Karen Luyt - Maternity and Neonatal Learning System: Stabilisation of the pre-term infant
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Presentation by Karen Luyt, Consultant and Reader in Neonatal Medicine, University Hospitals Bristol NHS Foundation Trust and University of Bristol National Clinical Lead for PReCePT at the Maternity and Neonatal Learning System: Stabilisation of the pre-term infant event on Tuesday 2 October at Haydock Park Racecourse.
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Karen Luyt - Maternity and Neonatal Learning System: Stabilisation of the pre-term infant
- 1. PReCePT Prevention of Cerebral Palsy in Pre-Term Labour Twitter: @PReCePT_MgSO4 #PReCePT Email: precept@weahsn.net
- 2. PReCePT: The case for Magnesium Sulphate Karen Luyt National Clinical Lead PReCePT Consultant and Reader in Neonatal Medicine UHBristol NHS Trust and University of Bristol
- 3. Background Magnesium Sulphate as brain protection for preterm babies
- 5. Preterm Birth and Cerebral Palsy • Preterm birth is the major risk factor for CP • 10% of very low birth weight babies develop CP
- 8. MgSO4 : Cerebral Palsy
- 9. MgSO4: Mechanism of Action
- 10. MgSO4 : Cerebral Palsy
- 11. NHS Litigation Cost for CP: £1.9 billion in 2016
- 14. MgSO4 : Cerebral Palsy
- 16. PReCePT1
- 17. PReCePT1
- 18. Public and Patient Involvement
- 19. NICE Guidance
- 23. PReCePT Programme Overview Tranche 1 – 7 AHSNs Tranche 2 – 7 AHSNs • Network approach • Delivered via the AHSNs • Standardised resources • 90 hours midwife backfill per unit • Regional clinical lead • Target: 85% (stretch target 95%) of eligible mothers receive MgSO4 by March 2020 • Avoid around 300 cases of CP per year National database: BadgerNet
- 24. Antenatal Steroids vs. MgSO4 NNAP 2016
- 25. PReCePT Aims • To improve compliance with NICE Guidance NG25 and increase the proportion of eligible women offered MgSO4 in England. • Long Term: Reduction in the incidence of cerebral palsy in babies born preterm.
- 26. PReCePT Study Prevention of Cerebral Palsy in Preterm Infants September 2018
- 27. PReCePT Study - funding • Selected to be part of an ambitious £3.5 million improvement programme funded by The Health Foundation. • One of seven UK projects awarded funding through The Scaling Up Improvement programme. • £0.6 million to scale up PReCePT1 to a further 16 hospital Trusts in England. 13-14 Sept 2018 PReCePT Study
- 28. PReCePT Study – the trial • RCT in 48 maternity/neonatal units in England • To assess whether an enhanced QI intervention improves the uptake of MgSO4 in preterm deliveries over and above the NPP roll-out • Compare two support models for implementation of PReCePT QI toolkit: 13-14 Sept 2018 PReCePT Study CONTROL Standard QI support (NPP) (32 units) INTERVENTION Enhanced QI support (16 units) versus
- 29. PReCePT Study - QI support models 13-14 Sept 2018 PReCePT Study Controls (standard support) • PReCePT QI Toolkit & materials • Regional level QI training (AHSNs) • Support funding • Regional neonatal lead • Local midwife (90 hours) Intervention (enhanced support) • Standard support, plus: • Unit level coaching from QI expert • Learning and celebration events • Support funding • Local Clinical lead (0.5PA) • Local midwife (+90 hours) • Tablet for micro-coaching • Small fund for study collateral
- 30. PReCePT Study - eligibility criteria Inclusion criteria • Units in England participating in national PReCePT Programme • Units with minimum of 10 preterm (<30 weeks GA) births in 2016 • Units with 70% or less MgSO4 uptake in 2016 • ~96 eligible units based on NNAP reports for 2016 (published 2017) 13-14 Sept 2018 PReCePT Study
- 31. PReCePT Study - trial design • 16 intervention units • Two tranche randomisation and implementation • 9 month intervention period • 9 month passive follow up using routine NNAP data (BadgerNet) 13-14 Sept 2018 PReCePT Study
- 32. PReCePT Study - outcomes 13-14 Sept 2018 PReCePT Study Primary: To evaluate the effectiveness of an enhanced support implementation of the PReCePT quality improvement toolkit to increase the uptake of MgSO4 in pre-term deliveries for the prevention of neurodisabilities. Secondary: To compare effectiveness, cost-effectiveness and implementation of an enhanced support to a standard support implementation of the PReCePT QI Toolkit.
