Agile Stepwise Quality Improvement: Enhancing change and learning in complex and volatile healthcare contexts

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Although limitations in improvement efforts are well known, transforming healthcare organisations remains a challenge. Practical use of quality improvement (QI) approaches, including the Plan-Do-Study-Act cycle, have revealed several shortcomings, often hindered by insufficient resources and lack of supportive context. Yet, even in volatile organisational contexts, the need for improvement and high-quality care remains critical. To be effective, QI must develop greater resilience in the face of unfavourable conditions. This study aimed to explore whether, and how, a new, more agile QI approach could strengthen QI efforts and foster learning within an obstetric unit, despite contextual instability. Methods. This case study of a large obstetric unit, with two geographically dispersed labour wards, employed an in-depth longitudinal process approach. It examined contextual factors, the implementation process, perceived impact, and the sustainability of the new approach. Conventional content analysis was used to analyse qualitative data from repeated interviews with key actors, organisational documents, field notes, and a qualitative questionnaire. Results. The implementation spanned nearly two years. Despite occurring during a volatile period with high staff and managerial turnover, the Agile Stepwise QI approach had a positive impact on QI within the unit. It supported change efforts, reduced feelings of failure when progress was difficult, and contributed to a more positive and effective perception of QI work. Testing before implementation became increasingly common. Although scaling tested solutions remained challenging, having team members with decision-making authority facilitated the process. Involving managers and senior staff was difficult due to high turnover, which affected sustainability. Nevertheless, the approach was still in use at one site 3.5 years after its initial implementation. Conclusions . Agile Stepwise QI positively influenced improvement work in the obstetric unit, even under volatile organisational conditions. Key features - open problem analysis, creative idea generation, agile small-scale testing, stepwise scaling, and interprofessional collaboration - proved valuable for driving change. The approach fostered learning at individual, team, and organisational levels, indicating a positive impact on overall improvement and learning capability. However, sustainability depended on the continuity of key staff, including QI team members, support functions and managers. Article classification: Research paper Quality improvement Organisational learning Agile improvement Implementation Organisational agility Maternity care Figures Figure 1 Figure 2 Figure 3 Figure 4 Introduction Over the past 20–30 years, the Swedish healthcare system has faced significant challenges due to advancements in medical technology, digitalisation, accelerating scientific development, demographic changes, a pandemic, and demands for efficiency and patient participation. These changes require new ways of organising and developing care, including co-created care assisted by technology and artificial intelligence. To thrive, healthcare organisations must enhance their learning capacity, focusing on improvement and development, reflective conversation, and understanding of complexity [ 1 , 2 ]. Despite the use of various structured approaches to change based on quality improvement (QI) [e.g., 3], achieving and sustaining improvement in healthcare is challenging. Challenges when working with improvement in healthcare A central challenge in healthcare improvement lie in establishing the legitimacy and urgency of a problem, demonstrating the value of a proposed solution and managing unrealistic ambitions, to ensure sustainable change [ 4 ]. Other challenges include overcoming inherent obstacles in organisational context and cultures, limitation in capacities, lack of staff engagement, leadership issues, incentivising participation, ensuring effective monitoring, mitigating unintended consequences, and securing long-term sustainability [ 4 ]. The Plan-do-study-act (PDSA) cycle, a core methodology in healthcare QI [ 5 ], provides a structure for experimental learning when iteratively testing ideas and solutions to problems. Such iterative, successive tests of ideas and hypotheses, analyses of effects and adaptation or change of initial ideas are central to QI approaches such as Lean management, Six sigma, and Total quality management [e.g., 6−8]. Studies have revealed several shortcomings in the use of QI and the PDSA cycle. System-wide implementation of QI-approaches in healthcare, such as Lean management is rare; the use of single techniques and tools in isolated organisational units is more common [ 6 ]. In a systematic review of the application of PDSA in healthcare, less than half of the studies met the minimum requirements of the method [ 9 ]. Highlighted challenges concerning PDSA include the complexity in its practical use [ 9 , 10 ], its appropriateness to address challenges of improving healthcare [ 4 ], and a lack of fidelity in its application sometimes with negative effects on learning [ 9 ]. Furthermore, the resources and the supportive context required for the approach to be successful are often underestimated [ 11 ]. Key failure modes in executing the Plan-Do-Study-Act steps have been identified [11, page 150]. These include failing to implement the QI intervention as intended [ 12 , 13 ], to collect data as planned [ 12 , 13 ], to capture unanticipated learning [ 12 , 14 , 15 ] and continuing with the ‘Do’ phase despite clear failure or serious negative side effects [ 16 ]. In the ‘Study’ phase common failures include not conducting the study [ 9 ], not following the study plan, and not communicating what has been learned [ 12 , 17 ]. In the ‘Act’ phase frequent failures include neglecting to engage in ‘double loop learning’ [ 14 , 18 ], failing to question aims and assumptions based on learnings and moving too quickly from small-scale tests to full-scale implementation and sustainment [ 9 ]. Additional contextual barriers include limited time for conducting tests, shifting or competing organisational priorities, and staff turnover [ 19 ]. Contextual barriers risk undermining the iterative foundation of the PDSA cycle, which is designed to support more effective and sustainable improvements. Conflicting objectives and strategic ambitions, e.g., maintaining quality, controlling costs, ensuring adequate staffing, complying with regulations, and fulfilling broader societal goals, can exert a significant influence on QI, innovation and organisational change [ 19 ]. Although such contextual conditions are inherent to organisational life, particularly within healthcare, improvements still need to take place. However, there is limited consensus on how to consider the potential effects of outer or inner contextual changes on QI and change processes, as well as how to navigate the dynamic tensions they produce. Several suggestions to improve QI approaches and enhance successful innovations and improvements in healthcare have been discussed by scientists. Reed and Card [ 11 ] emphasize the need to understand how to manage emergent learning while engaging diverse stakeholder groups to ensure the success of QI initiatives. Collaborative approaches between healthcare actors and researchers have been suggested as a way to enhance organisational learning [ 11 , 20 ]. Embracing multiple short and long-term objectives, while recognizing that all change occurs within an evolving and dynamic context, is essential for effective QI [ 19 ]. Cultivating a creative and innovative organisational culture that supports the exploration of solutions to core needs is considered important for addressing emergent challenges in healthcare settings [21 Promoting creativity and innovation in healthcare organisations through structured processes of problem analyses, idea generations, solution development, testing, and adaptation, is widely recognized as essential for driving change [e.g., 21]. At the organisational or unit level, innovative problem-solving processes are supported by adequate resources, a culture that tolerates errors and risk-taking, clearly defined objectives, a climate that values new ideas and collaboration, motivated and supportive leadership, and a management approach that prioritizes understanding individual behaviours and needs [ 21 ]. Improvement teams benefit from using participatory decision-making processes and methods that aid the development of new ideas as well as having sufficient time for reflection and problem-solving [ 21 ]. Effective coordination and collaboration within and across teams, autonomy in the use of dedicated resources, and sound project management practices are recognized as important enablers for improvement. Collaboration is also vital for engaging colleagues and communities, that hold multidisciplinary knowledge, while fostering interaction and promoting the sharing of knowledge and resources [ 22 ]. Organisational attributes that contribute to learning and improvement capabilities include leadership commitment, an open organisational culture, and space for team development [ 23 ]. Team development is facilitated by attention to motivation, education and training, capacity management, team member behaviours, team balance, and collaboration. These areas focus on how to enhance QI work, but they also indicate why QI efforts may fail to reach their full potential in healthcare. At the system level, continuous QI has primarily focused on the implementation of methods and techniques. Even successful organisations often spend substantial time on reactive problem-solving rather than proactively preventing or addressing issues at an early stage [ 24 ]. Numerous cultural, technical, structural, and strategic barriers to the full realization of continuous QI in healthcare still exists [ 25 ]. A frequently cited reason for the relatively limited success of continuous QI is the lack of emphasis on organisational learning, underscoring the need to strengthen the connection between organisational learning and QI [e.g., 26−28]. Organisational learning, agility and quality improvement Learning is an important feature of both creative and innovative processes and the PDSA cycle. To address current and future challenges, healthcare organisations and their employees must improve their ability to combine continuous QI with organisational learning [ 2 , 29 ]. A recent review [ 29 ] identified key elements of successful interventions for strengthening continuous organisational improvement and learning capability. These included engaged managers applying strategies and structured processes that supports improvement and learning by involving experimental learning. In addition, external training and guidance aids the development of internal knowledge, skills and confidence, while conditions, fostering autonomy, accountability and psychological safety empower individuals and teams to engage in improvement and learning [ 29 ]. However, more knowledge is still needed regarding how contextual factors influences the application of QI and how it can improve organisational learning and innovation [e.g., 30]. Organisational agility has emerged as a key concept in organisational learning, especially in dynamic environments [ 31 ]. The relationship between agile approaches and lean management, rooted in QI has been debated [ 32 ]. There is less consensus on how to define and describe organisational agility, but the framework of Wendler and colleagues [ 33 , 34 ] provide some understanding for its application in dynamic healthcare contexts. Organisational agility’s three components are structure, people and prerequisites. An organisation possessing organisational agility has structures that aid fast and flexible responses to change. Prerequisites consist of adequate organisational values and a supportive infrastructure, while people agility refers to the capabilities of staff and managers to deal with change and translate organisational agility into action. Learning is a key aspect of people agility and involves engaging in research and innovation, reflecting on experiences, and obtaining feedback on improvement efforts [ 35 ]. This aligns with the importance of collaboration when working with QI, i.e., ensuring that colleagues and communities with multidisciplinary knowledge work together, valuing interaction and the sharing of knowledge and resources [ 22 ]. One benefit of increased organisational learning is improved problem solving, which can ultimately lead to better organisational performance [36−38]. Organisational learning and continuous QI can mutually reinforce each other, for example, when teams go through multiple improvement cycles, processing experiences and knowledge, generating learnings, new knowledge, new ideas and solutions [ 23 ]. Building organisational capability for continuous improvement and learning involves strengthening these abilities in its members, which in turn supports changes in behaviour and work practices. Behavioural changes require capacity and motivation as well as supportive contextual opportunities [e.g. 39]. Although the benefits of QI and organisational learning for driving organisational change are well recognised, the time and effort required for double loop learning [ 14 , 18 ] often go overlooked in practice and receive limited attention in the literature. The Agile Stepwise Quality Improvement approach To address some of the practical challenges of implementing QI in dynamic healthcare settings, and to support the development of continuous organisational improvement and learning capacity and organisational agility [ 2 , 29 ], we developed a QI approach, Agile Stepwise QI, that integrates elements from multiple fields besides QI: organisational learning, organisational agility, behavioural psychology, implementation science, innovation and agile project management. In this study, Agile Stepwise QI was pilot tested at two labour wards in a large Swedish hospital. The process begins with an initial problem analysis of chosen challenges or issues, followed by a brainstorming of ideas. The latter involves identifying existing or needed motivation, capabilities, and opportunities as well as discussing the consequences of the suggested interventions, in line with the COM-B model for behavioural changes [ 39 ]. Small agile sprints, or test-loops, are inspired by agile project management and the Scrum framework [e.g., 40, 41], which use frequent feedback and collaborative decision-making when incrementally developing innovations and new products. These relatively small and quick tests of ideas using multiple feedback-loops, and fostering a collaborative environment [ 41 ], enhance learning and may address some of the identified shortcomings in the practice of the PDSA cycle. Breaking down what to test and simplifying incremental tests-loops is expected to make QI manageable. This approach helps ensure that progress remains achievable even when time and resources are limited during high workloads and understaffing, or in volatile periods. Slowing down a change process and testing smaller aspects of an idea or a solution, then building on the results, can be easier during such circumstances. The process of creative idea generation, experimentation and further adaptation, development, and new tests (or abandonment of an idea) is all seen as a natural part of a change process. Agile Stepwise QI places a strong emphasis on organisational and individual learning processes and their crucial role in behavioural and organisational change. More profound changes, requiring double loop learning, are often necessary when changing work approaches, and routines in organisations. The approach support staff in addressing challenges and problems and seeks to promote informal learning during work hours, which constitutes the primary form of workplace learning [e.g., 42−44]. Achieving both informal and more deliberate planned non-formal workplace learning aligns with the continuous learning expected in agile organisations [ 31 ]. To facilitate testing and support future full-scale implementation, the approach is divided into three phases: Phase 1 Ingroup and self-testing, Phase 2 Enlarged testing, and Phase 3 Scaling up. The improvement team and/or managers responsible for the change idea can revert to an earlier phase, if necessary (see Table 1 ). While the approach builds on iterative loops, the stepwise procedure is inspired by incremental change processes, in which the initial phases simplify the subsequent ones, thereby enhancing spread and sustainability (See Fig. 1 ). Table 1 Overview of the three phases in Agile Stepwise QI Phase 1 Ingroup and self-testing Description : Phase 1 consists of problem analysis, prioritization and development of improvement ideas, followed by small-scale, agile and iterative tests, carried out directly by the QI team during their work shifts. Rationale : Lowering the threshold for hands-on testing and enabling direct feedback can save both time and energy while also creating momentum for change initiatives [e.g., 45]. To achieve this, the team needs either a high degree of autonomy or access to managers who can make swift and relevant decisions. Phase 2 Enlarged testing Description : In Phase 2 the scope of testing is expanded by involving other colleagues as testers and change agents. These colleagues test the ideas during their work shifts and provide feedback to the team. The improvement team prepares the necessary information for the testers and organises the feedback sessions. Rationale : It is beneficial to begin with motivated and interested colleagues identified as early adopters [ 46 ]. Proper preparation is crucial for new testers to understand the rationale behind the change idea, its development, and its intended improvements. Feedback sessions are necessary to support learning and adaptation. Phase 3 Scaling up Description : Phase 3 involves scaling interventions that have been repeatedly tested, refined, and proven to work well. Scaling-up can encompass smaller or larger parts of the unit or organisation and involve managers and other key actors. Rationale : As in previous phases, it is important to learn by collecting feedback and suggestions, and to be ready to discuss, refine, adapt or further develop the intervention to suit new conditions and users. Support from managers and decision-makers is essential for successful implementation, follow-ups and potential adaptations [e.g., 23,47]. Individual or group reflections on feedback is central to iterative testing. To fully engage in learning during test cycles, repeated reflection sessions - where actions and outcomes are analysed – are essential. The approach includes two types of meta-reflection that should be carried out regularly: 1) Retrospective reflection (‘retrospect’) on the original problem analysis and how it has been addressed over time; and 2) Reflection on how the QI team and colleagues have engaged in the improvement process over time to identify lessons learned. The latter aims to strengthen organisational learning at the ward or unit level and promote sustainability, particularly when QI team members are replaced. Some external support (e.g., from an internal support function) is also needed to aid the QI team. The purpose of the study was to investigate whether, and how, an Agile Stepwise QI approach could enhance organisational improvement and learning in a large obstetric unit with two labour wards, despite contextual volatility. Three specific research questions were addressed: What impact does the approach have at individual, team and unit levels? What features of Agile Stepwise QI influence improvement and learning and how? What are the contextual conditions, barriers, and facilitators affecting implementation and use of the approach? Methods This case study of a large obstetric unit with two labour wards uses an in-depth, longitudinal process approach [ 48 ]. It is action-oriented and incorporates features of action research [ 49 , 50 ], as the approach and the implementation were adapted and refined over time. Such an adaptive strategy can better handle unforeseen events and has been suggested as feasible in fragmented organisational settings where the number of involved actors, potential relationships, and level of complexity are high [ 51 ]. Accordingly, the approach initially developed by two researchers (MEN and ME) was further refined and adapted to align with clinical practice during the initial implementation period. Features of process evaluation [ 52 , 53 ] were used, and over time, data about contextual features, the implementation process, and experiences and impact of the intervention on individual, group, and organisational levels were collected. The Agile Stepwise QI approach draws on knowledge from multiple disciplines, each with its own scientific traditions, concepts and models. In this study, we use the term ‘impact’ to refer to the perceived influence and effects of applying the new approach, based on subjective reports and observations. This usage may differ from how the term is defined or applied in other studies and models. Case characteristics Maternity care in Sweden is publicly funded and free of charge. Most women in Sweden give birth in physician-led obstetric units within hospitals. Currently, a few of the 21 Swedish regions responsible for providing healthcare offer alternative birth options with continuity of care throughout pregnancy, labour, and the postnatal period. Midwives are the primary care providers during labour and birth, enacting an autonomous role in caring for women considered low risk. If complications arise, or if the woman is considered high-risk, the midwife continues to provide care for her, while maintaining communication with physicians who, in these cases assume medical responsibility [ 54 ]. Maternity care includes nurse assistants, staff with secondary education and no formal training within midwifery or obstetrics [ 55 ], who assist midwives and provide supportive care to women. Since 2018, obstetric and midwifery care in Sweden has undergone changes and volatile periods, with challenges in staff retention and high turnover. The ongoing shortage of midwives in Sweden [ 56 ] is predicted to continue until 2035, despite efforts to address the problem. The study was conducted at two labour wards in a large teaching hospital, geographically spread across two main sites and organised under a single obstetric unit. The labour wards are hereafter referred to as Site 1 and Site 2. Site 1 has an annual birth rate of 3700 and is commissioned to provide care for women with severe chronic diseases, high-risk pregnancies, and extremely preterm births. Site 2 has an annual birth rate of 4500 and holds a special commission for perinatal psychiatry and care of women with HIV. Both labour wards, particularly Site 2, are in areas with high rates of immigrants and women of lower socio-economic status. Data collection Multiple sources of data were used to provide information on context, process, and impact. An overview of the types of data collected over time is presented in Table 2 . Table 2 Overview of the data used in the study. Data on: TOT N Pre-intervention period 2020 Main intervention period 2021–June 2022 Follow-up period June 2022–Sep 2024 Archival data I Context 225 Documentation about events in the hospital organisation, in maternity care in the region and in the obstetric unit 2017–2023 Archival data II Process Impact 91 Documentation made by improvement teams 2021–2022 Interviews Managers, QI teams, QI-facilitators Context Process Impact 24 Individual interviews n = 9 Dec 2020-Jan 2021 Individual n = 1 Group n = 1x5 people 2022 Spring Individual n = 14 2022 June-Sep Field observations Context