Strengthening Care for Rural Children (SC4RC): Study protocol for a stepped-wedge translational trial of an integrated general practitioner–paediatrician model of primary care in regional Victoria and New South Wales.

Strengthening Care for Rural Children (SC4RC): Study protocol for a stepped-wedge translational trial of an integrated general practitioner–paediatrician model of primary care in regional Victoria and New South Wales. | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Strengthening Care for Rural Children (SC4RC): Study protocol for a stepped-wedge translational trial of an integrated general practitioner–paediatrician model of primary care in regional Victoria and New South Wales. Raghu Lingam, Susan Bullock, Harriet Hiscock, Sonia Khano, Jack Murphy, and 16 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6650680/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 17 Dec, 2025 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract Background : Children living in regional and rural Australia have diminished health outcomes and are more likely to be developmentally vulnerable on one or more domains compared to urban peers. Despite this, children in regional and rural Australia often cannot access specialist care due to lack of availability, financial constraints or waiting times of over 12 months. Strengthening Care for Rural Children (SC4RC) aims to evaluate an integrated general practitioner (GP)-paediatrician model of care in rural communities to enhance the quality of paediatric care by ensuring children receive timely, accessible care within their communities by reducing referrals to public and private paediatric services. Methods : SC4RC is a stepped wedge randomised controlled trial of 22 general practice clinics in regional and rural Victoria and New South Wales, Australia. Control data for each general practice clinic will be collected for a minimum of one month and each clinic will be randomly allocated a start month, with the intervention running for 11 months at each clinic. The intervention will consist of fortnightly GP-paediatrician co-consultation sessions, weekday phone and email paediatrician support for GPs, and access to a paediatric online community of practice via a Project ECHO TM series. The primary outcome is the proportion of paediatric (0 to <18 years) GP appointments that result in a referral to a paediatric service (hospital emergency departments; outpatient clinics or private paediatricians) during the intervention period compared with the control period. Secondary outcomes include GP quality of care across 17 common childhood conditions; GP confidence in paediatric care; family confidence in GP care; and the sustainability of the SC4RC model. Integral to the project is our consumer engagement framework which will inform the translation and implementation of the project. An implementation evaluation will assess the acceptability, adaptability and scalability of the model, while a health economic evaluation will measure the cost-effectiveness/benefit of the intervention. Discussion : This protocol paper outlines how we will partner with primary care organisations and paediatric services to implement and evaluate SC4RC in some regional and rural communities in Victoria and NSW. Trial registration : Australia New Zealand Clinical Trials Registry ACTRN12623000550606 on 23 May 2023. Regional and rural healthcare primary care engagement paediatrics randomised controlled trial integrated care Figures Figure 1 Figure 2 Administrative information Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/). Title (1) Strengthening Care for Rural Children (SC4RC): Study protocol for a stepped-wedge pragmatic trial of an integrated general practitioner–paediatrician model of primary care in regional Victoria and New South Wales. Trial registration {2a and 2b}. Australia New Zealand Clinical Trials Registry (ACTRN) ACTRN12623000550606. Registered on 23 May 2023. Protocol version {3} Protocol V1.6, May, 2025. Funding {4} The study is funded through a 3-year Medical Future Fund (MRFF) Grant (MRFAR000223). This includes direct funding from the MRFF, as well as cash and in-kind support from the following Partner Organisations: UNSW; Sydney Children’s Hospital Network (SCHN); Ballarat Health Services; Barwon Health, Murrumbidgee Primary Health Network and Murrumbidgee Local Health District. Author details {5a} 1 Population Child Health Research Group, Discipline of Paediatrics & Child Health, Randwick Clinical Campus, School of Clinical Medicine, University of New South Wales, Sydney, NSW, Australia. 2 Sydney Children’s Hospitals Network, Sydney, NSW, 2031. 3 Health Services and Economics, Murdoch Children’s Research Institute, Parkville, VIC 3052. 4 Faculty of Medicine, Health and Dental Sciences, The University of Melbourne, Parkville, VIC 3052. 5 Department of Paediatrics, University of Melbourne, VIC 3052. 6 Department of General Practice and Primary Care, The University of Melbourne, Parkville, VIC 3052. 7 Western Victoria Primary Health Network, VIC 3220. 8 Murrumbidgee Local Health District, NSW 2650. 9 School of Public Health, UTS, Sydney NSW 2007. 10 Paediatric Unit, Women’s & Children’s Services, Barwon Health, VIC, 3220. 11 Faculty of Health,Inst. Health Transformation, Deakin University, VIC, 3216. 12 Paediatric Unit, Women’s & Children’s Services, Grampians Health, Ballarat 3352. 13 Deakin University, VIC, 3216. 14 Australian Institute of Health Innovation, Macquarie University, Macquarie Park NSW 2109. 15 IIMPACT in Health, University of South Australia, Adelaide SA 5000. 16 University of Notre Dame Australia, Rural Clinical School, Lithgow, NSW, 2790. 17 Melbourne Health Economics, Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, VIC 3052. Name and contact information for the trial sponsor {5b} Professor Mark Hargreaves University of Melbourne Address: The University of Melbourne, Parkville, Victoria 3010 Country: Australia Role of sponsor {5c} The sponsor played no part in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. Introduction Background and rationale {6a} Children living in regional and rural Australia have diminished health outcomes and are more likely to be developmentally vulnerable than their urban peers.( 1 ) This is largely attributable to a higher likelihood that children living in regional and remote areas will be exposed to social, economic and environmental circumstances that negatively impact health and development.( 1 , 2 ) However, despite increased risks of poor health, children in regional and remote regions often cannot access specialist care due to a lack of availability, financial constraints or waiting times of over 12 months.( 1 , 2 ) Regional and remote families, whose disposable income is 15% less than that of urban families ( 3 ), incur significantly greater disruption and financial costs in seeking medical care.( 4 ) It is estimated that travel distances of greater than 100km each way are not an unusual requirement for regional and remote families to attend a specialist appointment.( 1 , 4 ) Compared to urban families, these travel times contribute to greater loss of parental wages and child school absences for families in regional and remote areas.( 1 , 3 , 4 ) Barriers to attending specialist health appointments contribute to diagnostic and treatment delays which directly reduce quality of life and health outcomes whilst increasing health care costs.( 5 ) The current Australian healthcare system does not offer optimal care and is failing to deliver equitable healthcare for children and young people. A study examining quality of paediatric care in metropolitan and regional Australia based on adherence to best practice guidelines for the management of 17 common childhood conditions, found that only 60% of the care provided to children and young people were in line with these guidelines.( 6 ) Quality of care indicators were significantly worse in primary care than in secondary care e.g. for gastroenteritis, adherence was lower in the general practitioner (GP) setting (38.5%; 95% confidence interval [CI]: 33.7–43.4) than the emergency department (ED) (85.7%; 95% CI: 82.4–88.7) and hospital inpatient (87.1%; 95% CI: 80.2–92.3) settings; p < 0.0001 for both comparisons.( 7 ) The pattern held for mental health presentations, e.g. appropriate treatment of anxiety, occurred in 39.9% of consults in primary care (95% CI 20.6, 61.9) compared to 87.1% of consults (95% CI 62.0, 98.2) in specialised paediatric care.( 8 ) Providing high quality care to regional and rural children in their local area is a critical step toward reducing health inequalities in Australia. One potential solution to the need for increased access to care is care integration. Systematic review of specialist outreach clinics in primary care and rural hospitals found that integrated services explicitly involving collaboration between primary care and specialist services improved access, quality of care, and health outcomes compared with standard care.( 9 ) This is supported by an updated 2020 systematic review and meta-analysis which showed strong evidence that integrated models of care, including integration between primary and secondary care providers, improved health-related quality of life compared with standard care in children with chronic illness (standard mean difference [SMD] = 0.24; 95% CI = 0.03, 0.44; P = 0.02).( 10 ) A systematic review of Communities of Practice (peer-to-peer support and continuing professional development) found three intervention trials where Communities of Practice were a component of a health system, all of which reported improved rates of adherence to evidence-based process indicators and greater involvement of the patient in decision making.( 11 ) Strengthening Care for Children The Strengthening Care for Children (SC4C) model of integrated General Practitioner (GP)-paediatrician care was designed to improve access to quality paediatric care for children in a primary care setting.( 12 – 14 ) Adapted from the UK’s Connecting Care for Children model ( 15 ), SC4C comprises regular shared GP-paediatrician consulting sessions, monthly case discussions, and email and telephone support. The model was piloted in 5 general practice clinics in Melbourne, Victoria ( 11 ), where results showed reduced guideline-discordant prescribing for common paediatric conditions by 8–20%, reduced referrals to ED by 7% and to hospital outpatient (OP) by 5%.( 12 ) Additionally, parental trust in the GP and GP confidence in providing paediatric care increased by 16% and 12%, respectively.( 12 ) Following this successful pilot, SC4C is being evaluated in a multi-site, stepped wedge randomised controlled trial across 22 metropolitan general practice clinics in two Australian cities ( 13 , 14 ). The model has been found feasible and acceptable by GPs, paediatricians and families with GPs reporting increased knowledge and confidence in paediatric care ( 1 ). Paediatricians report that SC4C has improved their understanding of the general practice context and demands on GPs, enhancing collaboration and bridging gaps between hospital and primary care. Families expressed satisfaction with the quality and accessibility of the care provided by the SC4C model.( 16 ) Strengthening Care for Rural Children Building on the SC4C urban trial, our Strengthening Care for Rural Children (SC4RC) model was co-developed with our regional primary care partnership organisations - Murrumbidgee Primary Health Network (MPHN) and Western Victoria Primary Health Network (WVPHN), local GPs, nurses and general practice clinic managers, local health service paediatricians and consumers. Objectives {7} The aims of this trial are to assess strategies that may improve health outcomes for children to determine: The effectiveness of SC4RC compared to standard GP care, to: Reduce GP paediatric referrals (0 to < 18 years) to public and private paediatric services (hospital emergency departments (ED); hospital based paediatric outpatient clinics (OP); and private paediatricians) during the 11-month intervention period Reduce GP paediatric referrals (0 to < 18 years) to public and private paediatric services (hospital emergency departments (ED); paediatric outpatient clinics (OP); and private paediatricians) during the sustainability period. Increase the quality of paediatric care for children and young people aged 0–18 years delivered by GPs for up to 17 paediatric health conditions during the 11-month intervention period. Increase GP confidence in managing children and young people in primary care. Increase family trust in primary care and reduce family preference for paediatric referral. The incremental cost-effectiveness of SC4RC compared with standard GP care. The factors that help or hinder implementation of SC4RC to inform adaptability, sustainability and scalability. Trial design {8} A stepped-wedge cluster randomised controlled trial will be used to evaluate the SC4RC model compared with standard GP care. Twenty-four general practices will be randomly allocated to one of 11 dates to start the intervention. General practices will provide referral and medical record data during a control period (standard GP care, no SC4RC model operating) before being exposed to the SC4RC intervention, which will be rolled out sequentially to two practices (one from Murrumbidgee and one from Western Victoria) each month for up to 11-months. The first week the intervention is implemented at each general practice will be an embedding period during which practices will establish the administration and workflow of co-consultations with the paediatricians. Data will be extracted throughout the 11-months of the intervention period for each general practice. Collecting this data alongside the control period data will allow us to analyse referral and quality of care trends during the intervention period. Following the 11-month intervention period in each general practice, sustainability data will be collected over up to 13-months to analyse the long-term impact of the SC4RC model. Consumer Engagement The study will engage consumers across the life cycle of the project, across all levels of governance. Consumers will be involved in the co-design of the project, steering groups and through a consumer advisory group (CAG). The CAG will be led by a consumer with lived experience with a focus on better understanding the healthcare needs of regional and rural children and young people with chronic illnesses and their families meeting bimonthly. Consumer input will shape Project ECHO along with the translation and implementation of the projects. Discussions at CAG meeting will be recorded and thematically analysed. This will be an iterative process to inform this project and future activities. Methods: Participants, interventions and outcomes Study setting {9} SC4RC is a multi-site step wedge randomised control trial conducted in regional areas of Victoria (VIC) and New South Wales (NSW), Australia. The catchment area was selected based on pre-existing partnerships between the research team and the respective PHNs (MPHN in NSW and WVPHN in VIC). Eligibility criteria {10} Trial participants will be: All eligible and consenting general practice clinics within the WVPHN and MPHN; All consenting GPs at these general practice clinics, and; All consenting caregivers of patients < 18 years seen by participating GPs or within participating general practice clinics. Eligible general practice clinics are those who respond to the expression of interest and meet the inclusion criteria. GPs and caregivers will also need to meet the inclusion criteria (Table 1). Table 1 Trial population inclusion and exclusion criteria applied during recruitment Inclusion Exclusion General practice clinics Be located within either the WVPHN or MPHN catchment No active patients* aged 0–18 years attended the general practice clinic in the past 12 months Have Best Practice or Medical Director 3 as their electronic medical record software Be formally accredited by an independent accreditation agency against the Royal Australian College of General Practice standards ( 17 ) or working towards accreditation GPs See paediatric patients < 18 years of age GP registrars with less than 6 months of placement in the general practice clinic Can provide a minimum of 1 month of control referral data Families Caregivers of paediatric patients seen by a participating GP or within participating general practice clinic during the trial Children or young people who present to the general practice clinic without a parent/guardian Caregivers with sufficient English to complete survey Insufficient capabilities to complete the survey in English *An ‘active patient’ is a patient who has attended the practice/service three or more times in the past 2 years, as defined by the Royal Australian College of General Practitioners (RACGP) standards for general practice clinics. ( 17 ) Who will take informed consent? {26a} All consent processes outlined below proved feasible and effective in our pilot study and the SC4C urban trial.( 14 , 16 ) At recruitment, GPs will be asked by a member of the study team to consent by signing a participant information and consent form. Details of what is to be collected as part of the study will be included (including referral and diagnosis information), and GPs will have the opportunity to clarify any queries prior to agreeing to the terms. Signing of the consent form, and participation in the study, is voluntary and free from coercion. Further consent will be obtained prior to conducting an interview or focus group. For families recruited face-to-face, informed consent will be obtained by a member of the study team prior to study participation. This will involve the study team member telling the caregiver about the study; explaining the purpose of the study; that the only requirement of the study is a one-off anonymous survey; that there are no foreseen risks or benefits to the family participating in the study; and that whether they choose to participate in the survey won’t affect the care they receive for their child. For families who are recruited via SMS/email or through scanning the QR code, the caregiver’s consent will be indicated via a checkbox at the start of the survey. Prior to conducting an interview with parents or carers, and their children, the researcher will describe the study, providing a participant information sheet for parents or carers, a child-friendly version of the participant information sheet tailored to their child’s age/skills in comprehension to children, and a consent form. For parents/carers/children who do not have the digital capabilities to print, sign and scan the consent form, the researcher will explain the information statement via phone and send a SMS of an electronic version of consent form via REDCap to be signed electronically before scheduling the interview appointment. Additional consent provisions for collection and use of participant data and biological specimens {26b} Not applicable to current study. Interventions Explanation for the choice of comparators {6b} Comparator is usual standard GP based care. Explanation for this is given in the Background and rationale {6a} section. Intervention description {11a} The SC4RC intervention was adapted from the previously evaluated SC4C urban study ( 13 , 14 ) through co-design with rural parent-consumers, GPs, paediatricians and PHNs. The SC4RC model of care will be delivered by 8 (NSW) and 3 (VIC) paediatricians funded by their respective Local Health Districts. It comprises three components to be offered to all participating GPs: GP-led co-consultation sessions. Study paediatricians will offer face-to-face or video conference co-consultation sessions with GPs for their paediatric patients presenting with any issue for two half-day sessions per month. Paediatricians will work alongside GPs to provide support and mentorship in the primary care management of paediatric cases. The co-consultations are not intended to conduct specialist paediatric care but rather to assist GPs to advance their primary care assessment, management, and investigation beyond where they would normally feel confident, or to validate the care approach the GPs are already using. GPs are instructed to book a child for a co-consultation for any issue where they want this mentorship from the paediatrician. GP registrars with less than 6 months of placement will be excluded from participating in the data collection for this trial. However, they will be able to schedule co-consultations with their participating GP supervisors to support a ‘whole of general practice clinic’ approach. Patients will only be billed as per the usual billing practices for a GP consultation. Weekday paediatrician phone and email support outside of co-consultation sessions. Participating GPs will have access to dedicated phone and email support from paediatricians during business hours throughout the intervention period. Online community of practice via Project ECHO. ™ Continuing professional development will be delivered through the Project ECHO ™ (Extension for Community Healthcare Outcomes), an online tele-mentoring programme.