Balancing Standardisation and Flexibility in National Complex Intervention Scale-Up: A Qualitative Study of Leadership Experiences and Management in the Implementation of Proactive Health Support in Denmark

Balancing Standardisation and Flexibility in National Complex Intervention Scale-Up: A Qualitative Study of Leadership Experiences and Management in the Implementation of Proactive Health Support in Denmark | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Balancing Standardisation and Flexibility in National Complex Intervention Scale-Up: A Qualitative Study of Leadership Experiences and Management in the Implementation of Proactive Health Support in Denmark Mia FREDENS, Morten DELEURAN TERKILDSEN, Mette GRØNKJAER, Ulla TOFT, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7977843/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 10 You are reading this latest preprint version Abstract Background Policymakers increasingly aim to expand small-scale healthcare interventions to a national level to maximise reach and impact. However, scaling complex interventions presents challenges, particularly in balancing national standardisation with flexibility in local implementation across contexts. This study investigates how leaders experience and manage the national implementation of Proactive Health Support, a large-scale self-management support intervention in Denmark. Methods The study employed a single-case study design with embedded units to examine the national implementation of the Proactive Health support intervention. Data were collected through 10 semi-structured interviews with leaders from the five Danish regions, over 25 hours of participant observation of leadership meetings and workshops, and a document analysis of 468 pages of leadership meeting minutes and reports. Results Implementing Proactive Health Support required leaders to balance the tension between fidelity and adaptation within a standardised framework. While the national framework provided stability, leaders leveraged the flexibility of implementation strategies to preserve the core intervention components while enabling local adjustments to fit diverse contexts. Reflexive practices, characterised by real-time adjustments and operating through feedback loops, both reinforcing and stabilising, were pivotal for balancing standardisation with flexibility. Vertical leadership mediated alignment between national and regional levels, while horizontal collaboration fostered shared learning across regions. Conclusion This study demonstrates the complexity of scaling healthcare interventions across diverse contexts, underscoring the non-linear and dynamic nature of such processes and the significant ongoing leadership engagement required to navigate complexity and manage uncertainty. It highlights collaborative leadership as crucial for enabling real-time responsiveness, fostering alignment across levels, and balancing fidelity and adaptation in national implementations. The findings empirically demonstrate that fidelity and adaptation are not opposing forces but complementary in practice, with adaptation in implementation strategies supporting fidelity by allowing interventions to be applied meaningfully across diverse contexts. The findings further suggest that successful national implementation relies not on strict adherence to standardised guidelines but on a co-adaptive process within a standardised yet flexible framework, where intervention and context are co-constructed through ongoing, leadership-driven negotiation. Trial registration: Part of a research programme including a registered randomised controlled trial (ClinicalTrials.gov, NCT03628469). Not applicable to this study. Implementation Complex intervention Large-scale implementation Leadership Fidelity Adaptation Context up-scaling Background Policymakers focus increasingly on expanding successful small-scale healthcare interventions to a national scale to maximise their reach and impact ( 1 , 2 ). This trend aims to ensure that the entire target population has access to the most effective interventions and programs available ( 3 , 4 ). However, implementing complex national interventions in healthcare, in this case, a large-scale self-management support (SMS) program, can be challenging ( 5 ). A consistent trend in implementation science literature is that achieving widespread practice change is difficult, and successful interventions in one setting may face challenges when trialled elsewhere ( 6 – 8 ). The literature on complex interventions ( 7 , 9 ) and implementation science ( 10 , 11 ) concludes that a key challenge in achieving successful national implementation is the 'practical problem of context' ( 10 ). Interventions and their outcomes are deeply intertwined with the contexts in which they are implemented, making strict implementation across diverse settings particularly challenging. This challenge is especially pertinent when trialling large-scale interventions across multiple sites, where varying local conditions may lead to different implementation outcomes ( 10 ). Sarkies et al. ( 6 ) similarly argue that challenges of replicating and scaling interventions pertain to the complex social processes of implementation and the need for implementation strategies that adequately match local contexts. The ‘practical problem of context’ cannot be handled by treating it as a pure operationalisation issue that can be managed with a rational prescriptive checklist of, for example, implementation strategies ( 6 ). Instead, it is argued that the dynamic nature of contexts requires adaptive and responsive approaches to managing the complexities that arise instead of rigid standardisation ( 10 ). Therefore, a key challenge in implementing large-scale national complex interventions is the inherent tension between striving for standardisation and a complex system characterised by dynamically changing inter-relationships and tensions ( 8 , 12 – 14 ). In implementation science and complex interventions literature, this is often referred to as the tension between adaptation (i.e., flexibility) and maintaining fidelity ( 15 , 16 ). Fidelity refers to the degree to which an intervention is implemented as it was initially described, tested, or intended by the developer ( 17 , 18 ). In this study, adaptation is defined as 'making fit' often by modification, allowing for adjustments to the intervention itself, the implementation strategies, and the implementation context ( 15 , 19 ). In response to these challenges, various frameworks and guidelines have been developed. One example is determinant frameworks ( 20 ) that aim to improve implementation outcomes by acknowledging and adjusting for contextual factors. Others have focused on the importance of intervention adaptation to fit with local contexts ( 7 , 9 ). Fixsen et al. ( 11 ) contribute by introducing the concept of 'core implementation components', distinguishing these from 'core intervention components' to emphasise that successful interventions rely both on core intervention and implementation components. These implementation components, such as training, coaching, and program evaluation, are defined as the most essential and indispensable elements of an implementation program( 11 ), thought to be crucial for achieving fidelity to core intervention components ( 11 ). They further suggest that flexibility in the form of implementation core components (e.g. strategies and processes) allows adaptation to local contexts without compromising intervention fidelity in large-scale national implementations ( 11 ). Similarly, recent studies increasingly suggest that flexibility in implementation strategies and processes can complement rather than compromise fidelity, enabling necessary adaptations to meet local contextual needs without necessarily undermining intervention integrity ( 15 – 17 , 21 ). In line with this, Schwarz et al. ( 17 ) introduce a useful distinction between adaptations in the intervention, the context, or the implementation strategies. They propose that achieving fit between an intervention and its context does not always require adaptation of the intervention itself. They suggest that implementation strategies may act as tools to reconcile fidelity and adaptation by enabling modifications in either the intervention, the context, or both as needed. However, while much of this existing research highlights the potential coexistence of fidelity and adaptation, it often remains primarily focused on conceptual frameworks and theoretical discussions ( 21 ). This leaves a gap in understanding how leaders experience and manage this balance, particularly in the dynamic and complex realities of large-scale, policy-driven implementation efforts. Although leadership has been studied in policy implementation research for decades ( 22 ), its role in shaping implementation processes has only more recently gained attention in implementation science ( 23 ). Leadership is increasingly recognised as a critical factor for successful implementation within implementation science ( 24 – 26 ), and many implementation frameworks and theories in healthcare highlight the significance of organisational leadership in achieving high fidelity ( 26 ). Though recent research ( 26 ) has started to investigate and support this relationship experimentally, more knowledge on practices for building and maintaining intervention and implementation fidelity has been called for ( 21 ). We lack empirical research on how leaders experience and manage the actual processes involved in national-scale implementations, including actively balancing and operationalising the tension that may arise between adaptation and fidelity over time. A broader tendency in implementation science and empirical studies may compound this gap. Often, studies are front-loaded with a focus on program theories and prescriptive implementation models or end-loaded with a focus on process evaluations that study past implementation practices. Fewer studies follow implementation processes over time ( 10 ). As a result, less is known about the mechanisms that drive adaptation and sustainability over time ( 10 ), as well as how leadership is both experienced and enacted in navigating these dynamics. To address this gap, this study examines how leaders experience and manage the national implementation of a complex SMS intervention, Proactive Health Support (PaHS), in Denmark. The article is part of a multidisciplinary research program evaluating PaHS. Further evaluation results are reported elsewhere ( 27 – 33 ). Method This study utilises a qualitative case study design based on interviews, observations, and documents. This study adheres to the SRQR guideline ( 34 ). Aim This study aims to investigate the following research question: How do leaders experience and manage the national implementation of a complex SMS intervention, Proactive Health Support (PaHS), in Denmark? Study Setting The Danish healthcare system offers tax-financed universal healthcare and consists of three administrative and political levels: the state, five regions, and 98 municipalities. The Danish Ministry of Health is responsible for setting the regulatory and financial framework for the healthcare system ( 35 ). The five regional authorities govern and operate the hospitals, while general practitioners are gatekeepers to specialist services. The municipalities are responsible for prevention, community nursing, and rehabilitation outside hospitals ( 35 ). The PaHS Intervention The PaHS intervention was a large-scale, telephone-based SMS program designed to reduce preventable hospital admissions and improve health-related quality of life for participants. The intervention recruited participants through a prediction model identifying adults at risk of hospital admissions within 3 months. Registered nurses were trained to deliver the intervention, focusing on enhancing participants' self-management strategies and coping skills ( 31 ). The PaHS intervention was organised in specially established PaHS units, seven in total across the five regions. These PaHS units were independent of existing organisational units such as hospital departments and rehabilitation centres. The PaHS program, including both intervention and implementation core components, is described in further detail in Table 1 . Table 1 The PaHS Intervention - Intervention and Implementation Core Components Included citizens: • Adults (≥ 18 years) at high risk of hospital admission, identified monthly via a national prediction model using healthcare registry data. • Eligible individuals received an invitation via secure electronic mail (e-Boks) and follow-up phone calls. After consent, nurses performed a secondary screening to confirm eligibility before inclusion Intervention Core Components (Active Ingredients): • Initial Session: A face-to-face session with the same registered nurse (RN) who will conduct the entire intervention. • Telephone Follow-up Sessions: Regular phone-based follow-ups are conducted over a 6–9 month period. • Tools: Development of personal goals and assessment of hospitalisation risk at each session. • Nurses' Roles: o Caregiver: Provides support for the patient’s health and well-being. o Coach: Guides the patient through self-management techniques. o Healthcare Professional: Offers clinical expertise and advice on disease and treatment. • RCT protocol • Practice Handbook: A national standardised guide that outlines the delivery of core components of the intervention, including patient engagement, coaching methods, and the use of tools such as the risk management protocol. Core Implementation Components: 1. Performance Management: A system designed to ensure consistent quality and activity levels across regions. It includes set goals and standards for patient caseloads, conversation duration, and frequency of contact based on patient risk profiles. o M4 IT-System: Unified platform for data collection and patient progress tracking. An IT system allows nurses to track their own cases, while local and program management can monitor whether targets are being met. Additionally, it serves as a method for continuous learning and development, ensuring a high and uniform quality across all regional units. 