Process Impact 127 Field observations 2021–2022 Field observations 2023 Spring Questionnaire – qual. Key informants Impact Sustain-ability 2 Questionnaire n = 2 2024 Sep Interviews Semi-structured interviews were conducted by the MEN before the onset of the intervention, during the process and 2,5 years after the initial intervention. A first round of 9 interviews was conducted in December 2020 and January 2021 with key actors who had knowledge of the obstetric unit, each site and experiences with QI work in the unit. The sample included higher- and lower-level managers (3), improvement facilitators (2), and members of two QI teams (2 midwives and 2 obstetricians). Questions focused on the history, current situation, and improvement needs at the unit. In addition to background information (position, function and tenure) the questions (Supplementary 1) covered the following areas: perceived challenges and needs for improvement, QI strategies and QI approach, competence, knowledge, support and resources for development and QI; conditions, barriers and facilitators for development and for QI, follow-up, spread and sustainability of development and QI, views on development, suggestions, and future outlook for QI-work. In June 2021, two interviews were conducted to follow-up on the development process, gather experiences, and identify changes, learnings, and impact. One individual interview was conducted with the unit’s internal facilitator, and one group interview with five managers, representing all professions at both sites. Finally, 14 semi-structured interviews were conducted in 2022, 13 June−September with QI team members, first- and second-line managers, and the internal facilitator. An additional interview was conducted in November 2022 with the internal facilitator to follow up on further development. Questions addressed perceived effects and changes, whether and how features of the approach had been used, and whether and how they had been useful or effective when in enhancing QI work and introducing changes at the site/unit (Supplementary 1). All interviews were audio-recorded and transcribed verbatim. Field observations Four non-participant observations were conducted by MEN during three workshops and one QI team meeting. They were complemented by field observations made during and/or immediately after activities, meetings and interactions with QI teams and other key actors (e.g. senior midwives’ workshops). Field observations (n = 127) were documented by the internal facilitator (ME), with access to both sites due to her dual role as researcher and as a university midwife commissioned to support the introduction of new knowledge and development at the obstetric unit. Archival data Documents were collected to 1) describe the pre-intervention situation and historical context, 2) follow the change process at the two sites and monitor situations or contextual changes that could affect the implementation, and 3) gather information on organisational decisions and changes before, during and after the intervention period. This included documentation describing organisational structure, previous or ongoing organisational changes, goals and strategies. Documentation produced by the QI teams was collected to shed light on the progress of the QI teams. These consisted of meeting agendas, minutes and working material, such as notes, Miro boards [ 57 ] and Power points. All documents were screened and sorted to provide information on the context, the use of Agile Stepwise QI, and impact of the intervention. Qualitative questionnaire In September 2024, a questionnaire with five open-ended questions was sent to key members still working at the two sites to investigate the use and sustainability of Agile Stepwise QI, as well as the sustainability of the major changes the QI teams had implemented with the help of the new approach. Due to high turnover of involved staff, the questionnaire was sent to one person per site (n = 2) who had insight into the Agile Stepwise QI intervention: one QI team leader and one midwife participating in several QI team tests. The questionnaire was sent via e-mail in September 2024 and consisted of five open-ended questions addressing perceived indications of the continued use of the approach, barriers to using it, and the sustainability, usability and challenges in continued use the interventions implemented by the QI teams 2021-22. Data analysis All qualitative data, including interviews, documents, questionnaires, written observations, and field diary notes, were analysed using conventional content analysis [ 58 ]. The following areas were used to structure the analysis and answer the research questions (type of data used for each area in italics ): Characteristics of the pre-intervention situation (organisational documents and interviews) Use of the main parts of Agile Stepwise QI after the implementation, and their perceived importance for QI work (QI team documents, field-observations and interviews) Impact of the use of Agile Stepwise QI on: a) individual team members; b) the QI teams and their QI approach; c) the obstetric unit? (interviews, questionnaire) Contextual factors and their effect on implementation and use of Agile Stepwise QI (Organisational documents, field observations and interviews) All documents were screened and sorted chronologically to provide information on the context pre-intervention, during, and after implementation. Analyses were conducted by MEN, ST and ME using a Miro board to chronologically visualise events and interventions and to triangulate findings on the use of the approach in interviews and documents for RQ2-4. QI team documents were also scrutinised for information on the use of Agile Stepwise QI, improvement areas in focus, impact of the approach, and tested interventions. Triangulation among documents, field observations, and interviews were used to identify and validate contextual events reported to have influenced implementation or QI-work. QI team documents and field observations were also used to strengthen findings in the final interviews, particularly regarding the use of the approach and its reported impact. Interviews were transcribed verbatim, the text was sorted question by question and reduced to pieces of text with similar meanings, and content analysis was used to find patterns in relation to the three research questions. MEN and ST conducted the initial analyses, discussed interpretations, and once in agreement, reviewed them with ME to reach consensus on the interpretations. The qualitative questionnaire contained less extensive data and were read by MEN, ME, and ST, analysed and summarized by MEN, and interpretations presented and discussed with all authors. Results This section describes the pre-intervention situation, the implementation interventions, and the contextual factors influencing the implementation process. It outlines the impact of the approach on QI work, QI teams, key actors, and the obstetric unit and addresses sustainability of the approach and improvements. Finally, it summarises views on important conditions, enablers and barriers. Pre-implementation situation at the obstetric unit Interviews were conducted to provide vital contextual information, understand the pre-intervention situation, and identify challenges and needs, forming a basis for comparisons and practical planning. Between 2017 and 2020, the region decided to allocate funding received from a national programme to educating staff in QI and the use of national quality registries (e.g. the Swedish Pregnancy Register). As part of this initiative, three interprofessional QI teams were established at each of the two labour wards (Fig. 3 ). Each team had a designated team leader who received QI training and subsequently served as a QI coach. Additional QI training was provided to selected staff members. Initially, the teams were supported by external QI coaches. In 2020, a 24-month planning structure e.g., the yearly QI wheel was introduced, in which each QI team’s improvement area was prioritised for two months at the respective sites. This was done to enhance changes and clarify ongoing improvements for staff. Staff and managers at both sites expressed similar views on the obstetric unit’s difficulties and challenges, areas for improvement, and their own needs (see Table 3 ). Table 3 Pre-intervention challenges and difficulties, needed improvements and requirements for QI at both sites Expressed challenges/difficulties Needed improvements Expressed needs for QI work Staff situation : High staff turnover, particularly among midwives, resulting in a lack of competence, and a large number of new employees. Teamwork Support for QI from managers Impact of previous organisational changes : Recent reorganisation, physical relocation to a new hospital building, and multiple changes of first-line managers resulted in a need to build trust and for staff to gain influence in the organisation, which made QI work difficult. Communication Support for the managers in ways to implement changes. Organisational size, structure, and way to organise work : Many staff per manager, especially midwives and nurse assistants, made it hard to reach staff, create interest, and provide conditions for QI and changes. Consensus over tasks and responsibilities More knowledge about development/implemen-tation, incl. support tools Difficulties in improving work at the unit : Hard to implement improvement suggestions and decided changes, and an expressed need for a more structured approach to QI work. Sustainability of accomplished improvements A holistic view on the obstetric unit’s work , instead of focusing on parts or solely on production Teamwork, communication, and the sense of community : Lack of communication in teams providing care to women in labour and a need to strengthen a sense of community. Patient involvement Manager’s engagement : Lack of strategic vision, engagement in QI work and capacity and knowledge to support QI teams. Patient safety Quality of care : Patient safety, avoidable harm and interventions (e.g., perineal trauma, haemorrhage, CS, augmentation with oxytocin), and patient involvement were areas in need of improvement. Specific improvement areas (e.g., reduce severe perineal trauma*, postpartum haemorrhage, and CS) CS = caesarean section, *Injuries affecting the anal sphincter complex Interventions to implement Agile Stepwise QI Implementation of Agile Stepwise QI began in January 2021. During this period, activities were performed simultaneously at both sites for the interprofessional QI teams, consisting of midwives, obstetricians and nurse assistants, and for the managerial levels and senior midwives (see Fig. 2 ). Initial workshops were the same for the QI teams at both sites, while subsequent activities were adapted to the situation at each site. The implementation approach was interactive and iterative, building on the unfolding situation and fine-tuned to fit the targeted teams and managers. Most of the activities focused on the interprofessional QI teams , including four researcher-led workshops, team meetings, communication with team leaders, and periods of practical testing of improvement ideas. The first round of workshops was initiated with the two QI teams responsible for supporting vaginal birth. The teams were chosen based on the number of members (more than 4) and the higher complexity of the focus area (many factors impacting outcomes). Between workshops, the QI teams worked independently, developing and testing ideas, and holding team meetings, supported by an internal facilitator, a university midwife. Due to pandemic restrictions in 2021, conducting in-person workshops or joint sessions for the two sites was not always possible. Instead, some workshops were held digitally, with break-out sessions for discussion and the use of Miro boards to aid interaction. Workshop content remained consistent during spring 2021. Previous improvement approaches used by the QI teams often involved time-consuming reviews of medical records and evaluation via checklists, surveys, or by monitoring changes in outcomes, such as the number of unplanned CS or severe perineal trauma, i.e., injuries affecting the anal sphincter complex. The workshops aimed to improve the participants' QI knowledge and to guide and support the teams during the implementation process. Agile problem analysis, idea generation, small test loops, and the stepwise approach were introduced during the first two workshops. Workshop 1 introduced the Agile Stepwise QI approach. A problem analysis visualised on Miro boards were conducted where the teams identified issues mainly based on their experiences but also considering the unit’s recordings in national quality registries, e.g., the Swedish Pregnancy Registry. The analysis included desired behavioural changes across professions and shifts. Workshop 2 focused on small-scale agile testing during clinical work, encouraging teams to test multiple ideas in parallel to address several aspects of problems identified during the analysis. Each team developed 8–10 ideas for practical testing. Workshop 3 supported evaluation of tested ideas, guiding decisions to scale, refine, or abandon them. All phases of the stepwise approach were introduced - starting with in-group testing, followed by broader colleague involvement. Phase 3, focused wider spread, was addressed later in the implementation. Workshop 4 focused on retrospective reflection, reviewing how the original problem had been addressed over time and assessing what worked. Both teams faced challenges due to understaffing, making participation in workshops and testing difficult. At Site 2, frustration arose when a promising test - relocating the senior midwife’s office to improve conditions for leadership and support - failed. The change was not feasible, as coordinators also needed support. The retrospective reflection session helped shift the QI team’s perspective, fostering understanding and enabling continued development with a revised focus and new test ideas. This illustrates the value of the retrospect in enhancing learning throughout the testing process. Workshops 5–6 built on earlier efforts and included additional problem analyses, identification of test phases, and discussions on learning strategies and managing change during challenging periods. They also covered progression from Phase 2 to Phase 3 in the Agile Stepwise approach (see Fig. 1 ), analyses of upcoming challenges for 2022-23, support for the learning of other QI teams, clarification of tests for other staff, and analyses and testing of a top-down initiated intervention in which managers also became involved. The last workshops and meetings were mainly held by the internal facilitator to support further spread and sustainability. Senior midwives were identified as key actors for driving improvement, and it was considered important to mobilise their support for the QI teams. A senior midwife is an experienced midwife who provides guidance and advice to less experienced colleagues, supports and collaborates with the residents and obstetricians on duty, and takes a leading role in emergency situations. However, the support provided by senior midwives to their colleagues varied widely, likely due to differing views on what to prioritise or how to best offer support. A series of workshops were conducted with the unit’s 26 senior midwives during 2021 and 2022. The workshops included analyses of their role, focusing on how to provide support under various conditions, such as when testing change ideas. Midwifery care was discussed, and the senior midwives were asked to conduct small-scale agile tests of different ways to provide support. Managers at several levels were important for the introduction of an improved QI approach and for supporting the QI teams. Managerial approval had been secured before designing the implementation. The plan was to gradually involve managers in the process, but the numerous organisational changes and high turnover among managers made this difficult. Workshops and presentations for managers were carried out during the initial implementation period, primarily to keep first-line managers informed about the process, but also to update the entire management team. However, by 2022 onwards, few such opportunities were offered. Contextual factors affecting the obstetric unit Both previous and ongoing external events, as well as intra-organisational changes, affected the situation at the obstetric unit and its two sites during the implementation period (see Fig. 3 for an overview). Several external events and conditions at the national level affected the implementation, both directly and indirectly. Improving women’s healthcare had been a political priority for some time due to variation in care quality and provision, as well as an increasing problem with staff turnover, particularly among experienced midwives. To address these and other related issues, the government launched a national long-term programme in 2015 to improve care for women during pregnancy, childbirth, and the postnatal period, providing additional resources for improvement to all regions. The region hosting the study sites had used some of these resources to initiate QI in all obstetric units prior to the start of the study. Between 2020 and 2022, the Covid-19 pandemic affected all healthcare staff and patients, as well as the conditions for conducting QI-work. In October 2022, the general election in Sweden resulted in new government and a shift in political majority, both nationally and in the studied region, leading to a period of change. Various internal contextual factors , such as unfolding situations and organisational changes within the regional organisation, hospital, and obstetric unit before and during the study period, influenced the implementation and impact of Agile Stepwise QI. At the regional level, the extended shortage of midwives and their pressured work situation triggered an uprising among midwives in the region’s obstetric units in October 2021. Many midwives threatened to leave their employment and profession, which prompted the politicians to launch a regional political programme with several action-strategies to solve the crisis. For example, it was suggested to implement one midwife per childbirth (active phase), higher number of obstetricians at labour wards, improved care processes, work-place rotation, supervision and mentorship, and competence and career-model for midwives. Using funding from the national programme for women’s health, the region initiated a pilot project in 2018 to implement midwifery continuity of care during pregnancy, childbirth and the postnatal for women with fear of childbirth, which was launched at Site 2. The pilot was positively evaluated, and in 2022 it was decided to implement the care model regionally, but without the reimbursement and scheduled work-time agreements used in the pilot, sparking internal debate and disagreement at the obstetric unit. Furthermore, to address high staff workload and reduce pressure on existing obstetric units, politicians decided to open a new obstetric unit, scheduled to open in March 2023. This required recruiting midwives and obstetricians also from other obstetric units in the region, paradoxically increasing competition for skilled personnel. At the hospital level, several major structural changes demanded attention and adaptation, particularly from managers. In 2016, a comprehensive organisational change was implemented, introducing a matrix organisation in which horizontal thematic areas complemented the hierarchical structure. This new way of organising work required more cross-sectional meetings and long-term adjustments to function effectively. In 2021, the theme Women’s and Children’s health was reorganised to Women’s Health and Allied Health Professionals (i.e., to include physiotherapists, occupational therapists, and psychologists). Operations at both sites had to relocate several times during the implementation period, increasing strain on managers and staff and causing disruptions to both regular operations and QI-work. At Site 1, a new ward opened, and the labour ward was expanded to accommodate more births per year, from 3200 to 3700 in 2022. In 2020, two parallel management structures were introduced at the obstetric unit: one for midwifery, overseeing midwives and nurse assistants, and one for medical staff, overseeing physicians (denoted Manager midwifery, and Manager medical in Fig. 2 – 3 ). Additionally, the high staff turnover at both sites, except for physicians at Site 1, had a major impact on the implementation. The unit experienced a volatile management situation, as many managers left and were replaced by temporary managers and eventually by new permanent ones (see Fig. 3 ). This turnover occurred at all levels, from higher-level management to first-line managers. From the start of the implementation in 2021 until 2023, there were nine changes in higher and middle-level management and four changes among first-line managers. Regarding the QI teams, those at Site 1 were relatively stable in terms of staff, while the teams at Site 2 underwent considerably changes. Many QI team members at Site 2 left, therefore it was decided to move the remaining members from the three QI teams into a single team. By 2023, only one person who had participated in the main intervention remained at Site 2. The perceived impact of the Agile Stepwise QI approach After 12 months the main implementation period was followed by a consolidation period during which need-based support was provided by both researchers and members of the organisation, for example, the internal facilitator and QI team leaders. Table 4 summarises the perceived impact of Agile Stepwise QI on QI-work at the unit, on the QI teams and key actors and at the unit level. Specific interview questions addressed the perceived impact and influence of the Agile Stepwise QI approach, although this was also reflected in responses to other questions. The perceived impact encompassed learnings, acquired knowledge, and new ways of thinking and acting, both as an individual, as a QI team and/or at the unit. Table 4 Perceived impact on QI work and on individual, team and unit levels Perceived impact based on interviews Impact on QI work • Faster, easier and smoother way to achieve change • Stepwise testing provided insights, courage and better opportunities for forthcoming changes • Slowing down the process, and incorporating revisions and suggestions from others enhanced changes and the spread of improvements • Led to actual changes • Feasible and sustainable approach • Perceived as attractive by and for healthcare staff Impact on QI team and key members • Positive and motivating, made QI-work easier and more enjoyable • Increased inspiration, drive and creativity within the team • A new mindset and way to deal with issues – also beyond the workplace • Valuing both positive and negative feedback • Greater emphasis on clarity of information • Increased understanding of: - the importance of feedback - different perspectives (e.g., between professions or wards) - the value of ensuring diverse perspectives, discussions, reflections and arenas for open communication during change - change and learning processes at work, and the time change might require Impact and sustainability at unit level • Testing before implementation of any change became more common • Scaling up tested solutions remained challenging, though QI team members with decision mandate facilitated this • Involving managers and senior staff was difficult due to high turn-over, which affected sustainability. • Endures at one site 2,5 years after implementation but not on the other All QI team members and managers described a change in behavioural approach compared with previous QI work. Agile Stepwise QI was described as a faster and easier way to achieve change. Before the intervention, it was common for QI teams to find or develop a