antibiotics [9, 18, 19]. Pivotal studies of AMS in general practice have used a variety of implementation strategies, including mixed self-paced and interactive online education, peer-group audits, communication workshops, and in-person practice facilitation [20-24]. Assessing and redesigning workflows is a less commonly used implementation strategy but has been found to be effective [25]. However, the costs and scalability of these implementation strategies varied widely [20, 23]. Due to a lack of direct comparisons between these implementation strategies, it remains unclear which are most effective in promoting the uptake of evidence-based AMS interventions in general practice [26]. This feasibility study is part of a program of research called the Optimal Implementation of Antimicrobial Stewardship in General Practice (OptimasGP). The OptimasGP trial includes a co-design phase, a feasibility study, and a definitive Hybrid Type 3 implementation study [27] (Figure 1). As part of the OptimasGP trial, the workflow of how GPs access AMS resources was redesigned to centralize resources and collect outcome data in a single tool, which will be referred to as the AMS Toolbox. The co-design study reported on the barriers and facilitators of using AMS resources for shared decision-making, clinical decision support, and delayed prescribing. The findings of this stage were incorporated into the feasibility in a process that will be reported in a separate article. The current protocol is for the external feasibility study conducted as part of the research development process [28]. Due to the nature of the project, this feasibility study will inform a future implementation study but will not but will not be used to determine progression. Aims and objectives The aim of this feasibility study (Stage 2) is to assess the acceptability, feasibility, and utility of the trial method to inform the definitive implementation trial (Stage 3).The primary objective of this feasibility is to determine the acceptability of the AMS Toolbox for providing AMS resources and collecting relevant data. We define acceptability as the extent to which the individuals delivering care (e.g., GPs and practice staff) or receiving care (e.g., patients) using the AMS toolbox consider it to be appropriate. The secondary objectives are to 1) measure rates of recruitment and retention, 2) optimise the work-flow integration of the AMS Toolbox, 3) validate data collected through the AMS Toolbox against a manual electronic health record audit, and 4) test procedures for measuring Patient Reported Outcome Measures (PROMs) (e.g. re-consultations or hospitalizations) and Patient Reported Experience Measures (PREMs) (e.g. satisfaction). Methods Study design Design A mixed method, single-arm, pragmatic feasibility study will be used to assess the acceptability and feasibility of data collection using the AMS Toolbox and associated training (the implementation) to support the use of AMS resources (the intervention) for the treatment of patients with ARIs in general practice. Process GPs who have volunteered to be part of the study will consult with adult patients (18 years or older) with ARIs as per their standard clinical practice. GPs will access the AMS Toolbox online and select AMS interventions they plan to use ( Figure 2 ). An example of the AMS Toolbox is available online. At the conclusion of the consultation, GPs may prescribe an antibiotic or other medical treatment according to their standard clinical care practice. Selection of resources and antibiotic prescriptions will be recorded in the AMS Toolbox. All concomitant usual care is permitted during the trial. Usual care will continue throughout the trial, with no additional ancillary or post-trial care beyond standard practice. The study will be run for a duration of twelve weeks. Reporting This study is reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist [29]. As this is a feasibility study, items 2a and 20 were included from the Consolidated Standards of Reporting Trials (CONSORT) checklist for pilot or feasibility trials [30]. Implementation and interventions have been separated as per the Standards for Reporting Implementation Studies (StaRI) checklist [31]. Any protocol amendments will be noted in the publication of results. Ethical approval and registration This study was approved by the University of Wollongong’s Health and Medical Human Research Ethics Committee (2024/171) and registered prospectively with the Australian and New Zealand Clinical Trial Registry (ACTRN12624001011572). Amendments to the protocol will be updated in the trial registration and reported in the primary outcome paper. Study setting and participants Sites The study will be conducted at 4-6 general practices (also known as primary care clinics) in New South Wales, Australia. These sites will be recruited through the University of Wollongong’s Practice-Based Research Network. Each site will be paid an onboarding fee of $1000 and $600 per participating GP, to support the administrative aspects of the study ( Table 1 ). General practitioners Twelve GPs will be recruited from participating general practice sites using a participant information sheet and consent form. Recruitment will be conducted via email, phone, and face-to-face meetings. The inclusion criteria is that GPs are working at a participating practice for at least three days each week. There are no exclusion criteria. Participating GPs will complete 2 hours of online training at the start of the baseline period, collect data for 12 weeks, and participate in a 1.5 hour focus group at the end of the study. To improve recruitment and retention, GPs will receive $150/hour for all training and focus group activities and $50/week for data collection ( Table 1 ). General Practice Staff Six to eight general practice staff from participating sites will be recruited using a practice staff participant information sheet and consent form. Staff recruitment will be conducted using email, phone, and face-to-face meetings. The inclusion criteria require staff to work at a participating practice for at least three days each week, with no additional exclusion criteria. Participating staff will complete 2 hours of online training at the start of the baseline period, provide administrative support throughout the study period, and participate in a 1.5 hour focus group at the end of the study. To improve recruitment and retention, staff will receive $150/hour for training and focus group activities ( Table 1 ). sPatient surveys During the three month trial, patients who consulted with a participating GP for an ARI will receive information cards inviting them to complete anonymous surveys, with survey completion considered tacit consent. Ten to twenty patients are expected to complete a Patient Reported Outcome Measure (PROM) survey. The inclusion criteria for the PROM survey are that patients consulted with a participating GP for an ARI and subsequently either re-consulted or are hospitalized within 30 days. Additionally, between 50-100 patients are expected to complete the Patient Reported Experience Measure (PREM) survey. For the PREM survey, the inclusion criteria are that patients consulted with a participating GP for an ARI. Completion of either survey will be considered tacit consent. To encourage participation, patients who complete the survey will be eligible to win one of five $50 vouchers (patients will submit their contact details separately to the anonymous survey). Ten to twelve patients who completed the surveys will be recruited to participate in the focus groups at the completion of the study. These patients will be required to complete a written consent form. The inclusion criteria for these patients are that they consulted with a participating GP for an ARI, completed a PROM or PREM survey, and are able to read and speak English. Patients who participate in the one-hour focus group discussions will receive a $50 voucher. Timing Recruitment for the study will occur between 4 September 2024 and 30 November 2024. The date of final data collection is estimated to be 28 February 2025. Allocation and power calculation All participants will be allocated to a single arm of the trial, hence no blinding or power calculation is required. Table 1 . Summary of site and participant groups Site/ group Number recruited Criteria Recruitment strategy Consent Incentives for participating Healthcare providers General Practices 4-6 Located in NSW Recruited through UOW’s practice-based research network Written consent from practice owner/manager $1,000 onboarding $600 per participating GP General practitioners 2-3 per practice 10-12 in total Working at least three days per week at a participating practice Direct emails and face-to-face meetings with staff at participating practices Individual written consent $1125 for training, data collection, and participating in a focus group 3.5 hours of continuing professional development Practice staff 1-2 per practice 6-8 in total $350 for training and participating in a focus group Patients PREM Survey 50-100 Consulted with a participating GP for an ARI Patient information cards given by participating GPs Tacit consent Chance to win one of five $50 vouchers PROM Survey 10-20 Consulted with a participating GP for an ARI, re-consult or are hospitalized within 30 days Patient information cards given by participating GPs Focus groups 10-12 Consulted with a participating GP for a RTI, completed a patient survey, able to read and speak English Request for participation at the completion of patient surveys Individual written consent $50 voucher for participating in a 1hr focus group UOW, University of Wollongong; PROM, the patient-reported outcome measure; PREM, the patient-reported experience measure. Payments are in Australian dollars. Implementation strategies The implementation strategies used are defined using the ERIC guidelines [32], including updated items for assessing and redesigning workflow [25]. Assess and redesign workflow The AMS Toolbox will be used in standard patient consultations at participating general practices. As the AMS Toolbox is accessed online, participating GPs are expected to have access to a computer and the internet as part of their standard practice. The AMS Toolbox is a centralisation of multiple intervention resources (see intervention resources below) that are ordinarily