The East of England Neonatal Neuroprotection Project, funded by a grant from the Health Foundation, was launched to improve the quality of care for infants born with hypoxic-ischaemic encephalopathy (HIE) and their families by developing a coordinated, integrated and family centred pathway of care throughout the region. HIE, resulting from a lack of oxygen around birth, is a devastating condition for which until recently there was no specific treatment. Several large randomised controlled trials demonstrated that therapeutic hypothermia significantly improved neurodevelopmental outcome in these infants and in line with the NICE recommendation the East of England Neuroprotection Team strove to translate this research into standard clinical practice.
Aims and objectives
A high quality clinical service for neonatal neuroprotection can be summarised as a 'seamless patient journey from birth to long term follow up'. The management of a baby with HIE is complex from the moment of birth through to discharge home and provision of specialist long-term support services if required.
We sought to improve the quality of service in the following five areas, with the expectation that the interventions described would lead to quantifiable changes in clinical quality in terms of process, outcomes utilisation and structure.
1) Resuscitation, stabilisation and early management of HIE: We wanted to ensure that all infants eligible for cooling would be identified quickly and referred appropriately for treatment.
2) Neuroprotection: Ensuring that staff providing cooling treatment are able to do so effectively and safely.
3) Neuroimaging: To agree some standards of care across the region with regards to imaging protocol, including use of MRI.
4) Neurodevelopmental Follow up: To raise the profile of neurodevelopmental follow up and ensure that units are able to provide the service.
5) Family centred care: To evaluate the quality of existing services through engagement with families and improve family experience.
We have set out our main objectives against the five areas outlined in the aims section:
1) Resuscitation, stabilisation and early management of HIE: that all infants eligible for cooling are identified and appropriately referred, within a target of 2 hours.
2) Neuroprotection: that infants reach target temperature within 6 hours of life, thereby giving the best possible chance of recovery, and that incidents of overcooling should not rise as a result. All infants to have appropriate intracorporeal temperature monitoring as per NICE guidelines.
3) Neuroimaging: to establish a working group of neonatologists and radiologists, with a view to agreeing a regional imaging guideline.
4) Neurodevelopmental Follow up: all infants diagnosed with moderate to severe HIE at birth should attend a two year neurodevelopmental assessment follow up appointment.
5) Family centred care: following engagement with families it became clear that they would appreciate more written information that they could read in their own time and share with their family and so the project team set out to develop an information booklet and website that would help families to understand their baby's condition and treatment. In addition to this it was important to the project team that any improvements made or new interventions should be sustainable beyond the life of the project.
Reasons for implementing your project
Within the region there are 19 secondary care organisations, three of which are specialist tertiary centres providing ongoing cooling treatment. The geographic size of the region is considerable, which has presented unique challenges to this project. On average, a baby is 8 ½ hours old by the time it arrives at a tertiary centre for cooling, and so the referring unit and transfer team must cool prior to arrival if the baby is to receive treatment within the optimum 6 hours.
We have worked closely with the East of England Perinatal Network which has a specialist commissioning presence, as well as good support from the clinical community. The region is also supported by ANTS (the Acute Neonatal Transfer Service), a specialist neonatal ambulance service that manages and executes transfers within the region. Engagement with ANTS has been key to the success of the project.
In the early stages of the project we undertook a study of all 19 units within the region, in an attempt to understand the incidence and variation in practice relating to neuroprotection and preparedness across the region for providing therapeutic hypothermia treatment. Some of the key findings were that only 4 of the 19 units were able to monitor intracorporeal temperature as per NICE guidelines, wide variation across the region in uptake or availability of cooling protocols, no written information available to parents, varying use of hospice support and wide variation in MRI scanning practice. We undertook a similar exercise with families to gauge their feelings about the way they were dealt with whilst their baby was receiving treatment for HIE and after discharge. Feedback has been varied, however one theme came up time and time again: communication. Parents frequently felt that information wasn't available to them in a way that they found easy to understand.