2. Workflow Descriptions: National guideline including standards for how the intervention should be delivered and organised, ensuring that processes (e.g., patient screening, coaching, documentation) are standardised across regions. 3. Education and Supervision: o Three training modules of 2 days each, with a follow-up day focusing on learning the roles of caregiver, coach, and healthcare professional. Provided by a private consultancy firm. o Supervision: ♣ External supervision: Formal supervision by private consultancy firms to ensure adherence to intervention protocols. ♣ Peer and Internal Supervision: Ongoing peer-based and team-based support to help nurses refine their practical and relational skills. o Workshops and Team Meetings: Regional sessions for continuous professional development and refinement of personalised coaching skills. o Communication Techniques: ♣ Gamemaster Technique ♣ Karl Tomm's Interventive Interviewing ♣ Identification of essential keywords and exploring their meaning. ♣ Solutions-Focused Coaching Actors : • National Program Management: Responsible for coordinating and monitoring the program centrally across all regions. • Project Leaders: Ensure that implementation follows national guidelines and is adapted to local needs. • Nurse Leaders: Support frontline staff in maintaining fidelity in the delivery of the intervention. • Registered Nurses (RNs): Frontline staff delivering the intervention directly to patients through consultations and follow-ups. Intervention Outcomes : • Short-term Goals: Improve patient self-management. • Long-term Goals: Reduce hospital admissions, improve health-related quality of life, and decrease healthcare costs. In 2016, a national–regional political agreement was made to implement the PaHS intervention at a national scale running from 2017 to 2020. The intervention had previously been developed and tested in Sweden. The policy-level processes and challenges related to the early implementation of PaHS have been addressed in a previous publication ( 29 ). The agreement emphasised national uniformity by requiring the intervention to be developed and managed as a national program and by initiating a multidisciplinary research program, including a protocolled randomised controlled trial ( 31 ). While PaHS was initiated through a top-down national policy agreement, the five regions were granted authority to organise the intervention within a jointly defined national framework. This governance structure allowed for regional flexibility in organisation, resulting in variations in the size, structure, and organisational anchoring across the PaHS units. For example, some regions had two units with a nurse leader in each unit, while others had only one unit (See Table 2 ). Table 2 Regional Organisation of the PaHS Intervention Organisation Region 1 Region 2 Region 3 Region 4 Region 5 Number of Call Centres 1 2 2 1 2 Nurses 9 20 20 34 10 Nurse Leaders 1 2 1 1 0 Project Leaders 1 1 1 1 1 A national program management was established prior to implementation, to oversee coordination, standardisation, and quality assurance, in line with a formalised program governance model. This model emphasised structured collaboration between national and regional actors, with a strong focus on implementation and organisational processes. The program management consisted of a program manager and a support secretariat. From 2017 to 2020, this national program management oversaw the overall coordination, management, and implementation of PaHS in close collaboration with regional leaders. In addition to the program manager, the national implementation of PaHS involved two other formal leadership roles. Each region employed a project leader and one or two nurse leaders responsible for the implementation and operation of the intervention. As such, the national implementation was a collective responsibility shared between national program management, regional project leaders, and nurse leaders. These leaders, ten in total (excluding region 5, see Participant section), worked closely together across all regions, meeting regularly in the capital region. Meetings were held both in peer groups (project leaders together, nurse leaders together, often with the program manager present) and jointly. While the implementation involved leadership at different levels, this study investigates leadership collectively to protect the participants' anonymity by avoiding identifying specific leadership roles and regional distinctions. Study Design This study employs a single-case study design with embedded units, allowing for units of analysis on multiple levels and across contexts within the same case ( 36 ). The unit of analysis is the national PaHS implementation, while the embedded units consist of six PaHS units in four regions. Paparini and Papoutsi ( 37 ) note that case study research is particularly well-suited for investigating complex interventions in their natural settings, where implementation processes are deeply intertwined with dynamic contextual factors. Thus, the case study design provides a valuable methodological approach for capturing the complexity of the national PaHS implementation. Participants The present study involved the following participants: 1) four regional project leaders already working as project leaders within the regions where they were assigned to the PaHS project, 2) five nurse leaders overseeing one or two PaHS units in these regions. All nurse leaders had actively applied for the position, and 3) the national program manager. In total, 11 leaders were involved in the national implementation of PaHS, and all were invited to participate in this study. All leaders were contacted via email and informed about the study; all consented to participate in qualitative interviews. One of the five Danish regions was excluded from this study, as it had a somewhat different education program and several years of experience with the intervention as it functioned as a pilot region ( 30 ). The interview with the leader from that region was therefore excluded from the analysis. The final sample comprises 10 leaders from the remaining four regions - all with formal leadership responsibilities in the national implementation. Data Collection Data collection involved multiple qualitative methods: semi-structured interviews, observations, and document analysis. Some data collection spans 2017–2020, such as the observations and documents. Interviews were conducted in the more mature phase of the implementation process from late January to March 2019 and before trial results were known ( 32 , 33 ). The data collection over several years allowed for following the dynamics involved in the national implementation of the PaHS intervention. The first author, an experienced social scientist, and a research assistant collected data. The data presented in this article have not been previously published. Observation Participant observations were conducted ( 38 ) in workshops, including training sessions, performance management workshops, and leadership meetings with nurse leaders, project leaders, and program management, which amounted to more than 25 hours of observations. Access was granted through collaboration with national program management. Notes were taken during and immediately after each session by the first author, guided by an observational focus on the interactions, decision-making processes, and practical challenges faced during the implementation of the PaHS program. The observations also offered an opportunity to capture informal interactions and emergent challenges not readily accessible through interviews or documents, and they informed the development of the interview guides. The extent of observations was determined by the primary researcher, who was offered access to observe and participate in all leadership activities. Observations were concluded when the primary researcher assessed that data saturation was met. Document analysis The document analysis included a practice manual, workflow description, leadership meeting minutes, and a performance management catalogue. The practice manual and workflow description were collaboratively developed by leaders during the early stages of the implementation process before the RCT launch. They were based on the trial protocol and co-created and adjusted several times during this early phase, based on input from frontline staff (nurses) to ensure practical relevance. Leadership meeting minutes were written in relation to meetings between project leaders and program management (meeting minutes = 14), leading nurses and program management (meeting minutes = 11), and joint leadership meetings across the leaders (meeting minutes = 5). All leadership meeting minutes produced during the project period, 468 pages, were collected by the national program management secretary and forwarded to the first author. The performance management catalogue was developed by the program management with input from leaders to establish joint standards. Semi-structured individual Interviews The first author conducted all interviews (2019–2020), lasting 45 to 66 minutes. Participants were recruited via email, and interviews were conducted during working hours. The interview explored leaders’ experience and management in relation to the PaHS implementation process, focusing on their responsibilities and leadership collaboration within and across the regional and national levels. A semi-structured interview guide was developed for this study, with minor adaptations to reflect participants’ formal leadership roles in the program, nurse leaders, regional project leaders, and the national program manager, while maintaining a shared thematic structure across all interviews. The guides covered common topics such as leadership responsibilities and practices, organisational setup and local organisational adaptations, and experiences with implementing the intervention within a national framework. An English version of the interview guide is available as a Supplementary File. Interviews were digitally recorded and transcribed verbatim. Analysis A reflexive thematic analysis ( 39 , 40 ) was used, informed by an abductive analytical approach ( 41 ). Abduction is a mode of analysis that involves iteratively moving between empirical observations and theoretical concepts in order to develop meaningful interpretations. In this study, it supported an openness to empirical complexity and a sensitivity to patterns, tensions, and dilemmas in the data. This abductive approach allowed us to gradually refine the thematic structure by engaging theory in dialogue with emerging insights ( 41 ). The first step involved comprehensively reading interview transcripts, field notes, and