Scaling up an intervention to protect preterm infants from neurodevelopmental disabilities — findings from a qualitative process evaluation comparing standard with enhanced quality improvement support packages for maternity units in England

In total, 72 interviews were conducted with good representation from units across England and staff from the national AHSN network. Eighteen interviews were conducted with staff from units receiving ESP, comprising nine midwives, four obstetricians and five neonatologists; 33 interviews were conducted with staff from units receiving SSP, comprising 13 midwives, 10 obstetricians and 10 neonatologists. In addition, we interviewed nine regional AHSN leads responsible for the roll out of the NPP and 12 AHSN staff who worked with clinicians in local maternity units.

The clinical intervention to be scaled up involved the administration of an intravenous loading bolus dose of MgSO4, a relatively inexpensive drug, followed by a maintenance infusion.

Although relatively straightforward, what the initial analysis suggested is that the intervention destabilised the conventional professional organisation, or normative structure, of care for women in labour and preterm infants that resulted from introducing the treatment. The care of women was the responsibility of obstetricians and midwives, whereas the care of the infant was that of neonatologists and neonatal nurses. Preventing neurological damage to the preterm infant meant that MgSO4 had to be administered to women before birth — the responsibility of obstetric teams for the benefit of preterm infants who are the responsibility of neonatal teams. This structuring of responsibilities had practical implications because maternity and neonatal units were not always colocated at hospital sites, and this physical distance led to fewer opportunities for communication among staff. Other structural barriers included regulations about who can prescribe and administer medications and access to medical notes which are separate for mother and baby and held in separate physical locations or databases. ‘Ownership’ of PReCePT was therefore initially contested, but it was a crucial aspect of its success. The following interview excerpts illustrate the discussions around which professional group should provide leadership for implementing the required changes in clinical practice:

[Before the PReCePT intervention] it [was] the neonatologists trying to tell the obstetricians what to do and how to look after their patients. […] And that was quite frustrating that people weren’t implementing it and then when PReCePT came in, they suddenly were. And nothing new really, there wasn’t new data that came on board, it was just someone different telling them [obstetricians] should do it. (P26, Neonatologist, ESP Unit31)

It makes sense that actually this is an obstetric project really rather than sit with neonatology which was the original thinking […] It sits better with maternity because [they] are the ones who have to administer it […] with an obstetrician who has actually been doing degrees in pre-term deliveries so it made sense for that person [to lead]. (P46, Neonatologist, SSP Unit12)

What this shift in responsibility for leading the change signals is that it is not the technical complexity of the clinical intervention that needed to be addressed in implementation and spread, although it did require additional steps in workflows and time, mainly for midwives. Rather, it was the work of integrating the change into the wider ecology of clinical practice including the policy/regulatory context and the organisational, team and individual practitioner levels that required considerable thought and effort [20]. In the following sections, we focus on three of the NPT constructs relating to outcomes that explain how this work was accomplished: normative restructuring, relational restructuring and sustainment [13].

Normative restructuring

Normative restructuring refers to the changes that were required to increase MgSO4 uptake: changes to the norms, rules and resources that govern the actions of maternity and neonatal teams. An important precondition for starting the work was an acknowledgement that the change in clinical practice was necessary. Some clinicians assumed that the administration of MgSO4 was already routine and were surprised to learn that following the collection of baseline data for all maternity units, the actual recorded rates of administration did not align with their expectation, highlighting the value of real-time and accurate data collection, as suggested below:

Everyone’s first response is, ‘we already give it and it is a normal part of our everyday care when we are caring for women in prem labour’. But actually the data didn’t support that. (…) One of the first things we did when the project came in [was to feed back their administration data] because everybody was so adamant that they did do it already. (NPP support, AHSN6)