accessible from separate websites or sources. The AMS Toolbox’s resources are also provided in hardcopy. Each GP will be provided a unique link to their own AMS Toolbox. A new survey is generated for each patient when the participating GP accesses the link. The GP selects the resource(s) to use, and then may print them or show them to the patient as part of the consultation. The AMS Toolbox will record which resources were accessed, and the GP records the outcome of the consultation (e.g. was an antibiotic prescribed for immediate use, was an antibiotic prescribed for delayed use, or was no antibiotic prescribed). Conduct educational meetings GPs and practice staff will be provided with approximately two hours of online training from the research team prior to commencing the study. This training will cover the background of AMS, the need for AMS in general practice, and the role of GPs and practice staff in the study. This will include training on use of the point-of-care testing devices (mentioned below) for both GPs and practice staff in the study. Remind clinicians Participating GPs will be given a physical card to place on their desks to remind them to use the AMS Toolbox during consultations with adults presenting with ARIs. Intervention resources The following AMS resources will be provided in the online AMS Toolbox. They will also be provided in hardcopy to the GPs. Shared decision-making Shared decision-making between GPs and patients involves ‘discussion and collaboration between a consumer and their healthcare provider’ [11]. The Australian Commission on Safety and Quality in Health Care’s Decision Aid [33] is included as a resource for shared decision-making. Clinical decision support Clinical decision support systems, such as evidence-based diagnostic and treatment algorithms, will be provided to GPs [10]. The National Institute for Health Care Excellence (NICE) resource for ‘Cough (acute): antimicrobial prescribing’ [34] is included as an example of a clinical decision support. C-Reactive Protein testing National Institute for Health and Care Excellence Guidelines in the UK [34] recommend that biomarker point-of-care testing can augment clinical decision support to assist in diagnostic accuracy [10, 14]. Finger-prick tests will be conducted 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 between 20-100mg/L suggests a bacterial infection may be possible, warranting consideration of an antibiotic dependent on other factors (e.g. whether the patient has a chronic respiratory disease). While a CRP level above 100mg/L suggests the infection is bacterial, and an antibiotic should be prescribed. The point-of-care testing devices were the Afinion 2 analyser (Abbott Rapid Diagnostics, NSW, Australia) and the QuikRead Pro (Abacus DX Pty LTD, QLD, Australia). Results from these testing devices will not be recorded as part of the study, and will only be used as part of the clinical decision-making process. There will be no additional charge to the patient for the test. Delayed prescribing The original delayed prescribing resource considered was the Centre for Disease Control’s Delayed Prescribing resource [35]. Following co-design discussions, a new version of this resource was created in response to participant input. Both resources will be provided in the AMS Toolbox. Measures Outcome measures and their alignment with the study objectives are listed in Table 1 . Additional data, including site characteristics and participant demographics, will also be collected. Table 1 How study goals are informed by data collection tools OBJECTIVE GROUP Measures 1 PRIMARY Acceptability of AMS Toolbox GPs Practice staff Patients Focus groups Acceptability of Intervention Measure (AIM) [36] Intervention Appropriateness Measure (IAM) [36] SECONDARY 2 Recruitment and retention GPs Practice staff Patients Recruitment and completion rates Focus groups 3 Optimise the work-flow integration of the AMS Toolbox GPs Practice staff Patients Focus groups 4 Validation of AMS data collection GPs Intervention use Antibiotic prescription rates Audit of practice data Focus groups 5 Test procedures for PROMS and PREMS Patients PREM survey PROM survey Focus groups Focus groups Focus groups, consisting of 2-6 participants, will be conducted online, with separate sessions for each participant group (GPs, GP staff, and patients). Sessions will last 90 minutes for GPs and practice staff, and 60 minutes for patients. Focus groups will be facilitated by a member of the research team, recorded and transcribed verbatim. The focus group guide was developed by co-authors based on their clinical and professional expertise, in general practice etc. Focus group guides included open-ended questions about AMS Toolbox acceptability, appropriateness and utility, and feedback on AMS Toolbox resources and study procedures (e.g., remuneration, on-boarding, patient recruitment, audit and POCT devices) AIM and IAM measures During focus groups, participants will be asked to complete the Acceptability of Intervention Measure (AIM) and the Intervention Appropriateness Measure (IAM) [36] Both scales have four items that are scored using a 5-point Likert scale from ‘Completely disagree’ to ‘Completely agree’. Recruitment and completion rates Quantitative data for recruitment and retention of all participating groups will be determined from data collected in REDCap. Intervention use and antibiotic prescription rates During each consultation, the GP will record which AMS resources were used. Participating GPs may also indicate that no AMS resource was used during the consultation. Data will also be collected on whether an antibiotic was prescribed for immediate use, delayed use, or not at all. Audit of practice data An audit of prescription rates will be undertaken to compare AMS Toolbox results to study site records. The audit will include a measure of patient numbers, the number of patients with ARIs, and the number of antibiotics prescribed to patients with ARIs. Staff at each participating practice will conduct the audit. This will require examining medical records, which the practice nurse can access as part of their normal duties. The audit will be reported using a simple survey that identifies the participating GP but not patient information, and is expected to take between 60-120 minutes per month. Patient-reported experience measure survey (PROM) The survey will include a patient information statement and four short questions regarding patient consultation and hospitalizations. Patient-reported experience measure survey (PREM) PREM surveys include six questions adapted from a standard list [36]. Quantitative questions were selected from the domains of patient experience (e.g. ‘I am happy with my treatment’), shared decisions (e.g. ‘I feel fully involved in decisions about me’) and health confidence (e.g. ‘I can get the right help if I need it’). A seventh item allows for free-text responses. General Practice Site data survey At the time of recruitment, general practice site data will be collected via identifiable surveys, including practice location, patient volume, and staffing levels Demographics survey At recruitment of GPs and practice staff, demographic data will be collected using identifiable questionnaires. Surveys will include standard demographic questions e.g. gender, years of experience in primary care. Timing and workflow The timing of data collection is shown in Table 2 . Analysis plan Qualitative analysis Focus group data will be analyzed thematically [37], guided by the Theoretical Domains Framework [38], the COM-B framework [39] and conceptual frameworks for implementation outcomes [40]. These frameworks will provide guidance on the determinants of current and desired behaviors and assist the analysis of targeted behaviors of interventions, [41] and in assessing implementation outcomes [42]. They have been used to assess behavior change in healthcare settings, including general practice [43]. Transcriptions of audio-taped focus group discussions will be coded inductively by two independent coders, with codes compared and categorized into broader overarching themes. Disagreements will be resolved through discussion with a third researcher. This will be followed by categorization of themes according to the 14 domains of the Theoretical Domains Framework and corresponding COM-B framework. Quantitative analysis Quantitative analysis will be conducted in R. Analysis of quantitative outcomes will be descriptive in nature, and will include the rates of intervention used and antibiotics prescribed per 100 patients with ARIs seen, retention rates for each group, and quantitative analysis of PROM and PREM surveys. Data management Data collection and management Study data will be collected and managed using REDCap (Research Electronic Data Capture) tools hosted at the University of Wollongong [44, 45]. REDCap is a secure, web-based software platform designed to support best practice data capture for research studies. Consent and survey responses will be collected through REDCap, either through direct responses from participants or entered by the research team from hardcopy forms. Each participating GP will be provided with a unique link to the AMS Toolbox. All AMS Toolbox responses will be entered directly into REDCap. Audio recording of focus groups will be used for verbatim transcription by a professional transcription service. Transcripts will be de-identified before analysis. Only research team members and professional transcription services will have access to these audio files. To ensure data quality, incomplete demographic surveys will be queried with participants. Incomplete data AMS Toolbox forms will be excluded from analysis. PROM and PREM surveys with more than 50% missing responses will also be excluded. All qualitative and quantitative outcome data will be analyzed by members of the research team . No additional data will be collected from participants who discontinue the study. Data will be stored on Microsoft Teams and REDCap as per UOW research policy. Access will be password-controlled and limited to members of the research team and research students listed on the ethics application. Additional information regarding data storage is available in the Research Data Management Plan by request from the authors. Data monitoring committee As the feasibility study does not have a significant