Research Protocol: Evaluating Maternity Investigations and Review Tools: Process Evaluation (MatReP)

This document is the research study protocol for the MATREP study. The rationale and plan for the MATREP study is outlined below.

More babies die or are harmed in the UK either before, during or after birth, compared to other countries. This is why in 2015, the government set a target to halve the number of mothers and babies who die and are injured around the time of birth, by 2025. To achieve this target, we need to understand when and how problems with care happen so that maternity care can be improved and to prevent future harm. The government funded two investigation/review processes that would support this aim: the Healthcare Safety Investigation Branch (HSIB) maternity investigations and the Perinatal Mortality Review Tool (PMRT).

HSIB is an independent organisation which investigates the deaths of some mothers and around 1 in 12 babies who are injured or die .On the other hand, the PMRT is used by hospitals to review all baby deaths that occur in their units, whether they happen during pregnancy or after birth. This project aims to collect information from families, parents, staff members and maternity units to see whether these two investigation/review processes are successful in both supporting parents’ and families’ needs and improving maternity care.

First, the team of researchers and parent advocates will look at information already collected about the HSIB and PMRT reviews in other research to find gaps in what we know. We will then ask bereaved parents and families,and parents whose baby has been injured, about their experiences of the investigation/review process. This will help to understand what went well and where things could be improved. The families interviewed will include people from different ethnic and social groups. We will interview families who experienced loss or injury before, as well as after, the HSIB and PMRT processes began in 2018, to see whether investigations/reviews have improved and actually made a difference to care. We will use the information from the interviews to write a targeted questionnaire so we can hear the views of many more families and parents and use links with charities to reach them.

We will also work with seven maternity units across England and interview members of staff to understand how the HSIB investigations and PMRT reviews have affected them and how lessons learned from the investigations/reviews are put into practice. We are particularly interested in what stops changes being made and how to support effective change. We will collect information to work out how much investigations/reviews cost.

We will then share all these results with the parents and organizations directly involved in the research and policy teams at the Department of Health before sharing with the public more widely by writing about our findings in academic journals and in shorter plain English summaries available on the web.