NHS England’s Saving Babies Lives Care Bundle: A Care Bundle For Reducing Perinatal Mortality

Dr Matthew Jolly, MBBS MD MRCOG is the National Clinical Director for Maternity Review and Women’s Health of the UK National Health Service.

Dr. Jolly is an experienced clinician who is committed to providing excellent individual care and to the strategic improvement of maternity services and women’s health.

He qualified at St. Mary’s Hospital Medical School and trained as an obstetrician and gynaecologist in the North West Thames region, including two years researching the role of maternal metabolism in fetal growth at Imperial College School of Medicine. Matthew trained as a sub specialist in maternal and fetal medicine at the Centre for Fetal Care, Queen Charlotte’s & Chelsea Hospital. Since 2001 he has worked as a consultant obstetrician and gynaecologist at Western Sussex Hospitals NHS Trust and Portsmouth Hospitals NHS Trust. He has also worked as a departmental clinical director and since 2013 as joint clinical director for The Maternity Children and Young People South East Coast Strategic Clinical Network.

Dr. Jolly’s Strategic Clinical Network work has led to several national roles including sitting on the Women’s Health Patient Safety Expert Group, working with Specialised Commissioning, supporting the oversight and implementation of the NHSE stillbirth care bundle and working as a stakeholder with NICE.

Dr. Jolly has disclosed that he does not have any real or perceived conflicts of interest in making this presentation.

This presentation was part of the Stillbirth Summit 2021.   This individual lecture will be awarded .75 hours of continuing education credit to include viewing the lecture and completing evaluation and post-test.  Once received a certificate will be emailed to the address you provide in the post-test.  If you did not register for the Summit WITH Continuing Education, you can purchase the continuing education by clicking here.  This purchase will provide you access to all Stillbirth Summit 2021 lectures including continuing education credit. There is no charge for viewing the presentation.

To receive continuing education credit for this lecture, the participant must complete the evaluation and post-test.

Handouts

Yolanda King: Dr. Matthew Jolly is the National Clinical Director for Maternity Review and Women’s Health of the UK National Health Service. He is an experienced clinician committed to the strategic improvement of maternity services and women’s health. He qualified at St. Mary’s Hospital Medical School and trained as an obstetrician and gynecologist in the North West Thames region, including two years researching the role of maternal metabolism in fetal growth at Imperial College School of Medicine. In addition, Matthew trained as a subspecialist in maternal and fetal medicine at the Centre for Fetal Care, Queen Charlotte’s & Chelsea Hospital.

Since 2001, he worked as a consultant obstetrician and gynecologist at Western Sussex Hospitals NHS Trust and Portsmouth Hospitals NHS Trust. He has also worked as a departmental clinical director, and since 2013 as the joint clinical director for The Maternity Children and Youth People South East Coast Strategic Clinical Network. Dr. Jolly’s Strategic Clinical Network work has led to several national roles including sitting on the Women’s Health Patient Safety Expert Group, working with Specialized Commissioning, supporting the oversight and implementation of the NHSE stillbirth care bundle and working as a stakeholder with NICE. Dr. Jolly, welcome.

Dr. Matthew Jolly: Hello. My name is Matthew Jolly. I’m an obstetrician and I’m also National Clinical Director for the Maternity and Women’s Health at NHS England. I’ve also been the Clinical Lead for the Saving Babies’ Lives Care Bundle since 2015. I’d very much like to thank the Star Legacy Foundation for giving me this opportunity to speak with you today and share our learning and our journey in developing the Saving Babies’ Lives Care Bundle.

The story really starts in 2011 with The Lancet Global Health Series about stillbirths. We in the UK were ranked 33 out of 193 countries in relation to our stillbirth rates, which I have to admit was a big shock to our maternity services. We thought we were better than that. It was a bit of a wake-up call. As you can imagine, there was a lot of soul searching and debate, but relatively little action until we got to our reorganization of the British National Health Service system in 2013.