risk of harm or death, and as no interim analyses are planned, the study will not have a Data Safety Monitoring Board [46]. Harms such as re-consultations and hospitalizations reported to the research team will be discussed with an independent data monitor. The independent monitor retains the authority to terminate the study if safety concerns arise. Trial governance There will be regular meetings to govern the trial. A Steering Committee will meet every two months to monitor the progress of the project. The UOW research team will meet weekly to monitor the project. Dissemination Access to data Access to the final de-identified dataset will be available on request from the authors for relevant research purposes. Due to the small number of participants, only aggregate quantitative data will be provided. Dissemination policy Trial results will be disseminated by a final report and sent to participants or available on request. Additional dissemination will include conference presentations, presentations to shareholders, and publication in peer-reviewed journal articles. Authorship eligibility will be determined using CReDiT Taxonomy [47]. The full protocol and all statistical code use will be provided on request . Discussion There is a clear need to implement AMS interventions to reduce inappropriate antibiotic prescribing in general practice. Over seventy different implementation strategies have been proposed for healthcare [25, 32], but it is unclear which implementation strategies would be best placed for improving AMS in general practice, in terms of acceptability, fidelity, feasibility, scalability and sustainability [48]. The AMS Toolbox is an example of assessing and redesigning workflows, which will also collect data from audit and feedback activities [25]. The AMS Toolbox is planned to be a core component in a future definitive implementation trial, and this study will test its acceptability by users [48]. A key limitation of this work is that data collection will occur during spring and summer months, during which presentations for ARIs are typically lower [49, 50]. However, while this limitation will impact the number of times the AMS Toolbox is used, it will not affect the primary outcome of the study, which is the acceptability of the Toolbox. Another limitation of this work is the lack of progression thresholds for the trial outcomes [28]. The tools used to measure acceptability do not suggest thresholds for acceptability [36], and due to progression criteria thresholds were not set on other measures as the feasibility study results aimed to inform future work rather than determine progression to future work. Abbreviations AIM, Acceptability of Intervention Measure; AMS, Antimicrobial Stewardship; ARI, acute respiratory infections; COM-B, capability, opportunity, motivation, behaviour; CRP, C-reactive protein; IAM, Intervention Appropriateness Measure; GPs, General Practitioners; NICE, The National Institute for Health Care Excellence; OptimasGP, Optimal Implementation of Antimicrobial Stewardship in General Practice; PROM, patient-reported outcome measures; PREM, patient-reported experience measures; REDCap, Research Electronic Data Capture; UOW, University of Wollongong. Declarations Ethics approval and consent to participate: This study was approved by the University of Wollongong’s Health and Medical Human Research Ethics Committee (2024/171) Consent for publication : N/A Availability of data and materials: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Due to the small number of participants, only aggregate quantitative data will be provided. Competing interests: None. Neither sponsors nor funders had any role in the study design, collection, management, analysis, and interpretation of data, writing of the report, or the decision to submit the report for publication Funding: Australian Government’s Department of Health and Aged Care - Medical Research Future Fund (MRFF) Clinical Trials Activity [Stream 2] 2023. Author’s contributions: JM, GMR, NZ, DM, JR, GP, IG, SE, SB, CK, KM, CM, FW and MB were responsible for the conceptualization and funding acquisition. CHC was responsible for the conceptualization, funding acquisition, writing – original draft, and project administration. AB was responsible for conceptualization, funding acquisition, project administration, and supervision. MAB and MJ were responsible for project administration. All authors were responsible for the writing – review and editing. Governance: The steering committee includes the authors CHC, MB, JM, GMR, NZ, DM, JR, GP, IG, SE, SB, CK, KM, CM, FW, and AB. The data management team includes CHC, MB, JM, and AB. Acknowledgements : None. References World Health Organisation. Ten threats to global health in 2019 . 2024 1/5/2024]; Available from: https://www.who.int/news-room/spotlight/ten-threats-to-global-health-in-2019. Bell, B.G., et al., A systematic review and meta-analysis of the effects of antibiotic consumption on antibiotic resistance. BMC infectious diseases, 2014. 14 : p. 13. Dyar, O.J., et al., How can we improve antibiotic prescribing in primary care? 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Butcher, N.J., et al., Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension. Jama, 2022. 328 (23): p. 2345-2356. Abbade, L.P.F., J.F. Abbade, and L. Thabane, Introducing the CONSORT extension to pilot trials: enhancing the design, conduct and reporting of pilot or feasibility trials. J Venom Anim Toxins Incl Trop Dis, 2018. 24 : p. 4. Pinnock, H., et al., Standards for Reporting Implementation Studies (StaRI) Statement. BMJ, 2017. 356 : p. i6795. Waltz, T.J., et al., Use of concept mapping to characterize relationships among implementation strategies and assess their feasibility and importance: results from the Expert Recommendations for Implementing Change (ERIC) study. Implement Sci, 2015. 10 : p. 109. Australian Commission on Safety and Quality in Health Care, Acute bronchitis: should I take antibiotics? 2023, Australian Commission on Safety and Quality in Healthcare. National Institure forHealth and Care Excellence. Respiratory infections . 2023 20th May 2023]; Available from: https://www.nice.org.uk/guidance/conditions-and-diseases/respiratory-conditions/respiratory-infections. Centre of Disease Control., What is delayed prescribing? , C.f.D.C.a. Prevention, Editor. 2024: Atlanta, Georgia 30333. Weiner, B.J., et al., Psychometric assessment of three newly developed implementation outcome measures. Implementation science, 2017. 12 : p. 1-12. Benson, T., Measure what we want: a taxonomy of short generic person-reported outcome and experience measures (PROMs and PREMs). BMJ Open Qual, 2020. 9 (1). Braun, V. and V. Clarke, Using thematic analysis in psychology. Qualitative Research in Psychology, 2006. 3 (2): p. 77-101. 38. Atkins, L., et al., A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems. Implement Sci, 2017. 12(1): p. 77. Alexander, K.E., B. Brijnath, and D. Mazza, Barriers and enablers to delivery of the Healthy Kids Check: an analysis informed by the Theoretical Domains Framework and COM-B model. Implementation Science, 2014. 9 (1): p. 60. Proctor, E., et al., Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health, 2011. 38 (2): p. 65-76. Michie, S., M.M. van Stralen, and R. West, The behaviour change wheel: A new method for characterising and designing behaviour change interventions. Implementation Science, 2011. 6 (1): p. 42. Sinnott, C., M. Byrne, and C.P. Bradley, Improving medication management for patients with multimorbidity in primary care: a qualitative feasibility study of the MY COMRADE implementation intervention. Pilot Feasibility Stud, 2017. 3 : p. 14. Metusela, C., et al., CHIME-GP trial of online education for prescribing, pathology and imaging ordering in general practice – how did it bring about behaviour change? BMC Health Services Research, 2023. 23 (1): p. 1346. Harris, P.A., et al., The REDCap consortium: Building an international community of software platform partners. Journal of Biomedical Informatics, 2019. 95 : p. 103208. Harris, P.A., et al., Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. Journal of Biomedical Informatics, 2009. 42 (2): p. 377-381. NHMRC, Data Safety Monitoring Boards (DSMBs) , N.H.a.M.R. Council, Editor. 2018, National Health and Medical Research Council: Canberra ACT 2601. Allen, L., A. O’Connell, and V. Kiermer, How can we ensure visibility and diversity in research contributions? How the Contributor Role Taxonomy (CRediT) is helping the shift from authorship to contributorship. Learned Publishing, 2019. 32 (1): p. 71-74. Klaic, M., et al., Implementability of healthcare interventions: an overview of reviews and development of a conceptual framework. Implement Sci, 2022. 17 (1): p. 10. Grech, A.K., et al., Epidemiological trends of respiratory tract pathogens detected via mPCR in Australian adult patients before COVID-19. BMC Infect Dis, 2024. 24 (1): p. 38. Australian Centre for Disease Control, Australian Respiratory Surveillance Report - Report 10 , 2024. Table 2 Table 2 is available in the Supplementary Files section. Supplementary Files Table2.docx spirit.doc Cite Share Download PDF Status: Published Journal Publication published 30 Jul, 2025 Read the published version in Pilot and Feasibility Studies → Version 1 posted Reviewers agreed at journal 01 May, 2025 Reviewers invited by journal 01 May, 2025 Editor assigned by journal 30 Apr, 2025 First submitted to journal 28 Apr, 2025 Editorial decision: Minor revision 11 Apr, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6372829","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":450654459,"identity":"93b33bec-1c6e-43ec-a028-aaa4ec7c5a2d","order_by":0,"name":"Colin H 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03:07:42","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6372829/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6372829/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s40814-025-01686-6","type":"published","date":"2025-07-30T16:21:25+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":82300036,"identity":"151fd919-efd9-4a01-b969-161fb774eedd","added_by":"auto","created_at":"2025-05-08 20:39:37","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":35845,"visible":true,"origin":"","legend":"\u003cp\u003eStages of the OptimasGP program of research\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-6372829/v1/45ba593a85dace4e88758041.png"},{"id":82300039,"identity":"8c0dd6d2-2091-49fe-8d14-716f3772fa95","added_by":"auto","created_at":"2025-05-08 20:39:38","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":478875,"visible":true,"origin":"","legend":"\u003cp\u003eThe AMS Toolbox workflow. GPs select the resource they want to appear in the window and then record whether the antibiotic was used. Resource use and antibiotic outcome are recorded by the instrument. The AMS Toolbox is designed as a REDCap survey.