The restructuring activities observed in all SSP and ESP units included modifications to the professional organisation of care for women in labour and preterm infants, to clinical guidelines and processes and to procedures for documentation and communication across the perinatal team and with other members of the multidisciplinary team involved in care of women in preterm labour. These included anaesthetists and pharmacists, and settings outside the labour ward, for example in community care, emergency departments and triage. Some of these changes had already been identified during the initial PReCePT pilot phase and been codified in the QI toolkit and implementation guide. For example, one of the first actions taken by implementers was to compare their hospital clinical guidelines with the PReCePT QI clinical guideline included in the toolkit. All units reported their unit to already have MgSO4 guidelines in place, but amendments were needed for these to reflect national policy and PReCePT QI protocols. Changing existing guidelines was the most often reported change implemented in units. Guideline updates included administration of MgSO4 for neuroprotection, addressing repeat doses, and most units had adjusted the gestational threshold of eligible pregnancies to include women up to 34 weeks, as described below:

We’ve changed, a hundred percent. We chose, in our unit, to offer [MgSO4] to everyone up to 33 weeks and 6 days because our numbers are so small […] so it’s become the norm really to give it. […] (P15, Midwife, ESP unit23)

Others structural impacts were ‘discovered’ and addressed during the implementation process, as the following interview excerpts illustrate:

You need an extra person (…) to go and do the magnesium sulphate because of all the other things that need to be done if somebody is in pre-term labour. Somebody else needs to go away to do it and we’ve appreciated that more I think. (P01, Midwife, ESP unit31).

What we had to do was to drill it into our registrars [doctors-in-training] that if somebody comes in, in preterm labour you don’t just write up magnesium and walk away, because then the poor midwife (…) she’s got to monitor the baby, she’s got to get a resuscitaireFootnote 4 ready, she’s got to give her dexamethasone, she’s got to cannulate her, and then you expect her to give her the dose of magnesium as well, and then you wonder why when she delivers one hour later she’s not had the magnesium. So we drilled it into our registrars that you have to cannulate [the woman], you just give them magnesium straight away, you do it. (P27, Obstetrician, SSP unit15)

Workflows were actively restructured to remove barriers to women receiving MgSO4 in preterm labour, but they also restructured staff’s prioritising and decision-making. This is highlighted in the following excerpt describing the introduction of ‘PReCePT QI grab boxes’, resembling the ‘steroid boxes’ already in use. This was a box containing all the equipment and documentation needed when administering MgSO4. It was easily accessible in all places where MgSO4 needed to be administered such as in labour wards and operating theatres. These boxes helped make MgSO4 visible and act as a reminder, making administration as easy and quick as possible:

The biggest changes were essentially people’s mind-set, the thinking, just whenever somebody thinks of preterm labour, they not only have to think of transferring the baby, […] so in-utero transfers, steroids and magnesium sulphate. So we kept what we called grab box, so magnesium sulphate is available. This particular client comes through the door, we can just get hold of the whole bag, it’s all ready to go. (P43, Obstetrician, ESP unit23)

The ‘grab box’ was not only of practical value in reducing delays but also signalled the unit’s commitment to neonatal safety. Other normative restructuring changes included modifications to the way information was documented in patient notes: mainly clinical proformas and stickers to facilitate better recording of MgSO4 administration in maternity notes and easier transfer of information from maternity to neonatal databases. A powerful tool to improve uptake were the reviews of missed cases where audits revealed that women who should have received MgSO4 but did not, with findings being fed back into the system (through training, communication of results during meetings and handovers and one-to-one discussions). All units, irrespective of the level of implementation support they received, achieved some or most of the normative restructuring needed to increase their unit’s MgSO4 administration rate through use of the QI toolkit, implementation guide and ongoing QI support. This partly explains why there were no significant differences in MgSO4 administration rates between the ESP and SSP unit in the clinical trial results.