On the map on the left here, you see the map of the United Kingdom with Scotland at the top, Northern Ireland, and Wales over here on the left. On the right, you see a map of just England and our 12 strategic clinical networks. It was the role of the specific maternity clinical networks to try and drive quality improvements in maternity services. Our national clinical director at the time, Catherine Calderwood, who went on to be the chief medical officer of Scotland, brought us together to work out why we had not made any progress so far, and what could we do about it?

It’s interesting to reflect on this paper from 2011 from our confidential inquiry into stillbirths where almost false reassurance about a statistically significant downwards trend in stillbirths, but a fall of 0.2% over nine years is a woeful rate of improvement, and really, we needed to do some something.

This is a slide from Alex Heazell, who many of you will know, professor at Manchester, who’s done a lot of work on reducing stillbirth and providing better care for women who have experienced stillbirths. I’m very grateful to Alex for this slide. It puts research as the cornerstone of developing best practice care. Interestingly, I think the reliance on research is one of the reasons we made so little progress between 2000 and 2009. The reason for that is that we shouldn’t limit ourselves to evidence-based medicine, where there are real problems happening every day in our units and insufficient evidence be available.

My first key point in this talk is that while evidence-based medicine is the preferred option, if there is no evidence or the evidence is lacking, you still need to understand the problem. Why you’ve got unwarranted variation and outcomes across your system. Talk to your experts, identify what best practice care is, and lift everyone up to that best practice care. There may be more that we can do with good research, but at least you’ve created a baseline, a standard care that can be used as a comparator for future research initiatives. Lack of evidence is not a good reason to have a total lack of action. More needs to be done.

That was very much the conclusion of the clinical networks. Catherine Calderwood brought us together. Stillbirth reduction was identified as our number one priority, and it was agreed that we should develop a care bundle, and we involved a whole tranche of key stakeholders, including the NHS Litigation Authority. Now their work tends to revolve more about serious brain injury, but of course, a lot of intrapartum stillbirths have exactly the same causes as severe brain injury. They felt that there was a real advantage to them supporting, and being involved in this work, because then it could help with reducing claims and those awful brain injuries that can happen intrapartum.

We also had involvement from our Royal Colleges of Obstetricians & Gynecologists and Midwives, specialist such as the British Maternal & Fetal Medicine Society, and charities such as the Stillbirth and Neonatal Death Society, and Tommy’s, who have funded a huge amount of research in relation to both stillbirth and preterm birth prevention and more recently miscarriage prevention.

There was a consensus that we were going to do a care bundle and an agreement that we should have four key elements, which I will run through quickly. The first was about reducing smoking, particularly with a focus on carbon monoxide testing. Rather than just asking women if they smoke, an objective test to determine whether people smoke or not with a pathway to refer people to stop smoking services.

The second, and by far I think the most complex of our interventions was element 2, which was a risk assessment and surveillance for fetal growth restriction. That involved using an algorithm to identify women at risk and triage them onto a pathway of serial ultrasound scans. Also, for our low risk population, in England we use symphysis fundal height measurements, but often these were measured in a fairly imprecise way and just the numbers written down in the notes. By standardizing the way the symphysis fundal height measurements were made and making sure that they were plotted on appropriate charts, we felt that that would help improve identification of growth restriction.

We also introduced the audits to look at our SGA detection rate and audits to look into the care where we’d missed small for gestational age babies, to understand when in the pathway care might have been less than optimal. Whether that was in the risk assessment, the way the scans were arranged or performed or the actions that happened after the scan was completed.

This is the first algorithm we used in the care bundle. It served the purpose, but actually I’m much happier with the algorithm we now have in version 2 of the care bundle which I’ll come onto in a little while.