documents. During this initial exploration of the data, the broader preliminary codes of context , implementation processes , and outcomes were identified as essential aspects of the leaders' experiences and management of the intervention across different regions. The first author then developed subcodes within these broader preliminary codes. For example, within the preliminary code of context , subcodes like standardisation and flexibility began to take shape, reflecting early insights into how leaders experienced and balanced uniformity and adaptation. At this stage, the analysis remained data-driven, allowing patterns in the data to guide the initial coding structure. As the analysis progressed, theoretical concepts from the implementation science literature were gradually introduced to inform and refine the preliminary codes and emerging subcodes. The preliminary code of implementation processes was further refined with subcodes such as collaboration and monitoring , illustrating how leadership across regional and national levels engaged with the intervention. The coding process was iterative and collaborative. The first author led the coding, with continuous discussions to ensure reflexivity, consistency, and depth in the analysis. The second (MDT) and last (CPN) authors discussed preliminary test coding with the first author, and slight adaptations to the coding structure were made. The first author then coded all data. Alongside this interview coding, our findings were triangulated with field notes and documents, providing additional layers of insight and ensuring the credibility of the analytical findings ( 42 ). The development of themes followed an iterative process of identifying recurring patterns across interviews, documents, and observations. Codes and subcodes such as standardisation , flexibility , collaboration , and monitoring were refined and compared across the material and grouped into broader analytical categories, such as tensions between national standardisation and local realities, leadership responsiveness to and management of emerging challenges, and coordination across organisational levels and settings. These categories informed the construction of three overarching themes (see the results section). Thematic saturation was reached during the analysis, as no new codes or substantial variation emerged in the later stages of coding. The dataset provided sufficient depth and diversity to support the development of robust and meaningful themes across the material. Reflexivity was maintained throughout the research process. The first author, who led data collection and analysis, brought familiarity with the Danish healthcare context and prior qualitative experience. Interpretive and analytical decisions were continuously discussed with the second and last authors to surface and interrogate assumptions and to secure a critically warranted reading of the material. A Large Language Model (ChatGPT, OpenAI) was used to support the translation and language editing of participants' quotes from Danish to English, to preserve the tone and clarity of the original spoken expressions. In addition, Grammarly was used to check grammar, spelling, and adherence to academic English conventions. The authors retained full responsibility for the content, accuracy, and intellectual contributions of the manuscript. Results Three key themes emerged: 1) between national standardisation and local implementation, 2) navigating flexibility within a national framework, and 3) managing national-local balances through vertical and horizontal leadership. Themes one and two include related subthemes. A key finding across all themes was that the leaders consistently experienced the implementation of PaHS as a success. Although the multidisciplinary research program showed that the PaHS intervention was not cost-effective or displayed the expected outcomes ( 32 , 33 ), leaders frequently expressed a strong sense of accomplishment, which is reflected in comments like: “I think we stand quite strong in relation to what is on the agenda and standardising things, showing that it's actually possible even though we are different regions. I think we're a bit of proof that it can indeed succeed.” (Leader 5). Several leaders reported observing changes in nursing practice, with nurses adopting more coaching-oriented, patient-centred roles, and that these practice changes were implemented consistently across regions. This shift marked a broader normative restructuring towards a coherent 'PaHS Professional Practice .' Some leaders highlighted the ability to share nurses between regions without additional training, frequently using phrases like “we have seen that we can share nurses across regions” and “the initiative is developed uniformly across regions” (Leader 2), indicating intervention fidelity. Although PaHS did not achieve the desired outcomes ( 32 , 33 ), the implementation process was experienced as a success, offering valuable lessons for future national implementation endeavours. The following analysis examines how leaders experienced and managed the implementation process, contributing to the broadly shared perception of implementation success. Theme 1: Between National Standardisation and Local Implementation The overarching framework structure in PaHS was established through both top-down policy directives and national program management guidelines, including financial controls and operational boundaries such as the randomised controlled trial protocol to be followed. Initially, some leaders experienced the framework as restrictive, feeling constrained by standardised approaches and limited in their autonomy at the regional level. During observations, several participants expressed frustration with the “heavy logic” (Observation, Performance Management start-up meeting) imposed by the national framework, describing how its rigidity sometimes felt at odds with the need for flexibility in local implementation. One leader explained: “I think the difference here is the great uniformity and implementation consistency across the regions, which imposes different demands, both on us as leaders but also as implementation leaders. We've become that along the way. So, it definitely places demands on us. You can't autonomously decide, 'This is how I'm going to do it.' You are bound by a certain framework.” (Leader 8) This quote illustrates a core tension that leaders experienced when implementing a standardised intervention across diverse, dynamic local contexts. The framework necessitated adherence to set parameters, limiting autonomous decision-making. Over time, however, some recognised the national framework as a beneficial structure, particularly in offering legitimacy and stability in interactions with frontline staff: “In relation to the national framework for the project. That has actually been one of the biggest light bulb moments in the project. There was a lot of hassle at the beginning, with each region wanting to do things their own way : ' Can’t we use iPads instead of phones, for example? ' The Ministry was really adamant: 'You’re getting the money for this, nothing else! ' Everything we needed to adhere to was written down. But once all that was clarified, I’ve found that the national framework has provided peace and legitimacy.” (Leader 3) Despite this recognition, leaders continued to experience the challenge of balancing adherence to national standards with addressing local, context-specific implementation. They acknowledged that while local variation was necessary to ensure local implementation, consistency in core components was essential to maintain integrity: “We see a lot of variation across the regions. Some things are allowed to be different, but we must ensure that we are consistent in the important components.” (Leadership Meeting Minute 14) Thus, leaders found themselves continuously negotiating between national expectations and local realities. The need for a balance between standardisation and flexibility created an ongoing tension, where leaders had to ensure that the intervention remained true to its core components while also working in practice within diverse local settings. Theme 2: Navigating Flexibility within a Structured Framework This theme focuses on how leaders operationalised flexibility to navigate the tension between standardisation and local adaptation. Across all data material, many leaders described the implementation of PaHS as an evolving dynamic process with many uncertainties; as one leader explained during a leadership workshop: “ Many things will remain uncertain, and you will not get answers to everything you want. You have to be able to tolerate that.” (Observation, Performance management start-up meeting). The implementation process was experienced as inherently unpredictable, requiring leaders to manage emerging challenges in real-time and adapt to evolving conditions: “[…] we are working while laying the tracks sometimes, aren’t we?” (Leader 2) This quote illustrates how leaders needed to remain attentive and flexible, guiding the implementation processes in new and more favourable directions to ensure successful and unified implementation of the intervention's core components across settings, as such adaptation processes were an integral and iterative dynamic part of the implementation process. Managing National Standards in a Dynamic Process A key national strategy in managing this iterative implementation process was that “the components central for a possible effect should be nationally anchored” (Leadership Meeting Minute 19). This included the intervention core components and the development of national implementation core components involving standards and tools such as the workflow description, performance management system, and M4 data monitoring system. Although this national framework provided the necessary structure and standardisation to support intervention fidelity, leaders also described the core implementation components as flexible standards and subject to ongoing monitoring, evaluation, and revision to ensure local relevance and effectiveness. As one leader noted, this process involved leaders actively collaborating to adjust standards when they no longer aligned with regional or practical realities: "Yes, those are some of the key tools. I would say the workflow description is like the tool, as it also gathers the supporting tools, like how the risk management tool works […] There are 12 standards […] and we're discussing whether more standards are needed, both clinical standards and organisational, structural ones, like how many patients we need to process […] We are currently discussing how to revise, some of the standards don't make sense anymore or are not meaningful enough, so we need to change them, but most of them still hold." (Leader 10). This collaborative flexibility allowed leaders to ensure that the national implementation standards were flexible enough to accommodate changes while still providing the structure needed for consistency across regions. This was the case, for example, when the prediction model suddenly did not include the necessary patients on the lists. Standards had to be adjusted to address this issue, as there was a requirement to process a certain number of patients for the regions to receive funding from the central Danish government. This collaboration and ongoing evaluation process was especially evident in discussions surrounding performance management, one of the national implementation core components. Leaders across regions were engaged in determining not only how to standardise the overall performance management system but also whether the specific methods used in the regions, such as team meetings and review processes, should be uniform or allow for variation: “Various methods are being used across the regions to ensure a shared overview of production and progress within individual PaHS units, such as board meetings. There is a need to decide whether uniform methods should be applied, and if so, which ones” (Leadership Meeting Minute 10) This discussion exemplifies how the development of national implementation tools like performance management was not a one-size-fits-all process but rather a dynamic, adaptive, and collaborative effort. Local Adaptation of Implementation Strategies Leaders collaborated at the national level to define where consistency was essential and where local variation could be permitted. At the local level, leaders