Evaluating an enhanced quality improvement intervention in maternity units: PReCePT trial protocol

Abstract

The UK’s National Institute for Health and Care Excellence Preterm labour and birth guideline recommends use of magnesium sulfate (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. National Health Service England has rolled out the PReCePT (PRevention of Cerebral Palsy in Pre-Term labour) 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 compares the effectiveness of two different methods of implementing the QI toolkit (standard versus enhanced support). 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 microcoaching. It is funded by The Health Foundation. 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 10 or more preterm (<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 9 months. All units are followed up for a further 9 months. Blinding is not possible due to the nature of the intervention. The primary outcome is the proportion of MgSO4 uptake among 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. Semistructured qualitative staff interviews will inform understanding of the process and outcomes. Economic evaluation will describe total costs and cost-effectiveness.Trial registration number SRCTN 40938673.

National PReCePT Programme: a quasi-experimental before-and-after evaluation of the implementation of a national quality improvement programme to increase the uptake of magnesium sulphate in pre-term deliveries

“…From the 150 NPP units, a further 13 units were excluded as these comprised the PReCePT trial ESP group. 13 This left 137 maternity units in the evaluation.…”

“…The RCT comparing MgSO4 uptake in NPP units versus those receiving enhanced support is reported separately, but results were comparable to those reported here. 13,14 The analyses are also limited to the available data (i.e., to June 2020), it is probable that NPP benefits will persist; therefore, sustainability analyses need to be addressed in future studies.…”

“…As sensitivity analyses, we also looked at the effect of the following on the difference in mean monthly MgSO 4 uptake between the two NPP periods: (1) including the 13 PReCePT ESP trial units that received the enhanced QI support programme (NPP plus unit-level coaching, an additional 90 hours backfill funding for the local midwife champion and approximately 104 hours of funded backfill for the unit obstetrician/neonatologist lead); 13 and (2) excluding units in one AHSN that started adoption three months later than other AHSNs.…”

“…A cluster randomised trial to determine the effectiveness of an enhanced support QI programme (ESP) was conducted alongside the NPP implementation comparing uptake in 13 ESP units and 27 control units implementing the NPP. 13,14 In this study we evaluated the effectiveness and cost-effectiveness 15 of the NPP in increasing MgSO 4 uptake. We hypothesised that the implementation of the NPP would help increase MgSO 4 uptake beyond the expected increase due to the underlying trend rate.…”

“…A cluster randomised trial to determine the effectiveness of an enhanced support QI programme (ESP) was conducted alongside the NPP implementation comparing uptake in 13 ESP units and 27 control units implementing the NPP. 13,14…”