( 20 ) Led by a facilitator GP academic (BF) from the University of Melbourne (UoM) and WVPHN, GPs will have access to a series of monthly ECHO sessions via videoconference consisting of a brief presentation by the study paediatricians (from a set of curriculum designed in consultation with participating GPs), followed by case presentation and facilitated discussion between clinicians. Criteria for discontinuing or modifying allocated interventions {11b} Not applicable. Study is a stepped-wedge cluster randomised controlled trial. Strategies to improve adherence to interventions {11c} To determine how the intervention is being carried out in each site as compared to the intended rollout, we will draw on trial data, which will record the specific details of model delivery. This will include consistent recording of the number and frequency of: Co-consultations attended by participating GPs Formal monthly case discussions and attendance of GPs at each general practice clinic One-on-one discussions between GPs and SC4RC paediatricians Use of phone and email support The nature of paediatric support provided (e.g., reason for visit, topic of case study discussion) This information will be recorded in REDCap by the SC4RC paediatricians and research team. Several methods will be used to maintain general practice clinic and GP engagement in the trial. These will include pre-intervention onboarding sessions with GPs and general practice clinic administrative staff, regular meetings with general practice clinics once the intervention has commenced and quarterly newsletters providing updates and relevant trial information. The research team will work closely with the general practice clinics to address any barriers that arise as the project is progressing. Relevant concomitant care permitted or prohibited during the trial {11d} Not applicable. Study is a stepped-wedge cluster randomised controlled trial. Provisions for post-trial care {30} Not applicable. Study is a stepped-wedge cluster randomised controlled trial. Outcomes {12} Outline of the primary and secondary objectives, data sources, methods of collection, period of data collection, and outcomes of interest are outlined below (Table 2) Table 2 Description of outcomes Objectives Outcomes of Interest Data Sources Methods of collection Timeline of Data Collection Primary Objective What is the impact of SC4RC on number of GP referrals to public and private pediatric services (hospital OP/ ED, private paediatrician)? Proportion of children the GP referred to any public or private paediatric service GP medical records via the referral pop-up supported by GRHANITE™ GRHANITE data extraction of referral destination (including no referral) for each paediatric visit. Control and intervention periods. Secondary Objectives What is the impact of SC4RC on GP quality of care for up to 17 childhood conditions ( CareTrack Kids study ( 6 ))? 1. Noncommunicable: abdominal pain, asthma, gastrooesophageal reflux, crying unsettled infant, eczema 2. Mental health: autism, developmental delay, anxiety, depression, ADHD. 3. Acute infection: acute gastroenteritis, bronchiolitis, croup, fever, otitis media, tonsillitis, upper respiratory tract infection 4. Injury: head injury Proportion of GP consultations where the care quality is adhered to (based on the care quality indicator) for each childhood condition GP medical records GRHANITE data extraction of care quality based on the measurement of the CareTrack Kids indicators ( 6 ). Control and intervention periods. What is the impact of SC4RC on GPs? (E.g., confidence and self-perceived skills in paediatric care, feasibility, acceptability) Level of confidence in paediatric care; level of knowledge and skill in navigating the health system for children; reported use of clinical guidelines; reported feasibility/acceptability of the model. GP online survey Control and intervention surveys completed online via REDCap™ Control surveys: Month prior to the implementation commencing. Intervention surveys: Last month of implementation at each general practice clinic. What is the impact of SC4RC on patients and family experience? Level of confidence in GP care, level of satisfaction with GP care, desire for referral to specialist care, preference for GP or specialist review. Family online or in-person survey Control and intervention surveys completed with families in waiting room of general practice clinics or online via REDCap™. Control surveys: Month prior to the implementation commencing. Intervention surveys: Last month of implementation at each general practice clinic. Health economic evaluation What is the cost of implementing the model of care? What is the cost effectiveness? Costs of conducting the model of care compared with usual care; costs/savings of change in OP/ED referrals; costs/savings to families compared with accessing usual care. Incremental cost effectiveness ratio and net cost/cost savings. Trial data and supplementary uni costings Trial data on the model of care, health service costs, health service use and patient costs and outcomes will be combined with relevant unit costs. Data will be collected throughout the trial Implementation Evaluation What are the aspects of the model of care that make it effective or ineffective at producing system change? Identify strategies for successful implementation, practical difficulties and facilitators in adoption, delivery and maintenance to inform future scaling. Feasibility/acceptability of the model. Fidelity data, qualitative interviews, focus groups with GPs, general practice clinic staff, paediatricians, families and project team members. GP and family surveys. Consolidated Framework for Implementation Research; qualitative interviews with families, practitioners, administrative staff; online surveys. De-identified data on patient characteristics (i.e. age, gender) and nature of paediatric support provided (e.g., reason for visit) will be collected by paediatricians and research team. Interim qualitative data will be collected via focus groups/interviews with general practice clinics 6–7 months into the intervention period (iterative data collection process). Interviews with GPs, families and paediatricians will be conducted at the end of the intervention period. Describe the model of care, including number of co-consultations, reasons for co-consultations, number of phone and emails to paediatrician, number and topic of case study discussions. GP buy-in and appropriateness of the model; adoption and fidelity to the model. Online survey data will be collected upon completion of the intervention period in each general practice clinic. De-identified data will be collected as part of the co-consultations, case study discussions and phone/email support throughout the intervention period. Sustainability Explore the sustainability and enduring effects of SC4RC post-implementation on proportion of GP paediatric referrals to OP clinics or EDs and GP quality of care compared with pre-intervention GP care. How GP paediatric referrals (i) and quality of care (ii) in the sustainability period compared to the intervention period GP medical records and GP online survey GRHANITE data extraction of referral destination (including no referral) for each paediatric visit. GRHANITE data extraction of care quality based on the measurement of the CareTrack Kids ( 6 ) indicators. Data will be collected from the completion of the intervention period in each general practice clinic until the end of the sustainability period. Survey conducted 6 months post intervention period. Participant timeline {13} Sample size {14} Using data from our pilot study ( 12 ) and the CareTrack Kids Australia study ( 6 ), each general practice clinic is estimated to see at least 15 paediatric patients per week, amounting to 780 paediatric patients per year. Assuming each general practice clinic has an average of 1.4 consultations per paediatric patient, this equates to 91 paediatric consultations per month per general practice clinic. With 22 general practice clinics enrolled into the stepped-wedge design, we will have 90% power to be able to detect at least 1.1% decrease in the proportion of paediatric GP consultations where children were referred to public and private paediatric services, based on two-sided alpha of 0.05 and an intra-cluster correlation of 0.06 (derived from our SC4C urban study ( 14 )). Recruitment {15} General Practice Clinics and GPs A total of 22 general practice clinics (12 in NSW and 12 in VIC) will be recruited with the support from the respective PHNs and the Victorian Primary Care Practice-Based Research and Education Network (VicREN).( 18 ) Recruitment will occur through the dissemination of expression of interest (EOI) forms to general practice clinic managers, GPs, and general practice clinic nurses, facilitated by the PHNs. Interested general practice clinics will be visited by members of the research team to present the SC4RC model and are required to sign a Trial Site Agreement adhering to the requirements of their participation, and a license agreement to install the clinical data extraction software tool GRHANITE TM .( 19 ) Interested GPs will then be invited to formally consent to the project by signing a participant information consent form. Quality Improvement Grants of $3000 per general practice clinic for the duration of their participation and Royal Australian College of General Practitioners’ (RACGP) Continuing Professional Development (CPD) points will be provided to support general practice clinics participation in the trial. Families Eligible caregivers of patients < 18 who attend a participating general practice clinic during the control and intervention periods will be invited to complete a survey about their GP consultation experience. Families will be alerted to the study through posters at reception and in the waiting rooms of their general practice clinic. General practice clinics can specify if they prefer recruitment of family surveys to occur in-person by the research assistant, online via Short Message Service (SMS) message or via a QR code available in the waiting room. In-person recruitment will occur via trained researchers who will approach families in the waiting room to screen for eligibility and obtain informed consent. Caregivers who consent to complete the survey will be able to do so via a tablet or paper copy provided by the researcher. For SMS recruitment, the research team will provide the general practice clinics with an SMS script and link to the online family survey to send via their existing appointment system (e.g. HotDoc, Health Engine, HealthDirect or other). This survey will be sent to all families/caregivers of patients < 18 years seen in the last three months during the control and intervention periods. During the intervention period, in addition to completing the survey, caregivers will be invited to take part in a qualitative interview via telephone or online video, led by the implementation evaluation team of the study. These interviews will be offered to families who have participated in a SC4RC co-consultation with the paediatrician. Assignment of interventions: allocation Sequence generation {16a} An independent statistician will randomise the order for each participating general practice clinic to transition from usual care to the SC4RC model of care at one-month intervals. We will stratify all participating general practice clinics by State of location (NSW, VIC) and size (i.e., the number of participating GPs). We will ensure one general practice clinic from NSW and one general practice clinic from VIC will receive the intervention at each randomisation step and to minimise the imbalance of sample sizes between the sites in the control period and those in the intervention period across the steps. To avoid recruitment bias in clusters, randomisation will occur once all general practice clinics have been recruited and enrolled; that is, after all inclusion and exclusion criteria are addressed, and all general practice clinics sign the relevant project agreements. Concealment mechanism {16b} Randomisation will utilise a web-based randomisation system. Implementation {16c} Implementation will be by the research team. Assignment of interventions: Blinding Who will be blinded {17a} General practice clinics and their GPs will be unblinded to their allocation status (intervention start date) as it will be necessary for general practice clinics to know their start month in the stepped-wedge design to prepare their GPs. We do not anticipate the impact of GPs knowing their start month to change their standard practice due to their busy workload. The study team will not be blinded to the order of randomisation as it will be necessary to know which general practice clinics will be adopting the model of care at each step throughout the roll-out phase to best prepare and coordinate on-site staff. The statistician will be blinded to the randomisation order during data analysis. Procedure for unblinding if needed {17b} Participants will not be blinded. Data collection and management Table 3 Description of outcome measures and data collection timepoints of the trial Time point Control period Embedding period Intervention period Measure GP demographics X - X Family demographics X - X Paediatrician co-consultation data logs - - X Primary outcome GP referral outcomes GRAHNITE extracted from routinely collected GP EMR data X X* X Secondary outcomes GPs Quality of care GRHANITE EMR data extraction on care quality based on measurement of the CareTrack Kids indicators ( 6 ) for 17 common childhood conditions: 1. Noncommunicable: abdominal pain, asthma, gastrooesophageal reflux, crying unsettled infant, eczema 2. Mental health: autism, developmental delay, anxiety, depression, ADHD. 3. Acute infection: acute gastroenteritis, bronchiolitis, croup, fever, otitis media, tonsillitis, upper respiratory tract infection 4. Injury: head injury X X* X Confidence in paediatric care and access to paediatric services. Study design based on SC4C. X - X Skills to manage child health. Study designed based on SC4C X - X Awareness and use of HealthPathways Study designed based on SC4C X - X 9-item implementation culture (CFIR) X - - 5-item learning climate (CFIR) X - - 4-item measure of perceived intervention appropriateness Intervention Appropriateness Measure (IAM) X - - 18-item intervention buy-in adapted NoMAD tool based on Normalisation Process Theory. - - X Model feasibility, acceptability, feedback and patient benefit. Study designed based on SC4C. - - X Families Confidence in GP care Study designed based on pilot study X - X Quality of care and interactions with the GP Study designed based on pilot study X - X Preference for paediatrician referral and GP review Study designed based on pilot study X - X *Data collected during the one-week embedding period week will not be analysed. EMR, electronic medical records; GP, general practitioner ; CFIR, Consolidated Framework Implementation Research. Plans for assessment and collection of outcomes {18a} GP electronic medical records We will treat the primary outcome as a binary variable: for each paediatric visit, the child will be deemed either to have been referred or not referred to public and private paediatric services. To measure the primary outcome, data will be routinely collected from GP electronic medical records (EMR) via GRHANITE ™ . Developed by the Health and Biomedical Informatics Centre at the University of Melbourne ( 19 ), GRHANITE ™ is a secure and ethical acquisition of data for research purposes. It will be remotely embedded into all participating GP EMR systems (compatible with Best Practice or Medical Director software) to extract de-identified routinely collected data on paediatric patients seen throughout the trial. As GP referrals are not consistently recorded in EMR, the GRHANITE team will develop a tailored referral pop-up window with the most common referral options for consultations including no referral, referral to ED or OP, private paediatrician. GP referral data will be collected on every patient < 18 years seen in a consultation by a participating GP. This data will be de-identified at the patient level, although the identity of the GP will be supplied to the research team for monitoring purposes only. Collection of GP EMR data will commence for all general practice clinics following randomisation and will continue throughout the trial and sustainability period. Extracted GP data will also include de-identified paediatric patient information limited to patient demographics, reason for visit, diagnoses, referrals, prescriptions, imaging and pathology testing, and GP service item billing. The patient level data will be used to characterise GP paediatric visits (e.g., number of children seen, child age and gender, common diagnoses) and compare quality of care for common conditions before and after the model of care is implemented, based on the CareTrack Kids indicators.( 6 ) A natural language processing (NLP) algorithm, developed by the Computing and Information Systems at the University of Melbourne, will be used to automatically transform GP EMR clinical free text of “reason for visit” or diagnosis into structured clinical data, based on the Systematized Nomenclature of Medicine Clinical Terminology (SNOMED CT).( 24 ) GP and family data collection An online survey will be used to measure GP experience and confidence in paediatric care. These will be distributed to all participating GPs via REDCap™ during the control period (one-month prior to the intervention) and in the last month of the intervention for each general practice clinic. The survey collects demographic information about the GP, items relating to factors that impact their decision to refer a paediatric patient, knowledge and confidence of paediatric care and services. GP surveys have been developed specifically for SC4RC and are comprised of items adapted from the SC4C urban study and drawn from previously published literature.( 25 , 26 ) An online survey will be used to measure caregivers’ perceptions and experience of the paediatric care provided at their general practice clinic. To provide data on a ‘whole of general practice clinic’ level, caregivers of patients < 18 years will be eligible to complete the Family Survey via REDCap™, regardless of whether they have seen a GP participating in the SC4RC trial. Family survey data collection will occur during the control period (one-month prior to the intervention) and in the last month of the intervention for each general practice clinic. Implementation Evaluation The implementation evaluation will be based on a mixed methods approach developed for the SC4C trial. ( 16 ) We will use the Consolidated Framework for Implementation Research (CFIR) ( 27 ) to understand how and why our intervention was effective or ineffective in producing systems change. The CFIR has been widely used in diverse healthcare contexts, both metropolitan and regional, including primary care settings ( 28 ) and provides a theoretical lens to understand the processes of introducing and managing change within a complex healthcare system.