Elements 3 of the care bundle was about informing women about the importance of reduced fetal movements and ensure that if they came to hospital, they received the right care through a standard checklist. Here’s one of the leaflets that we ensured women got. This one was developed with the Tommy’s campaign which is fairly simple advice about when to attend, and this on the right is our checklist that staff could use to make sure that people got the appropriate comprehensive assessments and referral for onward investigations as indicated.

The final element related to CTG interpretations. Improving staff training so that they could interpret CTGs appropriately, but also equally important that staff knew how to escalate effectively. One of the things that the infant study showed us was that even when CTG interpretation is correct, lots of delays and bad outcomes are related to inadequate escalation.

Now, as many of the academics in the audience will know, bringing 20 professors into one room to try and agree a pathway is not an easy job. One of the things I used in my attempts to broker a consensus was I went back to this talk by Simon Sinek, his Ted talk, which I recommend, and I appealed to my colleagues’ reptilian brains. Tried to move them away from their strongly held academic arguments to understand that perhaps backing down a bit to find a consensus was important for the greater good, and then reminded people why we were in the room, which was to reduce stillbirth.

I have to say that my academic colleagues were incredibly tolerant of my attempts to broker a consensus, and I am incredibly grateful to them for their understanding and the way they were flexible and worked. I hope that the way we’ve implemented the care bundle will give them the opportunity to further research and perhaps prove the points they wanted to prove at the time that we were having the debate. It was important that we got something out there and over the line rather than waiting another five years to prove which of my colleagues was right about various arguments, particularly related to which growth charts to use and perhaps which risk assessment models to use and which scanning protocols to use.

My second key point really is that co-development is absolutely key to how you develop this sort of work and this sort of quality improvement project. We could have done better with our co-development. We could have evolved more women and more sonographers in the way we developed the first version of the care bundle. That was definitely less than I took through to the second version of the care bundle.

One of the next big events in the journey of the care bundle was the intervention from this man. This is Jeremy Hunt who was Secretary of State for Health back in 2015 and actually went on to be the longest serving Secretary of State for Health. Controversial figure in many ways, and I’m not an expert, but he seems to me to be a pretty clever politician. I think he’s absolutely genuine about his wish to improve patient safety, but if you’re going to campaign on something, that’s a pretty effective thing to campaign on because very few people can argue that they don’t want to improve patient safety.

At the time that he was developing what he wanted to do about patient safety, this paper from The Lancet came out, again, showing that our position in relation to other countries was fairly woeful. We were still doing very badly. He came up with the ambition to half the number of stillbirths, maternal deaths, neonatal deaths, and serious brain injury by 2030 which at the time seemed enormous impossible ask, but actually the evidence for both The Lancet paper I just showed, and from our confidential inquiries would suggest that at least half of those deaths were avoidable, so not as unreasonable as we initially thought.

I think the other thing is that if you’re going to set an ambition, all the science and all the evidence shows set a really big one, because that’s what will galvanize the population and create a movement. Certainly, Jeremy managed to achieve that. He then pushed the goalpost further and asked to do that by 2025, which caused assessment debate, but I think if you can’t be ambitious about reducing mortality, what can you be ambitious about?

My third key point and advice for any countries thinking about trying to develop something similar as far as care bundle is concerned is try and get some senior political support. They will help break down doors, get you support, help perhaps influence some of the people who are choosing to oppose the work or create barriers. Effective political support makes a huge difference. I’m very grateful to Jeremy and his team for the support they’ve given the care bundle. It has made a real difference.

One of the other really good things we did with the care bundle was make sure that we procured an evaluation of the care bundle. We could have properly done better in terms of trying to improve data collection to make the evaluation job easier. I’m incredibly grateful to Alex Heazell and his team at Manchester University who undertook to do this evaluation with SPIRE Group. It produced some very helpful information and gave us valuable learning so that we could iterate and improve the work we were doing.

What was exciting was that stillbirth rates appear to have declined by 20% in participating Trusts, but it’s important that we do see this in the context of a wider maternity transformation program that was underway in England at the time. I would never try to claim that all that reduction in stillbirth rates was down to the care bundle alone. There were other initiatives underway, some of which I will mention later in the talk, but nonetheless, it was credible that the care bundle was making a significant contribution.

