Safer Baby Bundle Study: Assessing the impact of a stillbirth prevention bundle of care for improving best practice care for women during pregnancy in Australia

Safer Baby Bundle (SBB): a bundle of care to address the priority evidence practice gaps in stillbirth prevention. This is a before and after study evaluating the impact of a healthcare improvement initiative across maternity services in three states; Queensland, Victoria and New South Wales. The impact of the SBB on stillbirth rates at 28 weeks’ gestation or more and other important maternal and newborn outcomes will be investigated. The SBB addresses areas associated with substandard care and stillbirth. The SBB is a structured package of change ideas and interventions (containing five evidence-based elements) and is designed to formalise care and reduce practice variation. The SBB contains five elements: Element 1: Supporting women to stop smoking in pregnancy Element 2: Improving detection and management of fetal growth restriction Element 3: Raising awareness and improving care for women with decreased fetal movements Element 4: Improving awareness of maternal safe going-to-sleep position in late pregnancy Element 5: Improving decision-making about the timing of birth for women with risk factors for stillbirth The five included elements are the same for women and their care providers, providing complimentary messaging and resources. For health care providers this includes an educational package (both eLearning and face-to-face training); best practice recommendations; clinical audit tools; evidence summaries with clinical care pathways. The educational program and resources for clinicians have been specifically developed for this project. Women and their families will be provided with written information including brochures (designed specifically for this study), supplemented by a public awareness program and a mobile phone app. Implementation of the SBB will be undertaken in partnership with each states health department. State healthcare quality and safety improvement agencies are responsible for recruitment of participating hospitals and implementation. Participation in the study is open to all eligible maternity hospitals across the three jurisdictions, with all those who voluntarily express an interest recruited. This study is a mixed methods, multi-centre, ‘before and after’ evaluation of the implementation of the SBB in three health jurisdictions. The study design is pragmatic to account for differences across jurisdictions for the level of implementation support provided and commencement dates. To allow for differences in commencement dates between jurisdictions and disruptions, the study implementation period (which includes pre and post implementation data collection as part of the implementation strategy) will run for 2.5 years, followed by a 2 year post-implementation phase. Participating jurisdictions- Each state has an implementation team to provide leadership, generate and sustain motivation for change and provide tools to support practice change through education, audit and feedback, bench-marking and implementation support forums. A mixed-methods approach will be used to assess the processes, impacts and outcomes of the SBB initiative. Change in rates for the primary clinical outcome, stillbirth rate at 28 or more weeks, will compare the implementation rate (including longer term trends over 15 years) with the rate in the 2 year post-implementation period using routinely collected perinatal data. Approval will be sought through the relevant state perinatal data collection custodians to access and analyse routinely collected population-based surveillance system data covering all births in NSW, VIC and QLD public and private hospitals over the study time period (15 years’ pre-implementation to 2 years’ post-implementation). The relevant duration for participant data collection is for the period from the first antenatal visit (booking appointment) through to six weeks post-birth. Participating hospitals are required to embed the SBB within their existing processes. Prevention champions at each site will provide leadership, collect baseline data, attend implementation learning support forums and drive implementation of best practice recommendations in the local context. All maternity staff at participating hospitals will be encouraged and supported to complete the 2 hour eLearning program (specifically designed for this project) covering each element of the bundle and to attend the complimentary one-day face-to-face workshop to improve practical skills and enhance learnings. Surveys of women, healthcare professionals and maternity service leads will be administered electronically pre and post implementation. The survey will be administered to women (with a singleton pregnancy without lethal fetal abnormalities) at participating hospitals following the birth (before hospital discharge) across a sample of 30 hospitals (10 hospitals per state) stratified by service capability level and geographic location (metropolitan, regional and remote). Midwives and doctors providing maternity care at the participating hospitals will also be invited to undertake pre and post-implementation questionnaires.