( 29 ) The CFIR identifies five major domains (Intervention Characteristics, Outer Context, Inner Context, Characteristics of Individuals, and Process) and provides a framework to guide the consideration and assessment of factors which might impact intervention implementation and effectiveness. In addition to mapping the barriers and facilitators to implementing the SC4RC model, the study team will evaluate specific implementation outcomes, as guided by the taxonomy proposed by Proctor and colleagues. ( 30 ) These outcomes include intervention acceptability, appropriateness, fidelity to the implementation strategy, coverage, and sustainability (Table 4). Table 4 Implementation metrics derived from Proctor et at. ( 30 ) Questions addressed by each implementation factor. Acceptability Do practitioners, parents and children view the SC4RC as agreeable? Adoption To what extent do practitioners and parents use the SC4RC model? Appropriateness Do stakeholders perceive SC4RC as relevant & useful? Fidelity Is SC4RC applied as intended? Are all component parts of the intervention delivered as planned? Coverage How many service users of those eligible are reached? Cost How much does it cost to successfully implement SC4RC? Sustainability What are the factors that will allow SC4RC to be scaled-up further? Logic model An implementation logic model ( 31 ) has been developed by the research team to inform the trial and the SC4RC process evaluation (Fig. 1). The logic model will be adapted from the SC4C urban study ( 13 ) and existing logic model frameworks ( 32 , 33 ) and guidelines ( 31 ). The logic model will be used to guide the implementation evaluation to consider factors both within (inner context representing individual factors and organisational settings) and external to the SC4RC sites (outer context, including area demographics, policy climate, and relevant geographically adjacent clinical services). In addition to the contextual factors, we included a detailed description of measurable intervention characteristics such as the number and type (face-to-face vs video) of scheduled co-consultations, attendance at Project ECHO case discussions and use of the phone and email support services as well as implementation strategies, mechanisms of action and outcomes. Fidelity to the model To determine how the intervention is being carried out in each site as compared to the intended rollout, we will draw on trial data, which will record the specific details of model delivery. This will include recording: Number of co-consultations attended by participating GPs Number of formal monthly case discussions and attendance of GPs at each general practice clinic The frequency of one-on-one discussions between GPs and SC4RC paediatricians The frequency of use of phone and email support The nature of paediatric support provided (e.g., reason for visit, topic of case study discussion) This information will be recorded in REDCap by the SC4RC paediatricians and research team. No identifiable information will be collected, and data will only be analysed to provide information on patterns of support provided. No data on individual children will be reported. Appropriateness and Intervention normalization within primary care GP surveys collected during the final month of the implementation period will include items measuring GP buy-in to and appropriateness of the SC4RC model. Intervention normalization within primary care will be measured using an adapted version of the NoMAD tool based on the Normalization Process Theory.( 34 ) The NoMAD tool will assess how the intervention was incorporated into standard work responsibilities. We will also include an adapted version of the Intervention Appropriateness Measure (IAM). The IAM is a pragmatic 4-item measure of the perceived fit, relevance or compatibility of an evidence-based practice for a context, person, or problem. Barriers and facilitators to running SC4RC To determine individuals knowledge and beliefs about the model of care; relative advantages and suitability of the model of care; GP and paediatrician self-efficacy; barriers and facilitators affecting the delivery of the intervention both from an individual and organisational perspective; the appropriateness and acceptability of the intervention; and recommendations for future implementation, we will conduct semi-structured interviews and focus groups with GPs, general practice clinic managers, administrative staff, paediatricians, and families who participated in co-consultations. Participants will be invited to complete a semi-structured interview or focus group after month six and the final month of the intervention. Interview guides have been derived from the logic model and CFIR online resources ( https://cfirguide.org/evaluation-design/qualitative-data/ ). General practice clinic managers and administrative staff will be asked about how the model of care affected the normal operation of their general practice clinics. GPs and paediatricians will be asked about features of the working relationship e.g. the collaborative nature of the relationship. Interviews with family members will explore their perceptions of the acceptability of the SC4RC model and any potential adaptations to the model to make it more acceptable for families of children presenting to GPs. Plans to promote participant retention and complete follow-up {18b} A number of processes are used to maintain GP practice and GP engagement in the project and minimise ‘withdrawals’ or ‘lost to follow-up’. These include a research assistant from the local region periodically travelling to check in on whether practice staff need assistance with the intervention and troubleshooting any issues, sending out quarterly newsletters tailored to each GP practice with updates and relevant project information. Data management {19} A single electronic, password protected database in REDCap™ (Research Electronic Data Capture) ( 21 , 22 ) will record all general practice clinic and GP details, and survey data. All participants (GPs, caregivers) will be assigned a unique numerical identifier (an ID code) generated in REDCap™ for use throughout the trial. Any data recorded will be stored on the secure University of Melbourne (UoM) network drive on a password protected computer and will be made available for importing into the project secure research environment. The project database will only be accessible by the designated research team members (investigators, statisticians, and project managers) and hosted on the UoM secure server, which meets security and ethical confidentiality requirements. Any information which connects participants’ contact details to their numerical code will be stored securely and separately to participant data during the study. At the conclusion of the study, all identifying participant data will be destroyed and final study data will be stored in a non-identifiable format. All interview data will be transcribed and de-identified for analysis and will be stored in a restricted access folder on UoM network drives on a password protected computer and will be accessible only by the project team. Any personal information revealed in interviews will be anonymised. Any quotes attributed to individual participants in published form will be anonymised. All data extracted by GRHANITE will be securely stored within a GRHANITE Research Databank located on the University of Melbourne Research Cloud. As per the Australian Code for the Responsible Conduct of Research ( 23 ), study records and data will be kept for a minimum of 5 years following the completion of the study, after which time the records may be kept indefinitely or destroyed. Confidentiality {27} Participant confidentiality will strictly be held in trust by the investigators, research staff, and the sponsoring institutions and their agents, and will be extended to cover clinical information relating to participants. All EMR data extracted by GRHANITE will be de-identified prior to extraction. The trial protocol, documentation, data and all other information generated will be held in strict confidence and in password-protected electronic files. No information or data concerning the trial will be released to any unauthorised third party, without prior written approval of the sponsoring institutions. Investigators will have access to the final dataset via permissions maintained by the data managers. Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} Not applicable. No biological specimens being collected. Statistical methods Statistical methods for primary and secondary outcomes {20a} All available data from each recruited GP and family will be analysed according to an intention-to-treat principle. The primary outcome will be analysed using mixed effects logistic regression fitted at the child level (e.g., the proportion of children referred to paediatric service). The model will include a fixed effect of group (intervention period vs control period) and calendar time (as a continuous variable), and a random effect for general practice clinic accounting for multiple patients visiting the same practice. We will also examine whether the intervention effect varies by patients’ socio-demographic group by the inclusion of interaction terms in the regression analysis. The quality of paediatric care for children and young people aged < 18 years delivered by GPs will be measured using standardised best practice care quality indicators across up to 17 paediatric health conditions developed within the national CareTrack Kids study during the study period, with the outcome of interest at the consultation level for each care quality indicator in the Care Track Kids study (e.g., the proportion of consultations adhering to the guidelines for each given indicator across all consultations involved).( 6 ) From a clinical perspective, there is variation among different care quality indicators for a given consultation, e.g. taking a good history may be consistent across conditions but may not relate to optimum asthma preventer prescription. Given this, it is important to capture the within-consultation variation, hence this outcome is for each indicator. GP and family survey outcomes will be analysed using mixed effects linear regression, again including a fixed effect for group and calendar time, and a random effect for general practice clinic, exploring the presence of interactions. We will produce appropriate measures based on the nature of the outcome (e.g., risk difference, risk ratio or odds ratio for proportions, and mean difference for continuous outcomes) with 95% confidence intervals constructed from the standard errors estimated from the regression models. All statistical analyses will be conducted using software including SAS and R. Interim analyses {21b} No interim analysis planned. Methods for additional analyses (e.g. subgroup analyses) {20b} Implementation evaluation In this study, reliability, validity and confidence will be maximised through cross verification and exploration of differences between the findings from interviews with results from the questionnaires, exploring and accounting for differences and mapping the perspectives of different stakeholders across the study. Quantitative questionnaire data will be imported into SPSS/STATA for analysis. Descriptive statistics will be calculated for each of the 2 general practice clinics recruited in the study including information about inner and outer context and the intervention use and its acceptability. Any open-ended questions will be analysed and, where possible, a coding scheme will be developed to enable descriptive analysis, and where this is not possible, open-ended questions will undergo inductive thematic analysis. The study team will audio-record and transcribe interviews verbatim and thematically analyse the transcripts to identify, interpret and report on the repeated patterns of meaning within the data, influenced by the CFIR constructs and drawing from Braun and Clark’s thematic analysis approach.( 35 ) The number and proportion of children seen in GP-Paediatrician co-consultations, reasons for co-consultations, number of phone and emails to the paediatrician support, number and topic of case study discussions as part of the SC4RC program over the study period, will be assessed using summary measures of the variables of interest during the intervention period only. Economic Analysis Using a standard economic evaluation framework( 36 ), we will determine the costs of conducting SC4RC (paediatrician time and supervision, GP training, general practice clinics administrative support, co-consults, and case-study discussions) relative to standard care. This information will be combined with the SC4RC outcomes (guideline adherent care, ED presentations, OP attendances). The economic evaluation will be presented from both a health system and societal perspective, with the latter also including impacts on parental time, productivity, travel and child school/kindergarten attendance. Cost-effectiveness results will be presented as a cost per ED presentation appropriately avoided, cost per OP attendance appropriately avoided and cost per additional child receiving care adherent to guidelines. Appropriate attendance will refer to non-primary care sensitive attendance. Net costs or savings will also be presented. Data will be sourced from the trial database, GRHANITE software and the trial hospitals (cost of ED and OP visits). One way and probabilistic sensitivity analyses will be conducted. The costs of implementing the model will be scaled to the national level along with a budget impact analysis from the perspective of potential payers (Medicare, PHNs, Hospitals, Families) to guide the translation of findings and sustainable implementation. Sustainability To assess the longer-term impact of the SC4RC model, sustainability data (GP referral data and quality of care indicators) will be collected from the time the initial general practice clinics complete the intervention for up to 4–14 months. This data will be analysed in conjunction with qualitative data collected from GPs and general practice clinic staff to assess whether changes in referral practices, adherence to standard practice guidelines and GP confidence are sustained after the intervention has ceased. Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} Analysis is at the cluster level and will be intention to treat. Prior to analysis, missing data in the primary and secondary outcomes will be explored. The frequency and patterns of missing data will be examined, and sensitivity analyses performed to compare the results of analyses restricted to GP and family surveys with complete data and analyses accounting for the missing data (such as multiple imputation). If there is a low level of missing data (< 5%), a complete case analysis will be presented as the primary analysis. We will develop a detailed statistical analysis plan (SAP) to guide the analysis. Plans to give access to the full protocol, participant level-data and statistical code {31c} This document is the full protocol. The corresponding author can be contacted with any requests for information on any additional data or documentation. Oversight and monitoring Composition of the coordinating centre and trial steering committee {5d} An experienced Research Assistant will assist for the duration of the trial in coordinating the day-to-day running of the project activities across both states (NSW & VIC). This role will be based in Victoria and assist throughout the project. The role will be supervised by the CIA. A Research Assistant will assist in each state (VIC & NSW) to support the study team(s) in recruitment and on-boarding of the 12 General Practitioner (GP) clinics and staff (Clinicians, Practice Managers, GPs, and Admin Staff) in each state (total 22 clinics). Stakeholders are closely aligned with the trial either as partner organisations or as members of our Advisory Committee. We have engaged with tertiary paediatric hospitals, primary health networks, state governments, professional GP bodies as well as universities and research centres across both states. Composition of the data monitoring committee, its role and reporting structure {21a} The investigators are responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data reported, and will maintain adequate records of study participant information and consent. No data monitoring committee is required for this trial due to the known minimal risks. Adverse event reporting and harms {22} Two senior clinicians in each state (CIs LS and RL) will meet regularly with the practice-based paediatricians so that any adverse events that they observe or that the GPs or practice staff raise will be recognised and managed in a timely manner. While we do not anticipate any major risks to families in this study, completion of the survey or interview may raise issues which are uncomfortable (confidence and competence in care), upsetting, or frustrating for participants. To reduce the potential for distress to families, the researcher will provide clear explanations about why the research is being conducted, how the information will be used, and the kinds of questions that will be asked in the questionnaire prior to recruiting the family. They will also emphasize that: All information families provide is confidential (unless we are legally compelled to disclose) Families do not have to answer any questions they don’t want to It is OK to stop the survey at any point. Frequency and plans for auditing trial conduct {23} The project will implement three tiers of governance in both rural NSW and VIC: Table 5 Outline of planned meetings to address governance in rural NSW and VIC Every fortnight ½ hour Project Team Meetings attended by the combined project team and Project Leads of each state Every 3 months 1-hour Quarterly Steering and Evidence Translation Committee Meetings attended by the Chief Investigators Every 6 months 1-hour Advisory Committee Meetings attended by the Chief Investigators, Partner Investigators, Associate Investigators, policy makers and associated health providers Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} Approval for protocol amendments will be appropriately gained through the University of Melbourne Human Research Ethics Committee and communicated with the research team and advisory committee, where appropriate. Trial participants will be in regular contact with the research team and will be routinely notified of any relevant protocol amendments. Dissemination plans {31a} Results will be submitted for publications in peer-reviewed journals and presented at relevant conferences. A report of study outcomes and implications will be delivered to partner organisations and relevant stakeholders. A summary of the study results will be sent to each general practice clinic. The study results will not be sent to families as we will only be obtaining contact information for a very small proportion of families. We will prepare a study report as a newsletter, which general practice clinics can share. GPs and any family who request this information through their general practice clinic will have access to the final, non-identifiable study results. Discussion Children living in rural and remote Australia have diminished health outcomes and are more likely to be developmentally vulnerable on one or more domains compared to their urban peers ( 1 ). Furthermore, despite increased risks of poor health, children in rural and remote regions often cannot access specialist care due to lack of availability, financial constraints or waiting times of over 12 months ( 1 – 5 ). Providing high-quality care to regional and rural children in their local area is a critical step toward reducing health inequalities in Australia. Primary care, with its network of experienced and highly motivated regional and rural doctors, can bridge the quality and access gap in healthcare delivery to regional and rural areas. However, targeted investment and support will be required not only to address current inequities facing regional and remote consumers and healthcare providers but also to tackle a widening gap in access brought about by the COVID-19 pandemic. Children and young people’s mental health and well-being were significantly impacted by the pandemic ( 37 ) with