solution, propose a change to the entire unit and implement it mainly by providing information at meetings and via written information. If full implementation failed, it often felt like a failure for the teams. By contrast, Agile Stepwise QI was experienced as a smoother way that led to tangible changes. It was easier to evaluate smaller tests than in previous attempts, and to recognise which changes were not worth pursuing. It was also easier to involve staff when it was framed as a test. Overall, the approach was perceived as attractive both for QI teams and staff. Informants commented on specific features of the approach and emphasised those they found most important. Smaller agile test-loops , initially tested by QI team members, were described as the most prominent benefit of Agile Stepwise QI. They provided speed and momentum, and involving team members created better opportunities to test ideas and quickly adapt or abandon them. Having a few people test first saved resources, and tests could easily be carried out during a work shift. The smaller scale also meant that several tests could run simultaneously, less well-defined ideas could be developed and clarified, and it felt safer to experiment. The value of being able to share one’s opinion and suggestions for improvement, as well as the importance of clearly communicating the purpose of each test, was highlighted. The process of prioritising ideas was sometimes described as disordered, with many suggestions and difficulties in choosing between them. Having too many ongoing tests was also considered challenging. The risk of favouring simple change ideas that were easy to achieve, while avoiding those requiring deeper transformation was highlighted. It was noted that revising or abandoning the thinking behind initial ideas could sometimes be frustrating. Stepwise implementation with follow-ups was generally perceived as positive and smooth. The team’s initial tests involved simpler types of changes, such as improving communication between midwives and physicians by relocating physicians’ workspace to the same office used by the midwives. The benefit of starting on a small scale instead of full implementation, which might not produce the desired change, was highlighted. The small tests worked well in both teams, and gathering feedback by listening to staff was seen as an important step in enhancing change and promoting wider adoption. One challenge was managing both one’s own and other’s expectation regarding the speed of change, because the stepwise testing of ideas slowed down the overall change process. This was less in line with the more common practice of presenting an intervention and then proceeding to full-scale implementation. The in-group small-scale testing in Phase 1 , which focused on testing ideas within the team, rather than persuading others to change behaviours, was perceived as simple, useful, effective, and enjoyable. It also worked well during night-shift conditions, where involving staff in changes usually is difficult. It was described how this phase was applied beyond the QI team, both by individuals and by senior midwives. Some tests were more challenging than others, and the opportunities to participate varied for each team member. The initial and secondary problem analyses were guided by the internal facilitator, with further analyses to be initiated by the QI team. These analyses were perceived positively, as they provided support, offered insights, and aided the team in prioritising problems and tests. The presence of varying perspectives on, and differing levels of a problem was emphasized, as were the difficulties the team experienced in agreeing on which problem and idea to choose. Some key learnings were highlighted, such as the importance of motivation and understanding the purpose of the test and completing the entire test loop before moving forward. The importance of the QI team’s composition and the mandate given to QI teams to decide which ideas to test was emphasised, in particular for Phase 1 and 2. Examples of ideas and solutions tested included: improving communication during work shifts by making information easily available about which midwife is responsible for each woman in labour and how to reach them; clarifying and agreeing on the work process during protracted labour; and adapting the TeamBirth care process, originally developed in the US [ 59 ] to improve patient involvement and team communication, to local conditions. The Phase 2 involvement of new colleagues in tests was described as more demanding than in-group testing. Usually, the team leaders, who were senior midwives, presented and disseminated the information, or the senior midwife group were approached to assist. Midwives and assistant nurses experienced better continuity and had more opportunities to reflect on the tests as a group, than physicians, who covered several wards. Obstetricians, and residents were approached more often than gynaecologists. Members of the interprofessional QI team belonged to different work teams and professional groups, for example physicians informed other physicians and the residents they supervised. Nonetheless, identifying motivated staff and encouraging their participation in tests, particularly physicians, remained challenging. The spread of information was carried out in various ways, from speaking directly with those involved to informing teams of staff working during a test period. Most informants emphasised the importance of clarifying the purpose of the test. Phase 1 tests with the TeamBirth care process involved patients, and obtaining their feedback was an important component. In Phase 2, patient and staff feedback, as well as and patient narratives were used to convey the purpose of patient involvement to colleagues, which was perceived as a strong motivator. The designated theme months in the unit’s yearly QI wheel provided opportunities for the QI team to share information and conduct tests. Scaling-up in Phase 3 meant that beneficial changes identified in previous phases, for example, a new work routine, were implemented across a larger part of the ward or to the entire unit. This included obtaining a mandate from higher level managers for a large-scale test and, eventually, for change itself. In general, more resources were required for information and communication during this phase. The teams regularly involved the lower-level managers in their work, either as team members or by inviting them to QI team meetings. This ensured access to a managerial mandate to approve further spread, particularly for smaller or medium-sized changes. In Phase 2, smaller changes also spread organically. Larger changes needed to be discussed and planned in collaboration with higher-level managers, particularly if both sites were involved or if the changes affected staff situations, organisation of work, or patient flow. Implementation and follow-ups therefore had to be planned in greater detail. Individuals with connections to higher-level management provided support in this communication. The fact that the QI teams had formal and informal channels to different professional groups, which had already been used to anchor and discuss tests in Phase 2, facilitated Phase 3. The senior midwives’ group also served as an important hub for support and dissemination. The theme month in the yearly QI wheel supported communication, information and implementation, particularly for larger changes. Information was shared and visualised through a variety of existing meetings, weekly information letters, emails, and often via a physical improvement board. The QI team also held workshops during their theme months. Challenges identified concerned the situation at the unit, with many ongoing changes and improvements and high staff turnover. It took considerable time and effort to ensure that new staff understand QI, the tests, the phases, and what was currently being implemented in Phase 3. Achieving change across the entire unit remained difficult, and the importance of recognising that such change requires time and effort was emphasised. Retrospective reflections and learning in the structured retrospect sessions focused on a longer period and were mainly led by the internal facilitator. The benefits of these sessions for motivation were noted by several members, particularly as a reminder of positive results that were easy to forget and as a way of recognising efforts made over time. However, making time for reflection and learning sessions were difficult, not all members participated, and the benefits of having external support during reflection were acknowledged. The new approach affected the QI teams and key individuals . At an individual level using Agile Stepwise QI was perceived as positive and motivating, making QI work easier and more enjoyable. It became easier to test new ideas and less intimidating to fail. Some team members described how, for them, the small agile tests had become a new mindset and a way of addressing issues outside of work, for example in family settings. The informants described that the use of Agile Stepwise QI had led to several insights, learnings and changes in the QI team’s approaches and action strategies. They reported increased inspiration, drive, and creativity within the team, and that it had become easier to focus, prioritise, and take the next step during change processes. Testing their ideas in practice themselves during work hours was a new and straightforward approach, described as providing better insights, courage, and opportunities for forthcoming changes. Having the mandate to test ideas and work with QI in a more agile way were perceived as feasible and sustainable, also making it easier to encourage others to test at a later stage. The learnings expressed included a new emphasis on clarity in information, an understanding of the importance of collecting and providing opinions on an idea or test, knowing when to abandon an idea, and appreciating both positive and negative feedback. Expanding tests beyond the team provided more information about what did or did not work and a better understanding of different perspectives, for example related to professions or wards. The importance of listening to different perspectives, engaging in discussions and reflections during change processes, and having arenas for open communication was highlighted. Informants further indicated gained knowledge about how to approach processes of change and learning at work, as well as an increased understanding of the time change may require. Slowing down the process by using a stepwise approach, with opportunities for revisions and for incorporating suggestions from others, enhanced changes and the spread of improvements. The perceived impact on the obstetric unit, its wards, and staff , was generally described as positive, particularly when staff recognised that the QI teams were testing suggestions that could be adjusted or abandoned based on their feedback. The process of reconsidering, putting ideas on hold, and improving or abandoning them were also described as providing important learning opportunities for staff in the unit. Testing was unfamiliar for staff initially, but over time there was greater understanding and less fear of tests or of them leading directly to large changes. Using terms like “agile” and “testing” became common. A more open mentality, with positive views on trying new approaches, had emerged, especially on Site 2. Agile Stepwise QI had begun to spread to the other QI teams and the senior midwives at the unit. Spreading the approach to managerial levels provided difficult, particularly to managers responsible for physicians. However, several informants noted that actual knowledge of the approach, and of the precise impact of its use on the majority of staff, remained diffuse, unclear, or largely absent. Sustainability of the approach and the implemented improvements To assess the sustainability of both the Agile Stepwise QI approach and the changes it introduced, qualitative follow-up questions were distributed to both sites 42 months after the initial implementation. Site 1 - Agile Stepwise QI continued to be actively used by several QI teams, supported by the QI team leader and the internal facilitator. The approach was gradually applied to new initiatives, such as implementing bedside rounds in the postnatal ward for women with medical conditions or birth complications and adapting and expanding a Swedish version of TeamBirth across antenatal and postnatal wards. The approach was adopted and embedded in many staff’s mindset, with a noticeable increase in openness to testing new ideas. Experiencing the benefits of small-scale testing made change easier to motivate and reduced resistance to change. Challenges included sustaining momentum, engaging staff across multiple change initiatives, and tracking who had tested which interventions - partly due to involving too many staff early on. It was also difficult to engage staff with highly variable daily tasks. Training days were suggested as a valuable way to deepen knowledge, scale improvements, and foster peer learning. Successfully tested interventions, such as bedside rounds, were introduced in the antenatal ward and retested in other areas such as the postnatal ward. Of the seven improvement ideas tested at Site 1 in 2021–2022, six remained in use, while the seventh was being revised with new tests planned (see Table 4 ). The TeamBirth care process, adapted by QI teams for the Swedish context and fully implemented in 2023, was partially in use with implementation still ongoing. Site 2 - Agile Stepwise QI was not sustained at Site 2, mainly due to high staff turnover. At follow-up, only one member from the original QI team remained. As a result, the remaining members from all three QI teams were merged into one single team with a broader remit, but continued turnover hindered progress, and no active QI team were in place at the time. Plans were underway to form new teams and launch a start-up programme to reintroduce Agile Stepwise QI. Despite these challenges, four improvement ideas tested and implemented in 2021–2022 were still in use by autumn 2024. Three were functioning well, while the TeamBirth care process implemented in 2023 was not yet fully operational (see Table 5 ). The influx of new and temporary staff, and how they were introduced to routines, was described as a general challenge affecting sustainability of the approach and as a contributing factor to slower implementation of TeamBirth. Table 5 Sustainability of implemented improvement ideas 3,5 years after initiation of Agile Stepwise QI Improvement ideas tested at Site 1 (N = 7) Status Structured plan for communication during the second stage of labour to be used before and during the three-hour reconciliation. Aim : Improve communication and to reduce operative births. Impact : Considered helpful. Variation in use : Adaptation to all staff categories involved was a challenge. Sustainability : Requires repeated attention. Senior midwives and physicians further deepened their methods of working with the arrow. In use – requires repeated attention Computers for doctors in a joint office for several professions Aim : Improve communication by enabling midwives, senior midwives, and physicians to reach each other. Variation in use : Some disturbances were reported initially, and screens were installed to minimise distractions. Impact and Sustainability not addressed. In use – works well Adding names and phone numbers on the occupancy list at the start of each shift Aim : Facilitate access to the responsible midwife and nurse assistant, thereby saving time and reducing frustration. Impact : Less time was spent contacting those responsible for women in labour. Variation in use : Challenging to get new staff to remember this and to make it a habit. Sustainability not addressed. In use – works well Introduction of the regional guideline for oxytocin in protracted labour Aim : Prevent prolonged labour and avoid unnecessary interventions. Impact : Most of the time, staff adhered to the guideline. Variation in use : Sometimes confusion about whether to apply this guideline or the one for women with induced labour. Sustainability not addressed In use – works well Structured night rounds Aim : Improve communication and information exchange. Variation in use : Not always performed at the scheduled time due variations in workload. The improvement board is not always reviewed. Impact and Sustainability not addressed In use - variation Planning flow of inductions – planning the flow of induction, organising the process in advance. Aim : Coordinate inductions for improved workflow and reduced waiting times for women. Impact : Not fully effective due to workload and lack of space. Variation in use : Not applicable. Sustainability : Testing of an alternative approach was planned. Not in use – new test planned Team Birth-SWE – a care process using brief team meetings and a designated planning board in the birthing room. Aim : Improve patient involvement and communication between staff. Tested and adapted to the Swedish context by the two QI teams; implemented in 2023. Variation in use : The planning board was used, but staff found it challenging to adhere to all components of the intervention. Writing up reconciliations and involving the couple remained difficult, particularly in stressful situations. Impact and Sustainability not addressed Partly used – Ongoing implement-tation Site 2 N = 4 Interactive micro meetings for enhancing an inviting and open climate. Aim : Support newly qualified midwives and residents. Impact : Appreciated by the newly qualified midwives. Variation in use : Depended on the senior midwife on duty. Sustainability : Taught to new employees and students. Regular reminders at daily staff start-up meetings. Impact not addressed In use – works well, minor variation Time-out (bedside) when protracted labour is diagnosed Aim: Improve communication and involve patients. Variation in use : Some time-outs were not conducted bedside. The checklist to use was less familiar to new staff. Impact and Sustainability not addressed In use – some variation New routine at ward rounds Aim : Improve working climate for open discussions so that all professions feel confident to speak up and share their knowledge. This was achieved by self-introductions, aimed at getting to know one another better including work experience. All professions participate. Impact : Improved in round routine, with more time for reporting, space for discussions and learning e.g., CTG assessments, clinical practices. Contributed to transparency, greater mutual understanding, and psychological safety. Sustainability : Recently used to highlight areas for discussion e.g., health factors, prevention of postpartum haemorrhage, severe perineal trauma. In use – works well, enlarged Team Birth-SWE (see above). Aim : Improve patient involvement and communication between staff. Variation in use : A challenge was the many new and temporary staff and the way they were introduced to routines. Impact and Sustainability not addressed Partly used – Ongoing impl-ementation Subcategories only included when mentioned by the informants Conditions, barriers and enablers for implementation Conditions, barriers and enablers were highlighted and summarised by the participants. The existence of the QI teams, with a mandate to test improvements was considered as essential to use the approach. Involving motivated and influential team members, who held informal mandates from their professional groups, was a key enabler. Team leaders and the internal facilitator played crucial roles, and their support was mentioned as an enabler. The content and design of the approach were seen as enabling practical QI work. The structure of the problem analyses, the adaptations of ideas through agile test loops, and the stepwise spread were perceived as feasible. The team could also act as a barrier to implementation if it lacked members capable of testing ideas in practice. The need to involve individuals from all relevant professions, holding both informal and formal mandates (e.g. peers, senior midwives, physicians, or first-line managers) was highlighted. Prioritising among many ideas and choosing between easier and more difficult problems was highlighted as a dilemma, with the risk of favouring minor issues over more important or challenging problems. Follow-ups and evaluations were also perceived as difficult, particularly since the long intervals between QI team meetings during test periods slowed the change process. Another barrier was the lack of support from managers and senior staff at various organisational levels, especially for scaling up tests. For example, engaging key staff, such as senior midwives and physicians, was challenging when transitioning to Phase 2 testing. Additionally, there was a lack of meetings and arenas where QI teams, senior midwives and physicians could discuss ideas and testing. Discussion This study aimed to address gaps and challenges in the practical use of QI in healthcare. Building on existing QI approaches and knowledge, Agile Stepwise QI was developed to strengthen the capacity for organisational improvement and learning and ed in round-the-clock maternity care. To inform future research and practice, we highlight key features of Agile Stepwise QI and the factors influencing its implementation, use, and sustainability in healthcare organisations. Influential features We identified five influential features of Agile Stepwise QI that supported QI work and enhanced change and learning. Firstly, the open, holistic problem analyses and creative idea generation included broader analyses based on experiences, perceived urgency, and mixed information, rather than focusing solely on fewer performance measures and indicators (e.g., quality registry data) or evidence-based clinical interventions, which are more common in QI [e.g., 60]. However, this does not diminish the value of such measures and knowledge; rather, QI teams require other types of information to complement the data recorded in national quality registries. Agile development is rooted in holistic thinking, and its adoption often requires shifts in organisational culture [ 61 ]. We observed some signs of cultural change, for example, staff regularly asking, “What do we test today?”, indicating a shift from initial hesitancy towards greater openness to experimentation and innovation. Encouraging QI teams to pursue their own ideas, rather than focusing solely on care quality measures, led to improvements in areas such as communication, collaboration, and role clarity. These are examples of conditions and enabling factors that affect care quality, efficiency, and the work environment, thereby extending impact beyond the clinical themes assigned to the QI teams, such as reducing severe perineal trauma or postpartum haemorrhage. This approach fostered a shared understanding and was perceived as motivating, promoting a sense of ownership and ability to influence. It also served as a unifying strategy for combining multiple interventions to achieve a common goal, in line with recommendations to find high leverage solutions rather than rely on a single intervention [ 62 ]. Secondly, the agile experimental tests, which were easy to launch , introduced change through very small incremental steps towards larger transformations, such as improved team collaboration. The ability to break down and test ideas within the team, gather direct feedback, and remain open to adaptation or abandonment proved to be a powerful tool for initiating change. Previous research has shown that improvement efforts in practice often focus on simpler, more easily implemented issues, while more complex and large-scale issues tend to be avoided [e.g., 63]. Similarly, the QI teams in this study began with more straightforward suggestions, such as changing routines for how to contact each other by phone when