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

Objective To 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. Design Unblinded cluster randomised controlled trial. Setting England, Academic Health Sciences Network (AHSN), 2018. Participants Maternity units with ≥10 preterm deliveries annually and MgSO4 uptake ≤70%. 40 maternity units (27 NPP, 13 enhanced support) were included (randomisation stratified by MgSO4 uptake). Interventions NHS 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 measures MgSO4 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. Results MgSO4 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. Conclusion PReCePT 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 registration ISRCTN 40938673 () WHAT IS ALREADY KNOWN ON THIS TOPIC WHAT THIS STUDY ADDS HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ISRCTN 40938673 ### Clinical Protocols ### Funding Statement The Health Foundation funded this trial (Funder reference 557668). The funders were not involved in study design, conduct, data collection, analysis, interpretation, or writing of this manuscript. This research was supported by the National Institute for Health and Care Research (NIHR) Applied Research Collaboration West (NIHR ARC West, core NIHR infrastructure funded: NIHR200181). The views expressed in this article are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The UK National Health Service Health Research Authority (NHS HRA) approved the conduct of the trial (HRA ID 242419) and gave authorisation that it did not require Research Ethics Committee approval as a low-risk study involving NHS staff who had given consent as participants and used anonymised patient data. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Anonymised individual-level data for this study comes from the NNRD. Our data sharing agreement with the NNRD prohibits sharing data extracts outside of the University of Bristol research team.