How did you implement the project
The project was structured around a number of interventions which, in line with Quality Improvement methodology, were tested then launched and continually reviewed:
1). Training packages were developed through working with early adopter units, and reviewed through attendee feedback. We aimed to visit each unit every 3-4 months, so that the message would be repeated regularly. With high staff turnover and relatively low incident rate of HIE within any one hospital, we found that key messages had to be repeated in order for information to be retained. We also ran regular study days throughout the region. Posters and laminated reminders were produced to support training.
2). We held debriefs on units between the clinical teams and someone from the Neuroprotection team following a cooling case. This helped to identify learning needs for staff and areas for improvement, as well as providing an opportunity to celebrate success.
3). After establishing a working group to deliver the objective of a more standardised imaging practice across the region, a quarterly videoconference was established between the three tertiary centres to discuss complex cases and their management and share learning.
4). Neuroprotection Care Pathway documentation was created for the region, with supporting guidelines, to enable standardised working.
5). We have developed relationships with a number of Sure Start centres and have been holding events, enabling families to meet one another and share their experiences. All centres have expressed their commitment to continuing these groups beyond the life of this project. Family engagement enabled us to write and publish a national family information booklet in collaboration with the charity BLISS, and to collect a number of families stories which we wrote up and shared with staff across the region. 6)We have developed a website with areas for families and clinical staff, enabling us to share all of these interventions and learning with a wider audience.
Improvement results were monitored for six key outcomes, results given are the baseline (October- December 2009) against the latest figures (June-December 2011):
1) Time of referral has gone from 122 to 112 minutes.
2) The age at which cooling is started has gone from 141 to 48 minutes
3) Time to target temperature has gone from 370 to 219 minutes.
4) The number of infants at target temperature within 6 hours has gone from 36% to 100% 5) Intracorporeal temperature monitoring has gone from 0% compliance to 81% 6) Incidents of overcooling have gone from 45% to 31% In the meta-analysis of clinical trials the number needed to treat with therapeutic hypothermia to have one case with normal neurodevelopment who would otherwise have an abnormal outcome at 18 months is 8 (Edwards et al, BMJ, 2010).
All infants in the trials were cooled within 6 hours of life; assuming those in whom cooling was started later would not benefit from the treatment and therefore would have suffered from long term disability, and taking the incremental improvements in performance against the 6 hour target from 36% to 100%, it is possible to calculate that to date 4 babies will have escaped long term disability (32 babies have now been cooled within 6 hours who would not have been if performance had remained at 36%).
As well as the significant benefit of this positive outcome on the infant and family, with lifetime costs of a disabled infant set between £5M to £7M, the total societal saving of this is between £20M and £28M. It is evident from our results that babies born in the East of England, diagnosed with HIE, now benefit from a safer and more effective service. The introduction of clinical pathways and documents have helped to significantly standardise the process. Our work with families has also provided a much needed support network, that previously had not been available for the families of infants diagnosed with HIE.
Key learning points
Our key areas of advice would be:
1) Ensure a solid evidence base: if change is to be adopted stakeholders must understand the need for change. While there is unequivocal scientific evidence on the benefit of cooling, it may be harder to persuade clinicians and managers of the need to improve the quality of the service. Obtaining baseline data is important in this aim.
2) Use a network approach: Utilise existing networks that cover the patient group. This will ensure that there is an existing group of interested people to engage with, but a resource that can help with monitoring and sustaining your improvements once the project is completed.
3) Choose some pertinent measures, and monitor: Identifying and selecting a few measures indicative of success and monitoring them regularly is very important. Collecting too much data however can sometimes obscure the key objectives being measured.
4) Engage with your patient group early: While it can be tempting to spend time early on working on clinical aspects that people are often more confident with, building up relationships with patients takes time and if meaningful with patient engagement is to occur, the sooner it is started the better.
5) Engage with your local transport team: The transport team are an essential resource in a project such as ours: they not only see firsthand what staff are doing, but they are able to reinforce training and good practice.
6) Start your interventions small and build up: It is important to avoid the temptation to work on developing an entire package of interventions, paperwork and pathways and deliver a 'complete and perfect product'. This can make it very difficult to change and adapt to issues arising following implementation as specific problems can be hard to pinpoint.