We see that in the stillbirth rates. I mean, there was already some reduction in the stillbirth rates, but definitely an improvement in the rates of stillbirth reduction following implementation of the care bundle with the most dramatic reductions in the term stillbirth rate.

Some of the other learning points from the SPIRE evaluation was that carbon monoxide testing was a relatively straightforward thing to implement, although there were some financial barriers in some Trusts. I think our real downfall as far as one was concerned is actually effective referrals to smoking cessation services, which was much more difficult.

We certainly improved the detection of small for gestational age babies with the care bundle and most Trusts fairly effective ensuring women received their reduced fetal movement leaflets. I think there were some problems with element 3 in reduced fetal movements, particularly in relation to our management pathways specifically relating to induction. I’ll talk a little bit more about that in a moment.

What became evident also was that if you try to track the competencies and training records of your staff nationally, certainly in England, we found that incredibly difficult, and that’s one of the things we are still working on about improving the way that we track competency training of our staff and make sure that everyone is receiving the right professional development and updates in their core competencies and skills particularly in relation to CTG interpretation.

The evaluation did identify some bad outcomes in relation to implementation of the care bundle. A big rise in the number of ultrasound scans being requested. Although, interestingly, I think some of the more effective Trusts were very good at getting rid of the unnecessary scans that had been done for fairly weak indications and replacing them with scans that were actually clinically indicated. There was quite a lot of variation in the pressure on scanning services across the country.

There was certainly an increase in the number of inductions and caesarean sections. I think the inductions were certainly in part due to the care bundle. I think the rise in caesarean section rates, there were a number of other factors involved in that not least a ruling from our Supreme Court on something called the Montgomery-Lanarkshire case, really emphasized the importance of respecting women’s autonomy in terms of decision-making during childbirth.

The woman should be at the center of the decision making. Ultimately, she’s the final arbiter about what management pathway she chooses to accept. It’s not a matter of trying to achieve a performance management target of lowest caesarean section rates, it’s about personalizing care for each woman, and the legal ruling on that was very clear indeed and something that we chose to reflect in the version 2 of the care bundle.

We had a number of challenges we needed to do. We need to try and reduce the burden in terms of data collection and administration. We also wanted to reduce unwarranted intervention, particularly, in relation to induction of labor. We wanted to put women at the center of decision-making, make sure that our care complied with our Supreme Court’s ruling on women’s decision-making during labor.

We chose to promote continuity carer, which is one of the initiatives we are promoting as part of our maternity transformation program. There’s really increasingly good evidence that continuity care, by which I mean the women are seen by either the same midwife or a small team and midwives throughout their maternity journey. There’s evidence that does improve outcomes, particularly in relation to preterm birth, but it’s also going to be a key parts of how we want to try and address inequality in health care in the future, making sure that our midwives champion the cause and make sure that women from deprived backgrounds or women who are more vulnerable really do get access to best practice care to try and improve outcomes.

We also were aware that there were things women could do themselves to improve pregnancy outcome. We developed a simple guideline of what women could do themselves to have a safe and healthy pregnancy. We did a lot with Sands and made sure that it was available on our national NHS website. There was advice about pre-pregnancy care, about planning your pregnancy, trying to be fit and healthy in a normal weight before you start the pregnancy, the importance of the preconceptual folic acid, having your vaccinations, if there’s a likelihood of a genetic disorder in your family, see a geneticist before you’re pregnant to get a plan in place and not when you’re pregnant. And of course, probably the most important modifiable risk for stillbirth, stop smoking.

Then there was a number of interventions for women during the pregnancy as well. I’m not going to read all these out now, but they are either available on the slides, or if you just put Saving Babies’ Lives Care Bundle Version 2 in an internet search engine you will find the document and all this information there. Or look at the nhs.uk website.