- 33. PReCePT Study - next steps 13-14 Sept 2018 PReCePT Study August 2018 Pre-email sent to eligible units - complete August 2018 HRA Approval received - complete September 2018 Local Trust C&C (R&D) review - in progress September 2018 Recruit units – in progress October 2018 Randomisation (Tranche 1) - not started December 2018 Randomisation (Tranche 2) - not started
- 34. PReCePT Study - overview • £0.6 million Health Foundation scaling Up Improvement Programme • Chief Investigator: Dr Karen Luyt, Consultant and Reader in Neonatal Medicine • Sponsor: UHBristol NHS Foundation Trust • Partners: NIHR CLAHRC West and WEAHSN • Duration: 36 months 13-14 Sept 2018 PReCePT Study
- 35. PReCePT – Builds on success • Proven evidence based intervention – NICE guidance • PPI and co-production at every stage • PReCePT1 Qualitative Evaluation • PReCePT1 – Effect sustained • Use of robust routinely collected data (BadgerNet) • Added value by using network approach to National dissemination (AHSNs, NHS-I, NHS Clinical Delivery Networks)
- 37. PReCePT Prevention of Cerebral Palsy in Pre-Term Labour Twitter: @PReCePT_MgSO4 #PReCePT @PReCePT_Study
- 38. PReCePT Data
- 39. PReCePT Data
- 40. Unit Level Data: Monthly Dashboards
- 41. Unit Level Data: Monthly Dashboards
- 42. Patient Safety Measurement Unit (PSMU)
Notes de l'éditeur
- Tasha to present
- The PReCePT Study is a research trial which is fully embedded within the national PReCePT Programme. The Study is funded by The Health Foundation as part of an ambitious £3.5 million improvement programme. It is one of seven projects in the UK to take their proven health care interventions and approaches and make them work at larger scale. The £0.6 million award will allow the research team to scale up the original PReCePT1 quality improvement model to a further 16 units across England.
- The Study is a multi-centre, cluster randomised controlled trial in 48 maternity/neonatal units across England. It aims to establish the added value (impact) and costs of delivering an enhanced QI support model, compared to the standard model being deployed by the national programme. Eligible units will be invited to provide consent at unit level to be randomised to receive enhanced QI support for implementing the PReCePT QI toolkit, or to continue implementation through the national programme as a study control. There will be 16 intervention units and 32 controls.
- The control units will implement the PReCePT toolkit according to the national AHSN roll-out, where QI training is cascaded via the AHSNs and units receive backfill for a local midwife champion. After participating in the initial implementation stage of the national programme, the level of support will be intensified for the 16 intervention units. On top of the support provided by their AHSN, units allocated to receive enhanced support will benefit from: Individual unit-level coaching by an experienced QI coach Access to learning and celebration events with other participating teams to share activity, training and to build peer support Funded time for local clinical champions (neonatologist and midwife) - over and above the backfill provided by the programme - to train their team and lead the QI implementation A tablet to facilitate micro coaching of colleagues. And there will be a small fund to purchase study collateral, such as pens, magnets, lanyards and aide-memoires.
- Inclusion criteria are maternity units with 10 or more deliveries under 30 weeks gestation per year and with MgSO4 uptake of 70% or less, according to 2016 NNAP data (published 2017). Based on the National Neonatal Audit Programme (NNAP) reports for 2016, and assuming further increase in uptake in 2017, we have identified 96 units potentially eligible to take part.
- The national programme is implementing the PReCePT QI toolkit across all NHS England units in two tranches via the AHSNs: the first tranche started in May 2018, the second will start in September 2018. To maintain optimal comparability of the two study arms, the randomisation procedure and implementation according to the enhanced support model will be aligned with this timeframe. As such, the first 8 units will be randomly selected from units participating in the first tranche, 3 months later the second group will be randomised from the second tranche. Implementation for enhanced support in units from the first tranche will start in October 2018; for units in the second tranche, implementation will start in January 2019. The 9-month follow-up period to evaluate the outcomes will reflect the same time-delay associated with the tranches
- We will use the National Neonatal Research Database (NNRD) to determine the primary outcome for this study. The most important outcome is whether eligible mothers of babies who were born preterm (<30 weeks gestation) have received MgSO4 prior to delivery. This can be measured effectively in the BadgerNet data system using existing routine data fields. Secondary outcomes will consider cost effectiveness and process analysis for implementing the QI toolkit.
- In early August, an email was sent to eligible maternity/neonatal units to highlight the study to staff and to request contact details for the lead neonatologist within the unit to whom an invitation to participate should be sent. Health Research Authority has now been received and local information packs have been sent to R&D departments in all eligible Trusts for capability and capacity review. This is still in progress. I would encourage you to speak to colleagues within your unit and local R&D teams to support this review process. Only once local Trust approval has been received are we able to send out invitation packs to units to consent to take part in the study. I have a list of eligible units with me here today. If you think you may not have received information about the study, please come and see me at the PReCePT stand.
- The study is led by Dr Karen Luyt, a consultant neonatologist at UHBristol, who has been the project lead since PReCePT first launched and is also the clinical lead for the national programme. NIHR CLAHRC West will be evaluating the study and we are partnering with West of England AHSN to ensure the study and national programme are fully aligned.