Codifying complex health care interventions

The previous chapter looked at how complexity poses challenges for codifying health care interventions in ways that can support effective replication. This chapter considers some possible approaches to codification in response.

Adequate description of an intervention’s technical components is, of course, often critical for effective replication. Research studies highlight the role that poor quality descriptions of technical components can play in preventing successful spread. This has led to the development of approaches to assist innovators and evaluators in producing more robust intervention descriptions – for example, the TIDieR framework.

However, the analysis in the previous chapter suggests that successfully replicating complex interventions also requires codifying them in ways that go beyond a description of the technical components and allow adopters to navigate the underlying social, contextual and dynamic forces.

Various approaches to codification are evident in the evaluation and implementation science literature, as well as in practice in the Health Foundation’s programmes. These are characterised by two contrasting impulses we would describe as ‘tightening’ and ‘loosening’.

Some approaches seek to ‘tighten’ the intervention description in response to the challenges of codification by attempting more comprehensive or fine-grained specifications than simply a straightforward description of the intervention’s technical components. This could include specifying the method for implementing particular components, for example, ‘lean’ principles. Another possible tightening approach is to set out relevant social mechanisms and dynamics in addition to technical components; the case of PROMPT, described in Box 4, could be viewed as an example of this kind of approach.

Other approaches, by contrast, seek to ‘loosen’ the description of the intervention by focusing less on specifying the details of each component and more on the ability of adopters to formulate their own versions of these components in their own setting. This includes approaches that focus on the theory of change underpinning the intervention and that see fidelity as replicating the function that components play within this theory of change rather than their original form. It also includes approaches that focus on the underlying principles and goals of the intervention and allow adopters to work towards their own way of fulfilling these – an example of which can be seen in the case study of Shared Haemodialysis Care at the end of this chapter. Another possible loosening approach is to focus on building the knowledge, skills and capabilities that adopters require to re-create the intervention’s effects in their own setting. In the language of intervention manuals, tightening approaches aim to lengthen the manual, while loosening approaches effectively support the adopter to write their own version.

Box 4: PROMPT: the importance of considering the social aspects of an intervention

PROMPT (Practical Obstetric Multi-Professional Training) is a one-day, multi-professional training course developed by a team at Southmead Hospital in Bristol. It uses simulation models to address the clinical and behavioural skills required by teams responding to obstetric emergencies. It has been associated with significant improvements in care outcomes, including a 50% reduction in babies born starved of oxygen and a 70% reduction in babies suffering from shoulder dystocia. The training course includes a detailed manual setting out technical components, such as emergency drills for dealing with obstetric haemorrhage, along with some principles for running the training, such as multi-professional participation and the use of props and patient actors.

While PROMPT has spread widely, consistent replication of the successes seen at Southmead has been harder. For example, implementation of PROMPT in one Australian state showed more modest improvements, and not all sites were able to implement it fully. This suggests that the training and the accompanying technical proficiency may not by themselves fully explain the outcomes seen at Southmead. Indeed, a survey of organisations adopting PROMPT suggests that how well a unit implements the package is related to their underlying safety culture and attitudes. This implies that PROMPT is not simply a technical intervention but a ‘social’ one, too, and that successful implementation relies on factors such as the values, behaviours and relationships within the organisations implementing it.

The Health Foundation is now funding new research to characterise the mechanisms underlying the improvements seen at Southmead. The research will also develop and test an additional ‘implementation package’ that incorporates an intervention to support the norms, behaviours and systems that need to be in place to reproduce Southmead’s safety outcomes.

Tightening and loosening approaches both represent attempts to absorb the context-dependent and social nature of complex interventions in order to support their successful implementation. Both also seek to reconcile the need for creativity and constraint, but via different routes. ‘Tight’ descriptions attempt to draw social and contextual factors into the intervention protocols, though in doing so tend to highlight the capabilities required for successful implementation. ‘Loose’ descriptions, by contrast, focus on helping adopters adapt the intervention to fit their own context, though in doing so make them ‘own’ the constraints within which they need to operate.

