In complexity-informed approaches to implementation it is not enough to leverage facilitators or eliminate barriers; the focus of implementation shifts from the fidelity of the intervention to its effective adaptation [37, 38]. Thus, Hawe et al. [34] argue that, rather than standardizing aspects of an intervention, despite some essential functions being replicable, the form of an intervention should be varied as required by context [39]. This type of CAS-oriented approach is particularly important when attempting to scale-up or spread interventions previously found to be effective in one, or a limited number of sites, to the whole system. Improvement structures may thus involve tailoring to context and harnessing the self-organizing and sense-making capacities of local agents [38]. Indeed, working with bottom-up local stakeholders is paramount to adapting an intervention to their practices, facilitating ways to get them onboard with the intervention, in piloting it, in reflecting on progress amongst stakeholders, and in providing feedback to participants to help them embrace implementation iteratively over time. In such a messy, complex set of circumstances, it makes less and less sense to think of ‘knowledge producers’ as conceptually distinct from ‘knowledge users’ [40] when indeed they are inter-related.
Chambers et al. [41] suggest that a further consideration is the sustainability of an intervention. Sustainable change requires the ongoing adaptation of an intervention to multilevel contexts, with expectations for lasting improvement rather than diminishing outcomes over time. In this regard, implementation in the hands of complexity theorists is increasingly recognized as an iterative and recursive, long-term process rather than a linear one [35]. Complexity science thereby encourages not only attention to the context of an intervention, but also to the interactions between elements and the consequences of this intervention for the system. The implementation method of choice will not necessarily be the randomized clinical trial or experimental design, but will be the iterative and responsive, more ecology-aware, social science-informed approaches such as those envisaged by longer term realist designs or process evaluation of implementation efforts [32, 42].
Despite the potential utility in harnessing complexity science for implementation, until now, not much conjoining of the two, either theoretically or empirically, has occurred. There have been intermittent examples of using a complex systems framework to inform clinical transformation, as when Best et al. [43] applied complexity thinking in the implementation of new clinical guidelines in British Columbia, Canada. They noted that the implementation of the guidelines required the ability to tailor system-level recommendations to local context. In another promising turn, there have been more recent attempts to explicitly challenge the pipeline view of knowledge translation, with Kitson et al. [40] undergoing an iterative process to develop a complexity-informed model that highlighted the connections between phases previously conceptualized as discrete such as problem identification and knowledge synthesis. This model (Fig. 3) in essence highlights the key issues to be considered, including the distinctions and connections between knowledge users and knowledge generators, the importance of arriving at good definitions for the gaps, and co-producing new knowledge and contextualizing it, as well as implementation and evaluation.
That said, a recent systematic review by Brainard et al. [29] found that health interventions using complexity science approaches have done so inconsistently, for example, often not incorporating an evaluation component or failing to analyze the potential, unintended consequences of the intervention. Nevertheless, this recent work has suggested the value of complexity science in creating large-scale system transformation, including sensitizing stakeholders to the natural properties of CAS that might then be leveraged by emphasizing distributed leadership, networks, sense-making, and feedback loops [38, 42, 44].
Thus, thinking is altering, at least amongst some leading theorists and researchers, and we are now more advanced in understanding systems change, with new models replacing the pipeline approach. Having established the juxtaposition of complexity and implementation, we now examine how some of these ideas have been leveraged to accomplish large-scale system transformations in Australia, exploiting the combined complexity–implementation paradigm.
Case 1: Rapid response systems and the New South Wales ‘Between the Flags’ (BtF) program
Since the 1980s, there has been an increasing focus on patient safety and quality of care in hospitals internationally, as well as in Australia. Many initiatives have been designed and conducted, but there is limited evidence to show that systems-level improvement has been achieved [45]. One notable exception has been the implementation of rapid response systems (RRSs), in which specialized teams attend to inpatients whose deteriorating condition has been identified through reference to a set of defined criteria. RRSs have had a significant impact on patient safety, with evidence that they have reduced inpatient mortality and cardiac arrests by about one-third [46, 47]. Yet, RRSs illustrate that even a relatively simple and intuitively sound intervention can struggle to be adopted into the CAS of healthcare, where history, path-dependence, and context, especially social influences, can have substantial effects.
