Strengthening Care for Children (SC4C): protocol for a stepped wedge cluster randomised controlled trial of an integrated general practitioner-paediatrician model of primary care.

ABSTRACT

INTRODUCTION: Australia's current healthcare system for children is neither sustainable nor equitable. As children (0-4 years) comprise the largest proportion of all primary care-type emergency department presentations, general practitioners (GPs) report feeling undervalued as an integral member of a child's care, and lacking in opportunities for support and training in paediatric conditions. This Strengthening Care for Children (SC4C) randomised trial aims to evaluate a novel, integrated GP-paediatrician model of care, that, if effective, will improve GP quality of care, reduce burden to hospital services and ensure children receive the right care, at the right time, closer to home. METHODS AND ANALYSIS: SC4C is a stepped wedge cluster randomised controlled trial (RCT) of 22 general practice clinics in Victoria and New South Wales, Australia. General practice clinics will provide control period data before being exposed to the 12-month intervention which will be rolled out sequentially each month (one clinic per state) until all 22 clinics receive the intervention. The intervention comprises weekly GP-paediatrician co-consultation sessions; monthly case discussions; and phone and email paediatrician support, focusing on common paediatric conditions. The primary outcome of the trial is to assess the impact of the intervention as measured by the proportion of children's (0-<18 years) GP appointments that result in a hospital referral, compared with the control period. Secondary outcomes include GP quality of care; GP experience and confidence in providing paediatric care; family trust in and preference for GP care; and the sustainability of the intervention. An implementation evaluation will assess the model to inform acceptability, adaptability, scalability and sustainability, while a health economic evaluation will measure the cost-effectiveness of the intervention. ETHICS AND DISSEMINATION Human research ethics committee (HREC) approval was granted by The Royal Children's Hospital Ethics Committee in August 2020 (Project ID 65955) and site-specific HRECs. The investigators (including Primary Health Network partners) will communicate trial results to stakeholders and participating GPs and general practice clinics via presentations and publications. TRIAL REGISTRATION NUMBER Australia New Zealand Clinical Trials Registry 12620001299998.