necessary, before gradually moving on to more complex interventions. The open holistic problem analysis was helpful, as identifying multiple causes generated diverse, often proactive, intervention ideas that could collectively drive change by targeting different aspects of the issue [ 62 ]. Thirdly, the stepwise scaling , starting with in-group testing and gradually involving motivated colleagues, helped spread interventions more smoothly across the ward or unit. This gradual process was seen as less threatening and more manageable. Seeking feedback at each stage made it easier to refine and adapt ideas to different situations. The approach also allowed room for failure without major consequences, as only a single step needed to be reversed rather than restarting entirely, reducing the sense of failure. However, evaluating ideas, obtaining feedback on feasibility, and identifying unintended consequences requires accessible qualitative data. Although process-related information is important for supporting change processes [ 64 , 65 ] the teams were initially unfamiliar with collecting qualitative data, as national quality registries had long been emphasised for evaluating QI at unit and national levels. Fourthly, the focus on joint reflection and learning through follow-ups, discussions of tests and feedback, and retrospective reviews shifted the emphasis from finding perfect solutions to learning from experience. This supported the development or abandonment of ideas based on practical insights. In knowledge-based organisations, a learning-oriented culture is essential; however, in environments where mistakes are penalised, it can be difficult to openly test and share imperfect ideas [ 66 ]. Retrospective sessions helped teams to recognise progress over time. Using a structured, experimental process that emphasises learning by doing is a key feature of successful approaches to fostering continuous organisational improvement and learning capability in healthcare organisations [ 29 ]. Finally, the characteristics of the interprofessional QI teams , bringing together representatives from all professions and senior staff, ensured that diverse perspectives were considered throughout the QI process. The importance of involving healthcare professionals and others affected by a QI project is well known [e.g., 67], and this inclusive setup helped engage a large part of the staff. Factors affecting implementation, use and sustainability The studied obstetric unit is one of the largest in the country and part of a hospital organisation with around 15 000 employees. In such large organisations, introducing agile methods can be particularly challenging, as change tends to occur more slowly than in smaller settings [ 68 ]. Furthermore, the period during which the approach was implemented was marked by organisational volatility within the obstetric unit. However, aside from the impact of the Covid-19 pandemic, such conditions are not uncommon in healthcare settings. Still, this study showed that the Agile Stepwise QI approach was embraced not only by the two involved QI teams, but also by additional QI teams at the sites, and some, though not all, staff at the obstetric unit. This partial uptake may be due to organisational instability and staffing challenges. Interestingly, some components of the approach still appeared to spread organically, possibly influenced by the absence of strong leadership, peer involvement in testing, and ongoing discussions about supporting others in using QI. While this supported its use, a non-strategic and partial adoption of the approach, combined with limited understanding of the full process, risks undermining its impact and perceived benefits. Inadequate adherence to important aspects of an intervention is a common problem connected to insufficient resources and strategies for implementation [e.g., 69,70]. High staff and managerial turnover, largely driven by a midwives’ uprising and other organisational challenges, was a major barrier to implementing the Agile Stepwise QI approach. Although designed to better accommodate volatile organisational conditions than traditional QI methods, the frequent turnover, especially among managers, hindered the development of competence and understanding of both QI and Agile Stepwise QI. Managerial support and engagement at multiple levels are essential for fostering and sustaining a culture of learning, experimentation, and improvement capability in healthcare organisations [e.g., 23,29]. In addition, the midwives’ uprising prompted regional politicians to initiate several large-scale reforms which, along with other ongoing projects, competed for the limited time and resources available for managing change efforts. The volatile situation and focus on urgent daily operations made it difficult to engage senior and managerial staff, limiting effective use of the approach at the unit. Consequently, the goal of giving all staff insight into the value of a functioning QI team was not achieved. Additional barriers included the perceived lack of clarity and consistency in the overarching organisational improvement and learning strategy. Sustaining change is always challenging, particularly under unfavourable conditions, and requires continuous effort and support [e.g., 71,72]. It is therefore notable that the approach has persisted at Site 1 despite staff turnover and shifting circumstances. One explanation may be the continued presence of key QI functions - QI team leaders, members, and an internal facilitator - who hold influence across multiple professions and functions. Champions with accountability, empathy, a vision, and the ability to inspire are vital for QI success [ 73 ]. However, if too many of these champions and carriers of knowledge leave, a full restart may be necessary. Several key enablers supported the implementation and use of Agile Stepwise QI. Empowering the existing interprofessional QI teams with autonomy, psychological safety, time, and a clear mandate to test ideas, alongside external guidance to build internal skills, reflects key features of successful interventions for continuous organisational improvement and learning [ 29 ]. The yearly QI wheel provided forums to engage staff and address focus areas. Other important factors included inclusive and structured team leadership, team members’ motivation, patience with change, prior QI experience, and continuous support from the internal facilitator. Strong team leadership is key for succeeding in QI efforts [ 74 ], while clear roles and responsibilities, advocacy by champions, and adequate support are known facilitators [ 75 ]. The involvement of senior midwives and first-line managers helped drive progress, but their eventual departure from their positions made it harder to sustain the work. Group-level barriers were fewer and mainly related to high team turnover at Site 2, and limited time and forums for discussion, especially with physicians. Figure 4 summarises potential enablers and barriers for building organisational and group-level capability for continuous organisational improvement and learning, as well as factors influencing the tested approach. Strengths and limitations of the study A clear strength of the study lies in its use of diverse, longitudinal data from multiple sources, which has enabled both contextual and temporal analysis. The study thus addresses common criticisms of empirical research on organisational and workplace change, particularly the lack of attention to contextual factors and long-term developments [e.g., 48]. This approach enhances understanding of how contextual factors influence the implementation and use of the Agile Stepwise QI approach, which can inform evaluations of its usefulness in other organisational settings. According to the original plan, the study was to conclude with a survey in September 2023, i.e., 2.5 years after the implementation started. However, this was deemed unfeasible by key actors at the unit and the researchers, due to the volatile situation within the organisation, which escalated further during 2023. Therefore, the results on impact and how, and to what extent, the QI teams’ ways of working influenced their colleagues, and to what degree the new QI practices were further disseminated to other teams in the obstetric unit, are based solely on interviews with members of the QI teams and a few senior staff conducted 1.5 years following initial implementation. The long-term sustainability of the approach and the implemented changes was evaluated after 3.5 years, through an open-ended survey completed by two informants. While broader participation could have provided deeper insights into how sustainability was expressed, the informants were key staff at both sites, with comprehensive involvement and understanding throughout the entire project. Furthermore, the impact of implemented changes in clinical practices on care quality was not investigated in this study. Conclusions We conclude that the Agile Stepwise QI effectively addresses several practical limitations of traditional QI methods, including the PDSA cycle, in dynamic and complex healthcare settings. It shows strong potential for broader application. Key features such as open problem analysis, creative idea generation, agile small-scale testing, ease of initiation, stepwise scaling, and interprofessional collaboration, problem-solving, and learning appear valuable for driving change in healthcare organisations. Findings suggest enhanced learning at individual, team and organisational levels, indicating a positive impact on organisational improvement, and learning capacity. However, its sustainability depends on the continuity of key staff, including QI team members, support functions and managers, particularly those with extensive knowledge and experience of the approach. Future research should examine the approach’s impact on staff and organisational dynamics in greater depth and assess its long-term effects on QI and organisational learning capacity, care quality, and work conditions. The Agile Stepwise QI approach should also be tested in other settings, with close attention to its core features. Abbreviations QI Quality improvement OL Organisational learning PDSA Plan Do Study Act cycle Declarations Competing interests The authors declare that they have no competing interests. Ethics approval and consent to participate The study received ethical approval by the Swedish Ethical Review Authority, no. 2020–02500 on October 20, 2020. All participants signed an informed consent document, and the study was conducted according to the Helsinki declaration. Consent for publication Not applicable Funding This study was financially supported by Swedish Research Councils for Health, Working Life and Welfare (FORTE) [Grant no 2020 − 01209]. The last author (ME) was during the project period also partly funded by Region Stockholm, grant no. FoUI-974668. Open Access funding was provided by Karolinska Institutet, Sweden. Author Contribution MEN and ME developed the intervention and designed the study, MEN and ME collected the data, MEN and ST conducted the analyses and MEN, ME and HS drafted the manuscript. All authors contributed to and approved the final manuscript. Acknowledgement The authors would like to thank the participants at the two labour wards and at the obstetric unit for their time and effort. Data Availability The datasets (in Swedish) used in the current study are available from the correspondingauthor on reasonable request. References Senge P, Kleiner A, Roberts C, Ross R, Smith B. The Fifth Discipline Fieldbook: Strategies and Tools for Building a Learning Organization. London: Nicholas Brealey Publishing; 2010. Nyström ME, Höög E, Garvare R, Andersson Bäck M, Terris DD, Hansson J. 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15:49:15","extension":"xml","order_by":13,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":223403,"visible":true,"origin":"","legend":"","description":"","filename":"8f11938d0e1a40cfa886a9596f152efe1structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-7601913/v1/62dcf45859eb8c8b3e1a3af0.xml"},{"id":94211914,"identity":"524c1052-0495-4b50-a9db-9aba1e3f3cc2","added_by":"auto","created_at":"2025-10-23 15:49:15","extension":"html","order_by":14,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":245588,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7601913/v1/cdbacb27ce2564d6a16d0476.html"},{"id":94213098,"identity":"eadfc70e-b248-44e4-b000-fab516f03ce1","added_by":"auto","created_at":"2025-10-23 15:57:15","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":637775,"visible":true,"origin":"","legend":"\u003cp\u003eOverview of the basic features of the Agile Stepwise QI approach\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7601913/v1/e9e21cb6c628d5b801d93911.jpeg"},{"id":94213443,"identity":"d978018b-fc26-4d05-ad6d-48df57f1d689","added_by":"auto","created_at":"2025-10-23 16:05:15","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":137343,"visible":true,"origin":"","legend":"\u003cp\u003eOverview of interventions and activities to support implementation of Agile Stepwise QI\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-7601913/v1/02907e388510faa0f908124f.png"},{"id":94213442,"identity":"55b66d28-a4e2-482a-8371-87a92e5a5edf","added_by":"auto","created_at":"2025-10-23 16:05:15","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":137343,"visible":true,"origin":"","legend":"\u003cp\u003eThe main internal and external contextual factors affecting the two sites during the project period.\u003c/p\u003e","description":"","filename":"floatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-7601913/v1/b9849d1c6612829810d1ab83.png"},{"id":94211901,"identity":"9a5e4606-d354-4efc-855b-7fea6b3ff7f1","added_by":"auto","created_at":"2025-10-23 15:49:15","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":239877,"visible":true,"origin":"","legend":"\u003cp\u003eOverview of potential enablers and barriers for building capability for continuous organisational improvement and learning using the Agile Stepwise QI approach\u003c/p\u003e","description":"","filename":"floatimage4.png","url":"https://assets-eu.researchsquare.com/files/rs-7601913/v1/175979371713592bb45142bd.png"},{"id":94214563,"identity":"c107d433-616c-47e9-bd29-dfd08add5b03","added_by":"auto","created_at":"2025-10-23 16:13:16","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2721523,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7601913/v1/7925b5f5-a3db-4f6a-91f6-13cdd6c0790e.pdf"},{"id":94213441,"identity":"c2ce1397-40ff-4366-8d12-3c94f5a534d0","added_by":"auto","created_at":"2025-10-23 16:05:15","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":35275,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementary1Interviewquestions.docx","url":"https://assets-eu.researchsquare.com/files/rs-7601913/v1/1cd0b6f9c2fd093dd33120d6.docx"},{"id":94211899,"identity":"f17a53c5-1e29-4c56-916a-8423bd8c49fc","added_by":"auto","created_at":"2025-10-23 15:49:15","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":24261,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementary2Examplesofquotationsfrominterviews.docx","url":"https://assets-eu.researchsquare.com/files/rs-7601913/v1/01cf0e1076666b856f138991.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Agile Stepwise Quality Improvement: Enhancing change and learning in complex and volatile healthcare contexts","fulltext":[{"header":"Introduction","content":"\u003cp\u003eOver the past 20\u0026ndash;30 years, the Swedish healthcare system has faced significant challenges due to advancements in medical technology, digitalisation, accelerating scientific development, demographic changes, a pandemic, and demands for efficiency and patient participation. These changes require new ways of organising and developing care, including co-created care assisted by technology and artificial intelligence. To thrive, healthcare organisations must enhance their learning capacity, focusing on improvement and development, reflective conversation, and understanding of complexity [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Despite the use of various structured approaches to change based on quality improvement (QI) [e.g., 3], achieving and sustaining improvement in healthcare is challenging.\u003c/p\u003e\n\u003ch3\u003eChallenges when working with improvement in healthcare\u003c/h3\u003e\n\u003cp\u003eA central challenge in healthcare improvement lie in establishing the legitimacy and urgency of a problem, demonstrating the value of a proposed solution and managing unrealistic ambitions, to ensure sustainable change [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Other challenges include overcoming inherent obstacles in organisational context and cultures, limitation in capacities, lack of staff engagement, leadership issues, incentivising participation, ensuring effective monitoring, mitigating unintended consequences, and securing long-term sustainability [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe Plan-do-study-act (PDSA) cycle, a core methodology in healthcare QI [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e], provides a structure for experimental learning when iteratively testing ideas and solutions to problems. Such iterative, successive tests of ideas and hypotheses, analyses of effects and adaptation or change of initial ideas are central to QI approaches such as Lean management, Six sigma, and Total quality management [e.g., 6\u0026minus;8].\u003c/p\u003e\u003cp\u003eStudies have revealed several shortcomings in the use of QI and the PDSA cycle. System-wide implementation of QI-approaches in healthcare, such as Lean management is rare; the use of single techniques and tools in isolated organisational units is more common [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. In a systematic review of the application of PDSA in healthcare, less than half of the studies met the minimum requirements of the method [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Highlighted challenges concerning PDSA include the complexity in its practical use [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e], its appropriateness to address challenges of improving healthcare [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e], and a lack of fidelity in its application sometimes with negative effects on learning [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Furthermore, the resources and the supportive context required for the approach to be successful are often underestimated [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eKey failure modes in executing the Plan-Do-Study-Act steps have been identified [11, page 150]. These include failing to implement the QI intervention as intended [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], to collect data as planned [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], to capture unanticipated learning [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] and continuing with the \u0026lsquo;Do\u0026rsquo; phase despite clear failure or serious negative side effects [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. In the \u0026lsquo;Study\u0026rsquo; phase common failures include not conducting the study [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e], not following the study plan, and not communicating what has been learned [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. In the \u0026lsquo;Act\u0026rsquo; phase frequent failures include neglecting to engage in \u0026lsquo;double loop learning\u0026rsquo; [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e], failing to question aims and assumptions based on learnings and moving too quickly from small-scale tests to full-scale implementation and sustainment [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Additional contextual barriers include limited time for conducting tests, shifting or competing organisational priorities, and staff turnover [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Contextual barriers risk undermining the iterative foundation of the PDSA cycle, which is designed to support more effective and sustainable improvements. Conflicting objectives and strategic ambitions, e.g., maintaining quality, controlling costs, ensuring adequate staffing, complying with regulations, and fulfilling broader societal goals, can exert a significant influence on QI, innovation and organisational change [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Although such contextual conditions are inherent to organisational life, particularly within healthcare, improvements still need to take place. However, there is limited consensus on how to consider the potential effects of outer or inner contextual changes on QI and change processes, as well as how to navigate the dynamic tensions they produce. Several suggestions to improve QI approaches and enhance successful innovations and improvements in healthcare have been discussed by scientists. Reed and Card [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e] emphasize the need to understand how to manage emergent learning while engaging diverse stakeholder groups to ensure the success of QI initiatives. Collaborative approaches between healthcare actors and researchers have been suggested as a way to enhance organisational learning [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Embracing multiple short and long-term objectives, while recognizing that all change occurs within an evolving and dynamic context, is essential for effective QI [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Cultivating a creative and innovative organisational culture that supports the exploration of solutions to core needs is considered important for addressing emergent challenges in healthcare settings [21\u003c/p\u003e\u003cp\u003ePromoting creativity and innovation in healthcare organisations through structured processes of problem analyses, idea generations, solution development, testing, and adaptation, is widely recognized as essential for driving change [e.g., 21]. At the organisational or unit level, innovative problem-solving processes are supported by adequate resources, a culture that tolerates errors and risk-taking, clearly defined objectives, a climate that values new ideas and collaboration, motivated and supportive leadership, and a management approach that prioritizes understanding individual behaviours and needs [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Improvement teams benefit from using participatory decision-making processes and methods that aid the development of new ideas as well as having sufficient time for reflection and problem-solving [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Effective coordination and collaboration within and across teams, autonomy in the use of dedicated resources, and sound project management practices are recognized as important enablers for improvement. Collaboration is also vital for engaging colleagues and communities, that hold multidisciplinary knowledge, while fostering interaction and promoting the sharing of knowledge and resources [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. Organisational attributes that contribute to learning and improvement capabilities include leadership commitment, an open organisational culture, and space for team development [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Team development is facilitated by attention to motivation, education and training, capacity management, team member behaviours, team balance, and collaboration.