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-6372829/v1/cf5e59f65104809674033ab1.png"},{"id":88268392,"identity":"ca5d1f8d-5592-4f75-907b-c06a63fe30d5","added_by":"auto","created_at":"2025-08-04 16:51:26","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1655423,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6372829/v1/13a137cb-669c-4112-9bc7-fcc95daa4540.pdf"},{"id":82300034,"identity":"dc7e4b11-ee9b-41d8-822c-491cceee61de","added_by":"auto","created_at":"2025-05-08 20:39:37","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":27079,"visible":true,"origin":"","legend":"","description":"","filename":"Table2.docx","url":"https://assets-eu.researchsquare.com/files/rs-6372829/v1/9e47038f4e58a24cc8b7ef98.docx"},{"id":82300040,"identity":"8b41cf62-c479-4ce6-864c-c41c34db065d","added_by":"auto","created_at":"2025-05-08 20:39:38","extension":"doc","order_by":5,"title":"","display":"","copyAsset":false,"role":"supplement","size":123904,"visible":true,"origin":"","legend":"","description":"","filename":"spirit.doc","url":"https://assets-eu.researchsquare.com/files/rs-6372829/v1/8aee32cbf6b97e928f1a9c70.doc"}],"financialInterests":"","formattedTitle":"Optimal Implementation of Antimicrobial Stewardship in General Practice: Protocol for a feasibility study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe World Health Organization considers antimicrobial resistance as one of the top 10 threats to global health\u0026nbsp;[1]. Of particular concern is antibiotic resistance, which is fueled by inappropriate use of antibiotics\u0026nbsp;[2]. The majority of antibiotics in the developed world are prescribed in primary care (general practice) settings, with over half used to treat acute respiratory infections (ARIs) [3, 4]. Most ARIs in otherwise healthy adults are caused by viruses and do not respond to antibiotic treatment -\u0026nbsp;for example, viruses cause 90% of acute bronchitis cases\u0026nbsp;[5]. An Australia-wide audit of routinely collected data found that 81.5% of patients with acute bronchitis received antibiotics, despite no evidence\u0026nbsp;\u0026nbsp;that antibiotics are beneficial in these cases\u0026nbsp;[4]. Community antibiotic prescribing rates in Australia were more than double those of the Netherlands\u0026nbsp;[4] and Sweden\u0026nbsp;[6] and four to nine-times higher than Australia\u0026rsquo;s own national guideline recommendations\u0026nbsp;[7]. One of the strategies which can be used to address the inappropriate prescribing of antibiotics is through anti-microbial stewardship (AMS) interventions. AMS interventions aim to measure and improve both clinician prescribing and patient use of antibiotics\u0026nbsp;[8].\u003c/p\u003e\n\u003cp\u003eThere is robust evidence that AMS interventions effectively reduce inappropriate antibiotic prescribing in general practice during face-to face consultations for ARIs [9, 10]. For example, shared decision-making, which involves discussion and collaboration between patients and their healthcare provider [11-13] is estimated to reduce antibiotic use by 36% [14]. Other AMS interventions which improve the appropriate prescribing of antibiotics in ARIs include clinical decision support resources [10, 11], which may include guideline-based algorithms or the use of biomarker point-of-care testing for C-reactive protein [10, 14]. Both computerized and paper-based clinical decision support have been shown to reduce antibiotic prescribing for ARIs in primary care and hospital settings [15], and biomarker point-of-care testing is estimated to reduce antibiotic use for ARIs by 32% [16, 17]. Another approach to AMS is using delayed prescribing, where patients are not prescribed antibiotics at the time of the consultation but have a mechanism for access to a prescription for antibiotics, if symptoms fail to improve or worsen over a defined timeframe. Delayed prescribing is estimated to reduce antibiotic use for ARIs in primary care by 34-76% [10]. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe challenges in effectively implementing AMS interventions in general practice in Australia are complex and multifaceted. Key factors include perceptions of patient expectations for antibiotic prescriptions, GPs\u0026rsquo; consultation time pressures, clinical uncertainty, and concerns about adverse outcomes from not prescribing antibiotics [9, 18, 19].\u0026nbsp;Pivotal studies of AMS in general practice have used a variety of implementation strategies, including mixed self-paced and interactive online education, peer-group audits, communication workshops, and in-person practice facilitation [20-24]. Assessing and redesigning workflows is a less commonly used implementation strategy but has been found to be effective [25]. However, the costs and scalability of these implementation strategies varied widely [20, 23]. Due to a lack of direct comparisons between these implementation strategies, it remains unclear which are most effective in promoting the uptake of evidence-based AMS interventions in general practice [26].\u003c/p\u003e\n\u003cp\u003eThis feasibility study is part of a program of research called the Optimal Implementation of Antimicrobial Stewardship in General Practice (OptimasGP). The OptimasGP trial includes a co-design phase, a feasibility study, and a definitive Hybrid Type 3 implementation study [27] (Figure 1). As part of the OptimasGP trial, the workflow of how GPs access AMS resources was redesigned to centralize resources and collect outcome data in a single tool, which will be referred to as the AMS Toolbox. The co-design study reported on the barriers and facilitators of using AMS resources for shared decision-making, clinical decision support, and delayed prescribing. The findings of this stage were incorporated into the feasibility in a process that will be reported in a separate article. The current protocol is for the external feasibility study conducted as part of the research development process [28]. Due to the nature of the project, this feasibility study will inform a future implementation study but will not but will not be used to determine progression.\u003c/p\u003e\n\u003ch3\u003eAims and objectives\u003c/h3\u003e\n\u003cp\u003eThe aim of this feasibility study (Stage 2) is to assess the acceptability, feasibility, and utility of the trial method to inform the definitive implementation trial (Stage 3).The primary objective of this feasibility is to determine the acceptability of the AMS Toolbox for providing AMS resources and collecting relevant data. We define acceptability as the extent to which the individuals delivering care (e.g., GPs and practice staff) or receiving care (e.g., patients) using the AMS toolbox consider it to be appropriate. The secondary objectives are to 1) measure rates of recruitment and retention, 2) optimise the work-flow integration of the AMS Toolbox, 3) validate data collected through the AMS Toolbox against a manual electronic health record audit, and 4) test procedures for measuring Patient Reported Outcome Measures (PROMs) (e.g. re-consultations or hospitalizations) and Patient Reported Experience Measures (PREMs) (e.g. satisfaction).\u0026nbsp;\u003c/p\u003e\n"},{"header":"Methods","content":"\u003ch2\u003eStudy design\u003c/h2\u003e\n\u003ch3\u003eDesign\u003c/h3\u003e\n\u003cp\u003e\u0026nbsp;A mixed method, single-arm, pragmatic feasibility study will be used to assess the acceptability and feasibility of data collection using the AMS Toolbox and associated training (the implementation) to support the use of AMS resources (the intervention) for the treatment of patients with ARIs in general practice.\u003c/p\u003e\n\u003ch3\u003eProcess\u003c/h3\u003e\n\u003cp\u003e\u0026nbsp;GPs who have volunteered to be part of the study will consult with adult patients (18 years or older) with ARIs as per their standard clinical practice. GPs will access the AMS Toolbox online and select AMS interventions they plan to use (\u003cstrong\u003eFigure 2\u003c/strong\u003e). An example of the AMS Toolbox is available online. At the conclusion of the consultation, GPs may prescribe an antibiotic or other medical treatment according to their standard clinical care practice. Selection of resources and antibiotic prescriptions will be recorded in the AMS Toolbox. All concomitant usual care is permitted during the trial. Usual care will continue throughout the trial, with no additional ancillary or post-trial care beyond standard practice. The study will be run for a duration of twelve weeks.\u003c/p\u003e\n\u003ch3\u003eReporting\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThis study is reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist [29]. As this is a feasibility \u0026nbsp;study, items 2a and 20 were included from the Consolidated Standards of Reporting Trials (CONSORT) checklist for pilot or feasibility trials [30]. Implementation and interventions have been separated as per the Standards for Reporting Implementation Studies (StaRI) checklist [31]. Any protocol amendments will be noted in the publication of results.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eEthical approval and registration\u003c/h3\u003e\n\u003cp\u003eThis study was approved by the University of Wollongong’s Health and Medical Human Research Ethics Committee (2024/171) and registered prospectively with the Australian and New Zealand Clinical Trial Registry (ACTRN12624001011572). Amendments to the protocol will be updated in the trial registration and reported in the primary outcome paper.\u003c/p\u003e\n\u003ch2\u003eStudy setting and participants\u0026nbsp;\u003c/h2\u003e\n\u003ch3\u003eSites\u003c/h3\u003e\n\u003cp\u003eThe study will be conducted at 4-6 general practices (also known as primary care clinics) in New South Wales, Australia. These sites will be recruited through the University of Wollongong’s Practice-Based Research Network. Each site will be paid an onboarding fee of $1000 and $600 per participating GP, to support the administrative aspects of the study (\u003cstrong\u003eTable 1\u003c/strong\u003e).