Table 3.

Initial program theory development work: CMO mapping and hypotheses

System level: organizational leadership level (macro or meso)
CMO hypothesis 1: If the values of organizational leaders are congruent with Lean philosophy, and leaders receive Lean leadership training (C), then organizational leaders are more likely to make-sense of, appreciate, and feel motivated to implement Lean (M), in turn, they become Lean messengers, promoting Lean philosophy to clinical leaders of the organization (O).
Context (C1)	Mechanism (M1)	Outcome (O1)	Link to formal theory
The degree of congruency between Lean philosophy and the values of the organizational leaders and the extent of other contextual forces (e.g., political and economic environments). The degree and nature of Lean leadership training for organizational leaders.	The degree of sense-making about how Lean is relevant to an organization. Realization of the fit between the Lean philosophy and the organizations vision and/or mandate. The degree of appreciation of the Lean philosophy from organizational leaders.	The extent of Lean capacity building at top level of an organization. The extent to which organizational leaders are motivated to be “Lean leaders” and “Lean messengers.” Messaging efforts The extent to which organizational leaders use their influence to promote “message” Lean to clinical leadership. *Ripple-effect 01➔ C2 Messaging efforts (outcome of hypothesis 1) becomes a new context (context for hypothesis 2)	NHS SM organization factor 9: fit with the organization’s strategic aims and culture. NPT coherence internalization: understanding the value, benefits, and importance around a set of practices. NPT coherence individual specification: participants need to do things that will help them understand their specific tasks and responsibilities around a set of practices.
CMO hypothesis 2: If there are strong “messaging” efforts from organization leaders in promoting Lean, in a way that resonates with clinical leaders and front-line staff (C), then people are more likely to see value in Lean, gain a shared cohesive understanding of Lean benefits throughout the organization (M), thus creating increased buy-in and engagement to Lean efforts(O).
Context (C2)	Mechanism (M2)	Outcome (O2)	Link to formal theory
*Ripple-effect 01➔ C2 The degree of messaging about the value and purpose of Lean by organizational leaders to the wider organization. The degree of congruency between Lean philosophy and personal-level reasoning of the clinical leaders and front-line healthcare providers. The degree of credible and respected senior leaders are seen as promoting and investing their own time in Lean efforts.	The nature of how organizational leaders promote “message” Lean (i.e., “you have to do it,” or “that is a new mandate”) (resource) will trigger a degree of receptivity and value (positively or negatively) by the clinical leaders and front-line staff.	The degree of shared understanding about Lean benefits. The degree of buy-in, uptake, and engagement for doing Lean activities by organizational leaders, clinical leaders, and front-line staff.	NPT coherence communal specification: sense-making relies on people working together to build a shared understanding of the aims, objectives, and expected benefits of a set of practices. NPT cognitive participation initiation: when a set of practices are new or modified, a core problem is whether or not key participants are working to drive them forward. NHS SM staff factor 7: senior leadership engagement.
CMO hypothesis 3: If front-line staff believe that Lean is more than the “latest quality improvement trend” in a context with good staff morale and continued resources for Lean efforts (C), then front-line staff will have greater trust and belief in the long-term benefits of Lean (M), resulting in improved Lean implementation and positive influences for a continuous quality improvement culture (O).
Context 3 (C3)	Mechanism 3 (M3)	Outcome 3 (O3)	Link to formal theory
The degree of staff turnover, staff morale, type of unit culture, and level of innovation fatigue. The extent of time, continual resources (e.g., staff, facilities, equipment, policies, and procedures), and staff capacity (training, audit and feedback, communication channels, senior leadership support) provided for sustainability.	The extent to which stakeholders in the organization believe that Lean is there for the long-term and not just the “latest quality improvement trend” (response). The degree of trust built by front-line staff in the Lean approach, the changes taking place, and the support from leadership.	Inefficiencies or efficiencies in Lean implementation. Increased workload (i.e., stress, burnout) or supported workload (i.e., reduced stress, burnout). Frustration or satisfaction with Lean efforts. Facilitated or hindered culture for continuous quality improvement.	NHS SM organization factor 10: infrastructure for sustainability.
System level: clinical leadership level (meso)
CMO hypothesis 4: If there is congruency between Lean philosophy and the personal-level reasoning of the clinical leaders and front-line healthcare providers, and clinical leaders and front-line healthcare providers receive Lean leadership training (C), then Lean is more likely to make sense and fit within the context (M), in turn, motivating clinical leaders to become Lean messengers, promoting Lean philosophy to front-line staff (O).