Whichever approach is taken will have implications for the concept of fidelity. Tight descriptions multiply the number of factors guiding faithful replication of the intervention, and can increase the likelihood that the ultimate form of the replicated intervention will resemble its original incarnation. Employing looser descriptions, by contrast, may well mean that fidelity is seen to reside in features of the intervention other than its original form, for example, in faithfulness to the goals of the intervention or the underlying principles, or in the use of a particular methodology to re-create it. As discussed earlier, loosening strategies also include theory-based approaches to codification, which see fidelity as residing in the function particular components play within the intervention’s theory of change. An example of a theory-based approach to fidelity, from the evaluation of the Health Foundation’s Safer Clinical Systems programme, is described in Box 5.

Box 5: Fidelity and adaptation in the Safer Clinical Systems programme

Safer Clinical Systems was a programme run by the Health Foundation between 2008–2016 to improve the safety and reliability of health care. The programme approach aimed to improve patient safety not by imposing pre-defined solutions on organisations, but by developing their capacity to diagnose system-level weaknesses and introduce interventions to address them. The tools and techniques used were mostly imported from other industries, then adapted and customised for health care. A prominent feature of the programme was its goal of changing the way organisations approached safety, from the prevailing reactive, incident-based approach to a more proactive, risk-based one.

The evaluation of Safer Clinical Systems identified the programme’s theory of change as consisting of two broad components: a stepwise method made up of diagnostic, implementation, measurement and reporting phases; and a proactive and collegial approach to safety. In the final phase of the programme, the evaluators assessed fidelity in terms of divergence from this theory of change. They outlined two types of divergence, which they termed ‘principled deviations’ and ‘conspicuous departures’. Principled deviations ‘served to address local needs and contextual pressures, but did not affect the two core elements of the theory of change’. Conspicuous departures, however, altered the core elements at the heart of the approach and transformed it into something different.

Principled deviations tended to be ‘functional’, allowing teams to overcome local constraints and maintain momentum in their work. For instance, during the diagnostic phase, one team renamed some of the tools and revised the language within them in response to concerns that they were off-putting for staff, while nevertheless maintaining the proactive, collegial and stepwise nature of the approach. The evaluators also saw these principled deviations as attempts by teams to gain ownership of the work and embed it into organisational practice.

In another site, however, the diagnostic phase was conducted by external consultants rather than permanent team members – a conspicuous departure from the programme approach, which had emphasised local ownership. The evaluation concluded that ‘the relationship between fidelity to and effectiveness of the Safer Clinical Systems was not straightforward, but there were indications that principled deviations led to satisfactory outcomes, while more conspicuous departures did not’.

Innovator views on tightening and loosening

In our survey of innovators from Health Foundation programmes, nine out of ten (91%) said adopters had made adaptations to the intervention during implementation, and nearly half of these innovators (47%) said they had seen instances of changes being made that had given them concerns about fidelity. So, we were interested to see their views on the best route for ensuring effective implementation.

Figure 2: Survey of innovators – adaptations made by adopters

As described above, a ‘tightening’ approach aims to specify more granular and detailed information about the intervention in order to reduce the risk of important factors being missed or changes being made that breach fidelity. A ‘loosening’ approach, by contrast, focuses less on the specific details of intervention components and more on the underlying goals, and on the capability of adopters to re-create their own version of the intervention in their own setting.

What did our innovators think of these approaches? Overwhelmingly, they favoured a loosening approach. When asked to choose between two statements, 90% of innovators chose ‘It is better to tackle adopters’ implementation challenges through providing more training and support to implement the intervention’, with only 10% choosing ‘It is better to tackle adopters’ implementation challenges through providing more detailed information about the intervention’.

Figure 3: Survey of innovators – tackling implementation challenges

This split was mirrored in innovators’ responses to a separate question, discussed in Chapter 5, about what, with hindsight, would have made the biggest difference for supporting adoption. The most popular options were capability-oriented – doing more in advance to support adopter readiness and providing more training and support – while the option of providing a more detailed written description of the intervention was one of the least popular.

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There are merits in all of these approaches to intervention description and a priority for improvement research is to investigate which might work best in which circumstances. Interviews with grant holders engaged in the Health Foundation’s programmes highlight both advantages and disadvantages of tightening and loosening strategies. Tight descriptions that seek greater prescription may highlight important factors that support effective replication, but in doing so may make it harder for adopters to feel a strong sense of agency in shaping the intervention. Such approaches could also be open to the accusation that they are seeking a level of determinism over the link between components and outcomes that might be hard to attain in practice. Conversely, loose descriptions that seek greater abstraction potentially allow an adopter more scope for creative responses to contextual issues, but may also make adoption more challenging and risky. Indeed, providing too little concrete information can be daunting for potential adopters, who may yearn for clearer guidance at the outset.

