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Background  Lean as a management system has been increasingly adopted in health care settings in an effort to enhance quality, capacity and safety, while simultaneously containing or reducing costs. The Ministry of Health in the province of Saskatchewan, Canada has made a multi-million dollar investment in Lean initiatives to create “better health, better value, better care, and better teams”, affording a unique opportunity to advance our understanding of the way in which Lean philosophy, principles and tools work in health care.    Methods  In order to address the questions, “What changes in leadership practices are associated with the implementation of Lean?” and “When leadership practices change, how do the changed practices contribute to subsequent outcomes?”, we used a qualitative, multi-stage approach to work towards developing an initial realist program theory. We describe the implications of realist assumptions for evaluation of this Lean initiative. Formal theories including Normalization Process Theory, Theories of Double Loop and Organization Leaning and the Theory of Cognitive Dissonance help understand this initial rough program theory. Data collection included: key informant consultation; a stakeholder workshop; documentary review; 26 audiotaped and transcribed interviews with health region personnel; and team discussions.    Results  A set of seven initial hypotheses regarding the manner in which Lean changes leadership practices were developed from our data. We hypothesized that Lean, as implemented in this particular setting, changes leadership practices in the following ways. Lean: a) aligns the aims and objectives of health regions; b) authorizes attention and resources to quality improvement and change management c) provides an integrated set of tools for particular tasks; d) changes leaders’ attitudes or beliefs about appropriate leadership and management styles and behaviors; e) demands increased levels of expertise, accountability and commitment from leaders; f) measures and uses data effectively to identify actual and relevant local problems and the root causes of those problems; and g) creates or supports a ‘learning organization’ culture.    Conclusions  This study has generated initial hypotheses and realist program theory that can form the basis for future evaluation of Lean initiatives. Developing leadership capacity and culture is theorized to be a necessary precursor to other systemic and observable changes arising from Lean initiatives.

Lean and leadership practices: development of an initial realist program theory