\u003c/p\u003e\u003cp\u003eThese areas focus on how to enhance QI work, but they also indicate why QI efforts may fail to reach their full potential in healthcare. At the system level, continuous QI has primarily focused on the implementation of methods and techniques. Even successful organisations often spend substantial time on reactive problem-solving rather than proactively preventing or addressing issues at an early stage [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. Numerous cultural, technical, structural, and strategic barriers to the full realization of continuous QI in healthcare still exists [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. A frequently cited reason for the relatively limited success of continuous QI is the lack of emphasis on organisational learning, underscoring the need to strengthen the connection between organisational learning and QI [e.g., 26\u0026minus;28].\u003c/p\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eOrganisational learning, agility and quality improvement\u003c/h2\u003e\u003cp\u003eLearning is an important feature of both creative and innovative processes and the PDSA cycle. To address current and future challenges, healthcare organisations and their employees must improve their ability to combine continuous QI with organisational learning [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. A recent review [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e] identified key elements of successful interventions for strengthening continuous organisational improvement and learning capability. These included engaged managers applying strategies and structured processes that supports improvement and learning by involving experimental learning. In addition, external training and guidance aids the development of internal knowledge, skills and confidence, while conditions, fostering autonomy, accountability and psychological safety empower individuals and teams to engage in improvement and learning [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. However, more knowledge is still needed regarding how contextual factors influences the application of QI and how it can improve organisational learning and innovation [e.g., 30].\u003c/p\u003e\u003cp\u003eOrganisational agility has emerged as a key concept in organisational learning, especially in dynamic environments [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. The relationship between agile approaches and lean management, rooted in QI has been debated [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. There is less consensus on how to define and describe organisational agility, but the framework of Wendler and colleagues [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e, \u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e] provide some understanding for its application in dynamic healthcare contexts. Organisational agility\u0026rsquo;s three components are structure, people and prerequisites. An organisation possessing organisational agility has structures that aid fast and flexible responses to change. Prerequisites consist of adequate organisational values and a supportive infrastructure, while people agility refers to the capabilities of staff and managers to deal with change and translate organisational agility into action. Learning is a key aspect of people agility and involves engaging in research and innovation, reflecting on experiences, and obtaining feedback on improvement efforts [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e]. This aligns with the importance of collaboration when working with QI, i.e., ensuring that colleagues and communities with multidisciplinary knowledge work together, valuing interaction and the sharing of knowledge and resources [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. One benefit of increased organisational learning is improved problem solving, which can ultimately lead to better organisational performance [36\u0026minus;38]. Organisational learning and continuous QI can mutually reinforce each other, for example, when teams go through multiple improvement cycles, processing experiences and knowledge, generating learnings, new knowledge, new ideas and solutions [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Building organisational capability for continuous improvement and learning involves strengthening these abilities in its members, which in turn supports changes in behaviour and work practices. Behavioural changes require capacity and motivation as well as supportive contextual opportunities [e.g. 39]. Although the benefits of QI and organisational learning for driving organisational change are well recognised, the time and effort required for double loop learning [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] often go overlooked in practice and receive limited attention in the literature.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eThe Agile Stepwise Quality Improvement approach\u003c/h3\u003e\n\u003cp\u003eTo address some of the practical challenges of implementing QI in dynamic healthcare settings, and to support the development of continuous organisational improvement and learning capacity and organisational agility [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e], we developed a QI approach, Agile Stepwise QI, that integrates elements from multiple fields besides QI: organisational learning, organisational agility, behavioural psychology, implementation science, innovation and agile project management. In this study, Agile Stepwise QI was pilot tested at two labour wards in a large Swedish hospital.\u003c/p\u003e\u003cp\u003eThe process begins with an initial problem analysis of chosen challenges or issues, followed by a brainstorming of ideas. The latter involves identifying existing or needed motivation, capabilities, and opportunities as well as discussing the consequences of the suggested interventions, in line with the COM-B model for behavioural changes [\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e]. Small agile sprints, or test-loops, are inspired by agile project management and the Scrum framework [e.g., 40, 41], which use frequent feedback and collaborative decision-making when incrementally developing innovations and new products. These relatively small and quick tests of ideas using multiple feedback-loops, and fostering a collaborative environment [\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e], enhance learning and may address some of the identified shortcomings in the practice of the PDSA cycle. Breaking down what to test and simplifying incremental tests-loops is expected to make QI manageable. This approach helps ensure that progress remains achievable even when time and resources are limited during high workloads and understaffing, or in volatile periods. Slowing down a change process and testing smaller aspects of an idea or a solution, then building on the results, can be easier during such circumstances. The process of creative idea generation, experimentation and further adaptation, development, and new tests (or abandonment of an idea) is all seen as a natural part of a change process.\u003c/p\u003e\u003cp\u003eAgile Stepwise QI places a strong emphasis on organisational and individual learning processes and their crucial role in behavioural and organisational change. More profound changes, requiring double loop learning, are often necessary when changing work approaches, and routines in organisations. The approach support staff in addressing challenges and problems and seeks to promote informal learning during work hours, which constitutes the primary form of workplace learning [e.g., 42\u0026minus;44]. Achieving both informal and more deliberate planned non-formal workplace learning aligns with the continuous learning expected in agile organisations [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eTo facilitate testing and support future full-scale implementation, the approach is divided into three phases: Phase 1 Ingroup and self-testing, Phase 2 Enlarged testing, and Phase 3 Scaling up. The improvement team and/or managers responsible for the change idea can revert to an earlier phase, if necessary (see Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). While the approach builds on iterative loops, the stepwise procedure is inspired by incremental change processes, in which the initial phases simplify the subsequent ones, thereby enhancing spread and sustainability (See Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eOverview of the three phases in Agile Stepwise QI\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePhase 1\u003c/p\u003e\u003cp\u003eIngroup and self-testing\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003eDescription\u003c/em\u003e: Phase 1 consists of problem analysis, prioritization and development of improvement ideas, followed by small-scale, agile and iterative tests, carried out directly by the QI team during their work shifts.\u003c/p\u003e\u003cp\u003e\u003cem\u003eRationale\u003c/em\u003e: Lowering the threshold for hands-on testing and enabling direct feedback can save both time and energy while also creating momentum for change initiatives [e.g., 45]. To achieve this, the team needs either a high degree of autonomy or access to managers who can make swift and relevant decisions.\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePhase 2\u003c/p\u003e\u003cp\u003eEnlarged testing\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003eDescription\u003c/em\u003e: In Phase 2 the scope of testing is expanded by involving other colleagues as testers and change agents. These colleagues test the ideas during their work shifts and provide feedback to the team. The improvement team prepares the necessary information for the testers and organises the feedback sessions.\u003c/p\u003e\u003cp\u003e\u003cem\u003eRationale\u003c/em\u003e: It is beneficial to begin with motivated and interested colleagues identified as early adopters [\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e]. Proper preparation is crucial for new testers to understand the rationale behind the change idea, its development, and its intended improvements. Feedback sessions are necessary to support learning and adaptation.\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePhase 3\u003c/p\u003e\u003cp\u003eScaling up\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003eDescription\u003c/em\u003e: Phase 3 involves scaling interventions that have been repeatedly tested, refined, and proven to work well. Scaling-up can encompass smaller or larger parts of the unit or organisation and involve managers and other key actors.\u003c/p\u003e\u003cp\u003e\u003cem\u003eRationale\u003c/em\u003e: As in previous phases, it is important to learn by collecting feedback and suggestions, and to be ready to discuss, refine, adapt or further develop the intervention to suit new conditions and users. Support from managers and decision-makers is essential for successful implementation, follow-ups and potential adaptations [e.g., 23,47].\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eIndividual or group reflections on feedback is central to iterative testing. To fully engage in learning during test cycles, repeated reflection sessions - where actions and outcomes are analysed \u0026ndash; are essential. The approach includes two types of meta-reflection that should be carried out regularly: 1) Retrospective reflection (\u0026lsquo;retrospect\u0026rsquo;) on the original problem analysis and how it has been addressed over time; and 2) Reflection on how the QI team and colleagues have engaged in the improvement process over time to identify lessons learned. The latter aims to strengthen organisational learning at the ward or unit level and promote sustainability, particularly when QI team members are replaced. Some external support (e.g., from an internal support function) is also needed to aid the QI team.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eThe purpose of the study was to investigate whether, and how, an Agile Stepwise QI approach could enhance organisational improvement and learning in a large obstetric unit with two labour wards, despite contextual volatility. Three specific research questions were addressed:\u003c/p\u003e\u003cp\u003e\u003col\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eWhat impact does the approach have at individual, team and unit levels?\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eWhat features of Agile Stepwise QI influence improvement and learning and how?\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eWhat are the contextual conditions, barriers, and facilitators affecting implementation and use of the approach?\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003c/ol\u003e\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThis case study of a large obstetric unit with two labour wards uses an in-depth, longitudinal process approach [\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e]. It is action-oriented and incorporates features of action research [\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e, \u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e], as the approach and the implementation were adapted and refined over time. Such an adaptive strategy can better handle unforeseen events and has been suggested as feasible in fragmented organisational settings where the number of involved actors, potential relationships, and level of complexity are high [\u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e]. Accordingly, the approach initially developed by two researchers (MEN and ME) was further refined and adapted to align with clinical practice during the initial implementation period. Features of process evaluation [\u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e52\u003c/span\u003e, \u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e] were used, and over time, data about contextual features, the implementation process, and experiences and impact of the intervention on individual, group, and organisational levels were collected. The Agile Stepwise QI approach draws on knowledge from multiple disciplines, each with its own scientific traditions, concepts and models. In this study, we use the term \u0026lsquo;impact\u0026rsquo; to refer to the perceived influence and effects of applying the new approach, based on subjective reports and observations. This usage may differ from how the term is defined or applied in other studies and models.\u003c/p\u003e\n\u003ch3\u003eCase characteristics\u003c/h3\u003e\n\u003cp\u003eMaternity care in Sweden is publicly funded and free of charge. Most women in Sweden give birth in physician-led obstetric units within hospitals. Currently, a few of the 21 Swedish regions responsible for providing healthcare offer alternative birth options with continuity of care throughout pregnancy, labour, and the postnatal period. Midwives are the primary care providers during labour and birth, enacting an autonomous role in caring for women considered low risk. If complications arise, or if the woman is considered high-risk, the midwife continues to provide care for her, while maintaining communication with physicians who, in these cases assume medical responsibility [\u003cspan citationid=\"CR54\" class=\"CitationRef\"\u003e54\u003c/span\u003e]. Maternity care includes nurse assistants, staff with secondary education and no formal training within midwifery or obstetrics [\u003cspan citationid=\"CR55\" class=\"CitationRef\"\u003e55\u003c/span\u003e], who assist midwives and provide supportive care to women. Since 2018, obstetric and midwifery care in Sweden has undergone changes and volatile periods, with challenges in staff retention and high turnover. The ongoing shortage of midwives in Sweden [\u003cspan citationid=\"CR56\" class=\"CitationRef\"\u003e56\u003c/span\u003e] is predicted to continue until 2035, despite efforts to address the problem.\u003c/p\u003e\u003cp\u003eThe study was conducted at two labour wards in a large teaching hospital, geographically spread across two main sites and organised under a single obstetric unit. The labour wards are hereafter referred to as Site 1 and Site 2. Site 1 has an annual birth rate of 3700 and is commissioned to provide care for women with severe chronic diseases, high-risk pregnancies, and extremely preterm births. Site 2 has an annual birth rate of 4500 and holds a special commission for perinatal psychiatry and care of women with HIV. Both labour wards, particularly Site 2, are in areas with high rates of immigrants and women of lower socio-economic status.\u003c/p\u003e\n\u003ch3\u003eData collection\u003c/h3\u003e\n\u003cp\u003eMultiple sources of data were used to provide information on context, process, and impact. An overview of the types of data collected over time is presented in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eOverview of the data used in the study.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"8\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eData on:\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eTOT\u003c/p\u003e\u003cp\u003eN\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e\u003cp\u003ePre-intervention period 2020\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eMain intervention period\u003c/p\u003e\u003cp\u003e2021\u0026ndash;June 2022\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003eFollow-up period June 2022\u0026ndash;Sep 2024\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eArchival data I\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eContext\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e225\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"5\" nameend=\"c8\" namest=\"c4\"\u003e\u003cp\u003eDocumentation about events in the hospital organisation, in maternity care in the region and in the obstetric unit \u003cem\u003e2017\u0026ndash;2023\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eArchival data II\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eProcess\u003c/p\u003e\u003cp\u003eImpact\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003e91\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e\u003cp\u003eDocumentation made by improvement teams \u003cem\u003e2021\u0026ndash;2022\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eInterviews\u003c/p\u003e\u003cp\u003eManagers, QI teams, QI-facilitators\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eContext\u003c/p\u003e\u003cp\u003eProcess\u003c/p\u003e\u003cp\u003eImpact\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e24\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e\u003cp\u003eIndividual interviews n\u0026thinsp;=\u0026thinsp;9\u003c/p\u003e\u003cp\u003eDec 2020-Jan 2021\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eIndividual n\u0026thinsp;=\u0026thinsp;1\u003c/p\u003e\u003cp\u003eGroup n\u0026thinsp;=\u0026thinsp;1x5 people\u003c/p\u003e\u003cp\u003e2022 Spring\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003eIndividual\u003c/p\u003e\u003cp\u003en\u0026thinsp;=\u0026thinsp;14\u003c/p\u003e\u003cp\u003e2022 June-Sep\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eField observations\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eContext\u003c/p\u003e\u003cp\u003eProcess\u003c/p\u003e\u003cp\u003eImpact\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003e127\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003eField observations\u003c/p\u003e\u003cp\u003e2021\u0026ndash;2022\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003eField observations\u003c/p\u003e\u003cp\u003e2023 Spring\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eQuestionnaire \u0026ndash; qual.\u003c/p\u003e\u003cp\u003eKey informants\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eImpact\u003c/p\u003e\u003cp\u003eSustain-ability\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003eQuestionnaire n\u0026thinsp;=\u0026thinsp;2\u003c/p\u003e\u003cp\u003e2024 Sep\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003eInterviews\u003c/h2\u003e\u003cp\u003eSemi-structured interviews were conducted by the MEN before the onset of the intervention, during the process and 2,5 years after the initial intervention. A first round of 9 interviews was conducted in December 2020 and January 2021 with key actors who had knowledge of the obstetric unit, each site and experiences with QI work in the unit. The sample included higher- and lower-level managers (3), improvement facilitators (2), and members of two QI teams (2 midwives and 2 obstetricians). Questions focused on the history, current situation, and improvement needs at the unit. In addition to background information (position, function and tenure) the questions (Supplementary 1) covered the following areas: perceived challenges and needs for improvement, QI strategies and QI approach, competence, knowledge, support and resources for development and QI; conditions, barriers and facilitators for development and for QI, follow-up, spread and sustainability of development and QI, views on development, suggestions, and future outlook for QI-work.\u003c/p\u003e\u003cp\u003eIn June 2021, two interviews were conducted to follow-up on the development process, gather experiences, and identify changes, learnings, and impact. One individual interview was conducted with the unit\u0026rsquo;s internal facilitator, and one group interview with five managers, representing all professions at both sites.\u003c/p\u003e\u003cp\u003eFinally, 14 semi-structured interviews were conducted in 2022, 13 June\u0026minus;September with QI team members, first- and second-line managers, and the internal facilitator. An additional interview was conducted in November 2022 with the internal facilitator to follow up on further development. Questions addressed perceived effects and changes, whether and how features of the approach had been used, and whether and how they had been useful or effective when in enhancing QI work and introducing changes at the site/unit (Supplementary 1). All interviews were audio-recorded and transcribed verbatim.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eField observations\u003c/h3\u003e\n\u003cp\u003eFour non-participant observations were conducted by MEN during three workshops and one QI team meeting. They were complemented by field observations made during and/or immediately after activities, meetings and interactions with QI teams and other key actors (e.g. senior midwives\u0026rsquo; workshops). Field observations (n\u0026thinsp;=\u0026thinsp;127) were documented by the internal facilitator (ME), with access to both sites due to her dual role as researcher and as a university midwife commissioned to support the introduction of new knowledge and development at the obstetric unit.\u003c/p\u003e\n\u003ch3\u003eArchival data\u003c/h3\u003e\n\u003cp\u003eDocuments were collected to 1) describe the pre-intervention situation and historical context, 2) follow the change process at the two sites and monitor situations or contextual changes that could affect the implementation, and 3) gather information on organisational decisions and changes before, during and after the intervention period. This included documentation describing organisational structure, previous or ongoing organisational changes, goals and strategies. Documentation produced by the QI teams was collected to shed light on the progress of the QI teams. These consisted of meeting agendas, minutes and working material, such as notes, Miro boards [\u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e57\u003c/span\u003e] and Power points. All documents were screened and sorted to provide information on the context, the use of Agile Stepwise QI, and impact of the intervention.\u003c/p\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003eQualitative questionnaire\u003c/h2\u003e\u003cp\u003eIn September 2024, a questionnaire with five open-ended questions was sent to key members still working at the two sites to investigate the use and sustainability of Agile Stepwise QI, as well as the sustainability of the major changes the QI teams had implemented with the help of the new approach. Due to high turnover of involved staff, the questionnaire was sent to one person per site (n\u0026thinsp;=\u0026thinsp;2) who had insight into the Agile Stepwise QI intervention: one QI team leader and one midwife participating in several QI team tests. The questionnaire was sent via e-mail in September 2024 and consisted of five open-ended questions addressing perceived indications of the continued use of the approach, barriers to using it, and the sustainability, usability and challenges in continued use the interventions implemented by the QI teams 2021-22.