Relational restructuring

Relational restructuring refers to how professional relationships and communication between different hospital units changed as a result of working with PReCePT to implement the new practice. Professional silo working was one of the greatest challenges for implementers who needed to promote perinatal team working, as the following excerpt highlights:

Obstetricians and neonatologists sometimes have a default tendency to operate in silos (…) the most optimistic interpretation I think I can give you is that the perinatal team is starting to form. (AHSN Clinical Lead 1)

Participants’ accounts suggest that poor team working was especially risky for the structural reasons explained above: vital information was not shared because it was stored in different locations, and communication was therefore suboptimal. The geographical distance between some maternity and neonatal units frequently exacerbated communication problems. Yet the care of women in preterm labour and the timely administration of MgSO4 required new routines that needed to be aligned with established responsibilities and a vision for joint working across maternity and neonatal unit staff. PReCePT activities (such as joint workshops and meetings, awareness training in different settings) enabled the perinatal team to engage in conversations about MgSO4 away from pressurised clinical environments, to develop networks across units and to raise and discuss concerns. They also enabled midwives to initiate conversations with obstetricians about when the administration of MgSO4 would be appropriate. These conversations facilitated a coming together of the perinatal team and the opening of opportunities for developing creative solutions to structural problems and for learning and improving practice, as illustrated below:

I think it [PReCePT] did have an impact as a joint project that everybody was involved with as a whole unit [….]. It gave the neonatal team the permission to say “is the mag sulph going up?” It gave the midwifery team permission to say “shall we start mag sulph?” And I think it was good that everybody was trying to do the same thing. (P01, Midwife, ESP, Unit31)

These outcomes were achieved more easily in ESP units that benefitted from additional backfill time for implementers drawn from all three professions (midwifery, obstetrics and neonatology) as well as additional events and meetings, focused training and coaching in QI methodology. Overall, there was more engagement from all three professions in the ESP units, while in the SSP units most of the implementation activities were carried out by midwives, as the excerpt below indicates:

It’s good having a midwife with dedicated time to go around doing some teaching […] To be honest a lot of that stuff I was doing I was juggling with other stuff, so I wasn’t doing it very well. […] At least now we’ve got a midwife there and she’s on labour ward all the time, whereas I’m all over the place. (P27, Obstetrician, SSP15)

However, one of the most notable differences between the two types of support was the way that PReCePT was viewed; in the ESP units, it was understood as a perinatal team project, involving all professions equally, whereas SSP units relied heavily on the lead midwives to support what was seen as either an obstetric or neonatal project. There was also less active involvement of obstetricians and neonatologists in SSP units. The strength and quality of these horizontal relationships had implications for the implementation process in ESP and SSP units. ESP units focused on collaboration, commitment and shared learning among participating units and invested in opportunities for this to happen. Regional and national support networks with which implementers engaged throughout the life of the study helped form ‘communities of practice’ within which knowledge was created and shared [21] and helped increase MgSO4 uptake in individual units, further enabling spread and scale-up of PReCePT QI. Another corollary of the enhanced QI support was the creation of ‘networks of networks’ where those participating in the PReCePT network also acted as links and access points to other networks, such as quality and safety collaboratives and local learning systems. This generated synergies which allowed the PReCePT message to be embedded within the wider system, raising the profile of MgSO4 as an important aspect of neonatal safety and transcending professional boundaries of responsibility.

These networks were facilitated by the national PReCePT team for ESP units but were lacking in SSP units resulting in fewer opportunities for implementers to be part of these mutually supportive, interprofessional collaborations. Nevertheless, clinicians and AHSN staff with QI and coordination roles also organised opportunities for local and regional meetings for training and exchanging knowledge and learning, replicating some but not all of the functions of the collaborative support received by ESP units. The AHSN support tended to focus on the SSP unit lead midwives who were seen as the main implementers. The SSP unit lead midwives were also highly proactive and creative in connecting with each other and seeking solutions to commonly experienced barriers and problems. For example, early in the implementation period, they formed a social media group as a peer support and information sharing tool and as a mechanism for spreading improvement ideas developed in local units. Inevitably, there was contact between ESP and SSP units, and while it may have been preferable to avoid cross-study arm contacts for the clinical trial to test the effectiveness of the enhanced intervention, in reality, this was impossible. Wider support networks encouraged commitment, motivation, exchanging ideas and networking which increased awareness and spread of MgSO4 administration.