extended flexibility to implementation strategies in response to specific PaHS unit needs. An example of this flexibility was the shared Performance Management catalogue that was collaboratively developed by program management, project leaders, and nurse leaders. While specific standards were established to ensure consistency, such as standardised registration practices within the M4 system, regional leaders were given the flexibility to develop and adapt the performance management implementation strategies to suit their local contexts best. The catalogue outlined a framework that leaders in the different regions were responsible for filling in based on their specific contexts, as stated in the document: “The PaHS-units themselves have been responsible for filling out [the theoretical PM framework].” (Performance Management catalogue document) This collaborative effort allowed for the creation of a shared theory of change, outlining the expected relationships between the organisational structure of PaHS, its activities and resources, and the desired outcomes. Project leaders and nurse leaders received training on performance management, ensuring that the foundational principles were consistent across regions, while the practical implementation strategies or methods could vary. For example, while meetings were held across all regions and PaHS units to review performance data, the frequency, terminology, and specific content of these meetings varied depending on the regional context. As one leader remarked: “But it probably also depends on the staff group because in [another region], you maybe can't gather 35 people around a board. It doesn't make sense. I do not know what they do over there.” (Leader 1). This illustrates how regional leaders adapted meetings to suit their specific team sizes and operational needs, ensuring that the national guidelines remained meaningful and practical within their local contexts. In this way, performance management, a core national implementation component, not only served to standardise practices but also became a dynamic space for regional and local adaptation, where strategies were monitored, shaped, and reshaped to fit local contexts. Theme 3: Managing National-Local Balances through Horizontal and Vertical Leadership The analysis identified two key types of leadership in the PaHS implementation: horizontal and vertical. Horizontal leadership describes cross-regional collaboration, enabling leaders to share best practices and maintain consistency. This position enabled them to facilitate continuous dialogue, ensuring that adaptations in the implementation process remained aligned with the intervention's core components while allowing local insights to shape national core implementation components. Vertical leadership refers to the top-down and bottom-up processes where leaders translate national directives into local practice and communicate local insights back to the national level, acting as mediators, ensuring alignment between national goals and local realities. Horizontal Leadership: Cross-regional Collaboration Many leaders described a national leadership structure as a key precondition for successful, cohesive, and consistent national implementation: “We are completely dependent on having such a well-functioning cross-regional leadership. In that sense, having a group of project leaders and a group of nurse leaders […] has in many ways practically functioned as part of the [national] leadership.” (Leader 10) The ongoing cross-regional collaboration among leaders allowed them to maintain a shared focus and uniform implementation while also facilitating the exchange of best practices and problem-solving strategies: “We have become very aware that we can only ensure a unified and consistent effort, both across and within the regions, by continuously being curious and communicating with each other.” (Leader 8) Leaders commonly experienced formal cross-regional meetings as a cornerstone of this collaboration. Regular in-person meetings created a space for regional leaders to discuss national strategies and to share local experiences. One leader described the structure of these meetings: “We have these joint meetings first, and then we each go our separate ways[...] I think our [leadership role] meetings have been good and constructive[...] it's a forum where we are equal and where you get the chance to talk about some of the things you've been thinking about.” (Leader 3) Much of the collaboration also occurred through informal networks. Several leaders described frequently reaching out to their peers across regions to seek advice or share solutions to practical challenges: “Personally, I do it if I have something I feel I can’t solve myself or something that puzzles me, or if I’m in doubt whether I’m doing it right, then I write to the others and ask, 'How do you see this?' 'Do you have a challenge here, because I do?' and 'How did you solve it?' Or vice versa, if I notice something that we discussed in a meeting, I can say, 'This is how it’s done,' and maybe they can use that.” (Leader 6) These informal networks were an essential support system, enabling leaders access to expertise and to discuss implementation challenges: “[name of a leader from another region] is incredibly skilled with our M4 system, which extracts data... If there’s something we really need... it’s her who can help with that.” (Leader 1) This example illustrates how informal collaborations were experienced as valuable for sharing technical expertise and resources, helping leaders manage the implementation process despite variations in skills and capacities among the regional leaders. Vertical Leadership: Mediating Between National and Regional Levels Within regions, the leaders demonstrated shared responsibility for both implementing and guiding the intervention to translate national decisions into local practice. A leader reflected: “So it’s me who can explain the history and make sense of why sometimes the things they [the nurses] have to do may not immediately seem meaningful in daily practice. What’s the reason behind it, and why does it still make sense?” (Leader 3) This illustrates how some leaders ensured that national directives were understood and meaningfully applied in daily practice. The focus was not only on issuing instructions but on creating a shared understanding of why certain practices were necessary, which supported smoother implementation. Leaders saw themselves as having a critical role in managing upward communication by ensuring that frontline staff concerns and insight were brought to the attention of higher leadership levels, e.g. the overarching cross-regional leadership group and program management: “I believe that the way we communicate is the most important part and that I listen a lot to their [the nurses'] inputs. There can be problems that I don't immediately understand or see as a problem, so I listen to them and try to figure out whether this is an issue at a staff level, something that needs to be raised with the team […] or the close leadership group [cross-regional leadership group].” (Leader 7) By bringing up these issues, the leaders facilitated the recognition and timely attention of potential challenges in the implementation process, helping to resolve local concerns and preventing them from affecting the program's overall success. This mediating leader role, based on vertical leadership, also encompassed managing uncertainties and reducing potential unwarranted turbulence within the local context: “Sometimes, I'm also kind of brought in as someone who has the professional authority when there is too much uncertainty about certain things. I'm used to setting the framework and saying, 'This is how it is done.'” (Leader 8) This balancing act was only possible because these leaders were embedded “on the ground,” close to the nurses and the local contexts they were trying to influence: "We should only focus on things that we find interesting to look at and can learn from, and I really like to use all the breaks to have dialogues with the staff in the break room and try to bring up the professional dialogue about how things are going, how many we have in the process, and 'Oh, now there were five no-shows this week,' all that, just to keep a finger on the pulse with those things […]." (Leader 4) This interaction with frontline staff was used as an informal opportunity to gather feedback, track progress, and identify potential issues early. By being embedded in the local context, leaders knew when to “step in” or “keep out” and trust the staff to manage daily operations effectively. Discussion This study aims to investigate how leaders experience and manage the national implementation of a complex SMS intervention (PaHS) in Denmark. Implementation is always a meeting between the new and the old, between intervention and context, stability and change, standardisation and adaptation. This intersection, where critical tensions and synergies arise, is essential for understanding the complexities of implementation. While these tensions, especially between intervention and context ( 10 ) and between fidelity and adaptation ( 15 , 17 ), are well-known in implementation research, few studies have explored the implementation processes over time ( 10 ), including the role of leaders in navigating these tensions during large-scale national implementations. Prospectively identified factors can certainly play an important role in finding contextual determinants for implementation (i.e. facilitators and barriers) and thereby guide decisions about the appropriate implementation strategies for matching the needs of local contexts ( 43 ). However, they also imply a somewhat static, formulaic, predictable understanding of the implementation context and process ( 10 , 13 ). Our findings demonstrate that leaders experienced the implementation process as unpredictable, and that the experienced successful PaHS implementation was not a result of simply following top-down directives and standardisations, but instead of embracing the complexity of a dynamic and ongoing process. Leaders managed this process by balancing stable, nationally defined intervention and implementation core components with adaptive, context-sensitive implementation strategies. May's concepts of plasticity and elasticity ( 10 ) provide valuable tools for a better understanding of the degree to which leaders could navigate this balance ( 10 ). Plasticity refers to the degree to which an intervention can be adapted to fit varying contexts. Elasticity describes the flexibility of the implementation strategies and the context's ability to accommodate the intervention. In our study, the leaders experienced the PaHS intervention to have limited plasticity – “a heavy logic”- due to its tightly coupled intervention core components. Leaders navigated these constraints by leveraging the elasticity of the implementation strategies, ensuring both fidelity and responsiveness to the unique demands of local realities. This required leaders to engage in significant adaptive work, aligning with May's proposition that the more tightly coupled the intervention components are, the less discretion participants have, and the more adaptive work is required for integration ( 10 ). Our analysis illustrates how the leaders’ reflexive practice, characterised by real-time adjustments and feedback loops ( 14 ), was crucial in managing this balance. Through this process, leaders did not simply follow national guidelines but actively mediated between standardisation and local realities, resulting in an experienced successful implementation with fidelity across the regions. This dynamic process aligns with May's notion of understanding context as a process rather than a place where continuous interaction and adaptation are necessary to ensure effective implementation ( 10 ). By demonstrating these real-time adaptive practices, this study provides a practical example of May’s theoretical concepts, showing how leaders’ adaptive work might support high-fidelity implementation in policy-driven contexts. By leveraging the elasticity of implementation strategies, leaders experienced that they were able to preserve the core intervention components with fidelity by creating a "fit" between intervention and context. This insight aligns well with the recent implementation science literature, which recognises that adaptations can be made both in the intervention itself and in the