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003eData analysis\u003c/h2\u003e\u003cp\u003eAll qualitative data, including interviews, documents, questionnaires, written observations, and field diary notes, were analysed using conventional content analysis [\u003cspan citationid=\"CR58\" class=\"CitationRef\"\u003e58\u003c/span\u003e]. The following areas were used to structure the analysis and answer the research questions (type of data used for each area in \u003cem\u003eitalics\u003c/em\u003e):\u003c/p\u003e\u003cp\u003e\u003col\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eCharacteristics of the pre-intervention situation \u003cem\u003e(organisational documents and interviews)\u003c/em\u003e\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eUse of the main parts of Agile Stepwise QI after the implementation, and their perceived importance for QI work \u003cem\u003e(QI team documents, field-observations and interviews)\u003c/em\u003e\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eImpact of the use of Agile Stepwise QI on: a) individual team members; b) the QI teams and their QI approach; c) the obstetric unit? \u003cem\u003e(interviews, questionnaire)\u003c/em\u003e\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eContextual factors and their effect on implementation and use of Agile Stepwise QI \u003cem\u003e(Organisational documents, field observations and interviews)\u003c/em\u003e\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003c/ol\u003e\u003c/p\u003e\u003cp\u003eAll documents were screened and sorted chronologically to provide information on the context pre-intervention, during, and after implementation. Analyses were conducted by MEN, ST and ME using a Miro board to chronologically visualise events and interventions and to triangulate findings on the use of the approach in interviews and documents for RQ2-4. QI team documents were also scrutinised for information on the use of Agile Stepwise QI, improvement areas in focus, impact of the approach, and tested interventions. Triangulation among documents, field observations, and interviews were used to identify and validate contextual events reported to have influenced implementation or QI-work. QI team documents and field observations were also used to strengthen findings in the final interviews, particularly regarding the use of the approach and its reported impact. Interviews were transcribed verbatim, the text was sorted question by question and reduced to pieces of text with similar meanings, and content analysis was used to find patterns in relation to the three research questions. MEN and ST conducted the initial analyses, discussed interpretations, and once in agreement, reviewed them with ME to reach consensus on the interpretations. The qualitative questionnaire contained less extensive data and were read by MEN, ME, and ST, analysed and summarized by MEN, and interpretations presented and discussed with all authors.\u003c/p\u003e\u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eThis section describes the pre-intervention situation, the implementation interventions, and the contextual factors influencing the implementation process. It outlines the impact of the approach on QI work, QI teams, key actors, and the obstetric unit and addresses sustainability of the approach and improvements. Finally, it summarises views on important conditions, enablers and barriers.\u003c/p\u003e\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\u003ch2\u003ePre-implementation situation at the obstetric unit\u003c/h2\u003e\u003cp\u003eInterviews were conducted to provide vital contextual information, understand the pre-intervention situation, and identify challenges and needs, forming a basis for comparisons and practical planning.\u003c/p\u003e\u003cp\u003eBetween 2017 and 2020, the region decided to allocate funding received from a national programme to educating staff in QI and the use of national quality registries (e.g. the Swedish Pregnancy Register). As part of this initiative, three interprofessional QI teams were established at each of the two labour wards (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Each team had a designated team leader who received QI training and subsequently served as a QI coach. Additional QI training was provided to selected staff members. Initially, the teams were supported by external QI coaches. In 2020, a 24-month planning structure e.g., the yearly QI wheel was introduced, in which each QI team\u0026rsquo;s improvement area was prioritised for two months at the respective sites. This was done to enhance changes and clarify ongoing improvements for staff. Staff and managers at both sites expressed similar views on the obstetric unit\u0026rsquo;s difficulties and challenges, areas for improvement, and their own needs (see Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003ePre-intervention challenges and difficulties, needed improvements and requirements for QI at both sites\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eExpressed challenges/difficulties\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNeeded improvements\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eExpressed needs for QI work\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eStaff situation\u003c/b\u003e: High staff turnover, particularly among midwives, resulting in a lack of competence, and a large number of new employees.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eTeamwork\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eSupport for QI from managers\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eImpact of previous organisational changes\u003c/b\u003e: Recent reorganisation, physical relocation to a new hospital building, and multiple changes of first-line managers resulted in a need to build trust and for staff to gain influence in the organisation, which made QI work difficult.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCommunication\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003eSupport for the managers\u003c/em\u003e in ways to implement changes.\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eOrganisational size, structure, and way to organise work\u003c/b\u003e: Many staff per manager, especially midwives and nurse assistants, made it hard to reach staff, create interest, and provide conditions for QI and changes.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eConsensus over tasks and responsibilities\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMore knowledge about development/implemen-tation, incl. support tools\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eDifficulties in improving work at the unit\u003c/b\u003e: Hard to implement improvement suggestions and decided changes, and an expressed need for a more structured approach to QI work.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eSustainability of accomplished improvements\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003eA holistic view on the obstetric unit\u0026rsquo;s work\u003c/em\u003e, instead of focusing on parts or solely on production\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eTeamwork, communication, and the sense of community\u003c/b\u003e: Lack of communication in teams providing care to women in labour and a need to strengthen a sense of community.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePatient involvement\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eManager\u0026rsquo;s engagement\u003c/b\u003e: Lack of strategic vision, engagement in QI work and capacity and knowledge to support QI teams.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePatient safety\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eQuality of care\u003c/b\u003e: Patient safety, avoidable harm and interventions (e.g., perineal trauma, haemorrhage, CS, augmentation with oxytocin), and patient involvement were areas in need of improvement.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003eSpecific improvement areas\u003c/em\u003e (e.g., reduce severe perineal trauma*, postpartum haemorrhage, and CS)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"3\"\u003eCS\u0026thinsp;=\u0026thinsp;caesarean section, *Injuries affecting the anal sphincter complex\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\u003ch2\u003eInterventions to implement Agile Stepwise QI\u003c/h2\u003e\u003cp\u003eImplementation of Agile Stepwise QI began in January 2021. During this period, activities were performed simultaneously at both sites for the interprofessional QI teams, consisting of midwives, obstetricians and nurse assistants, and for the managerial levels and senior midwives (see Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Initial workshops were the same for the QI teams at both sites, while subsequent activities were adapted to the situation at each site. The implementation approach was interactive and iterative, building on the unfolding situation and fine-tuned to fit the targeted teams and managers.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eMost of the activities focused on the \u003cem\u003einterprofessional QI teams\u003c/em\u003e, including four researcher-led workshops, team meetings, communication with team leaders, and periods of practical testing of improvement ideas. The first round of workshops was initiated with the two QI teams responsible for supporting vaginal birth. The teams were chosen based on the number of members (more than 4) and the higher complexity of the focus area (many factors impacting outcomes). Between workshops, the QI teams worked independently, developing and testing ideas, and holding team meetings, supported by an internal facilitator, a university midwife. Due to pandemic restrictions in 2021, conducting in-person workshops or joint sessions for the two sites was not always possible. Instead, some workshops were held digitally, with break-out sessions for discussion and the use of Miro boards to aid interaction. Workshop content remained consistent during spring 2021.\u003c/p\u003e\u003cp\u003ePrevious improvement approaches used by the QI teams often involved time-consuming reviews of medical records and evaluation via checklists, surveys, or by monitoring changes in outcomes, such as the number of unplanned CS or severe perineal trauma, i.e., injuries affecting the anal sphincter complex. The workshops aimed to improve the participants' QI knowledge and to guide and support the teams during the implementation process. Agile problem analysis, idea generation, small test loops, and the stepwise approach were introduced during the first two workshops.\u003c/p\u003e\u003cp\u003e\u003cem\u003eWorkshop 1\u003c/em\u003e introduced the Agile Stepwise QI approach. A problem analysis visualised on Miro boards were conducted where the teams identified issues mainly based on their experiences but also considering the unit\u0026rsquo;s recordings in national quality registries, e.g., the Swedish Pregnancy Registry. The analysis included desired behavioural changes across professions and shifts. \u003cem\u003eWorkshop 2\u003c/em\u003e focused on small-scale agile testing during clinical work, encouraging teams to test multiple ideas in parallel to address several aspects of problems identified during the analysis. Each team developed 8\u0026ndash;10 ideas for practical testing. \u003cem\u003eWorkshop 3\u003c/em\u003e supported evaluation of tested ideas, guiding decisions to scale, refine, or abandon them. All phases of the stepwise approach were introduced - starting with in-group testing, followed by broader colleague involvement. Phase 3, focused wider spread, was addressed later in the implementation. \u003cem\u003eWorkshop 4\u003c/em\u003e focused on retrospective reflection, reviewing how the original problem had been addressed over time and assessing what worked. Both teams faced challenges due to understaffing, making participation in workshops and testing difficult. At Site 2, frustration arose when a promising test - relocating the senior midwife\u0026rsquo;s office to improve conditions for leadership and support - failed. The change was not feasible, as coordinators also needed support. The retrospective reflection session helped shift the QI team\u0026rsquo;s perspective, fostering understanding and enabling continued development with a revised focus and new test ideas. This illustrates the value of the retrospect in enhancing learning throughout the testing process. \u003cem\u003eWorkshops 5\u0026ndash;6\u003c/em\u003e built on earlier efforts and included additional problem analyses, identification of test phases, and discussions on learning strategies and managing change during challenging periods. They also covered progression from Phase 2 to Phase 3 in the Agile Stepwise approach (see Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e), analyses of upcoming challenges for 2022-23, support for the learning of other QI teams, clarification of tests for other staff, and analyses and testing of a top-down initiated intervention in which managers also became involved. The last workshops and meetings were mainly held by the internal facilitator to support further spread and sustainability.\u003c/p\u003e\u003cp\u003e\u003cem\u003eSenior midwives\u003c/em\u003e were identified as key actors for driving improvement, and it was considered important to mobilise their support for the QI teams. A senior midwife is an experienced midwife who provides guidance and advice to less experienced colleagues, supports and collaborates with the residents and obstetricians on duty, and takes a leading role in emergency situations. However, the support provided by senior midwives to their colleagues varied widely, likely due to differing views on what to prioritise or how to best offer support. A series of workshops were conducted with the unit\u0026rsquo;s 26 senior midwives during 2021 and 2022. The workshops included analyses of their role, focusing on how to provide support under various conditions, such as when testing change ideas. Midwifery care was discussed, and the senior midwives were asked to conduct small-scale agile tests of different ways to provide support.\u003c/p\u003e\u003cp\u003e\u003cem\u003eManagers at several levels\u003c/em\u003e were important for the introduction of an improved QI approach and for supporting the QI teams. Managerial approval had been secured before designing the implementation. The plan was to gradually involve managers in the process, but the numerous organisational changes and high turnover among managers made this difficult. Workshops and presentations for managers were carried out during the initial implementation period, primarily to keep first-line managers informed about the process, but also to update the entire management team. However, by 2022 onwards, few such opportunities were offered.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\u003ch2\u003eContextual factors affecting the obstetric unit\u003c/h2\u003e\u003cp\u003eBoth previous and ongoing external events, as well as intra-organisational changes, affected the situation at the obstetric unit and its two sites during the implementation period (see Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e for an overview).\u003c/p\u003e\u003cp\u003eSeveral \u003cem\u003eexternal events and conditions\u003c/em\u003e at the national level affected the implementation, both directly and indirectly. Improving women\u0026rsquo;s healthcare had been a political priority for some time due to variation in care quality and provision, as well as an increasing problem with staff turnover, particularly among experienced midwives. To address these and other related issues, the government launched a national long-term programme in 2015 to improve care for women during pregnancy, childbirth, and the postnatal period, providing additional resources for improvement to all regions. The region hosting the study sites had used some of these resources to initiate QI in all obstetric units prior to the start of the study. Between 2020 and 2022, the Covid-19 pandemic affected all healthcare staff and patients, as well as the conditions for conducting QI-work. In October 2022, the general election in Sweden resulted in new government and a shift in political majority, both nationally and in the studied region, leading to a period of change.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eVarious \u003cem\u003einternal contextual factors\u003c/em\u003e, such as unfolding situations and organisational changes within the regional organisation, hospital, and obstetric unit before and during the study period, influenced the implementation and impact of Agile Stepwise QI. At the regional level, the extended shortage of midwives and their pressured work situation triggered an uprising among midwives in the region\u0026rsquo;s obstetric units in October 2021. Many midwives threatened to leave their employment and profession, which prompted the politicians to launch a regional political programme with several action-strategies to solve the crisis. For example, it was suggested to implement one midwife per childbirth (active phase), higher number of obstetricians at labour wards, improved care processes, work-place rotation, supervision and mentorship, and competence and career-model for midwives.\u003c/p\u003e\u003cp\u003eUsing funding from the national programme for women\u0026rsquo;s health, the region initiated a pilot project in 2018 to implement midwifery continuity of care during pregnancy, childbirth and the postnatal for women with fear of childbirth, which was launched at Site 2. The pilot was positively evaluated, and in 2022 it was decided to implement the care model regionally, but without the reimbursement and scheduled work-time agreements used in the pilot, sparking internal debate and disagreement at the obstetric unit. Furthermore, to address high staff workload and reduce pressure on existing obstetric units, politicians decided to open a new obstetric unit, scheduled to open in March 2023. This required recruiting midwives and obstetricians also from other obstetric units in the region, paradoxically increasing competition for skilled personnel.\u003c/p\u003e\u003cp\u003eAt the hospital level, several major structural changes demanded attention and adaptation, particularly from managers. In 2016, a comprehensive organisational change was implemented, introducing a matrix organisation in which horizontal thematic areas complemented the hierarchical structure. This new way of organising work required more cross-sectional meetings and long-term adjustments to function effectively. In 2021, the theme Women\u0026rsquo;s and Children\u0026rsquo;s health was reorganised to Women\u0026rsquo;s Health and Allied Health Professionals (i.e., to include physiotherapists, occupational therapists, and psychologists). Operations at both sites had to relocate several times during the implementation period, increasing strain on managers and staff and causing disruptions to both regular operations and QI-work. At Site 1, a new ward opened, and the labour ward was expanded to accommodate more births per year, from 3200 to 3700 in 2022.\u003c/p\u003e\u003cp\u003eIn 2020, two parallel management structures were introduced at the obstetric unit: one for midwifery, overseeing midwives and nurse assistants, and one for medical staff, overseeing physicians (denoted Manager midwifery, and Manager medical in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Additionally, the high staff turnover at both sites, except for physicians at Site 1, had a major impact on the implementation. The unit experienced a volatile management situation, as many managers left and were replaced by temporary managers and eventually by new permanent ones (see Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). This turnover occurred at all levels, from higher-level management to first-line managers. From the start of the implementation in 2021 until 2023, there were nine changes in higher and middle-level management and four changes among first-line managers.\u003c/p\u003e\u003cp\u003eRegarding the QI teams, those at Site 1 were relatively stable in terms of staff, while the teams at Site 2 underwent considerably changes. Many QI team members at Site 2 left, therefore it was decided to move the remaining members from the three QI teams into a single team. By 2023, only one person who had participated in the main intervention remained at Site 2.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec17\" class=\"Section2\"\u003e\u003ch2\u003eThe perceived impact of the Agile Stepwise QI approach\u003c/h2\u003e\u003cp\u003eAfter 12 months the main implementation period was followed by a consolidation period during which need-based support was provided by both researchers and members of the organisation, for example, the internal facilitator and QI team leaders. Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e summarises the perceived impact of Agile Stepwise QI on QI-work at the unit, on the QI teams and key actors and at the unit level. Specific interview questions addressed the perceived impact and influence of the Agile Stepwise QI approach, although this was also reflected in responses to other questions. The perceived impact encompassed learnings, acquired knowledge, and new ways of thinking and acting, both as an individual, as a QI team and/or at the unit.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003ePerceived impact on QI work and on individual, team and unit levels\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003ePerceived impact based on interviews\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eImpact on QI work\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026bull; Faster, easier and smoother way to achieve change\u003c/p\u003e\u003cp\u003e\u0026bull; Stepwise testing provided insights, courage and better opportunities for forthcoming changes\u003c/p\u003e\u003cp\u003e\u0026bull; Slowing down the process, and incorporating revisions and suggestions from others enhanced changes and the spread of improvements\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026bull; Led to actual changes\u003c/p\u003e\u003cp\u003e\u0026bull; Feasible and sustainable approach\u003c/p\u003e\u003cp\u003e\u0026bull; Perceived as attractive by and for healthcare staff\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eImpact on QI team and key members\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026bull; Positive and motivating, made QI-work easier and more enjoyable\u003c/p\u003e\u003cp\u003e\u0026bull; Increased inspiration, drive and creativity within the team\u003c/p\u003e\u003cp\u003e\u0026bull; A new mindset and way to deal with issues \u0026ndash; also beyond the workplace\u003c/p\u003e\u003cp\u003e\u0026bull; Valuing both positive and negative feedback\u003c/p\u003e\u003cp\u003e\u0026bull; Greater emphasis on clarity of information\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026bull; Increased understanding of:\u003c/p\u003e\u003cp\u003e- the importance of feedback\u003c/p\u003e\u003cp\u003e- different perspectives (e.g., between professions or wards)\u003c/p\u003e\u003cp\u003e- the value of ensuring diverse perspectives, discussions, reflections and arenas for open communication during change\u003c/p\u003e \u003cp\u003e- change and learning processes at work, and the time change might require\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eImpact and sustainability at unit level\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026bull; Testing before implementation of any change became more common\u003c/p\u003e\u003cp\u003e\u0026bull; Scaling up tested solutions remained challenging, though QI team members with decision mandate facilitated this\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026bull; Involving managers and senior staff was difficult due to high turn-over, which affected sustainability.