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Policy Research Programme - Evaluation of maternity investigations and review tools

Published

14 December 2021

Version

1.0 - December 2021

Contents

Timetable and Budget

DescriptionDeadline/Limit
Deadline for Stage 1 Applications 18 January 2022, 1 PM
Notification of outcome of Stage 1 Application March 2022
Deadline for Stage 2 application 03 May 2022, 1 PM
Notification of Stage 2 Application August 2022
Project Start September 2022
Budget £400,000 for a single project

Introduction

1. The NIHR Policy Research Programme (PRP) invites applications to conduct a process evaluation of The Healthcare Safety Investigation Branch’s (HSIB) Maternity Investigations Programme and the Perinatal Mortality Review Tool (PMRT) in England.

2. HSIB’s Maternity Investigation Programme and the PMRT were established in 2018. The remit of the HSIB maternity programme is to investigate a defined cohort of maternal and perinatal deaths and intrapartum brain injuries in babies. The remit of the PMRT is to review all perinatal deaths (i.e. stillbirths and neonatal deaths). The objectives of both programmes are to seek to identify the causes of these outcomes including any underpinning systemic issues in order to provide answers to families and to share any learning to improve safe outcomes in maternity and neonatal services.

3. This research is needed to assess if these initiatives have been delivered as anticipated and if they have led to system changes, improved process outcomes (e.g. appropriate case reviews/investigations taking place where required, parents involved to the extent that they want to be in reviews/investigations, improved sharing of learning and appropriate changes in care practices, etc.) and families having more positive experiences of the investigation processes.

4. Up to £400,000 in total is available for a single project judged to be of sufficiently high scientific quality.

Background

The Healthcare Safety Investigation Branch’s Maternity Investigation Programme

5. Since April 2018, HSIB has been responsible in England for all NHS investigations of maternity incidents which meet one of the following criteria: term stillbirths, early neonatal death (within the first 0-6 days), potential severe brain injury (diagnosed within the first 7 days of life) and direct or indirect maternal deaths (whilst pregnant or within 42 days of the end of pregnancy). HSIB investigate approximately 1,000 maternity cases each year using a ‘non-safe space’ approach.[1,2]

6. The purpose of the HSIB Maternity Investigation Programme is to achieve learning and improvement in maternity services, and to provide a driver for necessary system-wide change. For eligible cases, HSIB’s investigations replace the local NHS investigation. HSIB are expected to work closely with parents and families, healthcare staff and organisations during their investigations with reports provided directly back to the families and to the Trust.

7. Since 1 April 2019, HSIB have been operating in all NHS Trusts in England. HSIB has developed a national workforce of maternity investigators who are expected to work collaboratively with Trusts and families to ascertain and support rapid learning and improvements to prevent future harm.

8. HSIB is expected to transform into the Health Service Safety Investigation Body (HSSIB) in Summer 2023 as part of the Health and Care Bill and will continue with its existing programme of maternity investigations until this time. We are exploring options regarding the future of maternity investigations and will decide which is the most appropriate in due course. The research will inform any further changes to the Maternity Investigations Programme in the future.

The Perinatal Mortality Review Tool

9. In early 2018, the PMRT was introduced to support NHS maternity and neonatal units in England, Wales and Scotland (Northern Ireland joined later) to undertake high quality standardised reviews of the circumstances and care leading up to and surrounding every stillbirth and neonatal death.

10. The aim of the PMRT is to support NHS services to conduct objective, robust and standardised reviews to provide answers for bereaved parents about why their baby died, enabling parents to contribute to the process. Local summary reports and national reports of the themes and trends associated with perinatal deaths should be produced and are expected to support local and national learning to improve care and ultimately prevent future baby deaths.

11. The PMRT has been designed to support the review of the following perinatal deaths:

  • late miscarriages (also referred to as late fetal losses) where the baby is born between 22+0 and 23+6 weeks of pregnancy showing no signs of life 
  • all stillbirths where the baby is born from 24+0 gestational weeks showing no signs of life   
  • all neonatal deaths where the baby is born alive from 22+0 weeks and dies up to 28 days after birth
  • post-neonatal deaths where the baby is born alive from 22+0 weeks and dies after 28 days of birth following neonatal care; the baby may have died in hospital, a hospice or at home following palliative care.

12. The PMRT is now in use across every maternity service in all Trusts and Health Boards in England, Scotland, Wales and Northern Ireland. This research is for England only.

13. Between the launch of the PMRT in January 2018 and October 2020 over 14,000 reviews have been started and/or completed using the tool.[3]

Interaction between the PMRT and HSIB

14. PMRT and HSIB are both included in the Clinical Negligence Scheme for Trusts (CNST) Maternity Incentive Scheme, through which NHS maternity services need to fulfil ten safety actions to recover their CNST maternity contribution.

