Evaluating the impact of an enhanced support implementation of the PReCePT (PRevention of Cerebral palsy in Pre-Term labour) quality improvement toolkit to increase the uptake of magnesium sulphate in pre-term deliveries for the prevention of neurodisabilities: study protocol for a cluster randomized controlled trial

ABSTRACT The UK’s National Institute for Health and Care Excellence (NICE) Preterm labour and birth guideline recommends use of magnesium sulphate (MgSO4) in deliveries below 30 weeks’ gestation to prevent cerebral palsy and other neurological problems associated with preterm delivery. Despite national guidance, the uptake of MgSO4 administration in eligible women has been slow. NHS England has rolled out the PReCePT Quality Improvement (QI) toolkit to increase uptake of MgSO4 in preterm deliveries. The toolkit is designed to increase maternity staff knowledge about MgSO4 and provides training and practical tools to help staff consider use in eligible women. The PReCePT trial will evaluate the effectiveness of an enhanced support model of implementing the QI toolkit, compared with the standard support model. The standard support arm (control) receives the QI toolkit and regional-level support for a midwife/obstetric ‘champion’. The enhanced support arm (intervention) receives this plus additional clinical backfill funding and unit-level QI micro-coaching. This is a cluster randomised controlled trial designed to include 48 maternity units randomised (2:1 ratio) to standard or enhanced support. Units are eligible for inclusion if they have ten or more pre-term (< 30 weeks’ gestation) deliveries annually and MgSO4 uptake of 70% or less. Randomisation is stratified by previous level of MgSO4 uptake. The QI intervention is implemented over nine months. All units are followed up for a further nine months. Blinding is not possible due to the nature of the intervention. The primary outcome is the proportion of MgSO4 uptake amongst eligible women at follow-up, adjusting for uptake before implementation of the toolkit. The effectiveness of the intervention will be assessed using weighted linear regression on data from the National Neonatal Research Database. Semi-structured qualitative staff interviews will inform understanding of the process and outcomes. Economic evaluation will describe total costs and cost-effectiveness. STRENGTHS AND LIMITATIONS Strengths The first randomised controlled trial comparing two models of supporting the implementation of a Quality Improvement toolkit in perinatal medicine. A comprehensive evaluation, involving quantitative, qualitative and process measures including costs, to assess impact of the toolkit on the uptake of magnesium sulphate and team working. The National Neonatal Audit Programme (NNAP) and National Neonatal Registry Database (NNRD) provides robust routine data collection infrastructure for the primary outcome, also allowing future assessment of sustainability within participating units as well as uptake across the country. Limitations This pragmatic trial will reflect the conduct of scaling up a local initiative to a national level, where adherence to trial timelines may vary due to differences in local settings, procedures for permissions/approvals, and team capacity. Communication about the trial through formal and informal media channels may raise general awareness and thus improve background uptake nationally. Such contamination across trial groups may require assessment and adjustment in sensitivity analyses.