RRSs were a bottom-up initiative, coming from self-organizing clinicians who recognized that the deterioration of a patient’s condition could easily go undetected until it was too late to reverse. In their chapter outlining the history of the RRS in Australia, Braithwaite et al. [48] described the strong influence of context on the adoption of this intervention. Attempts in the early 1980s to introduce a Medical Emergency Team (MET), the precursor of RRSs, failed in a large London teaching hospital due to inertia and unconcealed opposition, but succeeded in a smaller, more recently established teaching hospital in Liverpool, New South Wales (NSW), Australia. Barriers and confounders of the London adoption were identified as the entrenched medical and management hierarchies, and an onerous bureaucracy. Perhaps more significantly, there were strongly deterministic path dependencies, represented by a pervasive belief in medical culture that patients were ‘owned’ by their admitting doctor, a belief that clouded who was authorized to treat and where accountability for patients lay. In Liverpool, innovation was more accepted, medical autonomy less jealously guarded, and there was a culture of readiness for experimentation and change.
The notion of the MET began to be taken up in other countries without active implementation mechanisms. Through deceptively simple knowledge dissemination means, such as articles in low-impact publications or conference presentations, and clinical networks and informal discussions, clinicians assessed their needs and adopted METs, tentatively at first, into their own context [49]. This highlights that, while an implementation plan is typically necessary for system-wide change, bottom-up, knowledge dissemination approaches can facilitate attitude change. That is, interconnected clinicians communicate locally and across the boundaries of their systems, influencing one another in their own and other environments, and self-organizing their practices in novel ways based on this new knowledge. This type of on-the-ground interactivity, whereby clinicians felt ownership of the incremental changes rather than having it imposed on them, made possible the eventual system-wide transformation.
The tipping point for dissemination of many large-scale, system-wide changes has been in the form of a perturbation to the system, such as the SARS epidemic in Canada or the tragic death of teenager Vanessa Anderson in NSW, Australia [50]. This latter case, deemed a preventable death caused by failure to recognize the teenager’s deteriorating condition, led to the BtF program, which flipped the bottom-up approach of previous MET implementations into a whole-of-system approach with concerted support from multiple sectors, including government [51].
BtF alludes to the Australian Surf Life Saving model that offers surveillance of bathers on popular surf beaches, who swim between two yellow and red flags, planted conspicuously in the sand. Surf Life Saving Australia estimate that they rescue 35 swimmers under threat of drowning and intervene in 913 other cases per hour on a typical summer’s day using this simple model. The BtF program used the imagery of a safe zone to redesign and standardize vital sign charts across the hospital system [52], with upper and lower unsafe limits reflecting the colors of the flags (yellow as early deterioration warning sign, red as late). Vital sign readings that were in the yellow zones triggered an urgent clinical review and the red triggered intervention by the specialized MET. The work was led by the Clinical Excellence Commission, an agency set up to oversee quality and safety across NSW healthcare.
For a linear thinker, this highly effective intervention would seem easy to implement with predictable, positive outcomes. However, the issue is not the relative simplicity of the model of monitoring a patient’s vital signs with a standardized form and the use of a MET intervention to ‘rescue’ them when straying into the unsafe yellow or red zones, but rather the complexity of the system into which the intervention is being introduced. BtF was implemented into NSW’s 225 public hospitals in January 2010. Many had already adopted RRS-style models in idiosyncratic ways. For its successful introduction, the Clinical Excellence Commission recognized the complexity of the system, including the independence and interdependence of agents, the presence of positive and negative social influences, and the generation of possible adverse knock-on effects. Accordingly, the program had five elements, namely governance, standard calling criteria (the red and yellow flags), a two-tiered RRS in each facility, an associated education program, and an evaluation plan. Governance mechanisms supported by well-staffed and supportive advisory boards, alongside a State-wide policy directive, held hospitals to an implementation schedule with scope for local flexibility and promulgated clearly defined roles and expectations. The standard calling criteria were incorporated into the new, mandatory NSW standard observation charts with a simple track-and-trigger design.
The two-tiered RRS response was developed to prevent the problem of false positives that could overwhelm the system, as well as false negatives that would result in failure to rescue [53]. Both types of errors could undermine the credibility of the program and lead to poor clinical compliance on the wards. BtF designers also understood the challenge of embedded social influences such as medical hierarchies and clinical tribalism [48]. The program diffused authority for intervention from medical consultants to any health professional detecting a patient outside the flags.
