Women with gestational diabetes mellitus (GDM) are at seven-fold to ten-fold increased risk of type 2 diabetes mellitus (T2DM) when compared with those who experience a normoglycaemic pregnancy, and the cumulative incidence increases with the time of follow-up post birth. This protocol outlines the development and validation of a risk prediction model assessing the 5-year and 10-year risk of T2DM in women with a prior GDM diagnosis.

Data from all birth mothers and registered births in Victoria and South Australia, retrospectively linked to national diabetes data and pathology laboratory data from 2008 to 2021, will be used for model development and validation of GDM to T2DM conversion. Candidate predictors will be selected considering existing literature, clinical significance and statistical association, including age, body mass index, parity, ethnicity, history of recurrent GDM, family history of T2DM and antenatal and postnatal glucose levels. Traditional statistical methods and machine learning algorithms will explore the best-performing and easily applicable prediction models. We will consider bootstrapping or K-fold cross-validation for internal model validation. If computationally difficult due to the expected large sample size, we will consider developing the model using 80% of available data and evaluating using a 20% random subset. We will consider external or temporal validation of the prediction model based on the availability of data. The prediction model’s performance will be assessed by using discrimination (area under the receiver operating characteristic curve, calibration (calibration slope, calibration intercept, calibration-in-the-large and observed-to-expected ratio), model overall fit (Brier score and Cox-Snell R2) and net benefit (decision curve analysis). To examine algorithm equity, the model’s predictive performance across ethnic groups and parity will be analysed. Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis-Artificial Intelligence (TRIPOD+AI) statements will be followed.

Ethics approvals have been received from Deakin University Human Research Ethics Committee (2021–179); Monash Health Human Research Ethics Committee (RES-22-0000-048A); the Australian Institute of Health and Welfare (EO2022/5/1369); the Aboriginal Health Research Ethics Committee of South Australia (SA) (04-23-1056); in addition to a Site-Specific Assessment to cover the involvement of the Preventative Health SA (formerly Wellbeing SA) (2023/SSA00065). Project findings will be disseminated in peer-reviewed journals and at scientific conferences and provided to relevant stakeholders to enable the translation of research findings into population health programmes and health policy.

Over one billion adults attend emergency departments (EDs) internationally every year, including 6.6 million in Australia. Up to half of these patients have a peripheral intravenous catheter (PIVC) inserted. Although healthcare workers believe that placing a cannula is helpful (‘just in case’), PIVCs often remain idle. PIVC insertion is painful for patients, takes clinicians’ attention away from other care, has adverse outcomes and causes major economic and environmental burden. Our aim is to codesign an implementation toolkit to reduce unnecessary PIVC insertions and improve other national quality indicators using an implementation science framework.

A stepped-wedge cluster-controlled trial will be conducted in nine ED sites (clusters) across Australia. The interventions will be codesigned with and adapted to sites based on local context. The interventions are evidence-based multimodal intervention (MMI) and aligned to the 2021 Australian Commission for Safety and Quality in Health Care National PIVC Clinical Care Standard. The Consolidated Framework for Implementation Research and Learning Health System will be used to guide implementation. Interventions will be phased across three steps (three sites per step), and each site will collect control and postintervention data using mainly routinely collected clinical data. Each site will be allocated to receive the intervention at one of three study steps. Implementation strategies will tailor broad clinician and consumer engagement, policy changes, education, audit and feedback and clinical champions, along with environment and equipment changes, to each site. The primary objective is to reduce the proportion of adult patients who have a PIVC inserted by 10%. We will evaluate the clinical, implementation and cost-effectiveness of the intervention.

Study findings will be used to conduct a health economic analysis, develop an implementation toolkit and inform a sustainable roadmap for national roll-out. This will meet the needs of a diverse range of EDs nationally and internationally.

The protocol was approved by the Monash Health Human Research Ethics Committee (HREC Reference Number: HREC/100808/MonH-2023-390692(v3)). The outcomes of this trial will be disseminated through peer-reviewed publications, conference presentations and communication with study partners and stakeholders including professional colleges and the Australian Commission for Safety and Quality in Health Care.

Australian New Zealand Clinical Trials Registry registration number: ACTRN12623001248651. Date of registration: 1 December 2023. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386256&showOriginal=true&isReview=true