15. Where there is overlap in cases investigated by HSIB and reviewed by the PMRT, the local review using the PMRT should be started but not completed until the HSIB report is complete. The Trust should consider inviting the HSIB reviewers to attend their PMRT reviews to act as the external members of the review team, thereby enabling the learning from the HSIB investigation to be automatically incorporated into the PMRT review.

Research needed

16. There is a need to understand whether HSIB’s Maternity Investigation Programme and the PMRT have been delivered as anticipated. This includes understanding whether and how these initiatives might have changed the experiences of the review/investigation processes for families, NHS clinicians and supporting staff.

17. The research should explore:

  • the acceptability of the PMRT and HSIB with those that are involved with these processes (e.g. clinicians, service managers) and with families affected by a perinatal death;
  • the experience of families including: 

i. how and when families were consulted during investigations
ii. how involved they were and whether families felt supported and listened to when they were involved in investigations and recommendations developed aimed at improving maternity care
iii. whether families felt they were provided with necessary information and understood the information that was given to them by reviewers/investigators
iv. the time families invested in these programmes and whether there were any unforeseen costs, including unintended negative impacts.

  • The experiences of clinicians and supporting staff who use the PMRT and engage with HSIB investigations, including;

i. whether appropriate training was provided to enable clinicians and supporting staff to competently engage with these programmes
ii. the impact on their workload
iii. support from senior management
iv. whether the introduction of these programmes led to any local systems changes in their trust.

  • whether learning has been disseminated and acted upon across the system or whether there have been any difficulties or barriers to the dissemination of learning;
  • a breakdown of the costs associated with the implementation of HSIB investigations and PMRT programmes to Trusts (e.g. staff time and training)-and a consideration as to whether there has been any unnecessary duplication or synergies between the two programmes and/or any other national programmes;
  • the impact of the pandemic on the processes of the HSIB investigations and PMRT (e.g. the affect on timelines or if discussion took place virtually rather than in person etc.);
  • what measures were in place before the HSIB investigations and PMRT; and
  • variation in implementation by location (e.g. in different areas of the country, in different size trusts etc.).

18. The research will inform policy decisions on how the PMRT and the HSIB Maternity Investigation Programme may be changed and improved in the future.

Technical requirements

19. Applicants are asked to consider the timing and nature of deliverables in their proposals. Policymakers will need research evidence to meet key policy decisions and timescales, so resource needs to be flexible to meet these needs.

20. Applicants are expected to have:

  • previous experience evaluating national policy programmes;
  • previous experience of qualitative research in order to gather and analyse views from various stakeholders (e.g. families, clinicians)
  • health economic expertise;
  • experience of working with vulnerable populations (e.g. families who have experienced baby loss)

Outputs

21. A meeting to discuss policy needs with DHSC officials will be convened as a matter of priority following contracting. Expected outputs include:

  • Policy-tailored briefings to explain key finding to policy officials.
  • An interim report and presentation highlighting initial findings and progress, followed by a meeting with officials.
  • A final evaluation report following evaluation of the HSIB’s Maternity Investigation Programme & the PMRT.

Budget and duration

22. A budget of £400,000 is available for this research over the period of 18 months starting no later than September 2022. Interim findings will be expected throughout the study in order to inform policy decisions.

23. In assessing proposals, the Department will be seeking value for money as well as scientific excellence and the potential policy impact which is key.

24. In order to maximise the benefit from the findings, the research will need to commence as soon as possible following selection of the successful bid and placing of a contract. Capability to start promptly will be an advantage and for this commissioning round, applicants should demonstrate that projects can start by September 2022.

25. Costings can include up to 100% full economic costing (FEC) but should exclude output VAT. Applicants are advised that value for money is one of the key criteria that peer reviewers and commissioning panel members will assess applications against.

Areas out of scope for this programme of work

26. This research should be focused on the PMRT and HSIB in England only.

Management arrangements

27. A research advisory group including, but not limited to, representatives of DHSC, and the successful applicants for the research should be established. The advisory group will provide guidance, meeting regularly over the lifetime of the research. The successful applicants should be prepared to review research objectives with the advisory group, and to share emerging findings on an ongoing basis. They will be expected to:

  • Provide regular feedback on progress
  • Produce timely reports to the advisory group
  • Produce a final report for sign off

28. Research contractors will be expected to work with nominated officials in DHSC, its partners and the NIHR. Key documents including, for example, research protocols, research instruments, reports and publications must be provided to DHSC in draft form allowing sufficient time for review.

References

  1. Healthcare Safety Investigation Branch. What we investigate.
  2. Healthcare Safety Investigation Branch. Maternity investigations
  3. National Perinatal Epidemiology Unit. Perinatal Mortality Review Tool. Third annual report. October 2021.