lifestyle disruptions that caused changes in neurobiology that represent greater risks for mental health issues into the future ( 38 ). Increasing mental health presentations drove demand for services at a time when child and youth mental health services were already in crisis ( 39 ). In regional and rural areas, consumers and primary care providers are disproportionately affected by limited access to mental health specialist assessment and care providers, placing further pressure on an already overburdened rural primary care system. ( 40 ) If primary care is to bridge the gap in high-quality treatment and care, targeted investment in primary care, secondary consultation, and corresponding care pathways will be required. Building on a promising UK model of integrated GP-paediatrician care ( 15 ) and our own pilot and urban trial studies confirming the feasibility and acceptability of a similar approach ( 12 – 14 , 16 ), this protocol paper outlines how we will partner with primary health nerwork organisations, local health districts, and paediatric hospitals to implement and evaluate the effectiveness and cost-effectiveness of SC4RC in some regional and rural communities of VIC and NSW, using a stepped-wedge cluster randomised controlled trial. If effective, evidence from this programme, through our linkage with the Royal Australasian Colleges of General Practitioners and Physicians, PHNs, LHDs, NSW and Victoria Departments of Health, will lead to the scale up and adoption of the SC4RC model into routine regional and rural primary care practice. Trial status Protocol version V1.6, April, 2025. The SC4RC trial is currently recruiting across 20 general practice clinics in NSW and VIC. Enrolment for SC4RC commenced in December 2023. Recruitment of practices was completed in March 2024. Ongoing recruitment and data collection is anticipated to be completed by September 2026. Participating practices were randomized on the 27th March 2024. Abbreviations Abbreviation Term CFIR Consolidated Framework for Implementation Research CI Chief Investigator ED Emergency Department EMR Electronic Medical Record EOI Expression of Interest GP General Practitioner HREC Human Research Ethics Committee MRFF Medical Future Fund Grant MLHD Murrumbidgee Local Health District MPHN Murrumbidgee Primary Health Network NSW New South Wales OP Outpatient clinic PHN Primary Health Network RACGP Royal Australian College of General Practitioners SC4RC Strengthening Care for Rural Children TGA Therapeutic Goods Administration UNSW University of New South Wales UoM University of Melbourne VIC Victoria WPHN Western Victoria Primary Health Network Declarations Acknowledgements SC4RC is a research collaboration between the Population Child Health Research Group, The University of New South Wales, Health Services and Economics Murdoch Children’s Research Institute; The Sydney Children’s Hospitals Network; The University of Melbourne; School of Public Health, UTS; Faculty of Health,Inst. Health Transformation, Deakin University; Australian Institute of Health Innovation, Macquarie University; IIMPACT in Health, University of South Australia; Western Victoria Primary Health Network (WVPHN); Murrumbidgee Primary Health Network (MPHN); Murrumbidgee Local Health District; Barwon Health; Ballarat Health Services and The University of Notre Dame, Australia. We thank all the general practice clinics, GPs, paediatricians and families who participated in the trial. Authors’ contributions {31b} The original study design was conceived by RL, LS, HH, JP, MF, MB, FM, DT, PH. NH and PC provided statistical expertise in the trial design; MH and CC provided expertise on qualitative analysis in the trial. JM, AT, KW, SK and SB are conducting the data collection, NH, SB, JM, SK, KW, AT are conducting data cleaning and NH, SB, JM and CC are conducting the statistical analysis. All authors listed have contributed to the data processes of the study and reviewed the paper. RL and LS are the overall guarantors. Funding {4} The study is funded through a 3-year Medical Future Fund (MRFF) Grant (MRFAR000223). This includes direct funding from the MRFF, as well as cash and in-kind support from the following Partner Organisations: UNSW; Sydney Childrens Hospital Network (SCHN); Ballarat Health Services; Barwon Health, and Murrumbidgee Local Health District. The MRFF has no direct role in study design; data collection, analysis and interpretation, or writing of final reports, presentations or publications. Representatives from each Partner Organisation will form the Advisory Committee for the project and will therefore have a role in the study and may influence the activities above. Availability of data and materials {29} Data available on request. Ethics approval and consent to participate {24} This study has approval from The University of Melbourne Human Research Ethics Committee [Ethics ID 25885] and site-specific HRECs. Written and informed consent will be obtained from all participants. All participants will be informed that they have the right to withdraw from the study at any time. Participants will be informed that their withdrawal from the study will not impact their relationship with the university or partner organizations and will not impact on their healthcare or the care of their child/ren. Consent for publication {32} Not applicable. All data will be de-identified prior to publication. Competing interests {28} The investigators declare no financial or other competing interests for the overall study and for each study site. References Arefadib N, Moore T. Reporting the Health and Development of Children in Rural and Remote Australia. The Centre for Community Child Health at the Royal Children’s Hospital. Parkville, Victoria: and the Murdoch Children’s Research Institute; 2017. Australian Institute of Health and Welfare. 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Supplementary Files C.SC4RCGPPLSV2.130323.docx D.SC4RCGPConsentV2.130323.docx F.ClinicianInterviewPICFV2.130323.docx I.SC4RCFamilySurveyPLSV2.130323.docx J.SC4RCFamilycontrolsurveyV1.1141222.docx K.SC4RCFamilyinterventionsurveyV1.1141222.docx N.ParentcaregiverinterviewPLSConsentV2.130323.docx R.GeneralPractitionerControlSurveyV1141222.docx S.GeneralPractitionerInterventionSurveyV1141222.docx Cite Share Download PDF Status: Published Journal Publication published 17 Dec, 2025 Read the published version in Trials → Version 1 posted Reviewers agreed at journal 18 Sep, 2025 Reviewers invited by journal 18 Sep, 2025 Editor assigned by journal 05 Jun, 2025 First submitted to journal 04 Jun, 2025 Editorial decision: Minor revision 28 May, 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. 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regional Victoria and New South Wales.","fulltext":[{"header":"Administrative information","content":"\u003cp\u003eNote: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"639\" class=\"fr-table-selection-hover\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTitle (1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eStrengthening Care for Rural Children (SC4RC): Study protocol for a stepped-wedge pragmatic trial of an integrated general practitioner\u0026ndash;paediatrician model of primary care in regional Victoria and New South Wales.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTrial registration {2a and 2b}.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAustralia New Zealand Clinical Trials Registry (ACTRN) ACTRN12623000550606. \u0026nbsp;Registered on 23 May 2023.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eProtocol version {3}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eProtocol V1.6, May, 2025.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eFunding {4}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eThe study is funded through a 3-year Medical Future Fund (MRFF) Grant (MRFAR000223). This includes direct funding from the MRFF, as well as cash and in-kind support from the following Partner Organisations: UNSW; Sydney Children\u0026rsquo;s Hospital Network (SCHN); Ballarat Health Services; Barwon Health, Murrumbidgee Primary Health Network and Murrumbidgee Local Health District.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAuthor details {5a}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003csup\u003e1\u0026nbsp;\u003c/sup\u003ePopulation Child Health Research Group, Discipline of Paediatrics \u0026amp; Child Health, Randwick Clinical Campus, School of Clinical Medicine, University of New South Wales, Sydney, NSW, Australia.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e2\u003c/sup\u003eSydney Children\u0026rsquo;s Hospitals Network, Sydney, NSW, 2031.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e3\u003c/sup\u003eHealth Services and Economics, Murdoch Children\u0026rsquo;s Research Institute, Parkville, VIC 3052.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e4\u003c/sup\u003e Faculty of Medicine, Health and Dental Sciences, The University of Melbourne, Parkville, VIC 3052. \u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e5\u003c/sup\u003eDepartment of Paediatrics, University of Melbourne, VIC 3052.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e6\u003c/sup\u003eDepartment of General Practice and Primary Care, The University of Melbourne, Parkville, VIC 3052.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e7\u003c/sup\u003eWestern Victoria Primary Health Network, VIC 3220.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e8\u003c/sup\u003eMurrumbidgee Local Health District, NSW 2650.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e9\u003c/sup\u003eSchool of Public Health, UTS, Sydney NSW 2007.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e10\u0026nbsp;\u003c/sup\u003ePaediatric Unit, Women\u0026rsquo;s \u0026amp; Children\u0026rsquo;s Services, Barwon Health, VIC, 3220.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e11\u0026nbsp;\u003c/sup\u003eFaculty of Health,Inst. Health Transformation, Deakin University, VIC, 3216.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e12\u003c/sup\u003ePaediatric Unit, Women\u0026rsquo;s \u0026amp; Children\u0026rsquo;s Services, Grampians Health, Ballarat 3352.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e13\u003c/sup\u003eDeakin University, VIC, 3216.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e14\u003c/sup\u003eAustralian Institute of Health Innovation, Macquarie University, Macquarie Park NSW 2109.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e15\u003c/sup\u003e IIMPACT in Health, University of South Australia, Adelaide SA 5000.\u0026nbsp;\u003csup\u003e16\u003c/sup\u003eUniversity of Notre Dame Australia, Rural Clinical School, Lithgow, NSW, 2790. \u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e17\u003c/sup\u003eMelbourne Health Economics, Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, VIC 3052. \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eName and contact information for the trial sponsor {5b}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eProfessor Mark Hargreaves\u003c/p\u003e\n \u003cp\u003eUniversity of Melbourne\u003cbr\u003e\u0026nbsp;Address: The University of Melbourne, Parkville, Victoria 3010\u003cbr\u003e\u0026nbsp;Country: Australia\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eRole of sponsor {5c}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eThe sponsor played no part in study design; collection, management, analysis, and interpretation of data; writing\u0026nbsp;of the report; and the decision to submit the report for publication.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Introduction","content":"\n\u003ch3\u003eBackground and rationale {6a}\u003c/h3\u003e\n\u003cp\u003eChildren living in regional and rural Australia have diminished health outcomes and are more likely to be developmentally vulnerable than their urban peers.(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) This is largely attributable to a higher likelihood that children living in regional and remote areas will be exposed to social, economic and environmental circumstances that negatively impact health and development.(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) However, despite increased risks of poor health, children in regional and remote regions often cannot access specialist care due to a lack of availability, financial constraints or waiting times of over 12 months.(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) Regional and remote families, whose disposable income is 15% less than that of urban families (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e), incur significantly greater disruption and financial costs in seeking medical care.(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) It is estimated that travel distances of greater than 100km each way are not an unusual requirement for regional and remote families to attend a specialist appointment.(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) Compared to urban families, these travel times contribute to greater loss of parental wages and child school absences for families in regional and remote areas.(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) Barriers to attending specialist health appointments contribute to diagnostic and treatment delays which directly reduce quality of life and health outcomes whilst increasing health care costs.(\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eThe current Australian healthcare system does not offer optimal care and is failing to deliver equitable healthcare for children and young people. A study examining quality of paediatric care in metropolitan and regional Australia based on adherence to best practice guidelines for the management of 17 common childhood conditions, found that only 60% of the care provided to children and young people were in line with these guidelines.(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) Quality of care indicators were significantly worse in primary care than in secondary care e.g. for gastroenteritis, adherence was lower in the general practitioner (GP) setting (38.5%; 95% confidence interval [CI]: 33.7\u0026ndash;43.4) than the emergency department (ED) (85.7%; 95% CI: 82.4\u0026ndash;88.7) and hospital inpatient (87.1%; 95% CI: 80.2\u0026ndash;92.3) settings; p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001 for both comparisons.(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e) The pattern held for mental health presentations, e.g. appropriate treatment of anxiety, occurred in 39.9% of consults in primary care (95% CI 20.6, 61.9) compared to 87.1% of consults (95% CI 62.0, 98.2) in specialised paediatric care.(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eProviding high quality care to regional and rural children in their local area is a critical step toward reducing health inequalities in Australia. One potential solution to the need for increased access to care is care integration. Systematic review of specialist outreach clinics in primary care and rural hospitals found that integrated services explicitly involving collaboration between primary care and specialist services improved access, quality of care, and health outcomes compared with standard care.(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) This is supported by an updated 2020 systematic review and meta-analysis which showed strong evidence that integrated models of care, including integration between primary and secondary care providers, improved health-related quality of life compared with standard care in children with chronic illness (standard mean difference [SMD]\u0026thinsp;=\u0026thinsp;0.24; 95% CI\u0026thinsp;=\u0026thinsp;0.03, 0.44; P\u0026thinsp;=\u0026thinsp;0.02).(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) A systematic review of Communities of Practice (peer-to-peer support and continuing professional development) found three intervention trials where Communities of Practice were a component of a health system, all of which reported improved rates of adherence to evidence-based process indicators and greater involvement of the patient in decision making.(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/p\u003e\n\u003ch3\u003eStrengthening Care for Children\u003c/h3\u003e\n\u003cp\u003eThe Strengthening Care for Children (SC4C) model of integrated General Practitioner (GP)-paediatrician care was designed to improve access to quality paediatric care for children in a primary care setting.(\u003cspan additionalcitationids=\"CR13\" citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e) Adapted from the UK\u0026rsquo;s \u003cem\u003eConnecting Care for Children\u003c/em\u003e model (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e), SC4C comprises regular shared GP-paediatrician consulting sessions, monthly case discussions, and email and telephone support. The model was piloted in 5 general practice clinics in Melbourne, Victoria (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e), where results showed reduced guideline-discordant prescribing for common paediatric conditions by 8\u0026ndash;20%, reduced referrals to ED by 7% and to hospital outpatient (OP) by 5%.(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e) Additionally, parental trust in the GP and GP confidence in providing paediatric care increased by 16% and 12%, respectively.(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eFollowing this successful pilot, SC4C is being evaluated in a multi-site, stepped wedge randomised controlled trial across 22 metropolitan general practice clinics in two Australian cities (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). The model has been found feasible and acceptable by GPs, paediatricians and families with GPs reporting increased knowledge and confidence in paediatric care (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Paediatricians report that SC4C has improved their understanding of the general practice context and demands on GPs, enhancing collaboration and bridging gaps between hospital and primary care. Families expressed satisfaction with the quality and accessibility of the care provided by the SC4C model.(\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e)\u003c/p\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eStrengthening Care for Rural Children\u003c/h2\u003e\u003cp\u003e Building on the SC4C urban trial, our Strengthening Care for Rural Children (SC4RC) model was co-developed with our regional primary care partnership organisations - Murrumbidgee Primary Health Network (MPHN) and Western Victoria Primary Health Network (WVPHN), local GPs, nurses and general practice clinic managers, local health service paediatricians and consumers.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eObjectives {7}\u003c/h3\u003e\n\u003cp\u003eThe aims of this trial are to assess strategies that may improve health outcomes for children to determine:\u003c/p\u003e\u003cp\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eThe effectiveness of SC4RC compared to standard GP care, to:\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eReduce GP paediatric referrals (0 to \u0026lt;\u0026thinsp;18 years) to public and private paediatric services (hospital emergency departments (ED); hospital based paediatric outpatient clinics (OP); and private paediatricians) during the 11-month intervention period\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eReduce GP paediatric referrals (0 to \u0026lt;\u0026thinsp;18 years) to public and private paediatric services (hospital emergency departments (ED); paediatric outpatient clinics (OP); and private paediatricians) during the sustainability period.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eIncrease the quality of paediatric care for children and young people aged 0\u0026ndash;18 years delivered by GPs for up to 17 paediatric health conditions during the 11-month intervention period.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eIncrease GP confidence in managing children and young people in primary care.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eIncrease family trust in primary care and reduce family preference for paediatric referral.