implementation strategies ( 17 , 44 ). Schwarz et al. ( 17 ) suggest that implementation strategies can be viewed as mechanisms for achieving a "fit" between intervention and context. Our findings extend this work by illustrating how leaders practically operationalise this "fit" in implementation strategies through real-time, context-sensitive adjustments. A study by Rodriguez et al. ( 16 ) likewise underscores that flexibility in implementation does not necessarily reduce fidelity but can enhance the adoption and penetration of interventions in real-world settings. Our findings further suggest that adaptations were not experienced as conflicting with fidelity, but rather as an essential part of the implementation process. Consistent with implementation science literature, which increasingly views adaptation and fidelity as complementary elements ( 16 , 17 , 45 ), we suggest that context-sensitive adaptation in implementation strategies enabled leaders to increase fidelity as it allowed the intervention to function in diverse local contexts. Braithwaite et al. ( 14 ) support this finding by highlighting that achieving system-level change necessitates moving beyond a narrow focus on intervention fidelity to embrace iterative, recursive adaptation to context, working closely with local stakeholders and embracing contextual complexity. Among the concepts he introduces as important in such processes are feedback loops ( 14 ). Feedback loops are described as recursive mechanisms that create reciprocal behaviours in which outputs feed back as new inputs. In a positive self-reinforcing feedback loop, the rate of change is amplified, resulting in the production of more of its own output. In a negative, self-correcting feedback loop, outputs dampen change or adjust their direction ( 14 ). In our study, these mechanisms became visible through leaders’ reflexive practices: reinforcing loops when successful practices were shared and amplified across regions, and stabilising loops when feedback from practice and performance management data led to the revision of standards or correction of misalignments. Together, these dynamics illustrate implementation as a non-linear and ongoing process, where interventions and contexts co-adapt over time ( 10 , 13 , 14 ). In such a system, Greenhalgh and Papoutsi ( 13 ) argue that the traditional quest for certainty and predictability must be supplemented by the capacity to manage uncertainty and emergent causality in dynamic systems. In our study, this capacity was enacted through both formal and informal vertical and horizontal leadership, where leaders collaborated to foster an environment in which reinforcing loops could spread successful practices and stabilising loops could correct misalignments. Our findings indicate that this collective approach to leadership was critical not only for ensuring consistency and accommodating local needs but also for maintaining momentum in the implementation process. This finding empirically supports Metz and Bartley ( 46 ), who argue that successful implementation is inherently collaborative and relies on shared responsibilities rather than individual leadership. Altogether, these findings illustrate that the experienced successful national implementation of PaHS required much more than strict adherence to a standardised implementation guideline; instead, it relied on a co-adaptive process within a national framework. This case highlights the need for implementation frameworks to move beyond static and prescriptive models, embracing a more fluid understanding of implementation where intervention and context are co-constructed through ongoing, leadership-driven negotiation, as seen in this study. Limitations When assessing the results, some limitations should be acknowledged. First, while leadership was involved at multiple levels, we chose to treat it collectively rather than distinguishing between specific roles. This approach highlighted the collective leadership practice and preserved participant anonymity but may overlook nuances unique to different levels of leadership. Second, this study did not measure fidelity; instead, it relied on performance management measures, adherence to the intervention's core components, and leaders' accounts of these aspects. Future research could incorporate objective fidelity assessments to measure fidelity alongside adaptive leadership strategies. Third, a limitation relates to the temporal variation in data collection. While interviews were conducted during a more mature phase of implementation, observations and documents spanned the whole implementation period from 2017 to 2020. This variation may have shaped how experiences were expressed and understood at different stages. However, triangulation across data sources helped mitigate this limitation by enabling interpretation of interview accounts in relation to documented and observed implementation practices over time. Conclusion This study highlights the complexity of scaling and implementing healthcare interventions across diverse contexts. The study underscores the crucial role of collaborative leadership in fostering vertical and horizontal leadership and facilitating feedback loops – both reinforcing (positive) and stabilising (negative) – together with real-time adjustments, ultimately ensuring what leaders perceived as a successful national implementation. It contributes empirically by demonstrating how fidelity and adaptation can, in practice, function not as opposing forces but complementary, with adaptation serving as a prerequisite for achieving fidelity. This dynamic interplay calls for moving beyond static, linear implementation models, recognising that success in implementing national complex interventions lies in continuous adaptation and real-time leadership-driven adjustments, where stability and flexibility co-evolve with complex and unfolding contexts. By providing empirical insights into the adaptive mechanisms, this study addresses calls for a deeper understanding of the processes that underpin successful implementation in complex systems. Abbreviations PaHS Proactive Health Support SMS Self-management support Declarations Ethics approval and consent to participate The randomized controlled trial in the overall research program was approved by the Regional Committee on Health Research Ethics for the Region of Zealand, Denmark (SJ-677). According to Danish legislation, this kind of qualitative research does not require separate approval by the Biomedical Research Ethics Committee. All informants have given informed consent. The study was conducted in accordance with the principles outlined in the Declaration of Helsinki. Trial registration Not applicable. This qualitative study is part of a larger multidisciplinary research programme that includes a randomised controlled trial registered at ClinicalTrials.gov (NCT03628469). Consent for publication Not applicable Availability of data and materials The qualitative datasets generated and analysed during the current study are not publicly available due to the confidential nature of the material and data protection obligations under the General Data Protection Regulation (GDPR). Competing interests The authors declare that they have no competing interests. Funding An unrestricted research grant from the Danish Ministry of Health funds the PaHS research program. The funding source was not involved in conducting the research program or preparing this article. JH works for the Centre for Development, Evaluation, Complexity, and Implementation in Public Health Improvement, funded by the Welsh Government via Health and Care Research Wales. Authors’ contribution MF conceptualised the study, designed the methodology, conducted data collection, performed the analysis, and drafted the manuscript. CPN and MDT provided substantial input during data interpretation and contributed to critical revisions of the manuscript. UT, MG, and JH contributed intellectual input and provided critical feedback to improve the manuscript's clarity and structure. All authors reviewed and approved the manuscript's final version and agreed to be personally accountable for their respective contributions to the study. Acknowledgments We want to express our gratitude to the leaders for their participation in the study. Additionally, we would like to thank Associate Professor and Senior Researcher Stina Lou for her thorough review of the article. References Wutzke S, Benton M, Verma R. Towards the implementation of large scale innovations in complex health care systems: views of managers and frontline personnel. BMC Res Notes. 2016;9:327. World Health Organization. Everybody's business — strengthening health systems to improve health outcomes: WHO's framework for action. 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The national implementation of ‘Proactive Health Support’ in Denmark since 2017: expectations and challenges for the telephone-based self-management program. Health Policy. 2020;124(7):674–678. Fredens M, Palmhøj Nielsen C, Grønkjær M, Kjaerside Nielsen B, Konstantin Nissen N, Benthien KS, et al. Nurses' perspectives on challenges and facilitators when implementing a self-management support intervention as an everyday healthcare practice: a qualitative study. J Adv Nurs. 2024;80(6):2475–86. Benthien KS, Rasmussen K, Nielsen CP, Hjarnaa L, Rasmussen MK, Kidholm K, et al. Proactive health support (PaHS) – telephone-based self-management support for persons at risk of hospital admission: study protocol for a randomized controlled trial. Contemp Clin Trials. 2020;93:106004. Benthien KS, Rasmussen K, Nielsen CP, Kidholm K, Grønkjær M, Toft U. Proactive Health Support: a randomised controlled trial of telephone-based self-management support for persons at risk of hospital admission. 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In: Jourdan D, Potvin L, editors. Global handbook of health promotion research. Vol 3: Doing health promotion research. Cham: Springer International Publishing; 2023. p. 141–9. Metz A, Bartley L. Implementation teams: a stakeholder view of leading and sustaining change. In: Albers B, Shlonsky A, Mildon R, editors. Implementation science 3.0. Cham: Springer; 2020. p. 199–225. Additional Declarations No competing interests reported. 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Health Support in Denmark","fulltext":[{"header":"Background","content":"\u003cp\u003ePolicymakers focus increasingly on expanding successful small-scale healthcare interventions to a national scale to maximise their reach and impact (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). This trend aims to ensure that the entire target population has access to the most effective interventions and programs available (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). However, implementing complex national interventions in healthcare, in this case, a large-scale self-management support (SMS) program, can be challenging (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). A consistent trend in implementation science literature is that achieving widespread practice change is difficult, and successful interventions in one setting may face challenges when trialled elsewhere (\u003cspan additionalcitationids=\"CR7\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eThe literature on complex interventions (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) and implementation science (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) concludes that a key challenge in achieving successful national implementation is the 'practical problem of context' (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Interventions and their outcomes are deeply intertwined with the contexts in which they are implemented, making strict implementation across diverse settings particularly challenging. This challenge is especially pertinent when trialling large-scale interventions across multiple sites, where varying local conditions may lead to different implementation outcomes (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Sarkies et al. (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) similarly argue that challenges of replicating and scaling interventions pertain to the complex social processes of implementation and the need for implementation strategies that adequately match local contexts. The \u0026lsquo;practical problem of context\u0026rsquo; cannot be handled by treating it as a pure operationalisation issue that