\u003c/p\u003e\n\u003ch3\u003eGeneral practitioners\u003c/h3\u003e\n\u003cp\u003eTwelve GPs will be recruited from participating general practice sites using a participant information sheet and consent form. Recruitment will be conducted via email, phone, and face-to-face meetings. The inclusion criteria is that GPs are working at a participating practice for at least three days each week. There are no exclusion criteria. Participating GPs will complete 2 hours of online training at the start of the baseline period, collect data for 12 weeks, and participate in a 1.5 hour focus group at the end of the study. To improve recruitment and retention, GPs will receive $150/hour for all training and focus group activities and $50/week for data collection (\u003cstrong\u003eTable 1\u003c/strong\u003e).\u003c/p\u003e\n\u003ch3\u003eGeneral Practice Staff\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eSix to eight general practice staff from participating sites will be recruited using a practice staff participant information sheet and consent form. Staff recruitment will be conducted using email, phone, and face-to-face meetings. The inclusion criteria require staff to work at a participating practice for at least three days each week, with no additional exclusion criteria. Participating staff will complete 2 hours of online training at the start of the baseline period, provide administrative support throughout the study period, and participate in a 1.5 hour focus group at the end of the study. To improve recruitment and retention, staff will receive $150/hour for training and focus group activities (\u003cstrong\u003eTable 1\u003c/strong\u003e).\u003c/p\u003e\n\u003ch3\u003esPatient surveys\u003c/h3\u003e\n\u003cp\u003eDuring the three month trial, patients who consulted with a participating GP for an ARI will receive information cards inviting them to complete anonymous surveys, with survey completion considered tacit consent. Ten to twenty patients are expected to complete a Patient Reported Outcome Measure (PROM) survey. The inclusion criteria for the PROM survey are that patients consulted with a participating GP for an ARI and subsequently either re-consulted or are hospitalized within 30 days. Additionally, between 50-100 patients are expected to complete the Patient Reported Experience Measure (PREM) survey. For the PREM survey, the inclusion criteria are that patients consulted with a participating GP for an ARI. Completion of either survey will be considered tacit consent. To encourage participation, patients who complete the survey will be eligible to win one of five $50 vouchers (patients will submit their contact details separately to the anonymous survey).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTen to twelve patients who completed the surveys will be recruited to participate in the focus groups at the completion of the study. These patients will be required to complete a written consent form. The inclusion criteria for these patients are that they consulted with a participating GP for an ARI, completed a PROM or PREM survey, and are able to read and speak English. Patients who participate in the one-hour focus group discussions will receive a $50 voucher.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eTiming\u003c/h3\u003e\n\u003cp\u003eRecruitment for the study will occur between 4 September 2024 and 30 November 2024. The date of final data collection is estimated to be 28 February 2025.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eAllocation and power calculation\u003c/h3\u003e\n\u003cp\u003eAll participants will be allocated to a single arm of the trial, hence no blinding or power calculation is required.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eTable 1\u003c/strong\u003e. Summary of site and participant groups\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"1030\"\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eSite/ group\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eNumber recruited\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eCriteria\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eRecruitment strategy\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eConsent\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eIncentives for participating\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"6\" style=\"width: 1030px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eHealthcare providers\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003e\n \u003cp\u003eGeneral Practices\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e4-6\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003eLocated in NSW\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003eRecruited through UOW’s practice-based research network\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003eWritten consent from practice owner/manager\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e$1,000 onboarding\u003c/p\u003e\n \u003cp\u003e$600 per participating GP\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003e\n \u003cp\u003eGeneral practitioners\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e2-3 per practice\u003c/p\u003e\n \u003cp\u003e10-12 in total\u003c/p\u003e\n \u003c/td\u003e\u003ctd rowspan=\"2\"\u003e\n \u003cp\u003eWorking at least three days per week at a participating practice\u003c/p\u003e\n \u003c/td\u003e\u003ctd rowspan=\"2\"\u003e\n \u003cp\u003eDirect emails and face-to-face meetings with staff at participating practices\u003c/p\u003e\n \u003c/td\u003e\u003ctd rowspan=\"2\"\u003e\n \u003cp\u003eIndividual written consent\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e$1125 for training, data collection, and participating in a focus group\u003c/p\u003e\n \u003cp\u003e3.5 hours of continuing professional development\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003e\n \u003cp\u003ePractice staff\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e1-2 per practice\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e6-8 in total\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e$350 for training and participating in a focus group\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"6\" style=\"width: 1030px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePatients\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003e\n \u003cp\u003ePREM Survey\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e50-100\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003eConsulted with a participating GP for an ARI\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003ePatient information cards given by participating GPs\u003c/p\u003e\n \u003c/td\u003e\u003ctd rowspan=\"2\"\u003e\n \u003cp\u003eTacit consent\u003c/p\u003e\n \u003c/td\u003e\u003ctd rowspan=\"2\"\u003e\n \u003cp\u003eChance to win one of five $50 vouchers\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003e\n \u003cp\u003ePROM Survey\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e10-20\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003eConsulted with a participating GP for an ARI, re-consult or are hospitalized within 30 days\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003ePatient information cards given by participating GPs\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd\u003e\n \u003cp\u003eFocus groups\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e10-12\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003eConsulted with a participating GP for a RTI, completed a patient survey, able to read and speak English\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003eRequest for participation at the\u0026nbsp;completion of patient surveys\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003eIndividual written consent\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\u003ctd\u003e\n \u003cp\u003e$50 voucher for participating in a 1hr focus group\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"6\" valign=\"top\" style=\"width: 1030px;\"\u003e\n \u003cp\u003eUOW, University of Wollongong; PROM, the patient-reported outcome measure; PREM, the patient-reported experience measure. Payments are in\u0026nbsp;Australian dollars.\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;Implementation strategies\u003c/p\u003e\n\u003cp\u003eThe implementation strategies used are defined using the ERIC guidelines [32], including updated items for assessing and redesigning workflow [25].\u003c/p\u003e\n\u003ch4\u003eAssess and redesign workflow\u003c/h4\u003e\n\u003cp\u003eThe AMS Toolbox will be used in standard patient consultations at participating general practices. As the AMS Toolbox is accessed online, participating GPs are expected to have access to a computer and the internet as part of their standard practice. The AMS Toolbox is a centralisation of multiple intervention resources (see intervention resources below) that are ordinarily accessible from separate websites or sources. The AMS Toolbox’s resources are also provided in hardcopy. Each GP will be provided a unique link to their own AMS Toolbox. A new survey is generated for each patient when the participating GP accesses the link. The GP selects the resource(s) to use, and then may print them or show them to the patient as part of the consultation. The AMS Toolbox will record which resources were accessed, and the GP records the outcome of the consultation (e.g. was an antibiotic prescribed for immediate use, was an antibiotic prescribed for delayed use, or was no antibiotic prescribed).\u003c/p\u003e\n\u003ch4\u003eConduct educational meetings\u003c/h4\u003e\n\u003cp\u003eGPs and practice staff will be provided with approximately two hours of online training from the research team prior to commencing the study. This training will cover the background of AMS, the need for AMS in general practice, and the role of GPs and practice staff in the study. This will include training on use of the point-of-care testing devices (mentioned below) for both GPs and practice staff in the study.\u003c/p\u003e\n\u003ch4\u003eRemind clinicians\u003c/h4\u003e\n\u003cp\u003eParticipating GPs will be given a physical card to place on their desks to remind them to use the AMS Toolbox during consultations with adults presenting with ARIs.