Following the extensive preparation period, uptake was rapid. Clinician fears of ‘extra paperwork’ were shown to be unfounded and the empowerment of nursing and junior medical staff to initiate a rescue reinforced its utility. Evaluation data, as it was collected, showed consistent falls in cardiac arrest and mortality rates (cardiac arrest by 42%; P < 0.05) and the rapid response rate increased by 135.9% (P < 0.05) [53].
Thus, BtF showed that successful implementation requires an understanding of the complex system into which even ‘simple’ interventions are being introduced. CAS theory can help to unpack the multi-dimensional contextual issues and address them with multifaceted solutions prior to the roll out of such a large-scale intervention.
Case 2: New nation-wide safety and quality standards
In 2013, systems-level reform of the Australian accreditation model occurred with the implementation of the Australian Health Service Safety and Quality Accreditation Scheme. A critical component of the scheme, overseen by the Australian Commission on Safety and Quality in Health Care (ACSQHC), has been the development and application of new National Safety and Quality Health Service Standards (NSQHSS). The development of the 10 standards represented an important element in the safety and quality of care architecture of the health system. The standards cover areas including governance arrangements, partnerships with consumers, and eight key clinical areas of health service operation (Box 1).
Each standard has a set of criteria, and for each criterion, a series of actions are required to be fulfilled. To achieve accreditation status, all core actions for health services must be demonstrated. The work has drawn international interest and is informing efforts to improve the safety and quality of healthcare in other countries [54].
The Australian Health Service Safety and Quality Accreditation Scheme has been enacted with an appreciation of the CAS features of healthcare, and the implementation process was dynamically modified in response to the multifarious and interlinked institutions, groups, and structural arrangements that can hinder or facilitate implementation, and must ultimately adopt the model. International experience shows that the inherent complexity of healthcare and in-built resistance, regardless of country, can be an impediment to adoption of such systems-level reforms [55,56,57,58].
To respond to this challenging environment, the ACSQHC undertook extensive consultation activities with the aim of determining appropriate methods of utilizing existing government legislative powers to support the reform measures, to align the views and actions of diverse groups, and to foster distributed leadership across reform elements [59,60,61]. In total, the ACSQHC arranged 227 separate consultation activities involving over 1000 stakeholders spanning the breadth of the Australian health system. The perceived importance of these activities for maximizing the effectiveness of the scheme reinforces the fundamental role of continued stakeholder engagement as a necessary facilitator of national reform [54]. The need for effective stakeholder engagement has also been identified in relation to other systems-level healthcare reforms internationally [62, 63]. The ACSQHC continues to undertake consultation with health services to facilitate effective implementation of the scheme and further revisions have been made to the standards over time (in 2016 and again in 2017), assuring their continued relevance [59,60,61].
Despite the nature of the standards’ implementation as seemingly a top-down, government-sponsored, homogeneous model, NSQHSS have been well received by the system due to the clinical focus of most of the standards. This was considered crucial for increasing the engagement of health professionals and board members in health and quality improvement activities [54]. Participants proposed that the NSQHSS provided, for the first time, a clearly evidenced-oriented, coherent, and integrated national framework. The scheme separated and clarified responsibilities of different actors for accreditation standards development, surveying processes and decisions, and regulation and policy matters. As a result, the initiative has been seen to mobilize expectations, integrate roles and responsibilities, and promote transparency [54].
From the outset, two potential risks to the credibility of and satisfaction with the scheme at the health system level were raised, namely the application of the NSQHSS across varied settings and the reliability of assessments by different accrediting agencies. The application of the NSQHSS across settings was discussed in the consultations as a point of credibility – that the same expectations would be applied to different health services, in different settings, was considered vital to the government’s interests in equity [54].
Four strategies to facilitate implementation, to reinforce the potential benefits, and to overcome the substantial challenges facing the scheme emerged (Fig. 4). The widespread ACSQHC consultation activities were seen to facilitate implementation by providing a common platform for knowledge transfer, encouraging widespread stakeholder engagement. At those meetings, high-quality, accessible educational activities and materials were provided. Feedback loops in the form of regular review of the program and updates to the system using progress data helped maintain momentum.