The care bundle is never going to be able to capture all events natal care. We have targeted areas where we think our intervention is going to have the biggest impact, but we did want to just acknowledge that good care the whole way through the pathway’s important. We took efforts to promote our guidance for Non-national Institute of Clinical Excellence or NICE as we know it within the care bundle.

We also understood that we were not going to be able to prevent every stillbirth and that the care of women following a stillbirth was a variable quality across England. We worked with one of our clinical networks again and Sands to develop a best practice pathway for women who’ve had a stillbirth in terms of the counseling, the care, the information about postmortems and the care of future pregnancies. A really fantastic pathway, and there are links to that pathway within the care bundle if you look at it.

One of the things that we were aware of which I’ve referred to before, induction rates and reduced fetal movements seem to be due to something that I’ve called intervention creep, where people just drifted into doing induction labor earlier and earlier. We wanted to find a bit of information about that. This is work from Gordon Smith, who’s a professor at Cambridge, his team showing the proportion of children with special educational needs plotted against gestational age.

You can see there’s a very strong association between prematurity and even at later gestations 37 and 38 weeks. Just inducing people a little bit earlier does cause harm. The problem is that this is harm that’s not going to be detected for many years later. The clinician may feel great about what they’ve done, because they never recognize the harm they’ve caused. It’s really important, we felt, to address the intervention creep and some of the unwarranted interventions that were creeping into the care.

We also found the ARRIVE study was very influential about explaining that if you could wait to induction of labor at 39 weeks, rather than going earlier, the evidence was that you were going to cause much less harm. I appreciate this as a controversial study, but it was useful in terms of trying to describe when the right time for induction might be. The combination of those two bits of research really gave us a threshold at 39 weeks as somewhere where we would be more comfortable about intervention if the evidence for problems perhaps wasn’t so clear. Obviously, if there’s clear evidence early in the pregnancy that the baby’s at significant risk, then intervention is indicated in earlier gestation.

The final thing we did was recommend the use of antenatal computerized CTGs. I’ve put the American spelling there, so we’re not just separated by a common language the whole time. This is an example about trying to bridge the gap between evidence-based medicine and best practice. I’m not going to read the whole of this section out, but it’s really about understanding that best practice care has its role rather than waiting for X number of years for what can be perhaps complicated and difficult studies to be produced to drive the intervention.

I feel almost uncomfortable saying that because I think evidence-based medicine is really important, but using a lack of evidence as a reason not to do anything really isn’t acceptable. Actually, even since production, the care bundle has been further emerging evidence that actually using computerized CTGs does reduce human error and does improve outcomes.

The other thing that we were aware of with the Saving Babies’ Lives Care Bundle was that we weren’t doing enough about neonatal death. There was a lot of work, particularly from the Tommy’s campaign explaining why preterm birth is so important. And of course the main reason is the personal tranches for the parents and the children who are either damaged or die because of avoidable preterm birth.

Of course, when you’re talking to health economists, the money matters as well. And so be able to articulate just quite how much money preterm birth is associated with it, and the long-term costs which we calculated as the costs to English and Welsh health services was in the reach of £3.4 billion a year. When you look at the long-term care costs of all those individuals with cerebral palsy and problems, nevermind the huge costs of neonatal services. The economist involved in this work calculate there’s a one week increase in gestational age at delivery would save the NHS £81.3 million per year. Really very strong financial arguments for addressing preterm birth above and beyond the human costs that as clinicians we care about so much.

Version 2 of the care bundle started to be developed. Five elements, an aim to reduce unwarranted variation and outcomes, and these key points that I’ve described really about respect women’s autonomy, trying to reduce the burden, real focus on quality improvement rather than just performance management, and automating the collection of data where we can through our move to electronic healthcare records, which is a completely different story that we didn’t have time for today.