\u003c/p\u003e\u003cp\u003e\u0026bull; Endures at one site 2,5 years after implementation but not on the other\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eAll QI team members and managers described a change in behavioural approach compared with previous QI work. Agile Stepwise QI was described as a faster and easier way to achieve change. Before the intervention, it was common for QI teams to find or develop a solution, propose a change to the entire unit and implement it mainly by providing information at meetings and via written information. If full implementation failed, it often felt like a failure for the teams. By contrast, Agile Stepwise QI was experienced as a smoother way that led to tangible changes. It was easier to evaluate smaller tests than in previous attempts, and to recognise which changes were not worth pursuing. It was also easier to involve staff when it was framed as a test. Overall, the approach was perceived as attractive both for QI teams and staff. Informants commented on specific features of the approach and emphasised those they found most important.\u003c/p\u003e\u003cp\u003e\u003cem\u003eSmaller agile test-loops\u003c/em\u003e, initially tested by QI team members, were described as the most prominent benefit of Agile Stepwise QI. They provided speed and momentum, and involving team members created better opportunities to test ideas and quickly adapt or abandon them. Having a few people test first saved resources, and tests could easily be carried out during a work shift. The smaller scale also meant that several tests could run simultaneously, less well-defined ideas could be developed and clarified, and it felt safer to experiment. The value of being able to share one\u0026rsquo;s opinion and suggestions for improvement, as well as the importance of clearly communicating the purpose of each test, was highlighted.\u003c/p\u003e\u003cp\u003eThe process of prioritising ideas was sometimes described as disordered, with many suggestions and difficulties in choosing between them. Having too many ongoing tests was also considered challenging. The risk of favouring simple change ideas that were easy to achieve, while avoiding those requiring deeper transformation was highlighted. It was noted that revising or abandoning the thinking behind initial ideas could sometimes be frustrating.\u003c/p\u003e\u003cp\u003e\u003cem\u003eStepwise implementation with follow-ups\u003c/em\u003e was generally perceived as positive and smooth. The team\u0026rsquo;s initial tests involved simpler types of changes, such as improving communication between midwives and physicians by relocating physicians\u0026rsquo; workspace to the same office used by the midwives. The benefit of starting on a small scale instead of full implementation, which might not produce the desired change, was highlighted. The small tests worked well in both teams, and gathering feedback by listening to staff was seen as an important step in enhancing change and promoting wider adoption. One challenge was managing both one\u0026rsquo;s own and other\u0026rsquo;s expectation regarding the speed of change, because the stepwise testing of ideas slowed down the overall change process. This was less in line with the more common practice of presenting an intervention and then proceeding to full-scale implementation.\u003c/p\u003e\u003cp\u003eThe \u003cem\u003ein-group small-scale testing in Phase 1\u003c/em\u003e, which focused on testing ideas within the team, rather than persuading others to change behaviours, was perceived as simple, useful, effective, and enjoyable. It also worked well during night-shift conditions, where involving staff in changes usually is difficult. It was described how this phase was applied beyond the QI team, both by individuals and by senior midwives. Some tests were more challenging than others, and the opportunities to participate varied for each team member.\u003c/p\u003e\u003cp\u003eThe initial and secondary \u003cem\u003eproblem analyses\u003c/em\u003e were guided by the internal facilitator, with further analyses to be initiated by the QI team. These analyses were perceived positively, as they provided support, offered insights, and aided the team in prioritising problems and tests. The presence of varying perspectives on, and differing levels of a problem was emphasized, as were the difficulties the team experienced in agreeing on which problem and idea to choose.\u003c/p\u003e\u003cp\u003eSome key learnings were highlighted, such as the importance of motivation and understanding the purpose of the test and completing the entire test loop before moving forward. The importance of the QI team\u0026rsquo;s composition and the mandate given to QI teams to decide which ideas to test was emphasised, in particular for Phase 1 and 2. Examples of ideas and solutions tested included: improving communication during work shifts by making information easily available about which midwife is responsible for each woman in labour and how to reach them; clarifying and agreeing on the work process during protracted labour; and adapting the TeamBirth care process, originally developed in the US [\u003cspan citationid=\"CR59\" class=\"CitationRef\"\u003e59\u003c/span\u003e] to improve patient involvement and team communication, to local conditions.\u003c/p\u003e\u003cp\u003eThe \u003cem\u003ePhase 2 involvement of new colleagues\u003c/em\u003e in tests was described as more demanding than in-group testing. Usually, the team leaders, who were senior midwives, presented and disseminated the information, or the senior midwife group were approached to assist. Midwives and assistant nurses experienced better continuity and had more opportunities to reflect on the tests as a group, than physicians, who covered several wards. Obstetricians, and residents were approached more often than gynaecologists. Members of the interprofessional QI team belonged to different work teams and professional groups, for example physicians informed other physicians and the residents they supervised. Nonetheless, identifying motivated staff and encouraging their participation in tests, particularly physicians, remained challenging.\u003c/p\u003e\u003cp\u003eThe spread of information was carried out in various ways, from speaking directly with those involved to informing teams of staff working during a test period. Most informants emphasised the importance of clarifying the purpose of the test. Phase 1 tests with the TeamBirth care process involved patients, and obtaining their feedback was an important component. In Phase 2, patient and staff feedback, as well as and patient narratives were used to convey the purpose of patient involvement to colleagues, which was perceived as a strong motivator. The designated theme months in the unit\u0026rsquo;s yearly QI wheel provided opportunities for the QI team to share information and conduct tests.\u003c/p\u003e\u003cp\u003e\u003cem\u003eScaling-up in Phase 3\u003c/em\u003e meant that beneficial changes identified in previous phases, for example, a new work routine, were implemented across a larger part of the ward or to the entire unit. This included obtaining a mandate from higher level managers for a large-scale test and, eventually, for change itself. In general, more resources were required for information and communication during this phase. The teams regularly involved the lower-level managers in their work, either as team members or by inviting them to QI team meetings. This ensured access to a managerial mandate to approve further spread, particularly for smaller or medium-sized changes. In Phase 2, smaller changes also spread organically.\u003c/p\u003e\u003cp\u003eLarger changes needed to be discussed and planned in collaboration with higher-level managers, particularly if both sites were involved or if the changes affected staff situations, organisation of work, or patient flow. Implementation and follow-ups therefore had to be planned in greater detail. Individuals with connections to higher-level management provided support in this communication. The fact that the QI teams had formal and informal channels to different professional groups, which had already been used to anchor and discuss tests in Phase 2, facilitated Phase 3. The senior midwives\u0026rsquo; group also served as an important hub for support and dissemination. The theme month in the yearly QI wheel supported communication, information and implementation, particularly for larger changes. Information was shared and visualised through a variety of existing meetings, weekly information letters, emails, and often via a physical improvement board. The QI team also held workshops during their theme months. Challenges identified concerned the situation at the unit, with many ongoing changes and improvements and high staff turnover. It took considerable time and effort to ensure that new staff understand QI, the tests, the phases, and what was currently being implemented in Phase 3. Achieving change across the entire unit remained difficult, and the importance of recognising that such change requires time and effort was emphasised.\u003c/p\u003e\u003cp\u003e\u003cem\u003eRetrospective reflections and learning\u003c/em\u003e in the structured retrospect sessions focused on a longer period and were mainly led by the internal facilitator. The benefits of these sessions for motivation were noted by several members, particularly as a reminder of positive results that were easy to forget and as a way of recognising efforts made over time. However, making time for reflection and learning sessions were difficult, not all members participated, and the benefits of having external support during reflection were acknowledged.\u003c/p\u003e\u003cp\u003eThe new approach affected the \u003cem\u003eQI teams and key individuals\u003c/em\u003e. At an individual level using Agile Stepwise QI was perceived as positive and motivating, making QI work easier and more enjoyable. It became easier to test new ideas and less intimidating to fail. Some team members described how, for them, the small agile tests had become a new mindset and a way of addressing issues outside of work, for example in family settings.\u003c/p\u003e\u003cp\u003eThe informants described that the use of Agile Stepwise QI had led to several insights, learnings and changes in the QI team\u0026rsquo;s approaches and action strategies. They reported increased inspiration, drive, and creativity within the team, and that it had become easier to focus, prioritise, and take the next step during change processes. Testing their ideas in practice themselves during work hours was a new and straightforward approach, described as providing better insights, courage, and opportunities for forthcoming changes. Having the mandate to test ideas and work with QI in a more agile way were perceived as feasible and sustainable, also making it easier to encourage others to test at a later stage. The learnings expressed included a new emphasis on clarity in information, an understanding of the importance of collecting and providing opinions on an idea or test, knowing when to abandon an idea, and appreciating both positive and negative feedback. Expanding tests beyond the team provided more information about what did or did not work and a better understanding of different perspectives, for example related to professions or wards. The importance of listening to different perspectives, engaging in discussions and reflections during change processes, and having arenas for open communication was highlighted. Informants further indicated gained knowledge about how to approach processes of change and learning at work, as well as an increased understanding of the time change may require. Slowing down the process by using a stepwise approach, with opportunities for revisions and for incorporating suggestions from others, enhanced changes and the spread of improvements.\u003c/p\u003e\u003cp\u003eThe perceived \u003cem\u003eimpact on the obstetric unit, its wards, and staff\u003c/em\u003e, was generally described as positive, particularly when staff recognised that the QI teams were testing suggestions that could be adjusted or abandoned based on their feedback. The process of reconsidering, putting ideas on hold, and improving or abandoning them were also described as providing important learning opportunities for staff in the unit. Testing was unfamiliar for staff initially, but over time there was greater understanding and less fear of tests or of them leading directly to large changes. Using terms like \u0026ldquo;agile\u0026rdquo; and \u0026ldquo;testing\u0026rdquo; became common. A more open mentality, with positive views on trying new approaches, had emerged, especially on Site 2. Agile Stepwise QI had begun to spread to the other QI teams and the senior midwives at the unit. Spreading the approach to managerial levels provided difficult, particularly to managers responsible for physicians. However, several informants noted that actual knowledge of the approach, and of the precise impact of its use on the majority of staff, remained diffuse, unclear, or largely absent.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec18\" class=\"Section2\"\u003e\u003ch2\u003eSustainability of the approach and the implemented improvements\u003c/h2\u003e\u003cp\u003eTo assess the sustainability of both the Agile Stepwise QI approach and the changes it introduced, qualitative follow-up questions were distributed to both sites 42 months after the initial implementation.\u003c/p\u003e\u003cp\u003e\u003cem\u003eSite 1 -\u003c/em\u003e Agile Stepwise QI continued to be actively used by several QI teams, supported by the QI team leader and the internal facilitator. The approach was gradually applied to new initiatives, such as implementing bedside rounds in the postnatal ward for women with medical conditions or birth complications and adapting and expanding a Swedish version of TeamBirth across antenatal and postnatal wards. The approach was adopted and embedded in many staff\u0026rsquo;s mindset, with a noticeable increase in openness to testing new ideas. Experiencing the benefits of small-scale testing made change easier to motivate and reduced resistance to change. Challenges included sustaining momentum, engaging staff across multiple change initiatives, and tracking who had tested which interventions - partly due to involving too many staff early on. It was also difficult to engage staff with highly variable daily tasks. Training days were suggested as a valuable way to deepen knowledge, scale improvements, and foster peer learning. Successfully tested interventions, such as bedside rounds, were introduced in the antenatal ward and retested in other areas such as the postnatal ward. Of the seven improvement ideas tested at Site 1 in 2021\u0026ndash;2022, six remained in use, while the seventh was being revised with new tests planned (see Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). The TeamBirth care process, adapted by QI teams for the Swedish context and fully implemented in 2023, was partially in use with implementation still ongoing.\u003c/p\u003e\u003cp\u003e\u003cem\u003eSite 2 -\u003c/em\u003e Agile Stepwise QI was not sustained at Site 2, mainly due to high staff turnover. At follow-up, only one member from the original QI team remained. As a result, the remaining members from all three QI teams were merged into one single team with a broader remit, but continued turnover hindered progress, and no active QI team were in place at the time. Plans were underway to form new teams and launch a start-up programme to reintroduce Agile Stepwise QI. Despite these challenges, four improvement ideas tested and implemented in 2021\u0026ndash;2022 were still in use by autumn 2024. Three were functioning well, while the TeamBirth care process implemented in 2023 was not yet fully operational (see Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e). The influx of new and temporary staff, and how they were introduced to routines, was described as a general challenge affecting sustainability of the approach and as a contributing factor to slower implementation of TeamBirth.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eSustainability of implemented improvement ideas 3,5 years after initiation of Agile Stepwise QI\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eImprovement ideas tested at Site 1 (N\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eStatus\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eStructured plan for communication during the second stage of labour\u003c/b\u003e to be used before and during the three-hour reconciliation. \u003cem\u003eAim\u003c/em\u003e: Improve communication and to reduce operative births. \u003cem\u003eImpact\u003c/em\u003e: Considered helpful. \u003cem\u003eVariation in use\u003c/em\u003e: Adaptation to all staff categories involved was a challenge. \u003cem\u003eSustainability\u003c/em\u003e: Requires repeated attention. Senior midwives and physicians further deepened their methods of working with the arrow.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIn use \u0026ndash;\u003c/p\u003e\u003cp\u003erequires repeated attention\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eComputers for doctors in a joint office for several professions\u003c/b\u003e \u003c/p\u003e\u003cp\u003e\u003cem\u003eAim\u003c/em\u003e: Improve communication by enabling midwives, senior midwives, and physicians to reach each other. \u003cem\u003eVariation in use\u003c/em\u003e: Some disturbances were reported initially, and screens were installed to minimise distractions. \u003cem\u003eImpact and Sustainability\u003c/em\u003e not addressed.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIn use \u0026ndash;\u003c/p\u003e\u003cp\u003eworks well\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eAdding names and phone numbers on the occupancy list at the start of each shift\u003c/b\u003e \u003c/p\u003e\u003cp\u003e\u003cem\u003eAim\u003c/em\u003e: Facilitate access to the responsible midwife and nurse assistant, thereby saving time and reducing frustration. \u003cem\u003eImpact\u003c/em\u003e: Less time was spent contacting those responsible for women in labour. \u003cem\u003eVariation in use\u003c/em\u003e: Challenging to get new staff to remember this and to make it a habit. \u003cem\u003eSustainability\u003c/em\u003e not addressed.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIn use \u0026ndash;\u003c/p\u003e\u003cp\u003eworks well\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eIntroduction of the regional guideline for oxytocin in protracted labour\u003c/b\u003e\u003c/p\u003e\u003cp\u003e\u003cem\u003eAim\u003c/em\u003e: Prevent prolonged labour and avoid unnecessary interventions. \u003cem\u003eImpact\u003c/em\u003e: Most of the time, staff adhered to the guideline. \u003cem\u003eVariation in use\u003c/em\u003e: Sometimes confusion about whether to apply this guideline or the one for women with induced labour. \u003cem\u003eSustainability\u003c/em\u003e not addressed\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIn use \u0026ndash;\u003c/p\u003e\u003cp\u003eworks well\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eStructured night rounds\u003c/b\u003e\u003c/p\u003e\u003cp\u003e\u003cem\u003eAim\u003c/em\u003e: Improve communication and information exchange. \u003cem\u003eVariation in use\u003c/em\u003e: Not always performed at the scheduled time due variations in workload. The improvement board is not always reviewed. \u003cem\u003eImpact and Sustainability\u003c/em\u003e not addressed\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIn use - variation\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePlanning flow of inductions\u003c/b\u003e \u0026ndash; planning the flow of induction, organising the process in advance. \u003cem\u003eAim\u003c/em\u003e: Coordinate inductions for improved workflow and reduced waiting times for women. \u003cem\u003eImpact\u003c/em\u003e: Not fully effective due to workload and lack of space. \u003cem\u003eVariation in use\u003c/em\u003e: Not applicable. \u003cem\u003eSustainability\u003c/em\u003e: Testing of an alternative approach was planned.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot in use \u0026ndash; new test planned\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eTeam Birth-SWE \u0026ndash;\u003c/b\u003e \u003cem\u003ea care process using brief team meetings and a designated planning board in the birthing room. Aim\u003c/em\u003e: Improve patient involvement and communication between staff. Tested and adapted to the Swedish context by the two QI teams; implemented in 2023. \u003cem\u003eVariation in use\u003c/em\u003e: The planning board was used, but staff found it challenging to adhere to all components of the intervention. Writing up reconciliations and involving the couple remained difficult, particularly in stressful situations. \u003cem\u003eImpact and Sustainability\u003c/em\u003e not addressed\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePartly used \u0026ndash;\u003c/p\u003e\u003cp\u003eOngoing implement-tation\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSite 2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eN\u0026thinsp;=\u0026thinsp;4\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eInteractive micro meetings\u003c/b\u003e for enhancing an inviting and open climate. \u003cem\u003eAim\u003c/em\u003e: Support newly qualified midwives and residents. \u003cem\u003eImpact\u003c/em\u003e: Appreciated by the newly qualified midwives. \u003cem\u003eVariation in use\u003c/em\u003e: Depended on the senior midwife on duty. \u003cem\u003eSustainability\u003c/em\u003e: Taught to new employees and students. Regular reminders at daily staff start-up meetings. \u003cem\u003eImpact\u003c/em\u003e not addressed\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIn use \u0026ndash; works well, minor variation\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eTime-out (bedside) when protracted labour is diagnosed\u003c/b\u003e \u003c/p\u003e\u003cp\u003eAim: Improve communication and involve patients. \u003cem\u003eVariation in use\u003c/em\u003e: Some time-outs were not conducted bedside. The checklist to use was less familiar to new staff. \u003cem\u003eImpact and Sustainability\u003c/em\u003e not addressed\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIn use \u0026ndash; some variation\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eNew routine at ward rounds\u003c/b\u003e \u003cem\u003eAim\u003c/em\u003e: Improve working climate for open discussions so that all professions feel confident to speak up and share their knowledge. This was achieved by self-introductions, aimed at getting to know one another better including work experience. All professions participate. \u003cem\u003eImpact\u003c/em\u003e: Improved in round routine, with more time for reporting, space for discussions and learning e.g., CTG assessments, clinical practices. Contributed to transparency, greater mutual understanding, and psychological safety. \u003cem\u003eSustainability\u003c/em\u003e: Recently used to highlight areas for discussion e.g., health factors, prevention of postpartum haemorrhage, severe perineal trauma.