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eThe incremental cost-effectiveness of SC4RC compared with standard GP care.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eThe factors that help or hinder implementation of SC4RC to inform adaptability, sustainability and scalability.\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003c/p\u003e\n\u003ch3\u003eTrial design {8}\u003c/h3\u003e\n\u003cp\u003eA stepped-wedge cluster randomised controlled trial will be used to evaluate the SC4RC model compared with standard GP care. Twenty-four general practices will be randomly allocated to one of 11 dates to start the intervention. General practices will provide referral and medical record data during a control period (standard GP care, no SC4RC model operating) before being exposed to the SC4RC intervention, which will be rolled out sequentially to two practices (one from Murrumbidgee and one from Western Victoria) each month for up to 11-months. The first week the intervention is implemented at each general practice will be an embedding period during which practices will establish the administration and workflow of co-consultations with the paediatricians. Data will be extracted throughout the 11-months of the intervention period for each general practice. Collecting this data alongside the control period data will allow us to analyse referral and quality of care trends during the intervention period. Following the 11-month intervention period in each general practice, sustainability data will be collected over up to 13-months to analyse the long-term impact of the SC4RC model.\u003c/p\u003e\n\u003ch3\u003eConsumer Engagement\u003c/h3\u003e\n\u003cp\u003eThe study will engage consumers across the life cycle of the project, across all levels of governance. Consumers will be involved in the co-design of the project, steering groups and through a consumer advisory group (CAG). The CAG will be led by a consumer with lived experience with a focus on better understanding the healthcare needs of regional and rural children and young people with chronic illnesses and their families meeting bimonthly. Consumer input will shape Project ECHO along with the translation and implementation of the projects. Discussions at CAG meeting will be recorded and thematically analysed. This will be an iterative process to inform this project and future activities.\u003c/p\u003e"},{"header":"Methods: Participants, interventions and outcomes","content":"\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n\u003ch2\u003eStudy setting {9}\u003c/h2\u003e\n\u003cp\u003eSC4RC is a multi-site step wedge randomised control trial conducted in regional areas of Victoria (VIC) and New South Wales (NSW), Australia. The catchment area was selected based on pre-existing partnerships between the research team and the respective PHNs (MPHN in NSW and WVPHN in VIC).\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eEligibility criteria {10}\u003c/h3\u003e\n\u003cp\u003eTrial participants will be:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eAll eligible and consenting general practice clinics within the WVPHN and MPHN;\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eAll consenting GPs at these general practice clinics, and;\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eAll consenting caregivers of patients\u0026thinsp;\u0026lt;\u0026thinsp;18 years seen by participating GPs or within participating general practice clinics.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eEligible general practice clinics are those who respond to the expression of interest and meet the inclusion criteria. GPs and caregivers will also need to meet the inclusion criteria (Table\u0026nbsp;1).\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab1\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eTrial population inclusion and exclusion criteria applied during recruitment\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eInclusion\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eExclusion\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003cth colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003eGeneral practice clinics \u0026nbsp;\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eBe located within either the WVPHN or MPHN catchment\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNo active patients* aged 0\u0026ndash;18 years attended the general practice clinic in the past 12 months\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHave Best Practice or Medical Director 3 as their electronic medical record software\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eBe formally accredited by an independent accreditation agency against the Royal Australian College of General Practice standards (\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e) or working towards accreditation\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eGPs\u003c/strong\u003e \u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSee paediatric patients\u0026thinsp;\u0026lt;\u0026thinsp;18 years of age\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eGP registrars with less than 6 months of placement in the general practice clinic\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCan provide a minimum of 1 month of control referral data\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eFamilies\u003c/strong\u003e \u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCaregivers of paediatric patients seen by a participating GP or within participating general practice clinic during the trial\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eChildren or young people who present to the general practice clinic without a parent/guardian\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCaregivers with sufficient English to complete survey\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eInsufficient capabilities to complete the survey in English\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cem\u003e*An \u0026lsquo;active patient\u0026rsquo; is a patient who has attended the practice/service three or more times in the past 2 years, as defined by the Royal Australian College of General Practitioners (RACGP) standards for general practice clinics.\u003c/em\u003e(\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e)\u003c/p\u003e\n\u003ch3\u003eWho will take informed consent? {26a}\u003c/h3\u003e\n\u003cp\u003eAll consent processes outlined below proved feasible and effective in our pilot study and the SC4C urban trial.(\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e) At recruitment, GPs will be asked by a member of the study team to consent by signing a participant information and consent form. Details of what is to be collected as part of the study will be included (including referral and diagnosis information), and GPs will have the opportunity to clarify any queries prior to agreeing to the terms. Signing of the consent form, and participation in the study, is voluntary and free from coercion. Further consent will be obtained prior to conducting an interview or focus group.\u003c/p\u003e\n\u003cp\u003eFor families recruited face-to-face, informed consent will be obtained by a member of the study team prior to study participation. This will involve the study team member telling the caregiver about the study; explaining the purpose of the study; that the only requirement of the study is a one-off anonymous survey; that there are no foreseen risks or benefits to the family participating in the study; and that whether they choose to participate in the survey won\u0026rsquo;t affect the care they receive for their child. For families who are recruited via SMS/email or through scanning the QR code, the caregiver\u0026rsquo;s consent will be indicated via a checkbox at the start of the survey.\u003c/p\u003e\n\u003cp\u003ePrior to conducting an interview with parents or carers, and their children, the researcher will describe the study, providing a participant information sheet for parents or carers, a child-friendly version of the participant information sheet tailored to their child\u0026rsquo;s age/skills in comprehension to children, and a consent form. For parents/carers/children who do not have the digital capabilities to print, sign and scan the consent form, the researcher will explain the information statement via phone and send a SMS of an electronic version of consent form via REDCap to be signed electronically before scheduling the interview appointment.\u003c/p\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n\u003ch2\u003eAdditional consent provisions for collection and use of participant data and biological specimens {26b}\u003c/h2\u003e\n\u003cp\u003eNot applicable to current study.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n\u003ch2\u003eInterventions\u003c/h2\u003e\n\u003cdiv id=\"Sec13\" class=\"Section3\"\u003e\n\u003ch2\u003eExplanation for the choice of comparators {6b}\u003c/h2\u003e\n\u003cp\u003eComparator is usual standard GP based care. Explanation for this is given in the \u003cstrong\u003eBackground and rationale {6a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003esection.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\n\u003ch2\u003eIntervention description {11a}\u003c/h2\u003e\n\u003cp\u003eThe SC4RC intervention was adapted from the previously evaluated SC4C urban study (\u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e) through co-design with rural parent-consumers, GPs, paediatricians and PHNs. The SC4RC model of care will be delivered by 8 (NSW) and 3 (VIC) paediatricians funded by their respective Local Health Districts. It comprises three components to be offered to all participating GPs:\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eGP-led co-consultation sessions.\u003c/strong\u003e Study paediatricians will offer face-to-face or video conference co-consultation sessions with GPs for their paediatric patients presenting with any issue for two half-day sessions per month. Paediatricians will work alongside GPs to provide support and mentorship in the primary care management of paediatric cases. The co-consultations are not intended to conduct specialist paediatric care but rather to assist GPs to advance their primary care assessment, management, and investigation beyond where they would normally feel confident, or to validate the care approach the GPs are already using. GPs are instructed to book a child for a co-consultation for any issue where they want this mentorship from the paediatrician. GP registrars with less than 6 months of placement will be excluded from participating in the data collection for this trial. However, they will be able to schedule co-consultations with their participating GP supervisors to support a \u0026lsquo;whole of general practice clinic\u0026rsquo; approach. Patients will only be billed as per the usual billing practices for a GP consultation.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eWeekday paediatrician phone and email support outside of co-consultation sessions.\u003c/strong\u003e Participating GPs will have access to dedicated phone and email support from paediatricians during business hours throughout the intervention period.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eOnline community of practice via Project ECHO.\u003c/strong\u003e\u003csup\u003e\u003cstrong\u003e\u0026trade;\u003c/strong\u003e\u003c/sup\u003e Continuing professional development will be delivered through the \u003cem\u003eProject ECHO\u003c/em\u003e\u003csup\u003e\u003cem\u003e\u0026trade;\u003c/em\u003e\u003c/sup\u003e (Extension for Community Healthcare Outcomes), an online tele-mentoring programme.(\u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e) Led by a facilitator GP academic (BF) from the University of Melbourne (UoM) and WVPHN, GPs will have access to a series of monthly ECHO sessions via videoconference consisting of a brief presentation by the study paediatricians (from a set of curriculum designed in consultation with participating GPs), followed by case presentation and facilitated discussion between clinicians.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\n\u003ch2\u003eCriteria for discontinuing or modifying allocated interventions {11b}\u003c/h2\u003e\n\u003cp\u003eNot applicable. Study is a stepped-wedge cluster randomised controlled trial.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\n\u003ch2\u003eStrategies to improve adherence to interventions {11c}\u003c/h2\u003e\n\u003cp\u003eTo determine how the intervention is being carried out in each site as compared to the intended rollout, we will draw on trial data, which will record the specific details of model delivery. This will include consistent recording of the number and frequency of:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eCo-consultations attended by participating GPs\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eFormal monthly case discussions and attendance of GPs at each general practice clinic\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eOne-on-one discussions between GPs and SC4RC paediatricians\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eUse of phone and email support\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eThe nature of paediatric support provided (e.g., reason for visit, topic of case study discussion)\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eThis information will be recorded in REDCap by the SC4RC paediatricians and research team.\u003c/p\u003e\n\u003cp\u003eSeveral methods will be used to maintain general practice clinic and GP engagement in the trial. These will include pre-intervention onboarding sessions with GPs and general practice clinic administrative staff, regular meetings with general practice clinics once the intervention has commenced and quarterly newsletters providing updates and relevant trial information. The research team will work closely with the general practice clinics to address any barriers that arise as the project is progressing.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec17\" class=\"Section2\"\u003e\n\u003ch2\u003eRelevant concomitant care permitted or prohibited during the trial {11d}\u003c/h2\u003e\n\u003cp\u003eNot applicable. Study is a stepped-wedge cluster randomised controlled trial.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec18\" class=\"Section2\"\u003e\n\u003ch2\u003eProvisions for post-trial care {30}\u003c/h2\u003e\n\u003cp\u003eNot applicable. Study is a stepped-wedge cluster randomised controlled trial.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec19\" class=\"Section2\"\u003e\n\u003ch2\u003eOutcomes {12}\u003c/h2\u003e\n\u003cp\u003eOutline of the primary and secondary objectives, data sources, methods of collection, period of data collection, and outcomes of interest are outlined below (Table\u0026nbsp;2)\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003ctable id=\"Tab4\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eDescription of outcomes\u003c/div\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eObjectives\u003c/div\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eOutcomes of Interest\u003c/div\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eData Sources\u003c/div\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eMethods of collection\u003c/div\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eTimeline\u0026nbsp;of Data Collection\u003c/div\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003cth colspan=\"5\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003ePrimary Objective\u003c/div\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eWhat is the impact of SC4RC on number of GP referrals to public and private pediatric services (hospital OP/ ED, private paediatrician)?\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eProportion of children the GP referred to any public or private paediatric service\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eGP medical records via the referral pop-up supported by GRHANITE\u0026trade;\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eGRHANITE data extraction of referral destination (including no referral) for each paediatric visit.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eControl and intervention periods.\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"5\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eSecondary Objectives\u003c/span\u003e\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eWhat is the impact of SC4RC on GP quality of care for up to 17 childhood conditions (\u003cspan class=\"Italic\"\u003eCareTrack Kids study\u003c/span\u003e (\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e))?\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003e1. Noncommunicable: abdominal pain, asthma, gastrooesophageal reflux, crying unsettled infant, eczema\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003e2. Mental health: autism, developmental delay, anxiety, depression, ADHD.\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003e3. Acute infection: acute gastroenteritis, bronchiolitis, croup, fever, otitis media, tonsillitis, upper respiratory tract infection\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003e4. Injury: head injury\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eProportion of GP consultations where the care quality is adhered to (based on the care quality indicator) for each childhood condition\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eGP medical records\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eGRHANITE data extraction of care quality based on the measurement of the \u003cspan class=\"Italic\"\u003eCareTrack Kids\u003c/span\u003e indicators (\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eControl and intervention periods.\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eWhat is the impact of SC4RC on GPs? \u003cspan class=\"Italic\"\u003e(E.g., confidence and self-perceived skills in paediatric care, feasibility, acceptability)\u003c/span\u003e\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eLevel of confidence in paediatric care; level of knowledge and skill in navigating the health system for children; reported use of clinical guidelines; reported feasibility/acceptability of the model.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eGP online survey\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eControl and intervention surveys completed online via REDCap\u0026trade;\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eControl surveys: Month prior to the implementation commencing. Intervention surveys: Last month of implementation at each general practice clinic.\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eWhat is the impact of SC4RC on patients and family experience?\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eLevel of confidence in GP care, level of satisfaction with GP care, desire for referral to specialist care, preference for GP or specialist review.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eFamily online or in-person survey\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eControl and intervention surveys completed with families in waiting room of general practice clinics or online via REDCap\u0026trade;.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eControl surveys: Month prior to the implementation commencing. Intervention surveys: Last month of implementation at each general practice clinic.\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"5\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eHealth economic evaluation\u003c/span\u003e\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eWhat is the cost of implementing the model of care? What is the cost effectiveness?\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eCosts of conducting the model of care compared with usual care; costs/savings of change in OP/ED referrals; costs/savings to families compared with accessing usual care. Incremental cost effectiveness ratio and net cost/cost savings.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eTrial data and supplementary uni costings\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eTrial data on the model of care, health service costs, health service use and patient costs and outcomes will be combined with relevant unit costs.