SUSTAIN- Strengthening Care for Children (SC4C), Strengthening Care for Children, A stepped-wedge translational trial of paediatric care in GP practice to assess the impact on hospital burden.

The SUSTAIN study aims to strengthen child healthcare provided by general practitioners (GPs) through an intervention providing virtual support by paediatricians to GPs across urban and rural NSW. The online support provided to GPs in their practices, includes; fortnightly telehealth GP-paediatrician co-consultations lasting up to 30 minutes each for a maximum of 3 hours per GP cluster, monthly hour-long online lunch and learn sessions led by the paediatrician, and weekday access by GPs directly to the paediatrician via phone/email. GPs who take part in the study will also enrol in the Sydney Child Health Program (SCHP), a modular online GP educational course in child health, usually taking a year to complete. The SUSTAIN study is likely to can directly change standard of care for families/paediatric patients in that they may undergo co-consultations with their GP and a paediatrician in the GP practice. A stepped-wedge cluster randomised control trial design will be used to evaluate the SUSTAIN intervention of care compared with standard GP care. This study design has the rigor of a cluster randomised controlled trial but allows all participating GP practices to be exposed to the SUSTAIN care model. Every GP practice will provide control period data (referral and medical record data) including; standard GP care, no SC4C model operating before being exposed to the SUSTAIN intervention which will be rolled out sequentially across the practices and will last 11 months in each practice (the intervention period). Every month, 3 GP practices one each in Central Eastern Sydney (CESPHN) Southwestern Sydney (SWSPHN) and South Eastern NSW (SENSWPHN) will be randomly selected to switch from standard GP care to the SUSTAIN model of care. The intervention will be rolled out concurrently in each of these areas. The population to be studied includes GP practices which represent the cluster (consisting of a single large GP practice or 2-3 small GP practices together), GPs who consent to participate, and families of children under 18 years of age attending the practices who consent to complete surveys. In each PHN 6 GP practices will be selected with a minimum of 3 and up to 6 GPs in participating practices, eligible to participate. The research team will visit each GP practice to explain the study and answer any questions the GPs and practice staff have (nurses, administrative support, practice managers etc.). The roles and expectations of the GPs, administrative staff (e.g., arrange co-consult bookings) and practice manager (e.g., ensure GPs have time for case discussion sessions) will be clearly explained. Every GP practice provides control period data (referral and medical record data) during a control period (standard GP care, no SC4C model operating) before being exposed to the SUSTAIN intervention which will be rolled out sequentially across the practices and will last 11 months in each practice (the intervention period. We will allow a one-month transition period to embed SUSTAIN into a GP practice, where data will not contribute to the analysis. The one-month transition and embedding period will involve one month of working with and training practice staff and GPs to implement the model of care into their practice. Data will then be extracted throughout the 11-month intervention period for each practice. Collecting this data will allow us to look at referral and quality of care trends across the period of the intervention In order to measure our primary outcome (i.e., referrals to hospitals) quickly, reliably and validly, we will use GRHANITE. GRHANITE is developed and managed by the HaBIC Research Information Technology Unit, Dept General Practice, the University of Melbourne. GRHANITE is a computer software program that allows researchers, managers, and health professionals across Australia to ethically extract de-identified GP Practice data from GP electronic medical records for research purposes. Also installed on GP desktops is a pop-up referral box which GPs check after each consultation to reflect whether and where the patient was referred. The GP practices will sign an MOU agreeing to have GRHANITE software installed to support the trial. GP data for research purposes during the trial will be collected on every child’s consultation diagnosis, referrals made, tests ordered, and medications prescribed. Data will be de-identified at the level of the patient although the identity of the GP will be supplied to the research team. GRHANITE is compatible with the most common GP practice software vendors - Best Practice and Medical Director. Informed consent will be obtained from 3-6 interested GPs per practice. Consented GPs will be asked to attend co-consults and case discussions, enroll into the Sydney Child Health program, complete surveys, participate in implementation evaluation and record consultation diagnosis and referral details via the GRHANITE system. Identified data reflecting participating GPs referral practices will be used. Paediatricians record in Redcap every encounter they have with participating GP’s including through co-consultation, case discussions and phone/email conversations, providing data about the engagement of the partipating GP. Likewise, GPs participation in the SCHP can be gauged through attendance of the modular online training sessions. GPs are required to complete an online survey prior to and at the end of the intervention seeking to assess the 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 surveys will take around 20-30 minutes to complete. It would not be feasible to obtain individual consent from parents of children attending GP consultations (2,000 children per month were seen by the 41 GPs in our pilot). As such, we have a waiver of consent to collect de-identified data on GP care during the child’s consultation. Nevertheless, families of children under 18 years of age attending the GP practices will be asked to complete an anonymous online survey about their perception of paediatric care at the practice in the 3 months before and leading up to the cessation of the intervention. This will not necessarily include the same families. These surveys take about 5-10 minutes to complete. At the time of the post-intervention survey, families who have had exposure to the intervention will be asked to participate in an interview about their experience of the model. Interviews will voluntary, and last 20-30 minutes in duration, anonymity of families will be preserved, only known to research staff. GPs practice staff, paediatricians and families may also consent to participate in the implementation evaluation consisting of interviews and/or focus groups, during and after the intervention to determine acceptability and sustainability of the model. Focus groups will be conducted with each cluster from 6 months into the intervention. Post-intervention, paediatricians and GPs are also invited to be interviewed to gauge their views on the factors that enable or hinder the intervention. Following the 11-month intervention period in each practice, sustainability data collection will continue until 6 months after the last GP practice completes the model of care. This data will allow us to examine sustainability of changes post-running of the SUSTAIN model. Sustainability data will be collected to examine referral patterns of GPs including the number and proportion of children referred to OP clinics and EDs, as well as GP quality of care for five common childhood conditions (asthma/wheeze, bronchiolitis, constipation/abdominal pain, upper respiratory infections, infant crying and reflux), compared to pre-intervention GP care.