can be managed with a rational prescriptive checklist of, for example, implementation strategies (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Instead, it is argued that the dynamic nature of contexts requires adaptive and responsive approaches to managing the complexities that arise instead of rigid standardisation (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Therefore, a key challenge in implementing large-scale national complex interventions is the inherent tension between striving for standardisation and a complex system characterised by dynamically changing inter-relationships and tensions (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan additionalcitationids=\"CR13\" citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). In implementation science and complex interventions literature, this is often referred to as the tension between adaptation (i.e., flexibility) and maintaining fidelity (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). Fidelity refers to the degree to which an intervention is implemented as it was initially described, tested, or intended by the developer (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). In this study, adaptation is defined as 'making fit' often by modification, allowing for adjustments to the intervention itself, the implementation strategies, and the implementation context (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e In response to these challenges, various frameworks and guidelines have been developed. One example is determinant frameworks (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e) that aim to improve implementation outcomes by acknowledging and adjusting for contextual factors. Others have focused on the importance of intervention adaptation to fit with local contexts (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Fixsen et al. (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) contribute by introducing the concept of 'core \u003cem\u003eimplementation\u003c/em\u003e components', distinguishing these from 'core \u003cem\u003eintervention\u003c/em\u003e components' to emphasise that successful interventions rely both on core intervention and implementation components. These implementation components, such as training, coaching, and program evaluation, are defined as the most essential and indispensable elements of an implementation program(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e), thought to be crucial for achieving fidelity to core intervention components (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). They further suggest that flexibility in the form of implementation core components (e.g. strategies and processes) allows adaptation to local contexts without compromising intervention fidelity in large-scale national implementations (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). Similarly, recent studies increasingly suggest that flexibility in implementation strategies and processes can complement rather than compromise fidelity, enabling necessary adaptations to meet local contextual needs without necessarily undermining intervention integrity (\u003cspan additionalcitationids=\"CR16\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). In line with this, Schwarz et al. (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e) introduce a useful distinction between adaptations in the intervention, the context, or the implementation strategies. They propose that achieving fit between an intervention and its context does not always require adaptation of the intervention itself. They suggest that implementation strategies may act as tools to reconcile fidelity and adaptation by enabling modifications in either the intervention, the context, or both as needed.\u003c/p\u003e\u003cp\u003eHowever, while much of this existing research highlights the potential coexistence of fidelity and adaptation, it often remains primarily focused on conceptual frameworks and theoretical discussions (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). This leaves a gap in understanding how leaders experience and manage this balance, particularly in the dynamic and complex realities of large-scale, policy-driven implementation efforts. Although leadership has been studied in policy implementation research for decades (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e), its role in shaping implementation processes has only more recently gained attention in implementation science (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). Leadership is increasingly recognised as a critical factor for successful implementation within implementation science (\u003cspan additionalcitationids=\"CR25\" citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e), and many implementation frameworks and theories in healthcare highlight the significance of organisational leadership in achieving high fidelity (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). Though recent research (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e) has started to investigate and support this relationship experimentally, more knowledge on practices for building and maintaining intervention and implementation fidelity has been called for (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). We lack empirical research on how leaders experience and manage the actual processes involved in national-scale implementations, including actively balancing and operationalising the tension that may arise between adaptation and fidelity over time. A broader tendency in implementation science and empirical studies may compound this gap. Often, studies are front-loaded with a focus on program theories and prescriptive implementation models or end-loaded with a focus on process evaluations that study past implementation practices. Fewer studies follow implementation processes over time (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). As a result, less is known about the mechanisms that drive adaptation and sustainability over time (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e), as well as how leadership is both experienced and enacted in navigating these dynamics. To address this gap, this study examines how leaders experience and manage the national implementation of a complex SMS intervention, Proactive Health Support (PaHS), in Denmark. The article is part of a multidisciplinary research program evaluating PaHS. Further evaluation results are reported elsewhere (\u003cspan additionalcitationids=\"CR28 CR29 CR30 CR31 CR32\" citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e).\u003c/p\u003e"},{"header":"Method","content":"\u003cp\u003eThis study utilises a qualitative case study design based on interviews, observations, and documents. This study adheres to the SRQR guideline (\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e).\u003c/p\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eAim\u003c/h2\u003e\u003cp\u003eThis study aims to investigate the following research question: How do leaders experience and manage the national implementation of a complex SMS intervention, Proactive Health Support (PaHS), in Denmark?\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eStudy Setting\u003c/h3\u003e\n\u003cp\u003eThe Danish healthcare system offers tax-financed universal healthcare and consists of three administrative and political levels: the state, five regions, and 98 municipalities. The Danish Ministry of Health is responsible for setting the regulatory and financial framework for the healthcare system (\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e). The five regional authorities govern and operate the hospitals, while general practitioners are gatekeepers to specialist services. The municipalities are responsible for prevention, community nursing, and rehabilitation outside hospitals (\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e).\u003c/p\u003e\n\u003ch3\u003eThe PaHS Intervention\u003c/h3\u003e\n\u003cp\u003eThe PaHS intervention was a large-scale, telephone-based SMS program designed to reduce preventable hospital admissions and improve health-related quality of life for participants. The intervention recruited participants through a prediction model identifying adults at risk of hospital admissions within 3 months. Registered nurses were trained to deliver the intervention, focusing on enhancing participants' self-management strategies and coping skills (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e). The PaHS intervention was organised in specially established PaHS units, seven in total across the five regions. These PaHS units were independent of existing organisational units such as hospital departments and rehabilitation centres. The PaHS program, including both intervention and implementation core components, is described in further detail in Table\u0026nbsp;\u003cspan refid=\"Tab1\" 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\u003eThe PaHS Intervention - Intervention and Implementation Core Components\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"1\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIncluded citizens:\u003c/p\u003e\u003cp\u003e\u0026bull; Adults (\u0026ge;\u0026thinsp;18 years) at high risk of hospital admission, identified monthly via a national prediction model using healthcare registry data.\u003c/p\u003e\u003cp\u003e\u0026bull; Eligible individuals received an invitation via secure electronic mail (e-Boks) and follow-up phone calls. After consent, nurses performed a secondary screening to confirm eligibility before inclusion\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIntervention Core Components (Active Ingredients):\u003c/p\u003e\u003cp\u003e\u0026bull; Initial Session: A face-to-face session with the same registered nurse (RN) who will conduct the entire intervention.\u003c/p\u003e\u003cp\u003e\u0026bull; Telephone Follow-up Sessions: Regular phone-based follow-ups are conducted over a 6\u0026ndash;9 month period.\u003c/p\u003e\u003cp\u003e\u0026bull; Tools: Development of personal goals and assessment of hospitalisation risk at each session.\u003c/p\u003e\u003cp\u003e\u0026bull; Nurses' Roles:\u003c/p\u003e\u003cp\u003eo Caregiver: Provides support for the patient\u0026rsquo;s health and well-being.\u003c/p\u003e\u003cp\u003eo Coach: Guides the patient through self-management techniques.\u003c/p\u003e\u003cp\u003eo Healthcare Professional: Offers clinical expertise and advice on disease and treatment.\u003c/p\u003e\u003cp\u003e\u0026bull; RCT protocol\u003c/p\u003e\u003cp\u003e\u0026bull; Practice Handbook: A national standardised guide that outlines the delivery of core components of the intervention, including patient engagement, coaching methods, and the use of tools such as the risk management protocol.\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCore Implementation Components:\u003c/p\u003e\u003cp\u003e1. Performance Management: A system designed to ensure consistent quality and activity levels across regions. It includes set goals and standards for patient caseloads, conversation duration, and frequency of contact based on patient risk profiles.\u003c/p\u003e\u003cp\u003eo M4 IT-System: Unified platform for data collection and patient progress tracking. An IT system allows nurses to track their own cases, while local and program management can monitor whether targets are being met. Additionally, it serves as a method for continuous learning and development, ensuring a high and uniform quality across all regional units.\u003c/p\u003e\u003cp\u003e2. Workflow Descriptions: National guideline including standards for how the intervention should be delivered and organised, ensuring that processes (e.g., patient screening, coaching, documentation) are standardised across regions.\u003c/p\u003e\u003cp\u003e3. Education and Supervision:\u003c/p\u003e\u003cp\u003eo Three training modules of 2 days each, with a follow-up day focusing on learning the roles of caregiver, coach, and healthcare professional. Provided by a private consultancy firm.\u003c/p\u003e\u003cp\u003eo Supervision:\u003c/p\u003e\u003cp\u003e\u0026clubs; External supervision: Formal supervision by private consultancy firms to ensure adherence to intervention protocols.\u003c/p\u003e\u003cp\u003e\u0026clubs; Peer and Internal Supervision: Ongoing peer-based and team-based support to help nurses refine their practical and relational skills.\u003c/p\u003e\u003cp\u003eo Workshops and Team Meetings: Regional sessions for continuous professional development and refinement of personalised coaching skills.