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eData will be collected throughout the trial\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"5\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eImplementation Evaluation\u003c/span\u003e\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"2\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eWhat are the aspects of the model of care that make it effective or ineffective at producing system change?\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eIdentify strategies for successful implementation, practical difficulties and facilitators in adoption, delivery and maintenance to inform future scaling. Feasibility/acceptability of the model.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd rowspan=\"2\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eFidelity data, qualitative interviews, focus groups with GPs, general practice clinic staff, paediatricians, families and project team members. GP and family surveys.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd rowspan=\"2\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eConsolidated Framework for Implementation Research; qualitative interviews with families, practitioners, administrative staff; online surveys. De-identified data on patient characteristics (i.e. age, gender) and nature of paediatric support provided (e.g., reason for visit) will be collected by paediatricians and research team.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eInterim qualitative data will be collected via focus groups/interviews with general practice clinics 6\u0026ndash;7 months into the intervention period (iterative data collection process). Interviews with GPs, families and paediatricians will be conducted at the end of the intervention period.\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eDescribe the model of care, including number of co-consultations, reasons for co-consultations, number of phone and emails to paediatrician, number and topic of case study discussions. GP buy-in and appropriateness of the model; adoption and fidelity to the model.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eOnline survey data will be collected upon completion of the intervention period in each general practice clinic. De-identified data will be collected as part of the co-consultations, case study discussions and phone/email support throughout the intervention period.\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"5\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eSustainability\u003c/span\u003e\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eExplore the sustainability and enduring effects of SC4RC post-implementation on proportion of GP paediatric referrals to OP clinics or EDs and GP quality of care compared with pre-intervention GP care.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eHow GP paediatric referrals (i) and quality of care (ii) in the sustainability period compared to the intervention period\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eGP medical records and GP online survey\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eGRHANITE data extraction of referral destination (including no referral) for each paediatric visit. GRHANITE data extraction of care quality based on the measurement of the \u003cspan class=\"Italic\"\u003eCareTrack Kids\u003c/span\u003e (\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e) indicators.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eData will be collected from the completion of the intervention period in each general practice clinic until the end of the sustainability period. Survey conducted 6 months post intervention period.\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec20\" class=\"Section2\"\u003e\n\u003ch2\u003eParticipant timeline {13}\u0026nbsp;\u003c/h2\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec21\" class=\"Section2\"\u003e\n\u003ch2\u003eSample size {14}\u003c/h2\u003e\n\u003cp\u003eUsing data from our pilot study (\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e) and the CareTrack Kids Australia study (\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e), each general practice clinic is estimated to see at least 15 paediatric patients per week, amounting to 780 paediatric patients per year. Assuming each general practice clinic has an average of 1.4 consultations per paediatric patient, this equates to 91 paediatric consultations per month per general practice clinic.\u003c/p\u003e\n\u003cp\u003eWith 22 general practice clinics enrolled into the stepped-wedge design, we will have 90% power to be able to detect at least 1.1% decrease in the proportion of paediatric GP consultations where children were referred to public and private paediatric services, based on two-sided alpha of 0.05 and an intra-cluster correlation of 0.06 (derived from our SC4C urban study (\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e)).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec22\" class=\"Section2\"\u003e\n\u003ch2\u003eRecruitment {15}\u003c/h2\u003e\n\u003cdiv id=\"Sec23\" class=\"Section3\"\u003e\n\u003ch2\u003eGeneral Practice Clinics and GPs\u003c/h2\u003e\n\u003cp\u003eA total of 22 general practice clinics (12 in NSW and 12 in VIC) will be recruited with the support from the respective PHNs and the Victorian Primary Care Practice-Based Research and Education Network (VicREN).(\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e) Recruitment will occur through the dissemination of expression of interest (EOI) forms to general practice clinic managers, GPs, and general practice clinic nurses, facilitated by the PHNs. Interested general practice clinics will be visited by members of the research team to present the SC4RC model and are required to sign a Trial Site Agreement adhering to the requirements of their participation, and a license agreement to install the clinical data extraction software tool GRHANITE\u003csup\u003eTM\u003c/sup\u003e.(\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e) Interested GPs will then be invited to formally consent to the project by signing a participant information consent form. Quality Improvement Grants of $3000 per general practice clinic for the duration of their participation and Royal Australian College of General Practitioners\u0026rsquo; (RACGP) Continuing Professional Development (CPD) points will be provided to support general practice clinics participation in the trial.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec24\" class=\"Section2\"\u003e\n\u003ch2\u003eFamilies\u003c/h2\u003e\n\u003cp\u003eEligible caregivers of patients\u0026thinsp;\u0026lt;\u0026thinsp;18 who attend a participating general practice clinic during the control and intervention periods will be invited to complete a survey about their GP consultation experience. Families will be alerted to the study through posters at reception and in the waiting rooms of their general practice clinic. General practice clinics can specify if they prefer recruitment of family surveys to occur in-person by the research assistant, online via Short Message Service (SMS) message or via a QR code available in the waiting room. In-person recruitment will occur via trained researchers who will approach families in the waiting room to screen for eligibility and obtain informed consent. Caregivers who consent to complete the survey will be able to do so via a tablet or paper copy provided by the researcher. For SMS recruitment, the research team will provide the general practice clinics with an SMS script and link to the online family survey to send via their existing appointment system (e.g. HotDoc, Health Engine, HealthDirect or other). This survey will be sent to all families/caregivers of patients\u0026thinsp;\u0026lt;\u0026thinsp;18 years seen in the last three months during the control and intervention periods. During the intervention period, in addition to completing the survey, caregivers will be invited to take part in a qualitative interview via telephone or online video, led by the implementation evaluation team of the study. These interviews will be offered to families who have participated in a SC4RC co-consultation with the paediatrician.\u003c/p\u003e\n\u003cdiv id=\"Sec25\" class=\"Section3\"\u003e\n\u003ch2\u003eAssignment of interventions: allocation\u003c/h2\u003e\n\u003cdiv id=\"Sec26\" class=\"Section4\"\u003e\n\u003ch2\u003eSequence generation {16a}\u003c/h2\u003e\n\u003cp\u003eAn independent statistician will randomise the order for each participating general practice clinic to transition from usual care to the SC4RC model of care at one-month intervals. We will stratify all participating general practice clinics by State of location (NSW, VIC) and size (i.e., the number of participating GPs). We will ensure one general practice clinic from NSW and one general practice clinic from VIC will receive the intervention at each randomisation step and to minimise the imbalance of sample sizes between the sites in the control period and those in the intervention period across the steps. To avoid recruitment bias in clusters, randomisation will occur once all general practice clinics have been recruited and enrolled; that is, after all inclusion and exclusion criteria are addressed, and all general practice clinics sign the relevant project agreements.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec27\" class=\"Section3\"\u003e\n\u003ch2\u003eConcealment mechanism {16b}\u003c/h2\u003e\n\u003cp\u003eRandomisation will utilise a web-based randomisation system.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec28\" class=\"Section2\"\u003e\n\u003ch2\u003eImplementation {16c}\u003c/h2\u003e\n\u003cp\u003eImplementation will be by the research team.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec29\" class=\"Section2\"\u003e\n\u003ch2\u003eAssignment of interventions: Blinding\u003c/h2\u003e\n\u003cdiv id=\"Sec30\" class=\"Section3\"\u003e\n\u003ch2\u003eWho will be blinded {17a}\u003c/h2\u003e\n\u003cp\u003eGeneral practice clinics and their GPs will be unblinded to their allocation status (intervention start date) as it will be necessary for general practice clinics to know their start month in the stepped-wedge design to prepare their GPs. We do not anticipate the impact of GPs knowing their start month to change their standard practice due to their busy workload. The study team will not be blinded to the order of randomisation as it will be necessary to know which general practice clinics will be adopting the model of care at each step throughout the roll-out phase to best prepare and coordinate on-site staff. The statistician will be blinded to the randomisation order during data analysis.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec31\" class=\"Section2\"\u003e\n\u003ch2\u003eProcedure for unblinding if needed {17b}\u003c/h2\u003e\n\u003cp\u003eParticipants will not be blinded.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec32\" class=\"Section2\"\u003e\n\u003ch2\u003eData collection and management\u003c/h2\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab5\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eDescription of outcome measures and data collection timepoints of the trial\u003c/div\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n\u003cth colspan=\"3\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eTime point\u003c/div\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eControl period\u003c/div\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eEmbedding period\u003c/div\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eIntervention period\u003c/div\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003cth colspan=\"4\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eMeasure\u003c/div\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eGP demographics\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eFamily demographics\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003ePaediatrician co-consultation data logs\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003ePrimary outcome\u003c/span\u003e\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eGP referral outcomes GRAHNITE extracted from routinely collected GP EMR data\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX*\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eSecondary outcomes\u003c/span\u003e\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eGPs\u003c/span\u003e\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eQuality of care\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003eGRHANITE EMR data extraction on care quality based on measurement of the CareTrack Kids indicators (\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e) for 17 common childhood conditions:\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003e1. Noncommunicable: abdominal pain, asthma, gastrooesophageal reflux, crying unsettled infant, eczema\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003e2. Mental health: autism, developmental delay, anxiety, depression, ADHD.\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003e3. Acute infection: acute gastroenteritis, bronchiolitis, croup, fever, otitis media, tonsillitis, upper respiratory tract infection\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003e4. Injury: head injury\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX*\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eConfidence in paediatric care and access to paediatric services. Study design based on SC4C.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eSkills to manage child health.\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003eStudy designed based on SC4C\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eAwareness and use of HealthPathways\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003eStudy designed based on SC4C\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e9-item implementation culture (CFIR)\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e5-item learning climate (CFIR)\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e4-item measure of perceived intervention appropriateness\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003eIntervention Appropriateness Measure (IAM)\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e18-item intervention buy-in adapted NoMAD tool based on Normalisation Process Theory.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eModel feasibility, acceptability, feedback and patient benefit. Study designed based on SC4C.\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eFamilies\u003c/span\u003e\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eConfidence in GP care\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003eStudy designed based on pilot study\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eQuality of care and interactions with the GP\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003eStudy designed based on pilot study\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003ePreference for paediatrician referral and GP review\u003c/div\u003e\n\u003cdiv class=\"SimplePara\"\u003eStudy designed based on pilot study\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e-\u003c/div\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003eX\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\" align=\"left\"\u003e\n\u003cdiv class=\"SimplePara\"\u003e*Data collected during the one-week embedding period week will not be analysed. EMR, electronic medical records; GP, general practitioner\u0026nbsp;; CFIR, Consolidated Framework Implementation Research.\u003c/div\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec33\" class=\"Section3\"\u003e\n\u003ch2\u003ePlans for assessment and collection of outcomes {18a}\u003c/h2\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec34\" class=\"Section3\"\u003e\n\u003ch2\u003eGP electronic medical records\u003c/h2\u003e\n\u003cp\u003eWe will treat the primary outcome as a binary variable: for each paediatric visit, the child will be deemed either to have been referred or not referred to public and private paediatric services. To measure the primary outcome, data will be routinely collected from GP electronic medical records (EMR) via GRHANITE\u003csup\u003e\u0026trade;\u003c/sup\u003e. Developed by the Health and Biomedical Informatics Centre at the University of Melbourne (\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e), GRHANITE\u003csup\u003e\u0026trade;\u003c/sup\u003e is a secure and ethical acquisition of data for research purposes. It will be remotely embedded into all participating GP EMR systems (compatible with Best Practice or Medical Director software) to extract de-identified routinely collected data on paediatric patients seen throughout the trial. As GP referrals are not consistently recorded in EMR, the GRHANITE team will develop a tailored referral pop-up window with the most common referral options for consultations including no referral, referral to ED or OP, private paediatrician. GP referral data will be collected on every patient\u0026thinsp;\u0026lt;\u0026thinsp;18 years seen in a consultation by a participating GP. This data will be de-identified at the patient level, although the identity of the GP will be supplied to the research team for monitoring purposes only.\u003c/p\u003e\n\u003cp\u003eCollection of GP EMR data will commence for all general practice clinics following randomisation and will continue throughout the trial and sustainability period. Extracted GP data will also include de-identified paediatric patient information limited to patient demographics, reason for visit, diagnoses, referrals, prescriptions, imaging and pathology testing, and GP service item billing. The patient level data will be used to characterise GP paediatric visits (e.g., number of children seen, child age and gender, common diagnoses) and compare quality of care for common conditions before and after the model of care is implemented, based on the CareTrack Kids indicators.(\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e)\u003c/p\u003e\n\u003cp\u003eA natural language processing (NLP) algorithm, developed by the Computing and Information Systems at the University of Melbourne, will be used to automatically transform GP EMR clinical free text of \u0026ldquo;reason for visit\u0026rdquo; or diagnosis into structured clinical data, based on the Systematized Nomenclature of Medicine Clinical Terminology (SNOMED CT).(\u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e)\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003ch3\u003eGP and family data collection\u003c/h3\u003e\n\u003cp\u003eAn online survey will be used to measure GP experience and confidence in paediatric care. These will be distributed to all participating GPs via REDCap\u0026trade; during the control period (one-month prior to the intervention) and in the last month of the intervention for each general practice clinic. The survey collects demographic information about the GP, items relating to factors that impact their decision to refer a paediatric patient, knowledge and confidence of paediatric care and services. GP surveys have been developed specifically for SC4RC and are comprised of items adapted from the SC4C urban study and drawn from previously published literature.(\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e)\u003c/p\u003e\n\u003cp\u003eAn online survey will be used to measure caregivers\u0026rsquo; perceptions and experience of the paediatric care provided at their general practice clinic. To provide data on a \u0026lsquo;whole of general practice clinic\u0026rsquo; level, caregivers of patients\u0026thinsp;\u0026lt;\u0026thinsp;18 years will be eligible to complete the Family Survey via REDCap\u0026trade;, regardless of whether they have seen a GP participating in the SC4RC trial. Family survey data collection will occur during the control period (one-month prior to the intervention) and in the last month of the intervention for each general practice clinic.