More than four years after the ambitious and costly launch of Lean as a province-wide strategy to improve health care quality and promote patient-centredness within healthcare in Saskatchewan, the findings of our survey reveal that major gaps remain in embedding the principles and activities of Lean into everyday health care practice, particularly among nurses and direct care providers. Assessing implementation processes of initiatives such as Lean that are ongoing can serve to target issues that require additional support and attention.
Significant differences in responses were evident between: leaders vs. direct care providers; nurses vs. other health professionals; and providers who reported increased workload as a result of Lean vs. those who did not. Respondents in leadership positions were much more likely to view the implementation and benefits of Lean in a positive manner than were direct care providers. More than 75% of respondents indicated that neither sufficient training nor resources (collective action) had been made available to them for the implementation of Lean. Compared to other health care providers, nurses were more likely to report that Lean increased their workload.
The importance of strong leadership in effecting the cultural changes needed for major health reform has been well-recognized . A wide gulf between the perspectives of leaders and direct care providers was apparent, however, with respect to the constructs of coherence, cognitive participation and reflexive monitoring. Based on the premise that senior leaders “are central to ensuring that Lean will pervade the organization’s management system and [to] provide an example of Lean principles to other personnel” , major investments had been made by the Ministry of Health to ensure that those in health leadership roles were “committed to learning and applying Lean principles” . These investments at the senior leadership level included a rigorous certification program that included didactic and experiential training, including leadership of Lean events, and an opportunity to visit organizations in the U.S. that have long experience with the use of Lean in manufacturing and health care . Given that only 30% of leaders had Lean Leader training, the basis for the strong support shown by leaders for Lean implementation might be better explained by factors other than training alone. A subsequent paper will compare the narrative responses on the survey between leaders and nurses to shed further light on this finding.
Adequate training and resources are foundational to any attempt to transform health care , but the majority of respondents believed these had not been sufficient (Additional file 2: Table S2). Only one quarter of all respondents believed that training had been sufficient and 18% felt that resources had been sufficient to implement Lean. The nature and type of Lean education and participation in Lean activities had interesting implications for the extent of normalization. The majority of respondents reported attending some form of Lean training, but only the variable of having no Lean training at all was associated with (lack of) support for Lean. Kaizen Basics training, which was originally an eight hour introductory program (later scaled back), was intended to provide staff with “a broad overview of Lean principles and methods, so they understand the changes taking place and have a sense of what to expect when they are invited to participate in an improvement event” . This training was attended by three quarters of respondents, but we found no associations between attendance at these sessions and the normalization outcomes examined in this study.
Participation in Lean activities was not associated with the items representing normalization of the Lean approach, in spite of the appeal of providing “hands-on training” as a pedagogical strategy. Our findings contrast with those reported in a recent study examining the introduction of Lean in primary care that noted that the time and intensity of exposure to redesign activities was a positive influence on acceptance by providers .
The anticipated benefits of the implementation of Lean are contingent upon widespread dissemination of the philosophy and processes throughout the entire system, resulting in a major cultural shift that focuses on continuous performance improvement . Critical factors such as perceived lack of ownership and subcultural diversity have been noted to derail attempts at transforming culture when direct care providers are not engaged . As recently noted by Bohmer , “delivery of care is ultimately governed by structure and process at the ward, clinic or practice level”. Lean implementation in health care can be perceived to compromise professional autonomy  and can challenge established professional hierarchy , thereby promoting resistance from key stakeholders required to enact the transformation within the system. McIntosh  noted that the Saskatchewan government failed to appreciate that key factors such as nurses (and physicians) had the independent ability to push back against this initiative in response to top-down implementation and that Lean “cannot be implemented in the top-down, directive manner displayed to date but must accommodate other powerful decision-makers in these sectors” .
Although nurses constitute the largest proportion of licensed health care providers in health care system and their contributions are well-recognized to be pivotal in ensuring patient safety and high-quality care , the perspectives of nurse respondents suggest that there are fundamental differences in the way in which Lean impacts the work of nurses compared to other health professionals, despite similarities in Lean training and participation in activities. Nurses play many critical roles in health care delivery, but globally share concerns about understaffing and inadequate training and support . Nurses have been found to encounter an average of 8.4 work system failures in an 8-h shift, a fact compounded by frequent interruptions of their work [39, 40]. Nurses, compared to physicians, have been found to have less work autonomy, fewer professional development opportunities and fewer options for career change ; nurses are considered the health professionals most exposed to work strain that compromises their physical and psychological well-being [41, 42]. The implications of Lean for nurses’ work, particularly for bedside nurses, requires further thoughtful consideration. A 2014 survey conducted by the Saskatchewan Union of Nurses  reported a statistically significant negative effect of Lean on nurse engagement, usefulness, patient care, time for patient care, workplace issues, availability of supplies, workload, stress and patient care. Our results lend support to the notion of a potential misalignment between the principles and activities of Lean as it had been implemented and the work of clinical nursing, which we are currently investigating in related projects.