Context 4 (C4)	Mechanism 4 (M4)	Outcome 4 (O4)	Link to formal theories
The degree of congruency between Lean philosophy and personal-level reasoning of the clinical leaders and front-line healthcare providers. The degree of Lean training received by clinical leaders and front-line healthcare providers.	The degree of sense-making process to understand how Lean is relevant for practice and patient care. Realization of the extent in which Lean philosophy fits to their particular health care context or mandate. The degree of appreciation of Lean philosophy from clinical leaders and front-line healthcare providers.	The extent to which clinical leaders are motivated to be “Lean leaders” and “Lean messengers.” The extent to which clinical leaders use their influence to promote “message” Lean to front-line staff. *CMO1 and CMO4 are about messaging efforts; however, the nature of the messaging may be different at different levels of systems	NPT coherence internalization: understanding value, benefits, and importance around a set of practices. NPT coherence individual specification: participants need to do things that will help them understand their specific tasks and responsibilities around a set of practices.
CMO hypothesis 5: In contexts where there are positive relationships between the clinical leader and front-line staff, and clinical leaders play an active role in Lean implementation (C), then front-line staff are more likely to believe in their leader’s commitment to Lean, engage in Lean activities themselves (M), leading to buy in and continued support of Lean efforts (O).
Context (C5)	Mechanism (M5)	Outcome (O5)	Link to formal theories
Competing demands on clinical leader and their workload, affecting time commitment Lean. Positive or negative relationships (e.g., trust, communication) between clinical leader andfront-line staff. Leadership approach used by clinical leaders’ (hierarchical versus distributive). The degree that clinical leaders play active role in promoting, participating, and investing own time in Lean assessment and improvement activities.	The extent to which front-line staff believe in managers’ commitment to Lean. The degree of front-line staff feeling engaged.	The extent of continued buy-in and engagement by front-line staff. The degree of continued input and support of Lean efforts and use of Lean activities. *Ripple-effect O5➔C6 engagement(outcome of hypothesis 5) becomes a new context (context for hypothesis 6).	NHS SM staff factor 8: clinical leadership engagement.
System level: front-line healthcare provider level (micro or meso)
CMO hypothesis 6: If contexts exist where staff are engaged, have received Lean training and the opportunity to lead Lean efforts (C), then staff are more likely to become empowered to use Lean (M), and can then see beneficial outcomes from Lean, have improved satisfaction leading to increased sustained use of Lean efforts(O).
Context 6 (C6)	Mechanism 6 (M6)	Outcome 6 (O6)	Link to formal theories
*Ripple-effect 05➔ C6 Engaged staff. Core values of front-line healthcare providers that align or impede their motivation; pre-existing levels of feeling empowered; pre-existing levels of work satisfaction; pre-existing attitude and buy-in of clinical leader; and pre-existing relationships between clinical leader and front-line healthcare providers. Level of morale in the department. Silo or collaborative nature of the system, degree of relationships and collaboration between various stakeholder professions. The degree of Lean training that front-line staff receive and are given the opportunity to drive or lead Lean efforts at the unit level.	The degree to which front-line staffs’ ideas are considered, and opportunities that they are given to test these ideas and their belief that Lean is a better way of doing things and should be sustained. The degree of engagement triggers empowerment of front-line staff in Lean efforts (co-production of Lean customization to local contexts with front-line healthcare providers).	The extent to which benefits to patients, staff, and the organization due to Lean implementation are visible; leading to increased satisfaction and increased sustainability of Lean activities over time. Level of satisfaction, motivation, and commitment by staff. The degree of sustained Lean efforts.	NPT Cognitive participation enrollment: participants may need to reorganize themselves and others in order to collectively contribute to work involved in new practices. This is complex work that may involve rethinking individual and group relationships between people and things. From MHS SM staff factor 5: staff involvement and training to sustain the process. NHS SM staff factor 6: staff attitudes towards sustaining the change. NPT cognitive participation: legitimation: ensuring that other participants believe it is right for them to be involved and that they can make a valid contribution to it.
CMO hypothesis 7: If there are contexts where there are visible benefits from Lean implementation, and a collaborative multi-disciplinary team approach to Lean implementation, with audit and feedback of changes (C), this triggers staff motivation and empowerment to sustain Lean efforts (M), then Lean efforts become integrated and sustained in practice (O).
Context 7 (C7)	Mechanism 7 (M7)	Outcome 7 (O7)	Link to formal theories
The extent to which the benefits to patients, staff, and the organization due to Lean implementation are visible. The degree of collaborative team building and multi-disciplinary team approach to Lean activities.	The degree of “healthy” audit and feedback loops, communication of outcomes. The degree staff feel heard, believe in Lean outcomes, and feel engaged and empowered to sustain Lean efforts.	The extent of Lean integration to everyday practice. The degree of sustained Lean efforts.	NHS SM process factor 2: credibility of the benefits. NHS SM process factor 1: benefits beyond helping patient.