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eIntervention resources\u003c/h3\u003e\n\u003cp\u003eThe following AMS resources will be provided in the online AMS Toolbox. They will also be provided in hardcopy to the GPs.\u003c/p\u003e\n\u003ch4\u003eShared decision-making\u003c/h4\u003e\n\u003cp\u003eShared decision-making between GPs and patients involves ‘discussion and collaboration between a consumer and their healthcare provider’ [11]. The Australian Commission on Safety and Quality in Health Care’s Decision Aid [33] is included as a resource for shared decision-making.\u003c/p\u003e\n\u003ch4\u003eClinical decision support\u003c/h4\u003e\n\u003cp\u003eClinical decision support systems, such as evidence-based diagnostic and treatment algorithms, will be provided to GPs [10]. The National Institute for Health Care Excellence (NICE) resource for ‘Cough (acute): antimicrobial prescribing’ [34] is included as an example of a clinical decision support.\u0026nbsp;\u003c/p\u003e\n\u003ch4\u003eC-Reactive Protein testing\u003c/h4\u003e\n\u003cp\u003eNational Institute for Health and Care Excellence Guidelines in the UK [34] recommend that biomarker point-of-care testing can augment clinical decision support to assist in diagnostic accuracy [10, 14]. Finger-prick tests will be conducted for C-reactive protein (CRP). A CRP level of \u0026lt;20mg/L indicates that bacterial infection is unlikely, and provides support for not prescribing an antibiotic. A CRP level between 20-100mg/L suggests a bacterial infection may be possible, warranting consideration of an antibiotic dependent on other factors (e.g. whether the patient has a chronic respiratory disease). While a CRP level above 100mg/L suggests the infection is bacterial, and an antibiotic should be prescribed. The point-of-care testing devices were the Afinion 2 analyser (Abbott Rapid Diagnostics, NSW, Australia) and the QuikRead Pro (Abacus DX Pty LTD, QLD, Australia). Results from these testing devices will not be recorded as part of the study, and will only be used as part of the clinical decision-making process. There will be no additional charge to the patient for the test.\u0026nbsp;\u003c/p\u003e\n\u003ch4\u003eDelayed prescribing\u0026nbsp;\u003c/h4\u003e\n\u003cp\u003eThe original delayed prescribing resource considered was the Centre for Disease Control’s Delayed Prescribing resource [35]. Following co-design discussions, a new version of this resource was created in response to participant input. Both resources will be provided in the AMS Toolbox.\u003c/p\u003e\n\u003ch2\u003eMeasures\u003c/h2\u003e\n\u003cp\u003eOutcome measures and their alignment with the study objectives are listed in \u003cstrong\u003eTable 1\u003c/strong\u003e. \u0026nbsp;Additional data, including site characteristics and participant demographics, will also be collected.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1\u003c/strong\u003e How study goals are informed by data collection tools\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"582\"\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd valign=\"top\" style=\"width: 28px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 185px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eOBJECTIVE\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGROUP\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\u003ctd valign=\"top\" style=\"width: 250px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMeasures\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 185px;\"\u003e\n \u003cp\u003ePRIMARY\u003c/p\u003e\n \u003cp\u003eAcceptability of AMS Toolbox\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 119px;\"\u003e\n \u003cp\u003eGPs\u003c/p\u003e\n \u003cp\u003ePractice staff\u003c/p\u003e\n \u003cp\u003ePatients\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 250px;\"\u003e\n \u003cp\u003eFocus groups\u003c/p\u003e\n \u003cp\u003eAcceptability of Intervention Measure (AIM)\u0026nbsp;[36]\u003c/p\u003e\n \u003cp\u003eIntervention Appropriateness Measure (IAM) [36]\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 185px;\"\u003e\n \u003cp\u003eSECONDARY\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 119px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 250px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 185px;\"\u003e\n \u003cp\u003eRecruitment\u003c/p\u003e\n \u003cp\u003eand retention\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 119px;\"\u003e\n \u003cp\u003eGPs\u003c/p\u003e\n \u003cp\u003ePractice staff\u003c/p\u003e\n \u003cp\u003ePatients\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 250px;\"\u003e\n \u003cp\u003eRecruitment and completion rates\u003c/p\u003e\n \u003cp\u003eFocus groups\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 185px;\"\u003e\n \u003cp\u003eOptimise the work-flow integration of the AMS Toolbox\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 119px;\"\u003e\n \u003cp\u003eGPs\u003c/p\u003e\n \u003cp\u003ePractice staff\u003c/p\u003e\n \u003cp\u003ePatients\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 250px;\"\u003e\n \u003cp\u003eFocus groups\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 185px;\"\u003e\n \u003cp\u003eValidation of AMS data collection\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 119px;\"\u003e\n \u003cp\u003eGPs\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 250px;\"\u003e\n \u003cp\u003eIntervention use\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eAntibiotic prescription rates\u003c/p\u003e\n \u003cp\u003eAudit of practice data\u003c/p\u003e\n \u003cp\u003eFocus groups\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd style=\"width: 28px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 185px;\"\u003e\n \u003cp\u003eTest procedures for PROMS and PREMS\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 119px;\"\u003e\n \u003cp\u003ePatients\u003c/p\u003e\n \u003c/td\u003e\u003ctd style=\"width: 250px;\"\u003e\n \u003cp\u003ePREM survey\u003c/p\u003e\n \u003cp\u003ePROM survey\u003c/p\u003e\n \u003cp\u003eFocus groups\u003c/p\u003e\n \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;Focus groups\u003c/p\u003e\n\u003cp\u003eFocus groups, consisting of 2-6 participants, will be conducted online, with separate sessions for each participant group (GPs, GP staff, and patients). Sessions will last 90 minutes for GPs and practice staff, and 60 minutes for patients. Focus groups will be facilitated by a member of the research team, recorded and transcribed verbatim.\u0026nbsp;The focus group guide was developed by co-authors based on their clinical and professional expertise, in general practice etc. Focus group guides included open-ended questions about AMS Toolbox acceptability, appropriateness and utility, and feedback on AMS Toolbox resources and study procedures (e.g., remuneration, on-boarding, patient recruitment, audit and POCT devices)\u003c/p\u003e\n\u003ch4\u003eAIM and IAM measures\u003c/h4\u003e\n\u003cp\u003eDuring focus groups, participants will be asked to complete the Acceptability of Intervention Measure (AIM) and the Intervention Appropriateness Measure (IAM)\u0026nbsp;[36] Both scales have four items that are scored using a 5-point Likert scale from ‘Completely disagree’ to ‘Completely agree’.\u003c/p\u003e\n\u003ch4\u003eRecruitment and completion rates\u003c/h4\u003e\n\u003cp\u003eQuantitative data for recruitment and retention of all participating groups will be determined from data collected in REDCap.\u0026nbsp;\u003c/p\u003e\n\u003ch4\u003eIntervention use and antibiotic prescription rates\u003c/h4\u003e\n\u003cp\u003eDuring each consultation, the GP will record which AMS resources were used. Participating GPs may also \u0026nbsp;indicate that no AMS resource was used during the consultation. Data will also be collected on whether an antibiotic was prescribed for immediate use, delayed use, or not at all.\u003c/p\u003e\n\u003ch4\u003eAudit of practice data\u003c/h4\u003e\n\u003cp\u003eAn audit of prescription rates will be undertaken to compare AMS Toolbox results to study site records. The audit will include a measure of patient numbers, the number of patients with ARIs, and the number of antibiotics prescribed to patients with ARIs. Staff at each participating practice will conduct the audit. This will require examining medical records, which the practice nurse can access as part of their normal duties. The audit will be reported using a simple survey that identifies the participating GP but not patient information, and is expected to take between 60-120 minutes per month.\u003c/p\u003e\n\u003ch4\u003ePatient-reported experience measure survey (PROM)\u003c/h4\u003e\n\u003cp\u003eThe survey will include a patient information statement and four short questions regarding patient consultation and hospitalizations.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Patient-reported experience measure survey (PREM)\u003c/p\u003e\n\u003cp\u003ePREM surveys include six questions adapted from a standard list [36]. Quantitative questions were selected from the domains of patient experience (e.g. ‘I am happy with my treatment’), shared decisions (e.g. ‘I feel fully involved in decisions about me’) and health confidence (e.g. ‘I can get the right help if I need it’). A seventh item allows for free-text responses.\u003c/p\u003e\n\u003ch4\u003eGeneral Practice Site data survey\u003c/h4\u003e\n\u003cp\u003e\u0026nbsp;At the time of recruitment, general practice site data will be collected via identifiable surveys, including practice location, patient volume, and staffing levels\u003c/p\u003e\n\u003ch4\u003eDemographics survey\u003c/h4\u003e\n\u003cp\u003eAt recruitment of GPs and practice staff, demographic data will be collected using identifiable questionnaires. Surveys will include standard demographic questions e.g. gender, years of experience in primary care.\u003c/p\u003e\n\u003ch3\u003eTiming and workflow\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThe timing of data collection is shown in \u003cstrong\u003eTable 2\u003c/strong\u003e.