\u003c/p\u003e\n\u003ch3\u003eImplementation Evaluation\u003c/h3\u003e\n\u003cp\u003eThe implementation evaluation will be based on a mixed methods approach developed for the SC4C trial. (\u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e) We will use the Consolidated Framework for Implementation Research (CFIR) (\u003cspan class=\"CitationRef\"\u003e27\u003c/span\u003e) to understand how and why our intervention was effective or ineffective in producing systems change. The CFIR has been widely used in diverse healthcare contexts, both metropolitan and regional, including primary care settings (\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e) and provides a theoretical lens to understand the processes of introducing and managing change within a complex healthcare system.(\u003cspan class=\"CitationRef\"\u003e29\u003c/span\u003e) The CFIR identifies five major domains (Intervention Characteristics, Outer Context, Inner Context, Characteristics of Individuals, and Process) and provides a framework to guide the consideration and assessment of factors which might impact intervention implementation and effectiveness.\u003c/p\u003e\n\u003cp\u003eIn addition to mapping the barriers and facilitators to implementing the SC4RC model, the study team will evaluate specific implementation outcomes, as guided by the taxonomy proposed by Proctor and colleagues. (\u003cspan class=\"CitationRef\"\u003e30\u003c/span\u003e) These outcomes include intervention acceptability, appropriateness, fidelity to the implementation strategy, coverage, and sustainability (Table\u0026nbsp;4).\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003ctable id=\"Tab2\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eImplementation metrics derived from Proctor et at. (\u003cspan class=\"CitationRef\"\u003e30\u003c/span\u003e)\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eQuestions addressed by each implementation factor.\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eAcceptability\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDo practitioners, parents and children view the SC4RC as agreeable?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eAdoption\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eTo what extent do practitioners and parents use the SC4RC model?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eAppropriateness\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDo stakeholders perceive SC4RC as relevant \u0026amp; useful?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eFidelity\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eIs SC4RC applied as intended? Are all component parts of the intervention delivered as planned?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCoverage\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHow many service users of those eligible are reached?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCost\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHow much does it cost to successfully implement SC4RC?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSustainability\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eWhat are the factors that will allow SC4RC to be scaled-up further?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec37\" class=\"Section2\"\u003e\n\u003ch2\u003e\u0026nbsp;\u003c/h2\u003e\n\u003cdiv id=\"Sec38\" class=\"Section3\"\u003e\n\u003ch2\u003eLogic model\u003c/h2\u003e\n\u003cp\u003eAn implementation logic model (\u003cspan class=\"CitationRef\"\u003e31\u003c/span\u003e) has been developed by the research team to inform the trial and the SC4RC process evaluation (Fig.\u0026nbsp;1). The logic model will be adapted from the SC4C urban study (\u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e) and existing logic model frameworks (\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e33\u003c/span\u003e) and guidelines (\u003cspan class=\"CitationRef\"\u003e31\u003c/span\u003e). The logic model will be used to guide the implementation evaluation to consider factors both within (inner context representing individual factors and organisational settings) and external to the SC4RC sites (outer context, including area demographics, policy climate, and relevant geographically adjacent clinical services). In addition to the contextual factors, we included a detailed description of measurable intervention characteristics such as the number and type (face-to-face vs video) of scheduled co-consultations, attendance at Project ECHO case discussions and use of the phone and email support services as well as implementation strategies, mechanisms of action and outcomes.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec39\" class=\"Section2\"\u003e\n\u003ch2\u003eFidelity to the model\u003c/h2\u003e\n\u003cp\u003eTo determine how the intervention is being carried out in each site as compared to the intended rollout, we will draw on trial data, which will record the specific details of model delivery. This will include recording:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of co-consultations attended by participating GPs\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of formal monthly case discussions and attendance of GPs at each general practice clinic\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eThe frequency of one-on-one discussions between GPs and SC4RC paediatricians\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eThe frequency of use of phone and email support\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eThe nature of paediatric support provided (e.g., reason for visit, topic of case study discussion)\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eThis information will be recorded in REDCap by the SC4RC paediatricians and research team. No identifiable information will be collected, and data will only be analysed to provide information on patterns of support provided. No data on individual children will be reported.\u003c/p\u003e\n\u003cdiv id=\"Sec40\" class=\"Section3\"\u003e\n\u003ch2\u003eAppropriateness and Intervention normalization within primary care\u003c/h2\u003e\n\u003cp\u003eGP surveys collected during the final month of the implementation period will include items measuring GP buy-in to and appropriateness of the SC4RC model. Intervention normalization within primary care will be measured using an adapted version of the NoMAD tool based on the Normalization Process Theory.(\u003cspan class=\"CitationRef\"\u003e34\u003c/span\u003e) The NoMAD tool will assess how the intervention was incorporated into standard work responsibilities. We will also include an adapted version of the Intervention Appropriateness Measure (IAM). The IAM is a pragmatic 4-item measure of the perceived fit, relevance or compatibility of an evidence-based practice for a context, person, or problem.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003ch3\u003eBarriers and facilitators to running SC4RC\u003c/h3\u003e\n\u003cp\u003eTo determine individuals knowledge and beliefs about the model of care; relative advantages and suitability of the model of care; GP and paediatrician self-efficacy; barriers and facilitators affecting the delivery of the intervention both from an individual and organisational perspective; the appropriateness and acceptability of the intervention; and recommendations for future implementation, we will conduct semi-structured interviews and focus groups with GPs, general practice clinic managers, administrative staff, paediatricians, and families who participated in co-consultations. Participants will be invited to complete a semi-structured interview or focus group after month six and the final month of the intervention.\u003c/p\u003e\n\u003cp\u003eInterview guides have been derived from the logic model and CFIR online resources (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://cfirguide.org/evaluation-design/qualitative-data/\u003c/span\u003e\u003c/span\u003e). General practice clinic managers and administrative staff will be asked about how the model of care affected the normal operation of their general practice clinics. GPs and paediatricians will be asked about features of the working relationship e.g. the collaborative nature of the relationship. Interviews with family members will explore their perceptions of the acceptability of the SC4RC model and any potential adaptations to the model to make it more acceptable for families of children presenting to GPs.\u003c/p\u003e\n\u003ch3\u003ePlans to promote participant retention and complete follow-up {18b}\u003c/h3\u003e\n\u003cp\u003eA number of processes are used to maintain GP practice and GP engagement in the project and minimise \u0026lsquo;withdrawals\u0026rsquo; or \u0026lsquo;lost to follow-up\u0026rsquo;. These include a research assistant from the local region periodically travelling to check in on whether practice staff need assistance with the intervention and troubleshooting any issues, sending out quarterly newsletters tailored to each GP practice with updates and relevant project information.\u003c/p\u003e\n\u003ch3\u003eData management {19}\u003c/h3\u003e\n\u003cp\u003eA single electronic, password protected database in REDCap\u0026trade; (Research Electronic Data Capture) (\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e) will record all general practice clinic and GP details, and survey data. All participants (GPs, caregivers) will be assigned a unique numerical identifier (an ID code) generated in REDCap\u0026trade; for use throughout the trial. Any data recorded will be stored on the secure University of Melbourne (UoM) network drive on a password protected computer and will be made available for importing into the project secure research environment. The project database will only be accessible by the designated research team members (investigators, statisticians, and project managers) and hosted on the UoM secure server, which meets security and ethical confidentiality requirements. Any information which connects participants\u0026rsquo; contact details to their numerical code will be stored securely and separately to participant data during the study. At the conclusion of the study, all identifying participant data will be destroyed and final study data will be stored in a non-identifiable format. All interview data will be transcribed and de-identified for analysis and will be stored in a restricted access folder on UoM network drives on a password protected computer and will be accessible only by the project team. Any personal information revealed in interviews will be anonymised. Any quotes attributed to individual participants in published form will be anonymised.\u003c/p\u003e\n\u003cp\u003eAll data extracted by GRHANITE will be securely stored within a GRHANITE Research Databank located on the University of Melbourne Research Cloud.\u003c/p\u003e\n\u003cp\u003eAs per the Australian Code for the Responsible Conduct of Research (\u003cspan class=\"CitationRef\"\u003e23\u003c/span\u003e), study records and data will be kept for a minimum of 5 years following the completion of the study, after which time the records may be kept indefinitely or destroyed.\u003c/p\u003e\n\u003ch3\u003eConfidentiality {27}\u003c/h3\u003e\n\u003cp\u003eParticipant confidentiality will strictly be held in trust by the investigators, research staff, and the sponsoring institutions and their agents, and will be extended to cover clinical information relating to participants. All EMR data extracted by GRHANITE will be de-identified prior to extraction. The trial protocol, documentation, data and all other information generated will be held in strict confidence and in password-protected electronic files. No information or data concerning the trial will be released to any unauthorised third party, without prior written approval of the sponsoring institutions. Investigators will have access to the final dataset via permissions maintained by the data managers.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable. No biological specimens being collected.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods\u003c/strong\u003e\u003c/p\u003e\n\u003ch3\u003eStatistical methods for primary and secondary outcomes {20a}\u003c/h3\u003e\n\u003cp\u003eAll available data from each recruited GP and family will be analysed according to an intention-to-treat principle. The primary outcome will be analysed using mixed effects logistic regression fitted at the child level (e.g., the proportion of children referred to paediatric service). The model will include a fixed effect of group (intervention period vs control period) and calendar time (as a continuous variable), and a random effect for general practice clinic accounting for multiple patients visiting the same practice. We will also examine whether the intervention effect varies by patients\u0026rsquo; socio-demographic group by the inclusion of interaction terms in the regression analysis.\u003c/p\u003e\n\u003cp\u003eThe quality of paediatric care for children and young people aged\u0026thinsp;\u0026lt;\u0026thinsp;18 years delivered by GPs will be measured using standardised best practice care quality indicators across up to 17 paediatric health conditions developed within the national CareTrack Kids study during the study period, with the outcome of interest at the consultation level for each care quality indicator in the Care Track Kids study (e.g., the proportion of consultations adhering to the guidelines for each given indicator across all consultations involved).(\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e) From a clinical perspective, there is variation among different care quality indicators for a given consultation, e.g. taking a good history may be consistent across conditions but may not relate to optimum asthma preventer prescription. Given this, it is important to capture the within-consultation variation, hence this outcome is for each indicator. GP and family survey outcomes will be analysed using mixed effects linear regression, again including a fixed effect for group and calendar time, and a random effect for general practice clinic, exploring the presence of interactions.\u003c/p\u003e\n\u003cp\u003eWe will produce appropriate measures based on the nature of the outcome (e.g., risk difference, risk ratio or odds ratio for proportions, and mean difference for continuous outcomes) with 95% confidence intervals constructed from the standard errors estimated from the regression models. All statistical analyses will be conducted using software including SAS and R.\u003c/p\u003e\n\u003ch3\u003eInterim analyses {21b}\u003c/h3\u003e\n\u003cp\u003eNo interim analysis planned.\u003c/p\u003e\n\u003ch3\u003eMethods for additional analyses (e.g. subgroup analyses) {20b}\u003c/h3\u003e\n\u003cp\u003e\u003cstrong\u003eImplementation evaluation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn this study, reliability, validity and confidence will be maximised through cross verification and exploration of differences between the findings from interviews with results from the questionnaires, exploring and accounting for differences and mapping the perspectives of different stakeholders across the study. Quantitative questionnaire data will be imported into SPSS/STATA for analysis. Descriptive statistics will be calculated for each of the 2 general practice clinics recruited in the study including information about inner and outer context and the intervention use and its acceptability. Any open-ended questions will be analysed and, where possible, a coding scheme will be developed to enable descriptive analysis, and where this is not possible, open-ended questions will undergo inductive thematic analysis.\u003c/p\u003e\n\u003cp\u003eThe study team will audio-record and transcribe interviews verbatim and thematically analyse the transcripts to identify, interpret and report on the repeated patterns of meaning within the data, influenced by the CFIR constructs and drawing from Braun and Clark\u0026rsquo;s thematic analysis approach.(\u003cspan class=\"CitationRef\"\u003e35\u003c/span\u003e) The number and proportion of children seen in GP-Paediatrician co-consultations, reasons for co-consultations, number of phone and emails to the paediatrician support, number and topic of case study discussions as part of the SC4RC program over the study period, will be assessed using summary measures of the variables of interest during the intervention period only.\u003c/p\u003e\n\u003ch3\u003eEconomic Analysis\u003c/h3\u003e\n\u003cp\u003eUsing a standard economic evaluation framework(\u003cspan class=\"CitationRef\"\u003e36\u003c/span\u003e), we will determine the costs of conducting SC4RC (paediatrician time and supervision, GP training, general practice clinics administrative support, co-consults, and case-study discussions) relative to standard care. This information will be combined with the SC4RC outcomes (guideline adherent care, ED presentations, OP attendances). The economic evaluation will be presented from both a health system and societal perspective, with the latter also including impacts on parental time, productivity, travel and child school/kindergarten attendance. Cost-effectiveness results will be presented as a cost per ED presentation appropriately avoided, cost per OP attendance appropriately avoided and cost per additional child receiving care adherent to guidelines. Appropriate attendance will refer to non-primary care sensitive attendance. Net costs or savings will also be presented. Data will be sourced from the trial database, GRHANITE software and the trial hospitals (cost of ED and OP visits). One way and probabilistic sensitivity analyses will be conducted. The costs of implementing the model will be scaled to the national level along with a budget impact analysis from the perspective of potential payers (Medicare, PHNs, Hospitals, Families) to guide the translation of findings and sustainable implementation.\u003c/p\u003e\n\u003ch3\u003eSustainability\u003c/h3\u003e\n\u003cp\u003eTo assess the longer-term impact of the SC4RC model, sustainability data (GP referral data and quality of care indicators) will be collected from the time the initial general practice clinics complete the intervention for up to 4\u0026ndash;14 months. This data will be analysed in conjunction with qualitative data collected from GPs and general practice clinic staff to assess whether changes in referral practices, adherence to standard practice guidelines and GP confidence are sustained after the intervention has ceased.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAnalysis is at the cluster level and will be intention to treat.\u003c/p\u003e\n\u003cp\u003ePrior to analysis, missing data in the primary and secondary outcomes will be explored. The frequency and patterns of missing data will be examined, and sensitivity analyses performed to compare the results of analyses restricted to GP and family surveys with complete data and analyses accounting for the missing data (such as multiple imputation). If there is a low level of missing data (\u0026lt;\u0026thinsp;5%), a complete case analysis will be presented as the primary analysis. We will develop a detailed statistical analysis plan (SAP) to guide the analysis.\u003c/p\u003e\n\u003ch3\u003ePlans to give access to the full protocol, participant level-data and statistical code {31c}\u003c/h3\u003e\n\u003cp\u003eThis document is the full protocol. The corresponding author can be contacted with any requests for information on any additional data or documentation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOversight and monitoring\u003c/strong\u003e\u003c/p\u003e\n\u003ch3\u003eComposition of the coordinating centre and trial steering committee {5d}\u003c/h3\u003e\n\u003cp\u003eAn experienced Research Assistant will assist for the duration of the trial in coordinating the day-to-day running of the project activities across both states (NSW \u0026amp; VIC). This role will be based in Victoria and assist throughout the project. The role will be supervised by the CIA. A Research Assistant will assist in each state (VIC \u0026amp; NSW) to support the study team(s) in recruitment and on-boarding of the 12 General Practitioner (GP) clinics and staff (Clinicians, Practice Managers, GPs, and Admin Staff) in each state (total 22 clinics).