Perhaps for these reasons, successful cases of codification often employ blends of these techniques. For example, specifying the function of different components within a theory of change could be combined with identifying the social and relational factors required to enable those components to function successfully, and which therefore have to be reproduced. Or a capability-building approach could be combined with detailed prescription of intervention components or implementation methods. An example of the latter, illustrated in Box 6, can be seen in the Flow Coaching Academy, which supports teams to improve flow along condition-based pathways using a training approach. A blended model can also be seen in franchising approaches to spreading innovation, (see Box 7), in which detailed manualisation is combined with ongoing training and support. So tightening and loosening strategies are not necessarily mutually exclusive, and can be simultaneously applied to different aspects of interventions.

Box 6: The Flow Coaching Academy

The Flow Coaching Academy supports teams to improve patient flow along condition-based pathways (such as stroke or acute paediatrics), using team coaching and ‘flow’ principles. It was developed from the learning gained in two previous Health Foundation-funded programmes: Flow Cost Quality and the Sheffield Microsystems Coaching Academy.41

Rather than prescribing specific intervention components or outcomes, the Academy instead trains individuals to use a ‘roadmap’ to coach flow improvement within their own organisations. An expert faculty delivers the one-year action learning curriculum at monthly sessions, which involves training in technical skills (such as process mapping) and relational skills (such as resolving difficult situations). This capability-building is combined with the ‘Big Room’ methodology (based on the ‘Oobeya process’, originally developed by Toyota) – a regular, standardised meeting that brings together staff and patients involved in a care pathway to iteratively test ideas, monitor data and progress, discuss issues, share experiences and agree next steps.

Work is now underway to develop a network of 10–12 such academies across the UK.

Box 7: Social franchising

Social franchising enables an adopter organisation to deliver a proven intervention or idea to agreed standards under a franchise agreement. The intervention is packaged up for franchisees to replicate, usually in the form of a manual, accompanied by training and support; in return, the franchisee pays a fee to cover the costs of the franchise operation and shares data and other information with the franchisor. The intervention manual usually sets out the essential components of the intervention, while permitting appropriate local flexibility where this is required for successful implementation.

As a method of replication, franchising sits in the middle of the spectrum in terms of the degree of affiliation between innovator and adopter. At one end of the spectrum, spread could be achieved through the growth of a single organisation, where ownership remains with the innovator; at the other end are approaches with no relationship whatsoever between innovator and adopter, for example where ideas are disseminated through publication and independently picked up by others. Franchising approaches sit somewhere in between: they require a degree of affiliation between franchisor and franchisee through the franchise agreement – both for the accountability of the franchisee to the franchisor and also for the support provided by the franchisor to the franchisee. As such, franchising has the potential to offer greater levels of support to adopters than some approaches to spread, and also greater control to the innovator to ensure fidelity to the original model. Different franchise operations strike different balances between these elements.

It is this combination of manualisation with training and implementation support that makes franchising a good example of a blended approach to codification and replication. It can permit tight specification of interventions and help ensure fidelity, while also recognising the importance of building adopter capability and providing ongoing support.

During 2018 and 2019, the Health Foundation will be testing the feasibility of using social franchising and licensing methods to spread complex health care interventions. Through the programme Exploring Social Franchising and Licensing, four teams are being funded to scale their intervention using these techniques. These range from a pharmacist-led IT intervention (PINCER) for reducing medication errors in general practice prescribing, led by the University of Nottingham, to an integrated care model (the Pathway model) to ensure homeless patients admitted to hospital have access to the care and support they need, led by the homeless health care charity Pathway. There will be a significant evaluation component to the programme, to generate wider learning on the applicability of franchising techniques to health care interventions.

In most discussions of innovation, the innovation itself – the thing that is to be spread – is taken as a given. The implication of the discussion here, by contrast, is that the notion of a health care intervention is to some extent a more moveable feast; it can be conceptualised in a variety of ways (as a set of component activities, capabilities, methods, principles, or a combination of these) and at varying levels of generality or specificity. As the examples above illustrate, exactly how an innovator chooses to characterise their intervention will have implications not only for the notion of fidelity, but also for the appropriate method for spreading the intervention. For example, a capability-based approach may lend itself to using training as a route to spread, whereas a theory-of-change approach will require a process that supports adopters to design their own corresponding version of the intervention.