\u003c/p\u003e\n\u003ch2\u003eAnalysis plan\u003c/h2\u003e\n\u003ch3\u003eQualitative analysis\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eFocus group data will be analyzed thematically [37], guided by the Theoretical Domains Framework [38], the COM-B framework [39] and conceptual frameworks for implementation outcomes [40]. These frameworks will provide guidance on the determinants of current and desired behaviors and assist the analysis of targeted behaviors of interventions, [41] and in assessing implementation outcomes [42]. They have been used to assess behavior change in healthcare settings, including general practice [43]. Transcriptions of audio-taped focus group discussions will be coded inductively by two independent coders, with codes compared and categorized into broader overarching themes. Disagreements will be resolved through discussion with a third researcher. This will be followed by categorization of themes according to the 14 domains of the Theoretical Domains Framework and corresponding COM-B framework.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eQuantitative analysis\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eQuantitative analysis will be conducted in R. Analysis of quantitative outcomes will be descriptive in nature, and will include the rates of intervention used and antibiotics prescribed per 100 patients with ARIs seen, retention rates for each group, and quantitative analysis of PROM and PREM surveys.\u0026nbsp;\u003c/p\u003e\n\n\n\n\n\n\n\n\n\n\n\n\n\n"},{"header":"Data management","content":"\u003ch3\u003eData collection and management\u003c/h3\u003e\u003cp\u003eStudy data will be collected and managed using REDCap (Research Electronic Data Capture) tools hosted at the University of Wollongong [44, 45]. REDCap is a secure, web-based software platform designed to support best practice data capture for research studies. Consent and survey responses will be collected through REDCap, either through direct responses from participants or entered by the research team from hardcopy forms. Each participating GP will be provided with a unique link to the AMS Toolbox. All AMS Toolbox responses will be entered directly into REDCap.\u003c/p\u003e\u003cp\u003eAudio recording of focus groups will be used for verbatim transcription by a professional transcription service. Transcripts will be de-identified before analysis. Only research team members and professional transcription services will have access to these audio files. To ensure data quality, incomplete demographic surveys will be queried with participants. Incomplete data AMS Toolbox forms will be excluded from analysis. \u0026nbsp;PROM and PREM surveys with more than 50% missing responses will also be excluded. All qualitative and quantitative outcome data will be analyzed by members of the research team\u003cem\u003e.\u003c/em\u003e No additional data will be collected from participants who discontinue the study.\u003c/p\u003e\u003cp\u003eData will be stored on Microsoft Teams and REDCap as per UOW research policy. Access will be password-controlled and limited to members of the research team and research students listed on the ethics application. Additional information regarding data storage is available in the Research Data Management Plan by request from the authors.\u003c/p\u003e\u003ch3\u003eData monitoring committee\u003c/h3\u003e\u003cp\u003eAs the feasibility study does not have a significant risk of harm or death, and as no interim analyses are planned, the study will not have a Data Safety Monitoring Board [46]. Harms such as re-consultations and hospitalizations reported to the research team will be discussed with an independent data monitor. \u0026nbsp;The independent monitor retains the authority to terminate the study if safety concerns arise.\u003c/p\u003e\u003ch2\u003eTrial governance\u003c/h2\u003e\u003cp\u003eThere will be regular meetings to govern the trial. A Steering Committee will meet every two months to monitor the progress of the project. The UOW research team will meet weekly to monitor the project.\u0026nbsp;\u003c/p\u003e\u003ch2\u003eDissemination \u0026nbsp;\u003c/h2\u003e\u003ch3\u003eAccess to data\u003c/h3\u003e\u003cp\u003eAccess to the final de-identified dataset will be available on request from the authors for relevant research purposes. Due to the small number of participants, only aggregate quantitative data will be provided.\u0026nbsp;\u003c/p\u003e\u003ch3\u003eDissemination policy\u003c/h3\u003e\u003cp\u003eTrial results will be disseminated by a final report and sent to participants or available on request. Additional dissemination will include conference presentations, presentations to shareholders, and publication in peer-reviewed journal articles. Authorship eligibility will be determined using CReDiT Taxonomy [47]. The full protocol and all statistical code use will be provided on request\u003cem\u003e.\u003c/em\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThere is a clear need to implement AMS interventions to reduce inappropriate antibiotic prescribing in general practice. Over seventy different implementation strategies have been proposed for healthcare [25, 32], but it is unclear which implementation strategies would be best placed for improving AMS in general practice, in terms of acceptability, fidelity, feasibility, scalability and sustainability [48]. The AMS Toolbox is an example of assessing and redesigning workflows, which will also collect data from audit and feedback activities [25]. The AMS Toolbox is planned to be a core component in a future definitive implementation trial, and this study will test its acceptability by users [48].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA key limitation of this work is that data collection will occur during spring and summer months, during which presentations for ARIs are typically lower [49, 50]. However, while this limitation will impact the number of times the AMS Toolbox is used, it will not affect the primary outcome of the study, which is the acceptability of the Toolbox.\u0026nbsp;Another limitation of this work is the lack of progression thresholds for the trial outcomes [28]. The tools used to measure acceptability do not suggest thresholds for acceptability [36], and due to progression criteria thresholds were not set on other measures as the feasibility study results aimed to inform future work rather than determine progression to future work.\u003c/p\u003e\n"},{"header":"Abbreviations","content":"\u003cp\u003eAIM, Acceptability of Intervention Measure; AMS, Antimicrobial Stewardship; \u0026nbsp;ARI, acute respiratory infections; COM-B, capability, opportunity, motivation, behaviour; CRP, C-reactive protein; \u0026nbsp;IAM, Intervention Appropriateness Measure; GPs, General Practitioners; NICE, The National Institute for Health Care Excellence; \u0026nbsp;OptimasGP, Optimal Implementation of Antimicrobial Stewardship in General Practice; PROM, patient-reported outcome measures; PREM, patient-reported experience measures; REDCap, Research Electronic Data Capture; UOW, University of Wollongong.\u003c/p\u003e\n"},{"header":"Declarations","content":"\u003cp\u003eEthics approval and consent to participate: This study was approved by the University of Wollongong\u0026rsquo;s Health and Medical Human Research Ethics Committee (2024/171)\u003c/p\u003e\n\u003cp\u003eConsent for publication :\u0026nbsp;N/A\u003c/p\u003e\n\u003cp\u003eAvailability of data and materials:\u0026nbsp;The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Due to the small number of participants, only aggregate quantitative data will be provided.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCompeting interests:\u0026nbsp;None.\u0026nbsp;Neither sponsors nor funders had any role in the study design, collection, management, analysis, and interpretation of data, writing of the report, or the decision to submit the report for publication\u003c/p\u003e\n\u003cp\u003eFunding:\u0026nbsp;Australian Government\u0026rsquo;s Department of Health and Aged Care - Medical Research Future Fund (MRFF) Clinical Trials Activity [Stream 2] 2023.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAuthor\u0026rsquo;s contributions: JM, GMR, NZ, DM, JR, GP, IG, SE, SB, CK, KM, CM, FW and MB were responsible for the conceptualization and funding acquisition. CHC was responsible for the conceptualization, funding acquisition, writing \u0026ndash; original draft, and project administration. AB was responsible for conceptualization, funding acquisition, project administration, and supervision. MAB and MJ were responsible for project administration. All authors were responsible for the writing \u0026ndash; review and editing.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eGovernance:\u0026nbsp;\u003c/strong\u003eThe steering committee includes the authors CHC, MB, JM, GMR, NZ, DM, JR, GP, IG, SE, SB, CK, KM, CM, FW, and AB. The data management team includes CHC, MB, JM, and AB.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e: None.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eWorld Health Organisation. \u003cem\u003eTen threats to global health in 2019\u003c/em\u003e. 2024 1/5/2024]; Available from: https://www.who.int/news-room/spotlight/ten-threats-to-global-health-in-2019.\u003c/li\u003e\n\u003cli\u003eBell, B.G., et al., \u003cem\u003eA systematic review and meta-analysis of the effects of antibiotic consumption on antibiotic resistance.\u003c/em\u003e BMC infectious diseases, 2014. \u003cstrong\u003e14\u003c/strong\u003e: p. 13.\u003c/li\u003e\n\u003cli\u003eDyar, O.J., et al., \u003cem\u003eHow can we improve antibiotic prescribing in primary care?\u003c/em\u003e Expert Review of Anti-infective Therapy, 2016. \u003cstrong\u003e14\u003c/strong\u003e: p. 403-413.\u003c/li\u003e\n\u003cli\u003eAustralian Commission on Safety and Quality in Health Care, \u003cem\u003eAURA 2021: Fourth Australian report on antimicrobial use and resistance in human health\u003c/em\u003e. 2021. p. 308.\u003c/li\u003e\n\u003cli\u003eTherapeutic Guidelines. \u003cem\u003eTherapeutic Guidelines\u003c/em\u003e. 2023: Melbourne, Victoria, Australia.\u003c/li\u003e\n\u003cli\u003eGlasziou, P., et al., \u003cem\u003eAntibiotic stewardship: A review of successful, evidence-based primary care strategies.\u003c/em\u003e AJGP, 2022. \u003cstrong\u003e51\u003c/strong\u003e: p. 15-20.\u003c/li\u003e\n\u003cli\u003eMcCullough, A.R., et al., \u003cem\u003eAntibiotics for acute respiratory infections in general practice: comparison of prescribing rates with guideline recommendations.\u003c/em\u003e MJA, 2017. \u003cstrong\u003e207\u003c/strong\u003e: p. 65-69.