We put various levers in place to improve implementation, put it in our standard contracts. We’ve also got something called the CNST incentive scheme, which was very influential, which in a nutshell is part of our health insurance scheme where Trusts are financially rewarded or penalized, depending on how effectively they implement best practice care.

Implementation of that care bundle was part of that scheme. Trusts successfully implement the care bundle, they save money. They don’t implement the care bundle, they lose quite a lot of money and what money they do get back has to be linked to specific quality improvement work to implement the care bundle. Really quite a powerful financial lever, and you can find out more about that on the NHS resolution website if you want to understand more about those mechanisms.

This is the algorithm we developed for the care bundle in terms of element 2 using risk factors and uterine artery Dopplers to triage people through to different scan pathways. Here is a scan request to my own Trust, which is really a demand management tool. It makes it easy to request scans that are indicated, but harder to request scans for weak indications. It’s been really very effective at reducing the scan burden on the service by really making sure that every scan we request has purpose.

We implemented element 5 which was about preterm birth prevention with a focus on prediction, prevention and preparation. The next key points really relate to look at ways you can incentivize participation and really go for quality improvement approach and just a performance management approach to begin to implement a care bundle.

We put some educational support with the care bundle for version 2. We worked with our education colleagues in Health Education England, and we developed five online trainings sessions that all staff could use to develop their skills to help them comply with the care bundle. Probably at a later date that will be linked to their electronic staff record, and we will actually start to be able to track whether staff have taken this training or not, and find out who perhaps aren’t maintaining the skills in a way that would be optimal.

This is Reason’s Swiss cheese model, and I think I just put it up here to explain that outcomes usually have a lot of multifactorial complex problems. It’s important to appreciate that the care bundle isn’t a silver bullet. Is not going to prevent every care bundle, but it’s really important marginal gain. The improvements the care bundle makes in conjunction with the other improvements we’re doing within our maternity services add up to really very significant improvements. This is the same methodology that the British cycling team use, which is why we have that picture.

What we’re trying to do is implement improvements all the way along the care pathways. I’ve mentioned some of the interventions we’ve talked about in pre-pregnancy care and early pregnancy care and other initiatives such as continuity carer that aren’t actually part of the care bundle’s main key elements, but some of the care bundle absolutely supports and promotes.

The final thing I’m going to talk about is the perinatal mortality review tool. That is a structured way of reviewing the care when there has been a perinatal death and comparing the care received with what best practice care looks like to provide learning. It’s done in conjunction with the bereaved parents so they really understand what’s happened and we get the parents’ perspectives about what really happened in their care.

It’s a fantastic tool. We’ve now had two national report from PMRT, which again are available on the internet. It provides a really good feedback link to the care bundle where people can see how well they are really implementing the care bundle and where perhaps they need to do better when there is a perinatal death.

It’s a good news story in many ways where the stillbirth rate using our politically agreed baseline 2010 has fallen by 25% by 2019. We’re halfway to meeting Mr. Hunt’s ambition. There’s much more in the pipeline and we’ve still got more to do about how we make sure the care bundle is effectively implemented, and it’s going to be a continuous iterative process. We’re already considering ideas for version 3 of the care bundle, but it is making a difference. Although I won’t claim all the improvements in our stillbirth rates down to the care bundle, I think it has made a significant contribution. We have more than 750 babies alive today that we wouldn’t have had if we hadn’t achieved these improvements.

I’d like to thank all of those clinicians who have contributed to the Saving Babies’ Lives Care Bundle, and acknowledge that we often talk about transformational change, and I think what we’re trying to achieve is transformational, but it doesn’t happen without hard, transactional work. Really hard work, changing pathways, implementing change, winning over your colleagues. I’m really very grateful for all those people whether it’s from the political world, the policy world, or the clinical world who’ve worked together to achieve his improvements.

I hope you felt that useful, and please look at the main care bundle document. I will do what I can to help any healthcare systems who wants to try and do something similar. Thank you very much, and goodbye.