Adopter views on flexibility versus prescription

Our survey found mixed views among adopters of the right balance between prescription and flexibility. On the one hand, 81% of adopters in Health Foundation programmes said they had made adaptations to the intervention they were adopting, and nearly all of these adopters (94%) said the adaptations had been necessary in order to implement the intervention successfully in their own setting.

Figure 4: Survey of adopters – adaptations during implementation

And in response to a further question (discussed in more detail in Chapter 5) about what would have made the biggest difference in helping them adopt the intervention, adopters tended to favour capability-building over greater specification: more opportunities to share learning, more support to ensure adopter readiness and more training were the most popular options, while providing a more detailed written description of the intervention was the least popular.

On the other hand, adopters emphasised in interviews that there is a balance to be struck; it can be daunting to implement a new intervention with insufficient information and guidance from the innovator. This sentiment also emerged in our survey, where adopters were evenly split on whether specifying lots of detail was a good thing or not. When asked to choose, 49% favoured the statement ‘It is better if the innovator/programme leader sets out lots of detail about the intervention in order to help others implement it, even if this constrains the freedom for adapting it to new settings’. The other 51% chose ‘It is better if the innovator/programme leader does not set out too much detail about the intervention in order to allow others sufficient freedom to adapt it, even if this poses a greater challenge for those implementing it’.

Figure 5: Survey of adopters – optimum level of detail

In a related question, three-quarters of adopters (76%) favoured the statement ‘The innovator is generally the ideal person to lead the initial spread process because they know most about the intervention’, with only a quarter (24%) choosing ‘The innovator is not generally the ideal person to lead the initial spread process because they are too wedded to their original design’.

Figure 6: Survey of adopters – leadership of the initial spread process

So, although adopters clearly value flexibility and the freedom to adapt the intervention to their own context, it would be wrong to conclude they want as little prescription as possible or an environment where anything goes.

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One of the benefits of formative and process evaluations is that they can uncover an intervention’s underlying theory of change and throw light on the role played by various contextual factors in facilitating or hindering an intervention’s success, thereby supporting future replication. However, it is clearly also important for innovators, policymakers and programme leaders – not just evaluators and researchers – to be aware of these approaches to conceptualising and describing interventions in order to codify and spread them more effectively. For example, we would echo others who have advocated greater use of programme theory by innovators and improvers in order to enhance intervention description and promote successful replication.

Despite the fact that it contains rich, practical insights for those engaged in spread and adoption, the majority of discussion of these issues tends to reside in the academic literature on evaluation and implementation science, rather than in literature aimed at practitioners. We believe there is a case for making these approaches to codification a standard part of the innovator’s toolkit alongside more familiar skills such as how to make a pitch or how to design a business case. We would therefore encourage those involved in supporting innovators to scale up their work, and those involved in designing courses for innovators, to incorporate these ideas and approaches to conceptualising and describing interventions.

Case study 1

Shared Haemodialysis Care: From a task-focused intervention to a cultural shift

Haemodialysis is a treatment for people whose kidneys are no longer functioning properly. It involves diverting blood through a machine, where it is filtered to remove waste products and excess fluid, before being returned to the body. Easy access to the blood vessels is necessary. If the treatment is undertaken in a hospital setting it is usually required three times a week. The treatment becomes a major part of people’s lives, with each hospital visit lasting up to four hours, and it can sometimes leave patients feeling powerless and entirely dependent on the health professionals caring for them.

A team working out of Sheffield Teaching Hospitals NHS Foundation Trust formalised an intervention called Shared Haemodialysis Care, which gives hospital dialysis patients the opportunity to take a greater role in their own care. Patients are supported to perform any of the 14 standard tasks involved in haemodialysis, such as checking blood pressure, preparing the dialysis machine and inserting needles. Involving haemodialysis patients in their care has been found to empower them and improve motivation, confidence and wellbeing.

From 2016, with funding from a Health Foundation Scaling Up grant, the Sheffield team developed a programme to spread Shared Haemodialysis Care across 12 dialysis units in England, split into two waves of six. This followed a previous initiative that had defined the intervention, as part of the Health Foundation’s earlier programme Closing the Gap through Changing Relationships (2010–2013), which proved essential in providing pilot data and informing plans for the subsequent Scaling Up project.