\u003c/li\u003e\n\u003cli\u003eCentre of Disease Control. \u003cem\u003eCore Elements of Antibiotic Stewardship\u003c/em\u003e. 2021 6th May 2023]; Available from: https://www.cdc.gov/antibiotic-use/core-elements/index.html.\u003c/li\u003e\n\u003cli\u003eAustralian Commission on Safety and Quality in Health Care. \u003cem\u003eChapter 13 - Role of general practice in antimicrobial stewardship\u003c/em\u003e. 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Abbade, and L. Thabane, \u003cem\u003eIntroducing the CONSORT extension to pilot trials: enhancing the design, conduct and reporting of pilot or feasibility trials.\u003c/em\u003e J Venom Anim Toxins Incl Trop Dis, 2018. \u003cstrong\u003e24\u003c/strong\u003e: p. 4.\u003c/li\u003e\n\u003cli\u003ePinnock, H., et al., \u003cem\u003eStandards for Reporting Implementation Studies (StaRI) Statement.\u003c/em\u003e BMJ, 2017. \u003cstrong\u003e356\u003c/strong\u003e: p. i6795.\u003c/li\u003e\n\u003cli\u003eWaltz, T.J., et al., \u003cem\u003eUse of concept mapping to characterize relationships among implementation strategies and assess their feasibility and importance: results from the Expert Recommendations for Implementing Change (ERIC) study.\u003c/em\u003e Implement Sci, 2015. \u003cstrong\u003e10\u003c/strong\u003e: p. 109.\u003c/li\u003e\n\u003cli\u003eAustralian Commission on Safety and Quality in Health Care, \u003cem\u003eAcute bronchitis: should I take antibiotics?\u003c/em\u003e 2023, Australian Commission on Safety and Quality in Healthcare.\u003c/li\u003e\n\u003cli\u003eNational Institure forHealth and Care Excellence. \u003cem\u003eRespiratory infections\u003c/em\u003e. 2023 20th May 2023]; Available from: https://www.nice.org.uk/guidance/conditions-and-diseases/respiratory-conditions/respiratory-infections.\u003c/li\u003e\n\u003cli\u003eCentre of Disease Control., \u003cem\u003eWhat is delayed prescribing?\u003c/em\u003e, C.f.D.C.a. Prevention, Editor. 2024: Atlanta, Georgia 30333.\u003c/li\u003e\n\u003cli\u003eWeiner, B.J., et al., \u003cem\u003ePsychometric assessment of three newly developed implementation outcome measures.\u003c/em\u003e Implementation science, 2017. \u003cstrong\u003e12\u003c/strong\u003e: p. 1-12.\u003c/li\u003e\n\u003cli\u003eBenson, T., \u003cem\u003eMeasure what we want: a taxonomy of short generic person-reported outcome and experience measures (PROMs and PREMs).\u003c/em\u003e BMJ Open Qual, 2020. \u003cstrong\u003e9\u003c/strong\u003e(1).\u003c/li\u003e\n\u003cli\u003eBraun, V. and V. Clarke, \u003cem\u003eUsing thematic analysis in psychology.\u003c/em\u003e Qualitative Research in Psychology, 2006. \u003cstrong\u003e3\u003c/strong\u003e(2): p. 77-101.\u003c/li\u003e\n\u003cli\u003e\u003cem\u003e38. Atkins, L., et al., A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems. Implement Sci, 2017. 12(1): p. 77.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eAlexander, K.E., B. Brijnath, and D. Mazza, \u003cem\u003eBarriers and enablers to delivery of the Healthy Kids Check: an analysis informed by the Theoretical Domains Framework and COM-B model.\u003c/em\u003e Implementation Science, 2014. \u003cstrong\u003e9\u003c/strong\u003e(1): p. 60.\u003c/li\u003e\n\u003cli\u003eProctor, E., et al., \u003cem\u003eOutcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda.\u003c/em\u003e Adm Policy Ment Health, 2011. \u003cstrong\u003e38\u003c/strong\u003e(2): p. 65-76.\u003c/li\u003e\n\u003cli\u003eMichie, S., M.M. van Stralen, and R. West, \u003cem\u003eThe behaviour change wheel: A new method for characterising and designing behaviour change interventions.\u003c/em\u003e Implementation Science, 2011. \u003cstrong\u003e6\u003c/strong\u003e(1): p. 42.\u003c/li\u003e\n\u003cli\u003eSinnott, C., M. Byrne, and C.P. Bradley, \u003cem\u003eImproving medication management for patients with multimorbidity in primary care: a qualitative feasibility study of the MY COMRADE implementation intervention.\u003c/em\u003e Pilot Feasibility Stud, 2017. \u003cstrong\u003e3\u003c/strong\u003e: p. 14.\u003c/li\u003e\n\u003cli\u003eMetusela, C., et al., \u003cem\u003eCHIME-GP trial of online education for prescribing, pathology and imaging ordering in general practice \u0026ndash; how did it bring about behaviour change?\u003c/em\u003e BMC Health Services Research, 2023. \u003cstrong\u003e23\u003c/strong\u003e(1): p. 1346.\u003c/li\u003e\n\u003cli\u003eHarris, P.A., et al., \u003cem\u003eThe REDCap consortium: Building an international community of software platform partners.\u003c/em\u003e Journal of Biomedical Informatics, 2019. \u003cstrong\u003e95\u003c/strong\u003e: p. 103208.\u003c/li\u003e\n\u003cli\u003eHarris, P.A., et al., \u003cem\u003eResearch electronic data capture (REDCap)\u0026mdash;A metadata-driven methodology and workflow process for providing translational research informatics support.\u003c/em\u003e Journal of Biomedical Informatics, 2009. \u003cstrong\u003e42\u003c/strong\u003e(2): p. 377-381.\u003c/li\u003e\n\u003cli\u003eNHMRC, \u003cem\u003eData Safety Monitoring Boards (DSMBs)\u003c/em\u003e, N.H.a.M.R. Council, Editor. 2018, National Health and Medical Research Council: Canberra ACT 2601.\u003c/li\u003e\n\u003cli\u003eAllen, L., A. O\u0026rsquo;Connell, and V. Kiermer, \u003cem\u003eHow can we ensure visibility and diversity in research contributions? How the Contributor Role Taxonomy (CRediT) is helping the shift from authorship to contributorship.\u003c/em\u003e Learned Publishing, 2019. \u003cstrong\u003e32\u003c/strong\u003e(1): p. 71-74.\u003c/li\u003e\n\u003cli\u003eKlaic, M., et al., \u003cem\u003eImplementability of healthcare interventions: an overview of reviews and development of a conceptual framework.\u003c/em\u003e Implement Sci, 2022. \u003cstrong\u003e17\u003c/strong\u003e(1): p. 10.\u003c/li\u003e\n\u003cli\u003eGrech, A.K., et al., \u003cem\u003eEpidemiological trends of respiratory tract pathogens detected via mPCR in Australian adult patients before COVID-19.\u003c/em\u003e BMC Infect Dis, 2024. \u003cstrong\u003e24\u003c/strong\u003e(1): p. 38.\u003c/li\u003e\n\u003cli\u003eAustralian Centre for Disease Control, \u003cem\u003eAustralian Respiratory Surveillance Report - Report 10\u003c/em\u003e, 2024.\u003c/li\u003e\n\u003c/ol\u003e "},{"header":"Table 2","content":"\u003cp\u003eTable 2 is available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-6372829/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6372829/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003eBackground:\u003c/em\u003e Antimicrobial resistance is a worldwide problem caused by the inappropriate use of antibiotics. In Australia, antibiotics are frequently prescribed in general practice (primary care) settings for acute respiratory infections (ARIs) despite these infections most commonly being caused by viruses. The Optimal Implementation of Antimicrobial Stewardship in General Practice (OptimasGP) study aims to provide implementation support for effective antimicrobial stewardship (AMS) interventions for ARIs. The current study will examine if a redesigned workflow, and an AMS Toolbox containing AMS resources, is an acceptable way to access AMS interventions and clinical data collected in general practice settings.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eMethods\u003c/em\u003e: A mixed methods approach will be applied using a single-arm, pragmatic feasibility study. Data will be collected for a period of 3 months. Data collection from general practice settings in New South Wales, Australia will involve the participation of four to six practices, twelve General Practitioners (GPs), and six to eight practice staff. We also aim to recruit 50-100 patients to complete surveys and twelve patients to participate in focus group discussions. Participating GPs and practice staff will be provided with an online AMS Toolbox to facilitate access to AMS resources. Two hours of online training and a reminder card will also be provided. The AMS Toolbox will contain AMS resources for shared decision-making, clinical decision support (including point-of-care testing), and delayed antibiotic prescribing in patients with ARIs. The primary outcome of the study will be the acceptability of the AMS Toolbox to GPs, practice staff and patients. Secondary outcomes will include recruitment and completion rates, qualitative findings from the focus group discussions, resource use and antibiotic prescription rates, patient-reported outcome measures (PROMs), and patient-reported experience measures (PREMS).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eDiscussion:\u003c/em\u003e AMS interventions are needed to help reduce inappropriate antibiotic prescribing for ARIs in general practice settings. The findings of this study will inform a Hybrid Type 3 implementation trial.\u003c/p\u003e\n\u003cp\u003eTrial registration: Registered prospectively with the Australian and New Zealand Clinical Trial Registry (ACTRN12624001011572) on 20/08/2024.\u003c/p\u003e","manuscriptTitle":"Optimal Implementation of Antimicrobial Stewardship in General Practice: Protocol for a feasibility study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-08 20:39:33","doi":"10.21203/rs.3.rs-6372829/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2025-05-01T13:11:33+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-05-01T13:05:29+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-04-30T05:24:27+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pilot and Feasibility Studies","date":"2025-04-29T02:26:58+00:00","index":"","fulltext":""},{"type":"decision","content":"Minor revision","date":"2025-04-11T11:51:09+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"2ededec6-679a-44e6-99b5-1c272c6ace3a","owner":[],"postedDate":"May 8th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-08-04T16:43:34+00:00","versionOfRecord":{"articleIdentity":"rs-6372829","link":"https://doi.org/10.1186/s40814-025-01686-6","journal":{"identity":"pilot-and-feasibility-studies","isVorOnly":false,"title":"Pilot and Feasibility Studies"},"publishedOn":"2025-07-30 16:21:25","publishedOnDateReadable":"July 30th, 2025"},"versionCreatedAt":"2025-05-08 20:39:33","video":"","vorDoi":"10.1186/s40814-025-01686-6","vorDoiUrl":"https://doi.org/10.1186/s40814-025-01686-6","workflowStages":[]},"version":"v1","identity":"rs-6372829","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6372829","identity":"rs-6372829","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}