Overall, relational restructuring was more challenging for SSP units. Midwives reported that it was often difficult to protect their time from clinical pressures, despite the funded backfill. This also had an impact on their capacity to attend training and meetings and complete tasks related to PReCePT such as training and awareness raising among staff in their units and hospitals, accurate data collection, data auditing and the investigation of missed doses and follow-up actions. These tasks were often carried out in their own time. Although ESP unit midwives were also called on to provide clinical support during their dedicated ‘PReCePT time’, they were better supported by their fellow implementers, and momentum was less likely to be lost during times of high pressure.

One way of securing more support for their efforts involved SSP unit midwives forging alliances with other members of the multidisciplinary obstetric and neonatal teams. For example, advanced neonatal nurse practitioners were enthusiastic supporters of MgSO4 uptake as the following excerpt illustrates:

It’s now become a sort of midwife-advance neonatal nurse practitioner led project […]. It’s become us two sort of leading it […] Our plans are to carry on the monthly meetings even once the PReCePT support has finished so we can maintain that. (P14, Midwife, SSP unit36)

Vertical relationships with the senior hospital leadership were not explicitly restructured as a result of implementation. However, they formed an important part of the context because explicit leadership support meant that structural and practical barriers with bureaucratic systems and policies could be overcome. Where that support was missing, implementers had difficulties in accessing PReCePT funds, and some hospital policies prevented the use of some parts of the PReCePT toolkit. However, this was not related to whether units received the SSP or ESP.

Sustainment

Sustainment refers to how changes have become incorporated into routine practice following the ending of the implementation period, QI support and backfill funding. This coincided with the beginning of the COVID-19 pandemic. Sustainment of the increases in the administration of MgSO4 required ongoing work including the continued (re)evaluation of performance, dissemination and review of audit results, the identification of ‘missed cases’ and subsequent action to promote MgSO4 administration and address barriers. Improvements in data collection introduced in the implementation phase, regular training updates for existing staff and incorporating PReCePT training into mandatory staff induction programmes continued into the post-implementation phase, although some participant accounts suggested that clinical pressures and the impact of the COVID-19 pandemic led to falls in their administration rates. Reasons included staff shortages and reliance on untrained and agency staff, while opportunities for training were also reduced. Reported threats to sustainment included staff turnover and the resultant loss of QI expertise, the loss of protected midwife time through dedicated funding and potential competing demands from other safety initiatives.

Quantitative evaluation data [11] suggested that ESP units were more likely to sustain their administration rates, and that this was related to stronger perinatal team working. Team working had been encouraged in ESP units through implementer backfill time, the inclusion of all three professional groups responsible for maternal and neonatal safety in the implementation and opportunities for joint learning and networking, resulting in relational restructuring which in turn was critical to sustainment. Participants’ themselves also observed the importance of team working for sustainment:

It was good to have time with your team to talk about things which you normally just don’t have. Normally you always do things in between, […] and now you had the time to talk so it definitely improved our communication within the team and the collaboration with the neonatal unit. (P39, Obstetrician, ESP, Unit31)

I think when we do PReCePT compared to what we were doing in the past, we succeeded to train everyone and everybody has to sing from the same hymn book. […] the thing is even if one or two people were not doing it, […] then these people are going to stand out like a sore thumb, and they will (need to change their practice) and that’s what we can do now. (P25, Neonatologist, ESP, Unit07)

Participants also suggested that sustainment was strengthened by the inclusion of a wider membership in the perinatal team such as obstetric anaesthetists, pharmacists and advanced neonatal practitioners. Furthermore, participants’ accounts from both ESP and SSP units indicated that enhancing QI capacity in the workforce also had positive impacts on teams and individuals and their motivation to improve MgSO4 uptake. Finally, the use of social media, linking individual implementers to peer support, created a national forum for what was growing into a national community of implementers and became a powerful driver for the sustainment.

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