The Scaling Up project, which ran from 2016 to 2018, was structured as a quality improvement collaborative. It included supporting materials such as a patient competency handbook (to support patients to carry out the standard haemodialysis tasks), posters and leaflets, as well as vehicles for sharing learning such as events, teleconferences, peer networking and an online knowledge-sharing platform. An additional seven sites, including some in Northern Ireland and Scotland, subsequently joined, bringing the total to 19.

The experience of trying to spread the intervention has led those involved to reflect on what Shared Haemodialysis Care actually consists of, and what the essence of the intervention is. As part of the previous Closing the Gap initiative, the programme leaders had specified that ‘doing’ shared haemodialysis required patients to be carrying out at least seven of the 14 haemodialysis tasks (subsequently revised down to five). However, through testing the intervention in multiple sites, the team has discovered that enhanced patient experience is not necessarily achieved by patients carrying out a certain number of tasks, but rather by asking them, ‘What would you like to learn?’ and helping them achieve their goal.

‘Shared care is engaging patients in any aspect of their own care that’s meaningful to them… it’s a concept, really. It’s not a number of tasks that people do.’ Interview with a member of the programme team

This has led the programme leaders to realise that the core of the intervention actually lies in fostering a cultural shift, one where patients and professionals become genuine partners in delivering care, rather than simply teaching patients to perform a certain number of tasks.

‘… When we first started, we thought we were going to find the answer and go, “Oh, bingo”… “This is easy”… It’s much clearer to me now what the essential ingredients are, but it does change and change over time and just recently I’ve… felt, well, this is huge actually, this is a huge culture change, engaging patients in their own care.’ Interview with a member of the programme team

Reflecting the cultural and relational shift that underpins the intervention, the team found that some of the greatest implementation challenges have involved overcoming resistance from staff, who may feel their professional status is threatened, and among patients, who have sometimes been concerned about the security of nurses’ jobs.

So while the tasks remain central to the technical side of Shared Haemodialysis Care and are useful for measurement, the intervention is now conceptualised primarily as a cultural one. In line with this, the intervention is now characterised in a ‘loose’ way, where the emphasis is on achieving an overall goal – supporting patient involvement to a degree that is meaningful to them – and using a capability-building approach to help adopter teams get there. A major focus of the programme is the use of quality improvement methodology, using small tests of change to enable teams to test the intervention and find their own ways forward; teams are supported in improving different aspects of the intervention using PDSA (Plan, Do, Study, Act) cycles, whether that is one of the 14 haemodialysis tasks or aspects of the environment in which care is delivered.

‘… It’s a very loose intervention. I think there’s always a debate about how much you have to know before you start conducting a trial, and how much iteration there can be… There are quite specific ideas around the delivery of care, but [it’s] possibly less specific about how to actually make those changes within a unit.’ Interview with the programme evaluator

And while teams are provided with materials needed to support patients – such as information about the procedures, the patient competency handbook, and so on – programme leaders have encouraged teams to customise these in order to make them suitable to the local setting.

‘… One of the things we learnt… last time, perhaps, was that ‘dissemination by lamination’ wasn’t the thing to do. It wasn’t going to work. This needs to be locally configured by the teams in a way that means something to them, and it would be very different at each site.’ Interview with the programme leader

All of this has meant that, in practice, the intervention looks very different from site to site, though only occasionally has the innovator had concerns about adopters’ interpretations of the original model, such as when one site stipulated that shared haemodialysis could only be performed by patients on a designated ‘shared care’ bed. As a general rule, local flexibility and customisation of the intervention by adopters has been viewed positively by the programme leaders, as both a central aspect of making the intervention work in new settings, and an important source of learning as the intervention spreads further.

‘To just pick up what was happening at Sheffield and say, “Right, this seems to be working at Sheffield. We’re just going to do exactly the same everywhere,” it would be just trying to bang square pegs into round holes all over the country. I think there’d be a lot of resistance. Things clearly wouldn’t work, and they wouldn’t… necessarily be the priorities of the staff. There might be local difficulties which meant that they’d get discouraged.’ Interview with the programme evaluator

‘You’re getting a different perspective on it all the time, aren’t you? I’ve kind of thought that we were all doing similar things, but it turns out everybody has got their own interpretation of it, and learning about and listening to what they’ve got has helped us to understand what the key ingredients actually are, because there were some that were very successful.’ Interview with a member of the programme team

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