Our findings also point to the importance of context in the implementation of Lean. Greater agreement with normalization constructs was noted for non-urban respondents, whose practice involves different demands than larger urban settings and highlights again the importance of context in introducing system-wide change. Context is a critical consideration in the implementation of large-scale interventions [44,45,46,47], with “dynamic elements of context play[ing] a powerful role in shaping participants’ capacity and potential”  Complex interventions that cannot be integrated smoothly within organizational contexts and do not prove to be workable alongside other tasks and duties are unlikely to be normalized . Conversely, adaptations to organizational contexts and tasks and duties may act to facilitate the normalization of interventions such as Lean.
Our results highlight the importance of attending to increased job demands that may result from new interventions. Job demands are aspects of work associated with physical, emotional and cognitive efforts and can translate into job stressors and burn-out if sufficient resources are not available . Perceived increased workload was the only variable to be a significant predictor of negative responses across all five of the models. The implementation of Lean was reported to have different implications for the workload of individual respondents, pointing to the need for leaders to carefully evaluate how interventions may impact upon the workload of their subordinates.
The use of Lean as a large-scale quality improvement strategy has generated controversy on multiple fronts, but evidence on outcomes of Lean implementation is still emerging. Batalden et al.  have questioned the wisdom and appropriateness of implementing quality improvement systems such as Lean which are underpinned by “goods-dominated” logic systems in health care. Improvement strategies that recognize the dynamic environment of health care provision, where goods and services are consumed and produced simultaneously, may be more easily integrated into health care practice.
While our cross-sectional survey findings include the responses of over 1000 health care professionals with a wide range of professional roles, diverse practice settings and geographic locations, we acknowledge the potential for non-response bias resulting from the lower than desired response rates. Because reasons for nonresponse are not known to researchers, one strategy to assess the effect of non-response bias is to analyze the known demographic or organizational characteristics of the population . The demographic profile of respondents in this survey reflects some of the key aspects of the Canadian healthcare workforce. Eighty per cent of all health care providers in Canada are female with an average age of 43 years , although the proportion of nurses was over-represented in this survey, given that registered nurses, licensed practical nurses and registered psychiatric nurses account for slightly more than one-third of all Canadian health care workers . Within the province of Saskatchewan, the 2011 census indicates that one-third of the population resides in a rural location , suggesting that the views of rural health care professionals (41.4%) may have also been over-represented.
Sampling bias was mitigated by having professional associations distribute the invitation to participate to all members, with the exception of Registered Nurses whose members could choose to opt out of surveys. According to Dillman and colleagues , our sample sizes of 734 nurses out of 10,000 possible respondents and 298 HPs out of 1219 possible respondents (excluding physicians) achieved the completed sample size necessary for a ± 5% margin of error in both groups. Strategies to maximize response rates, such as having the associations send reminders , were employed.
The decision to recruit professionals through their licensing bodies for this online survey was made consciously to maintain independence of the survey from those with vested interests in the outcomes of evaluation, such as employers, government or unions. Because exposure to Lean had been widespread throughout Saskatchewan, it was not possible to identify a priori individuals who were actually engaged in Lean implementation versus those who were not in order to better tailor the sampling frame. Potential explanations for the low response rate are myriad - mode of administration, time of year, survey fatigue, email or work overload, and perceived lack of relevance are just a few possibilities. Surveys, as a research strategy, are recognized to be challenged by declining response rates throughout developed countries . In spite of these issues, the survey method allowed us to hear the voices of a broad cross-section of health providers across the province in a manner other research designs would not have.
Over 300 respondents chose not to identify their profession, but went on to complete the remainder of the survey. Their responses were not included in this analysis, but subsequent analysis is planned to compare responses between those who did and did not list their professions. Although Lean reforms were putatively meant as a vehicle to empower both patients and workers , the highly polarized nature of the debate surrounding Lean in health care, an atmosphere of mistrust in health care and fear of reprisal  from employers may have contributed to the reluctance to identify profession on the survey. Hearing the voices and perspectives of health care providers is essential to authentic and sustainable transformation of health care . Creating opportunities to engage direct providers in reform would support achievement of this large-scale transformation.
Low rates of participation on the part of physicians and subsequent exclusion of their perspectives on this topic also limits the conclusions we can draw from this cross-sectional survey. Physicians’ lack of participation was unfortunate, but not surprising, in a professional group recognized to have low survey response rates  and when the regulations of their professional association did not allow for the individual email contacts that were sent to the other groups of health care providers. Physician leadership and engagement has been noted as a strong lever for driving interdisciplinary work forward  and are critical to the successful implementation of health care reforms , making their viewpoints central to assessment of implementation of complex interventions such as Lean. Further work is needed to identify strategies to hear the perspectives of physicians.
The outcomes for this study were selected to reflect the extent to which Lean had been embedded in Saskatchewan health care. While a number of survey instruments were evaluated for use in this study, the NoMAD was selected on the basis of its strong conceptual underpinnings and relevance to our objectives. Currently undergoing psychometric assessment (T. Finch, personal communication, September 2016), the NoMAD requires additional evaluation to guide overall and subscale scoring and interpretation. Because each of the items was considered to have face validity and reflected a key aspect of normalization important for assessment in this study and because scoring directions for the NoMAD are not yet available, the decision was made to conduct the analyses using individual items.