\u003c/p\u003e\u003cp\u003eo Communication Techniques:\u003c/p\u003e\u003cp\u003e\u0026clubs; Gamemaster Technique\u003c/p\u003e\u003cp\u003e\u0026clubs; Karl Tomm's Interventive Interviewing\u003c/p\u003e\u003cp\u003e\u0026clubs; Identification of essential keywords and exploring their meaning.\u003c/p\u003e\u003cp\u003e\u0026clubs; Solutions-Focused Coaching\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\u003eActors\u003c/b\u003e:\u003c/p\u003e\u003cp\u003e\u0026bull; National Program Management: Responsible for coordinating and monitoring the program centrally across all regions.\u003c/p\u003e\u003cp\u003e\u0026bull; Project Leaders: Ensure that implementation follows national guidelines and is adapted to local needs.\u003c/p\u003e\u003cp\u003e\u0026bull; Nurse Leaders: Support frontline staff in maintaining fidelity in the delivery of the intervention.\u003c/p\u003e\u003cp\u003e\u0026bull; Registered Nurses (RNs): Frontline staff delivering the intervention directly to patients through consultations and follow-ups.\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eIntervention Outcomes\u003c/b\u003e:\u003c/p\u003e\u003cp\u003e\u0026bull; Short-term Goals: Improve patient self-management.\u003c/p\u003e\u003cp\u003e\u0026bull; Long-term Goals: Reduce hospital admissions, improve health-related quality of life, and decrease healthcare costs.\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\u003eIn 2016, a national\u0026ndash;regional political agreement was made to implement the PaHS intervention at a national scale running from 2017 to 2020. The intervention had previously been developed and tested in Sweden. The policy-level processes and challenges related to the early implementation of PaHS have been addressed in a previous publication (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e). The agreement emphasised national uniformity by requiring the intervention to be developed and managed as a national program and by initiating a multidisciplinary research program, including a protocolled randomised controlled trial (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e). While PaHS was initiated through a top-down national policy agreement, the five regions were granted authority to organise the intervention within a jointly defined national framework. This governance structure allowed for regional flexibility in organisation, resulting in variations in the size, structure, and organisational anchoring across the PaHS units. For example, some regions had two units with a nurse leader in each unit, while others had only one unit (See 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\u003eRegional Organisation of the PaHS Intervention\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOrganisation\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRegion 1\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eRegion 2\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eRegion 3\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eRegion 4\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eRegion 5\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNumber of Call Centres\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNurses\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e20\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e20\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e34\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e10\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNurse Leaders\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eProject Leaders\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e1\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\u003eA national program management was established prior to implementation, to oversee coordination, standardisation, and quality assurance, in line with a formalised program governance model. This model emphasised structured collaboration between national and regional actors, with a strong focus on implementation and organisational processes. The program management consisted of a program manager and a support secretariat. From 2017 to 2020, this national program management oversaw the overall coordination, management, and implementation of PaHS in close collaboration with regional leaders. In addition to the program manager, the national implementation of PaHS involved two other formal leadership roles. Each region employed a project leader and one or two nurse leaders responsible for the implementation and operation of the intervention. As such, the national implementation was a collective responsibility shared between national program management, regional project leaders, and nurse leaders. These leaders, ten in total (excluding region 5, see Participant section), worked closely together across all regions, meeting regularly in the capital region. Meetings were held both in peer groups (project leaders together, nurse leaders together, often with the program manager present) and jointly. While the implementation involved leadership at different levels, this study investigates leadership collectively to protect the participants' anonymity by avoiding identifying specific leadership roles and regional distinctions.\u003c/p\u003e\n\u003ch3\u003eStudy Design\u003c/h3\u003e\n\u003cp\u003eThis study employs a single-case study design with embedded units, allowing for units of analysis on multiple levels and across contexts within the same case (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e). The unit of analysis is the national PaHS implementation, while the embedded units consist of six PaHS units in four regions. Paparini and Papoutsi (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e) note that case study research is particularly well-suited for investigating complex interventions in their natural settings, where implementation processes are deeply intertwined with dynamic contextual factors. Thus, the case study design provides a valuable methodological approach for capturing the complexity of the national PaHS implementation.\u003c/p\u003e\n\u003ch3\u003eParticipants\u003c/h3\u003e\n\u003cp\u003e The present study involved the following participants: 1) four regional project leaders already working as project leaders within the regions where they were assigned to the PaHS project, 2) five nurse leaders overseeing one or two PaHS units in these regions. All nurse leaders had actively applied for the position, and 3) the national program manager. In total, 11 leaders were involved in the national implementation of PaHS, and all were invited to participate in this study. All leaders were contacted via email and informed about the study; all consented to participate in qualitative interviews. One of the five Danish regions was excluded from this study, as it had a somewhat different education program and several years of experience with the intervention as it functioned as a pilot region (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e). The interview with the leader from that region was therefore excluded from the analysis. The final sample comprises 10 leaders from the remaining four regions - all with formal leadership responsibilities in the national implementation.\u003c/p\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003eData Collection\u003c/h2\u003e\u003cp\u003eData collection involved multiple qualitative methods: semi-structured interviews, observations, and document analysis. Some data collection spans 2017\u0026ndash;2020, such as the observations and documents. Interviews were conducted in the more mature phase of the implementation process from late January to March 2019 and before trial results were known (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e). The data collection over several years allowed for following the dynamics involved in the national implementation of the PaHS intervention. The first author, an experienced social scientist, and a research assistant collected data. The data presented in this article have not been previously published.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eObservation\u003c/h3\u003e\n\u003cp\u003eParticipant observations were conducted (\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e) in workshops, including training sessions, performance management workshops, and leadership meetings with nurse leaders, project leaders, and program management, which amounted to more than 25 hours of observations. Access was granted through collaboration with national program management. Notes were taken during and immediately after each session by the first author, guided by an observational focus on the interactions, decision-making processes, and practical challenges faced during the implementation of the PaHS program. The observations also offered an opportunity to capture informal interactions and emergent challenges not readily accessible through interviews or documents, and they informed the development of the interview guides. The extent of observations was determined by the primary researcher, who was offered access to observe and participate in all leadership activities. Observations were concluded when the primary researcher assessed that data saturation was met.\u003c/p\u003e\n\u003ch3\u003eDocument analysis\u003c/h3\u003e\n\u003cp\u003eThe document analysis included a practice manual, workflow description, leadership meeting minutes, and a performance management catalogue. The practice manual and workflow description were collaboratively developed by leaders during the early stages of the implementation process before the RCT launch. They were based on the trial protocol and co-created and adjusted several times during this early phase, based on input from frontline staff (nurses) to ensure practical relevance. Leadership meeting minutes were written in relation to meetings between project leaders and program management (meeting minutes\u0026thinsp;=\u0026thinsp;14), leading nurses and program management (meeting minutes\u0026thinsp;=\u0026thinsp;11), and joint leadership meetings across the leaders (meeting minutes\u0026thinsp;=\u0026thinsp;5). All leadership meeting minutes produced during the project period, 468 pages, were collected by the national program management secretary and forwarded to the first author. The performance management catalogue was developed by the program management with input from leaders to establish joint standards.\u003c/p\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003eSemi-structured individual Interviews\u003c/h2\u003e\u003cp\u003eThe first author conducted all interviews (2019\u0026ndash;2020), lasting 45 to 66 minutes. Participants were recruited via email, and interviews were conducted during working hours. The interview explored leaders\u0026rsquo; experience and management in relation to the PaHS implementation process, focusing on their responsibilities and leadership collaboration within and across the regional and national levels. A semi-structured interview guide was developed for this study, with minor adaptations to reflect participants\u0026rsquo; formal leadership roles in the program, nurse leaders, regional project leaders, and the national program manager, while maintaining a shared thematic structure across all interviews. The guides covered common topics such as leadership responsibilities and practices, organisational setup and local organisational adaptations, and experiences with implementing the intervention within a national framework. An English version of the interview guide is available as a Supplementary File. Interviews were digitally recorded and transcribed verbatim.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003eAnalysis\u003c/h2\u003e\u003cp\u003eA reflexive thematic analysis (\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e, \u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e) was used, informed by an abductive analytical approach (\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e). Abduction is a mode of analysis that involves iteratively moving between empirical observations and theoretical concepts in order to develop meaningful interpretations. In this study, it supported an openness to empirical complexity and a sensitivity to patterns, tensions, and dilemmas in the data. This abductive approach allowed us to gradually refine the thematic structure by engaging theory in dialogue with emerging insights (\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eThe first step involved comprehensively reading interview transcripts, field notes, and documents. During this initial exploration of the data, the broader preliminary codes of \u003cem\u003econtext\u003c/em\u003e, \u003cem\u003eimplementation processes\u003c/em\u003e, and \u003cem\u003eoutcomes\u003c/em\u003e were identified as essential aspects of the leaders' experiences and management of the intervention across different regions.