\u003c/p\u003e\n\u003cp\u003eStakeholders are closely aligned with the trial either as partner organisations or as members of our Advisory Committee. We have engaged with tertiary paediatric hospitals, primary health networks, state governments, professional GP bodies as well as universities and research centres across both states.\u003c/p\u003e\n\u003ch3\u003eComposition of the data monitoring committee, its role and reporting structure {21a}\u003c/h3\u003e\n\u003cp\u003eThe investigators are responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data reported, and will maintain adequate records of study participant information and consent. No data monitoring committee is required for this trial due to the known minimal risks.\u003c/p\u003e\n\u003ch3\u003eAdverse event reporting and harms {22}\u003c/h3\u003e\n\u003cp\u003eTwo senior clinicians in each state (CIs LS and RL) will meet regularly with the practice-based paediatricians so that any adverse events that they observe or that the GPs or practice staff raise will be recognised and managed in a timely manner. While we do not anticipate any major risks to families in this study, completion of the survey or interview may raise issues which are uncomfortable (confidence and competence in care), upsetting, or frustrating for participants. To reduce the potential for distress to families, the researcher will provide clear explanations about why the research is being conducted, how the information will be used, and the kinds of questions that will be asked in the questionnaire prior to recruiting the family. They will also emphasize that:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eAll information families provide is confidential (unless we are legally compelled to disclose)\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eFamilies do not have to answer any questions they don\u0026rsquo;t want to\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eIt is OK to stop the survey at any point.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003ch3\u003eFrequency and plans for auditing trial conduct {23}\u003c/h3\u003e\n\u003cp\u003eThe project will implement three tiers of governance in both rural NSW and VIC:\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003ctable id=\"Tab3\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eOutline of planned meetings to address governance in rural NSW and VIC\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eEvery fortnight\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e\u0026frac12; hour Project Team Meetings attended by the combined project team and Project Leads of each state\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eEvery 3 months\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1-hour Quarterly Steering and Evidence Translation Committee Meetings attended by the Chief Investigators\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eEvery 6 months\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1-hour Advisory Committee Meetings attended by the Chief Investigators, Partner Investigators, Associate Investigators, policy makers and associated health providers\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003ch3\u003ePlans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}\u003c/h3\u003e\n\u003cp\u003eApproval for protocol amendments will be appropriately gained through the University of Melbourne Human Research Ethics Committee and communicated with the research team and advisory committee, where appropriate. Trial participants will be in regular contact with the research team and will be routinely notified of any relevant protocol amendments.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDissemination plans {31a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eResults will be submitted for publications in peer-reviewed journals and presented at relevant conferences. A report of study outcomes and implications will be delivered to partner organisations and relevant stakeholders. A summary of the study results will be sent to each general practice clinic. The study results will not be sent to families as we will only be obtaining contact information for a very small proportion of families. We will prepare a study report as a newsletter, which general practice clinics can share. GPs and any family who request this information through their general practice clinic will have access to the final, non-identifiable study results.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eChildren living in rural and remote Australia have diminished health outcomes and are more likely to be developmentally vulnerable on one or more domains compared to their urban peers (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Furthermore, despite increased risks of poor health, children in rural and remote regions often cannot access specialist care due to lack of availability, financial constraints or waiting times of over 12 months (\u003cspan additionalcitationids=\"CR2 CR3 CR4\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e–\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Providing high-quality care to regional and rural children in their local area is a critical step toward reducing health inequalities in Australia. Primary care, with its network of experienced and highly motivated regional and rural doctors, can bridge the quality and access gap in healthcare delivery to regional and rural areas.\u003c/p\u003e\u003cp\u003eHowever, targeted investment and support will be required not only to address current inequities facing regional and remote consumers and healthcare providers but also to tackle a widening gap in access brought about by the COVID-19 pandemic. Children and young people’s mental health and well-being were significantly impacted by the pandemic (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e) with lifestyle disruptions that caused changes in neurobiology that represent greater risks for mental health issues into the future (\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e). Increasing mental health presentations drove demand for services at a time when child and youth mental health services were already in crisis (\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e). In regional and rural areas, consumers and primary care providers are disproportionately affected by limited access to mental health specialist assessment and care providers, placing further pressure on an already overburdened rural primary care system. (\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e) If primary care is to bridge the gap in high-quality treatment and care, targeted investment in primary care, secondary consultation, and corresponding care pathways will be required.\u003c/p\u003e\u003cp\u003eBuilding on a promising UK model of integrated GP-paediatrician care (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e) and our own pilot and urban trial studies confirming the feasibility and acceptability of a similar approach (\u003cspan additionalcitationids=\"CR13\" citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e–\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e), this protocol paper outlines how we will partner with primary health nerwork organisations, local health districts, and paediatric hospitals to implement and evaluate the effectiveness and cost-effectiveness of SC4RC in some regional and rural communities of VIC and NSW, using a stepped-wedge cluster randomised controlled trial. If effective, evidence from this programme, through our linkage with the Royal Australasian Colleges of General Practitioners and Physicians, PHNs, LHDs, NSW and Victoria Departments of Health, will lead to the scale up and adoption of the SC4RC model into routine regional and rural primary care practice.\u003c/p\u003e\u003cp\u003e\u003cb\u003eTrial status\u003c/b\u003e\u003c/p\u003e\u003cp\u003eProtocol version V1.6, April, 2025. The SC4RC trial is currently recruiting across 20 general practice clinics in NSW and VIC. Enrolment for SC4RC commenced in December 2023. Recruitment of practices was completed in March 2024. Ongoing recruitment and data collection is anticipated to be completed by September 2026. Participating practices were randomized on the 27th March 2024.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003e\u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003ctable float=\"No\" id=\"Tabb\" border=\"1\"\u003e\u003ccolgroup cols=\"2\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAbbreviation\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eTerm\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCFIR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eConsolidated Framework for Implementation Research\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCI\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eChief Investigator\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eED\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eEmergency Department\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEMR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eElectronic Medical Record\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEOI\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eExpression of Interest\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGP\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eGeneral Practitioner\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHREC\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eHuman Research Ethics Committee\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMRFF\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMedical Future Fund Grant\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMLHD\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMurrumbidgee Local Health District\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMPHN\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMurrumbidgee Primary Health Network\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNSW\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNew South Wales\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOP\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eOutpatient clinic\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePHN\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePrimary Health Network\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRACGP\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRoyal Australian College of General Practitioners\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSC4RC\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eStrengthening Care for Rural Children\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTGA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eTherapeutic Goods Administration\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUNSW\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eUniversity of New South Wales\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUoM\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eUniversity of Melbourne\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVIC\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eVictoria\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWPHN\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eWestern Victoria Primary Health Network\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSC4RC is a research collaboration between the Population Child Health Research Group, The University of New South Wales, Health Services and Economics Murdoch Children’s Research Institute; The Sydney Children’s Hospitals Network; The University of Melbourne; School of Public Health, UTS; Faculty of Health,Inst. Health Transformation, Deakin University; Australian Institute of Health Innovation, Macquarie University;\u0026nbsp;IIMPACT in Health, University of South Australia; Western Victoria Primary Health Network (WVPHN); Murrumbidgee Primary Health Network (MPHN); Murrumbidgee Local Health District; Barwon Health; Ballarat Health Services and The University of Notre Dame, Australia. We thank all the general practice clinics, GPs, paediatricians and families who participated in the trial.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors’ contributions {31b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe original study design was conceived by RL, LS, HH, JP, MF, MB, FM, DT, PH. NH and PC provided statistical expertise in the trial design; MH and CC provided expertise on qualitative analysis in the trial. JM, AT, KW, SK and SB are conducting the data collection, NH, SB, JM, SK, KW, AT are conducting data cleaning and NH, SB, JM and CC are conducting the statistical analysis. All authors listed have contributed to the data processes of the study and reviewed the paper. RL and LS are the overall guarantors.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding {4}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study is funded through a 3-year Medical Future Fund (MRFF) Grant (MRFAR000223). This includes direct funding from the MRFF, as well as cash and in-kind support from the following Partner Organisations: UNSW; Sydney Childrens Hospital Network (SCHN); Ballarat Health Services; Barwon Health, and Murrumbidgee Local Health District.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe MRFF has no direct role in study design; data collection, analysis and interpretation, or writing of final reports, presentations or publications. Representatives from each Partner Organisation will form the Advisory Committee for the project and will therefore have a role in the study and may influence the activities above.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials {29}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData available on request.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate {24}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study has approval from The University of Melbourne Human Research Ethics Committee [Ethics ID 25885] and site-specific HRECs. \u0026nbsp;Written and informed consent will be obtained from all participants. All participants will be informed that they have the right to withdraw from the study at any time. Participants will be informed that their withdrawal from the study will not impact their relationship with the university or partner organizations and will not impact on their healthcare or the care of their child/ren.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication {32}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable. All data will be de-identified prior to publication.\u003cbr\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests {28}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe investigators declare no financial or other competing interests for the overall study and for each study site.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eArefadib N, Moore T. Reporting the Health and Development of Children in Rural and Remote Australia. The Centre for Community Child Health at the Royal Children\u0026rsquo;s Hospital. 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Mental health of young Australians: dealing with a public health crisis. Med J Aust. 2023;219(6):246\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAustralian Institute of Health and Welfare. Mental health. 2024 \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.aihw.gov.au/mental-health/topic-areas/workforce\u003c/span\u003e\u003cspan address=\"https://www.aihw.gov.au/mental-health/topic-areas/workforce\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed Jan, 2025.\u003c/span\u003e\u003c/li\u003e\u003c/ol\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":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Regional and rural healthcare, primary care, engagement, paediatrics, randomised controlled trial, integrated care","lastPublishedDoi":"10.21203/rs.3.rs-6650680/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6650680/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Children living in regional and rural Australia have diminished health outcomes and are more likely to be developmentally vulnerable on one or more domains compared to urban peers.\u003csup\u003e \u003c/sup\u003eDespite this, children in regional and rural Australia often cannot access specialist care due to lack of availability, financial constraints or waiting times of over 12 months.\u003csup\u003e\u0026nbsp;\u003c/sup\u003e Strengthening Care for Rural Children (SC4RC) aims to evaluate an integrated general practitioner (GP)-paediatrician model of care in rural communities to enhance the quality of paediatric care by ensuring children receive timely, accessible care within their communities by reducing referrals to public and private paediatric services.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: SC4RC is a stepped wedge randomised controlled trial of 22 general practice clinics in regional and rural Victoria and New South Wales, Australia. Control data for each general practice clinic will be collected for a minimum of one month and each clinic will be randomly allocated a start month, with the intervention running for 11 months at each clinic. The intervention will consist of fortnightly GP-paediatrician co-consultation sessions, weekday phone and email paediatrician support for GPs, and access to a paediatric online community of practice via a Project ECHO\u003csup\u003eTM\u003c/sup\u003e series. The primary outcome is the proportion of paediatric (0 to \u0026lt;18 years) GP appointments that result in a referral to a paediatric service (hospital emergency departments; outpatient clinics or private paediatricians) during the intervention period compared with the control period. Secondary outcomes include GP quality of care across 17 common childhood conditions; GP confidence in paediatric care; family confidence in GP care; and the sustainability of the SC4RC model. Integral to the project is our consumer engagement framework which will inform the translation and implementation of the project. An implementation evaluation will assess the acceptability, adaptability and scalability of the model, while a health economic evaluation will measure the cost-effectiveness/benefit of the intervention.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e: This protocol paper outlines how we will partner with primary care organisations and paediatric services to implement and evaluate SC4RC in some regional and rural communities in Victoria and NSW.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e:\u0026nbsp;Australia New Zealand Clinical Trials Registry ACTRN12623000550606 on 23 May 2023.\u0026nbsp;\u003c/p\u003e","manuscriptTitle":"Strengthening Care for Rural Children (SC4RC): Study protocol for a stepped-wedge translational trial of an integrated general practitioner–paediatrician model of primary care in regional Victoria and New South Wales.","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-30 16:29:29","doi":"10.21203/rs.3.rs-6650680/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2025-09-18T20:19:33+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-09-18T20:17:53+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-06-05T06:13:38+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-06-04T23:27:05+00:00","index":"","fulltext":""},{"type":"decision","content":"Minor revision","date":"2025-05-28T07:34:11+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"6d6c9e46-42aa-48b6-98ac-46f88ee45f2c","owner":[],"postedDate":"September 30th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-12-22T16:03:24+00:00","versionOfRecord":{"articleIdentity":"rs-6650680","link":"https://doi.org/10.1186/s13063-025-09307-6","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2025-12-17 15:58:34","publishedOnDateReadable":"December 17th, 2025"},"versionCreatedAt":"2025-09-30 16:29:29","video":"","vorDoi":"10.1186/s13063-025-09307-6","vorDoiUrl":"https://doi.org/10.1186/s13063-025-09307-6","workflowStages":[]},"version":"v1","identity":"rs-6650680","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6650680","identity":"rs-6650680","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}