Evaluation of standard and enhanced quality improvement methods to increase the uptake of magnesium sulphate in pre-term deliveries for the prevention of neurodisability (PReCePT Study): a cluster randomized controlled trial

ObjectiveTo compare the impact of the National PReCePT Programme (NPP) versus an enhanced Quality Improvement (QI) support programme in improving magnesium sulfate (MgSO4) uptake in English maternity units. DesignUnblinded cluster randomised controlled trial. SettingEngland, Academic Health Sciences Network (AHSN), 2018. ParticipantsMaternity units with [&ge;]10 preterm deliveries annually and MgSO4 uptake [&le;]70%. 40 maternity units (27 NPP, 13 enhanced support) were included (randomisation stratified by MgSO4 uptake). InterventionsNHS England commissioned the NPP to increase MgSO4 uptake in very preterm deliveries to reduce risk of cerebral palsy. NPP maternity units received PReCePT QI materials, regional support, and midwife backfill funding. Enhanced support units received this plus extra backfill funding and unit-level QI coaching. Outcome measuresMgSO4 uptake post-implementation was compared between groups using routine data and multivariable linear regression. Net monetary benefit was estimated, based on implementation costs, lifetime quality-adjusted life-years and societal costs. The implementation process was assessed through qualitative process evaluation. ResultsMgSO4 uptake increased in all units, with no evidence of difference between groups (0.84 percentage points lower uptake in the enhanced group, 95% Confidence Interval -5.03 to 3.35 percentage points). The probability of enhanced support being cost-effective was <30%. NPP midwives allocated more than their funded hours. Units varied in support required to successfully implement the intervention. Enhanced support units reported better understanding, engagement, and perinatal teamwork. ConclusionPReCePT improved MgSO4 uptake in all maternity units. Enhanced support did not further improve uptake but may improve teamwork, and more accurately represented the time needed for implementation. Targeted enhanced support, sustainability of improvements and the possible indirect benefits of stronger teamwork associated with enhanced support should be explored further. Trial registrationISRCTN 40938673 (https://www.isrctn.com/ISRCTN40938673) WHAT IS ALREADY KNOWN ON THIS TOPICO_LIDespite long-standing evidence that Magnesium Sulfate (MgSO4) confers fetal neuroprotection and reduces risk of cerebral palsy in very preterm babies, by 2017 only two-thirds of eligible women in England were receiving it, with wide regional variation. C_LIO_LIThe pilot PReCePT (Prevention of Cerebral Palsy in preterm labour) Quality Improvement (QI) study appeared to effectively accelerate uptake of MgSO4, and a version of this support model was rolled-out nationwide in 2018. C_LI WHAT THIS STUDY ADDSO_LIPReCePT improved MgSO4 uptake in all maternity units, and the full ( enhanced) support model did not appear to improve uptake beyond the achievements of the standard support model used in the National PReCePT Programme. However, enhanced support may be associated with improved perinatal team working, and the funding more accurately represented the staff time needed for implementation. C_LI HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICYO_LIPReCePT may serve as a blueprint for other improvement programs to accelerate uptake of evidence-based interventions, and future studies should consider the potential for indirect but far-reaching benefits to staff and patients. C_LI