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIn use \u0026ndash;\u003c/p\u003e\u003cp\u003eworks well, enlarged\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eTeam Birth-SWE\u003c/b\u003e \u003cem\u003e(see above). Aim\u003c/em\u003e: Improve patient involvement and communication between staff. \u003cem\u003eVariation in use\u003c/em\u003e: A challenge was the many new and temporary staff and the way they were introduced to routines. \u003cem\u003eImpact and Sustainability\u003c/em\u003e not addressed\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePartly used \u0026ndash;\u003c/p\u003e\u003cp\u003eOngoing impl-ementation\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eSubcategories only included when mentioned by the informants\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec19\" class=\"Section2\"\u003e\u003ch2\u003eConditions, barriers and enablers for implementation\u003c/h2\u003e\u003cp\u003eConditions, barriers and enablers were highlighted and summarised by the participants. The existence of the QI teams, with a mandate to test improvements was considered as essential to use the approach. Involving motivated and influential team members, who held informal mandates from their professional groups, was a key enabler. Team leaders and the internal facilitator played crucial roles, and their support was mentioned as an enabler. The content and design of the approach were seen as enabling practical QI work. The structure of the problem analyses, the adaptations of ideas through agile test loops, and the stepwise spread were perceived as feasible. The team could also act as a barrier to implementation if it lacked members capable of testing ideas in practice. The need to involve individuals from all relevant professions, holding both informal and formal mandates (e.g. peers, senior midwives, physicians, or first-line managers) was highlighted.\u003c/p\u003e\u003cp\u003ePrioritising among many ideas and choosing between easier and more difficult problems was highlighted as a dilemma, with the risk of favouring minor issues over more important or challenging problems. Follow-ups and evaluations were also perceived as difficult, particularly since the long intervals between QI team meetings during test periods slowed the change process. Another barrier was the lack of support from managers and senior staff at various organisational levels, especially for scaling up tests. For example, engaging key staff, such as senior midwives and physicians, was challenging when transitioning to Phase 2 testing. Additionally, there was a lack of meetings and arenas where QI teams, senior midwives and physicians could discuss ideas and testing.\u003c/p\u003e\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study aimed to address gaps and challenges in the practical use of QI in healthcare. Building on existing QI approaches and knowledge, Agile Stepwise QI was developed to strengthen the capacity for organisational improvement and learning and ed in round-the-clock maternity care. To inform future research and practice, we highlight key features of Agile Stepwise QI and the factors influencing its implementation, use, and sustainability in healthcare organisations.\u003c/p\u003e\u003cdiv id=\"Sec21\" class=\"Section2\"\u003e\u003ch2\u003eInfluential features\u003c/h2\u003e\u003cp\u003eWe identified five influential features of Agile Stepwise QI that supported QI work and enhanced change and learning. Firstly, the \u003cem\u003eopen, holistic problem analyses and creative idea generation\u003c/em\u003e included broader analyses based on experiences, perceived urgency, and mixed information, rather than focusing solely on fewer performance measures and indicators (e.g., quality registry data) or evidence-based clinical interventions, which are more common in QI [e.g., 60]. However, this does not diminish the value of such measures and knowledge; rather, QI teams require other types of information to complement the data recorded in national quality registries.\u003c/p\u003e\u003cp\u003eAgile development is rooted in holistic thinking, and its adoption often requires shifts in organisational culture [\u003cspan citationid=\"CR61\" class=\"CitationRef\"\u003e61\u003c/span\u003e]. We observed some signs of cultural change, for example, staff regularly asking, \u0026ldquo;What do we test today?\u0026rdquo;, indicating a shift from initial hesitancy towards greater openness to experimentation and innovation. Encouraging QI teams to pursue their own ideas, rather than focusing solely on care quality measures, led to improvements in areas such as communication, collaboration, and role clarity. These are examples of conditions and enabling factors that affect care quality, efficiency, and the work environment, thereby extending impact beyond the clinical themes assigned to the QI teams, such as reducing severe perineal trauma or postpartum haemorrhage. This approach fostered a shared understanding and was perceived as motivating, promoting a sense of ownership and ability to influence. It also served as a unifying strategy for combining multiple interventions to achieve a common goal, in line with recommendations to find high leverage solutions rather than rely on a single intervention [\u003cspan citationid=\"CR62\" class=\"CitationRef\"\u003e62\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eSecondly, the \u003cem\u003eagile experimental tests, which were easy to launch\u003c/em\u003e, introduced change through very small incremental steps towards larger transformations, such as improved team collaboration. The ability to break down and test ideas within the team, gather direct feedback, and remain open to adaptation or abandonment proved to be a powerful tool for initiating change. Previous research has shown that improvement efforts in practice often focus on simpler, more easily implemented issues, while more complex and large-scale issues tend to be avoided [e.g., 63]. Similarly, the QI teams in this study began with more straightforward suggestions, such as changing routines for how to contact each other by phone when necessary, before gradually moving on to more complex interventions. The open holistic problem analysis was helpful, as identifying multiple causes generated diverse, often proactive, intervention ideas that could collectively drive change by targeting different aspects of the issue [\u003cspan citationid=\"CR62\" class=\"CitationRef\"\u003e62\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThirdly, the \u003cem\u003estepwise scaling\u003c/em\u003e, starting with in-group testing and gradually involving motivated colleagues, helped spread interventions more smoothly across the ward or unit. This gradual process was seen as less threatening and more manageable. Seeking feedback at each stage made it easier to refine and adapt ideas to different situations. The approach also allowed room for failure without major consequences, as only a single step needed to be reversed rather than restarting entirely, reducing the sense of failure. However, evaluating ideas, obtaining feedback on feasibility, and identifying unintended consequences requires accessible qualitative data. Although process-related information is important for supporting change processes [\u003cspan citationid=\"CR64\" class=\"CitationRef\"\u003e64\u003c/span\u003e, \u003cspan citationid=\"CR65\" class=\"CitationRef\"\u003e65\u003c/span\u003e] the teams were initially unfamiliar with collecting qualitative data, as national quality registries had long been emphasised for evaluating QI at unit and national levels.\u003c/p\u003e\u003cp\u003eFourthly, the \u003cem\u003efocus on joint reflection and learning\u003c/em\u003e through follow-ups, discussions of tests and feedback, and retrospective reviews shifted the emphasis from finding perfect solutions to learning from experience. This supported the development or abandonment of ideas based on practical insights. In knowledge-based organisations, a learning-oriented culture is essential; however, in environments where mistakes are penalised, it can be difficult to openly test and share imperfect ideas [\u003cspan citationid=\"CR66\" class=\"CitationRef\"\u003e66\u003c/span\u003e]. Retrospective sessions helped teams to recognise progress over time. Using a structured, experimental process that emphasises learning by doing is a key feature of successful approaches to fostering continuous organisational improvement and learning capability in healthcare organisations [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eFinally, the \u003cem\u003echaracteristics of the interprofessional QI teams\u003c/em\u003e, bringing together representatives from all professions and senior staff, ensured that diverse perspectives were considered throughout the QI process. The importance of involving healthcare professionals and others affected by a QI project is well known [e.g., 67], and this inclusive setup helped engage a large part of the staff.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec22\" class=\"Section2\"\u003e\u003ch2\u003eFactors affecting implementation, use and sustainability\u003c/h2\u003e\u003cp\u003eThe studied obstetric unit is one of the largest in the country and part of a hospital organisation with around 15 000 employees. In such large organisations, introducing agile methods can be particularly challenging, as change tends to occur more slowly than in smaller settings [\u003cspan citationid=\"CR68\" class=\"CitationRef\"\u003e68\u003c/span\u003e]. Furthermore, the period during which the approach was implemented was marked by organisational volatility within the obstetric unit. However, aside from the impact of the Covid-19 pandemic, such conditions are not uncommon in healthcare settings. Still, this study showed that the Agile Stepwise QI approach was embraced not only by the two involved QI teams, but also by additional QI teams at the sites, and some, though not all, staff at the obstetric unit. This partial uptake may be due to organisational instability and staffing challenges. Interestingly, some components of the approach still appeared to spread organically, possibly influenced by the absence of strong leadership, peer involvement in testing, and ongoing discussions about supporting others in using QI. While this supported its use, a non-strategic and partial adoption of the approach, combined with limited understanding of the full process, risks undermining its impact and perceived benefits. Inadequate adherence to important aspects of an intervention is a common problem connected to insufficient resources and strategies for implementation [e.g., 69,70].\u003c/p\u003e\u003cp\u003eHigh staff and managerial turnover, largely driven by a midwives\u0026rsquo; uprising and other organisational challenges, was a major barrier to implementing the Agile Stepwise QI approach. Although designed to better accommodate volatile organisational conditions than traditional QI methods, the frequent turnover, especially among managers, hindered the development of competence and understanding of both QI and Agile Stepwise QI. Managerial support and engagement at multiple levels are essential for fostering and sustaining a culture of learning, experimentation, and improvement capability in healthcare organisations [e.g., 23,29]. In addition, the midwives\u0026rsquo; uprising prompted regional politicians to initiate several large-scale reforms which, along with other ongoing projects, competed for the limited time and resources available for managing change efforts. The volatile situation and focus on urgent daily operations made it difficult to engage senior and managerial staff, limiting effective use of the approach at the unit. Consequently, the goal of giving all staff insight into the value of a functioning QI team was not achieved. Additional barriers included the perceived lack of clarity and consistency in the overarching organisational improvement and learning strategy.\u003c/p\u003e\u003cp\u003eSustaining change is always challenging, particularly under unfavourable conditions, and requires continuous effort and support [e.g., 71,72]. It is therefore notable that the approach has persisted at Site 1 despite staff turnover and shifting circumstances. One explanation may be the continued presence of key QI functions - QI team leaders, members, and an internal facilitator - who hold influence across multiple professions and functions. Champions with accountability, empathy, a vision, and the ability to inspire are vital for QI success [\u003cspan citationid=\"CR73\" class=\"CitationRef\"\u003e73\u003c/span\u003e]. However, if too many of these champions and carriers of knowledge leave, a full restart may be necessary.\u003c/p\u003e\u003cp\u003eSeveral key \u003cem\u003eenablers\u003c/em\u003e supported the implementation and use of Agile Stepwise QI. Empowering the existing interprofessional QI teams with autonomy, psychological safety, time, and a clear mandate to test ideas, alongside external guidance to build internal skills, reflects key features of successful interventions for continuous organisational improvement and learning [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. The yearly QI wheel provided forums to engage staff and address focus areas. Other important factors included inclusive and structured team leadership, team members\u0026rsquo; motivation, patience with change, prior QI experience, and continuous support from the internal facilitator. Strong team leadership is key for succeeding in QI efforts [\u003cspan citationid=\"CR74\" class=\"CitationRef\"\u003e74\u003c/span\u003e], while clear roles and responsibilities, advocacy by champions, and adequate support are known facilitators [\u003cspan citationid=\"CR75\" class=\"CitationRef\"\u003e75\u003c/span\u003e]. The involvement of senior midwives and first-line managers helped drive progress, but their eventual departure from their positions made it harder to sustain the work.\u003c/p\u003e\u003cp\u003eGroup-level barriers were fewer and mainly related to high team turnover at Site 2, and limited time and forums for discussion, especially with physicians. Figure\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e summarises potential enablers and barriers for building organisational and group-level capability for continuous organisational improvement and learning, as well as factors influencing the tested approach.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cdiv id=\"Sec23\" class=\"Section3\"\u003e\u003ch2\u003eStrengths and limitations of the study\u003c/h2\u003e\u003cp\u003eA clear strength of the study lies in its use of diverse, longitudinal data from multiple sources, which has enabled both contextual and temporal analysis. The study thus addresses common criticisms of empirical research on organisational and workplace change, particularly the lack of attention to contextual factors and long-term developments [e.g., 48]. This approach enhances understanding of how contextual factors influence the implementation and use of the Agile Stepwise QI approach, which can inform evaluations of its usefulness in other organisational settings. According to the original plan, the study was to conclude with a survey in September 2023, i.e., 2.5 years after the implementation started. However, this was deemed unfeasible by key actors at the unit and the researchers, due to the volatile situation within the organisation, which escalated further during 2023. Therefore, the results on impact and how, and to what extent, the QI teams\u0026rsquo; ways of working influenced their colleagues, and to what degree the new QI practices were further disseminated to other teams in the obstetric unit, are based solely on interviews with members of the QI teams and a few senior staff conducted 1.5 years following initial implementation. The long-term sustainability of the approach and the implemented changes was evaluated after 3.5 years, through an open-ended survey completed by two informants. While broader participation could have provided deeper insights into how sustainability was expressed, the informants were key staff at both sites, with comprehensive involvement and understanding throughout the entire project. Furthermore, the impact of implemented changes in clinical practices on care quality was not investigated in this study.\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"Conclusions","content":"\u003cp\u003eWe conclude that the Agile Stepwise QI effectively addresses several practical limitations of traditional QI methods, including the PDSA cycle, in dynamic and complex healthcare settings. It shows strong potential for broader application. Key features such as open problem analysis, creative idea generation, agile small-scale testing, ease of initiation, stepwise scaling, and interprofessional collaboration, problem-solving, and learning appear valuable for driving change in healthcare organisations. Findings suggest enhanced learning at individual, team and organisational levels, indicating a positive impact on organisational improvement, and learning capacity. However, its sustainability depends on the continuity of key staff, including QI team members, support functions and managers, particularly those with extensive knowledge and experience of the approach. Future research should examine the approach\u0026rsquo;s impact on staff and organisational dynamics in greater depth and assess its long-term effects on QI and organisational learning capacity, care quality, and work conditions. The Agile Stepwise QI approach should also be tested in other settings, with close attention to its core features.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eQI\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eQuality improvement\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eOL\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eOrganisational learning\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003ePDSA\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003ePlan Do Study Act cycle\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"Declarations","content":"\u003ch2\u003e\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study received ethical approval by the Swedish Ethical Review Authority, no. 2020\u0026ndash;02500 on October 20, 2020. All participants signed an informed consent document, and the study was conducted according to the Helsinki declaration.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eThis study was financially supported by Swedish Research Councils for Health, Working Life and Welfare (FORTE) [Grant no 2020\u0026thinsp;\u0026minus;\u0026thinsp;01209]. The last author (ME) was during the project period also partly funded by Region Stockholm, grant no. FoUI-974668. Open Access funding was provided by Karolinska Institutet, Sweden.\u003c/p\u003e\n\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\n\u003cp\u003eMEN and ME developed the intervention and designed the study, MEN and ME collected the data, MEN and ST conducted the analyses and MEN, ME and HS drafted the manuscript. All authors contributed to and approved the final manuscript.\u003c/p\u003e\n\u003ch2\u003eAcknowledgement\u003c/h2\u003e\n\u003cp\u003eThe authors would like to thank the participants at the two labour wards and at the obstetric unit for their time and effort.\u003c/p\u003e\n\u003ch2\u003eData Availability\u003c/h2\u003e\n\u003cp\u003eThe datasets (in Swedish) used in the current study are available from the correspondingauthor on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eSenge P, Kleiner A, Roberts C, Ross R, Smith B. The Fifth Discipline Fieldbook: Strategies and Tools for Building a Learning Organization. London: Nicholas Brealey Publishing; 2010.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNystr\u0026ouml;m ME, H\u0026ouml;\u0026ouml;g E, Garvare R, Andersson B\u0026auml;ck M, Terris DD, Hansson J. 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BMC Health Serv Res. 2020;20(1):588. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1186/s12913-020-05434-9\u003c/span\u003e\u003cspan address=\"10.1186/s12913-020-05434-9\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Quality improvement, Organisational learning, Agile improvement, Implementation, Organisational agility, Maternity care","lastPublishedDoi":"10.21203/rs.3.rs-7601913/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7601913/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAlthough limitations in improvement efforts are well known, transforming healthcare organisations remains a challenge. Practical use of quality improvement (QI) approaches, including the Plan-Do-Study-Act cycle, have revealed several shortcomings, often hindered by insufficient resources and lack of supportive context. Yet, even in volatile organisational contexts, the need for improvement and high-quality care remains critical. To be effective, QI must develop greater resilience in the face of unfavourable conditions. This study aimed to explore whether, and how, a new, more agile QI approach could strengthen QI efforts and foster learning within an obstetric unit, despite contextual instability.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis case study of a large obstetric unit, with two geographically dispersed labour wards, employed an in-depth longitudinal process approach. It examined contextual factors, the implementation process, perceived impact, and the sustainability of the new approach. Conventional content analysis was used to analyse qualitative data from repeated interviews with key actors, organisational documents, field notes, and a qualitative questionnaire.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe implementation spanned nearly two years. Despite occurring during a volatile period with high staff and managerial turnover, the Agile Stepwise QI approach had a positive impact on QI within the unit. It supported change efforts, reduced feelings of failure when progress was difficult, and contributed to a more positive and effective perception of QI work. Testing before implementation became increasingly common. Although scaling tested solutions remained challenging, having team members with decision-making authority facilitated the process. Involving managers and senior staff was difficult due to high turnover, which affected sustainability. Nevertheless, the approach was still in use at one site 3.5 years after its initial implementation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAgile Stepwise QI positively influenced improvement work in the obstetric unit, even under volatile organisational conditions. Key features - open problem analysis, creative idea generation, agile small-scale testing, stepwise scaling, and interprofessional collaboration - proved valuable for driving change. The approach fostered learning at individual, team, and organisational levels, indicating a positive impact on overall improvement and learning capability. However, sustainability depended on the continuity of key staff, including QI team members, support functions and managers.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eArticle classification:\u003c/strong\u003e Research paper\u003c/p\u003e","manuscriptTitle":"Agile Stepwise Quality Improvement: Enhancing change and learning in complex and volatile healthcare contexts","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-23 15:49:10","doi":"10.21203/rs.3.rs-7601913/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2025-10-19T15:03:51+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"210556189658054259467840708002976377537","date":"2025-10-09T20:56:11+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-09T18:22:46+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-09-17T18:12:28+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-09-16T12:10:28+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-09-16T12:10:24+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Health Services Research","date":"2025-09-12T15:18:53+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"b0f7a0b2-4dd3-44f0-823b-5b50aa419bd8","owner":[],"postedDate":"October 23rd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-10-23T15:49:10+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-23 15:49:10","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7601913","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7601913","identity":"rs-7601913","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}