\u003c/p\u003e\u003cp\u003eThe first author then developed subcodes within these broader preliminary codes. For example, within the preliminary code of \u003cem\u003econtext\u003c/em\u003e, subcodes like \u003cem\u003estandardisation\u003c/em\u003e and \u003cem\u003eflexibility\u003c/em\u003e began to take shape, reflecting early insights into how leaders experienced and balanced uniformity and adaptation. At this stage, the analysis remained data-driven, allowing patterns in the data to guide the initial coding structure.\u003c/p\u003e\u003cp\u003eAs the analysis progressed, theoretical concepts from the implementation science literature were gradually introduced to inform and refine the preliminary codes and emerging subcodes. The preliminary code of \u003cem\u003eimplementation processes\u003c/em\u003e was further refined with subcodes such as \u003cem\u003ecollaboration\u003c/em\u003e and \u003cem\u003emonitoring\u003c/em\u003e, illustrating how leadership across regional and national levels engaged with the intervention.\u003c/p\u003e\u003cp\u003eThe coding process was iterative and collaborative. The first author led the coding, with continuous discussions to ensure reflexivity, consistency, and depth in the analysis. The second (MDT) and last (CPN) authors discussed preliminary test coding with the first author, and slight adaptations to the coding structure were made. The first author then coded all data. Alongside this interview coding, our findings were triangulated with field notes and documents, providing additional layers of insight and ensuring the credibility of the analytical findings (\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e). The development of themes followed an iterative process of identifying recurring patterns across interviews, documents, and observations. Codes and subcodes such as \u003cem\u003estandardisation\u003c/em\u003e, \u003cem\u003eflexibility\u003c/em\u003e, \u003cem\u003ecollaboration\u003c/em\u003e, and \u003cem\u003emonitoring\u003c/em\u003e were refined and compared across the material and grouped into broader analytical categories, such as tensions between national standardisation and local realities, leadership responsiveness to and management of emerging challenges, and coordination across organisational levels and settings. These categories informed the construction of three overarching themes (see the results section). Thematic saturation was reached during the analysis, as no new codes or substantial variation emerged in the later stages of coding. The dataset provided sufficient depth and diversity to support the development of robust and meaningful themes across the material.\u003c/p\u003e\u003cp\u003eReflexivity was maintained throughout the research process. The first author, who led data collection and analysis, brought familiarity with the Danish healthcare context and prior qualitative experience. Interpretive and analytical decisions were continuously discussed with the second and last authors to surface and interrogate assumptions and to secure a critically warranted reading of the material.\u003c/p\u003e\u003cp\u003eA Large Language Model (ChatGPT, OpenAI) was used to support the translation and language editing of participants' quotes from Danish to English, to preserve the tone and clarity of the original spoken expressions. In addition, Grammarly was used to check grammar, spelling, and adherence to academic English conventions. The authors retained full responsibility for the content, accuracy, and intellectual contributions of the manuscript.\u003c/p\u003e\u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eThree key themes emerged: 1) between national standardisation and local implementation, 2) navigating flexibility within a national framework, and 3) managing national-local balances through vertical and horizontal leadership. Themes one and two include related subthemes.\u003c/p\u003e\u003cp\u003eA key finding across all themes was that the leaders consistently experienced the implementation of PaHS as a success. Although the multidisciplinary research program showed that the PaHS intervention was not cost-effective or displayed the expected outcomes (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e), leaders frequently expressed a strong sense of accomplishment, which is reflected in comments like: \u003cem\u003e\u0026ldquo;I think we stand quite strong in relation to what is on the agenda and standardising things, showing that it's actually possible even though we are different regions. I think we're a bit of proof that it can indeed succeed.\u0026rdquo;\u003c/em\u003e (Leader 5).\u003c/p\u003e\u003cp\u003eSeveral leaders reported observing changes in nursing practice, with nurses adopting more coaching-oriented, patient-centred roles, and that these practice changes were implemented consistently across regions. This shift marked a broader normative restructuring towards a coherent \u003cem\u003e'PaHS Professional Practice\u003c/em\u003e.' Some leaders highlighted the ability to share nurses between regions without additional training, frequently using phrases like \u003cem\u003e\u0026ldquo;we have seen that we can share nurses across regions\u0026rdquo;\u003c/em\u003e and \u003cem\u003e\u0026ldquo;the initiative is developed uniformly across regions\u0026rdquo;\u003c/em\u003e (Leader 2), indicating intervention fidelity. Although PaHS did not achieve the desired outcomes (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e), the implementation process was experienced as a success, offering valuable lessons for future national implementation endeavours. The following analysis examines how leaders experienced and managed the implementation process, contributing to the broadly shared perception of implementation success.\u003c/p\u003e\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\u003ch2\u003eTheme 1: Between National Standardisation and Local Implementation\u003c/h2\u003e\u003cp\u003e The overarching framework structure in PaHS was established through both top-down policy directives and national program management guidelines, including financial controls and operational boundaries such as the randomised controlled trial protocol to be followed. Initially, some leaders experienced the framework as restrictive, feeling constrained by standardised approaches and limited in their autonomy at the regional level. During observations, several participants expressed frustration with the \u003cem\u003e\u0026ldquo;heavy logic\u0026rdquo;\u003c/em\u003e (Observation, Performance Management start-up meeting) imposed by the national framework, describing how its rigidity sometimes felt at odds with the need for flexibility in local implementation. One leader explained:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;I think the difference here is the great uniformity and implementation consistency across the regions, which imposes different demands, both on us as leaders but also as implementation leaders. We've become that along the way. So, it definitely places demands on us. You can't autonomously decide, 'This is how I'm going to do it.' You are bound by a certain framework.\u0026rdquo;\u003c/em\u003e (Leader 8)\u003c/p\u003e\u003cp\u003eThis quote illustrates a core tension that leaders experienced when implementing a standardised intervention across diverse, dynamic local contexts. The framework necessitated adherence to set parameters, limiting autonomous decision-making. Over time, however, some recognised the national framework as a beneficial structure, particularly in offering legitimacy and stability in interactions with frontline staff:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;In relation to the national framework for the project. That has actually been one of the biggest light bulb moments in the project. There was a lot of hassle at the beginning, with each region wanting to do things their own way\u003c/em\u003e: '\u003cem\u003eCan\u0026rsquo;t we use iPads instead of phones, for example?\u003c/em\u003e' \u003cem\u003eThe Ministry was really adamant: 'You\u0026rsquo;re getting the money for this, nothing else!\u003c/em\u003e' \u003cem\u003eEverything we needed to adhere to was written down. But once all that was clarified, I\u0026rsquo;ve found that the national framework has provided peace and legitimacy.\u0026rdquo;\u003c/em\u003e (Leader 3)\u003c/p\u003e\u003cp\u003eDespite this recognition, leaders continued to experience the challenge of balancing adherence to national standards with addressing local, context-specific implementation. They acknowledged that while local variation was necessary to ensure local implementation, consistency in core components was essential to maintain integrity:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;We see a lot of variation across the regions. Some things are allowed to be different, but we must ensure that we are consistent in the important components.\u0026rdquo;\u003c/em\u003e (Leadership Meeting Minute 14)\u003c/p\u003e\u003cp\u003eThus, leaders found themselves continuously negotiating between national expectations and local realities. The need for a balance between standardisation and flexibility created an ongoing tension, where leaders had to ensure that the intervention remained true to its core components while also working in practice within diverse local settings.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\u003ch2\u003eTheme 2: Navigating Flexibility within a Structured Framework\u003c/h2\u003e\u003cp\u003eThis theme focuses on how leaders operationalised flexibility to navigate the tension between standardisation and local adaptation. Across all data material, many leaders described the implementation of PaHS as an evolving dynamic process with many uncertainties; as one leader explained during a leadership workshop: \u0026ldquo;\u003cem\u003eMany things will remain uncertain, and you will not get answers to everything you want. You have to be able to tolerate that.\u0026rdquo;\u003c/em\u003e (Observation, Performance management start-up meeting).\u003c/p\u003e\u003cp\u003eThe implementation process was experienced as inherently unpredictable, requiring leaders to manage emerging challenges in real-time and adapt to evolving conditions:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;[\u0026hellip;] we are working while laying the tracks sometimes, aren\u0026rsquo;t we?\u0026rdquo;\u003c/em\u003e (Leader 2)\u003c/p\u003e\u003cp\u003eThis quote illustrates how leaders needed to remain attentive and flexible, guiding the implementation processes in new and more favourable directions to ensure successful and unified implementation of the intervention's core components across settings, as such adaptation processes were an integral and iterative dynamic part of the implementation process.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\u003ch2\u003eManaging National Standards in a Dynamic Process\u003c/h2\u003e\u003cp\u003eA key national strategy in managing this iterative implementation process was that \u003cem\u003e\u0026ldquo;the components central for a possible effect should be nationally anchored\u0026rdquo;\u003c/em\u003e (Leadership Meeting Minute 19). This included the intervention core components and the development of national implementation core components involving standards and tools such as the workflow description, performance management system, and M4 data monitoring system. Although this national framework provided the necessary structure and standardisation to support intervention fidelity, leaders also described the core implementation components as flexible standards and subject to ongoing monitoring, evaluation, and revision to ensure local relevance and effectiveness. As one leader noted, this process involved leaders actively collaborating to adjust standards when they no longer aligned with regional or practical realities:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\"Yes, those are some of the key tools. I would say the workflow description is like the tool, as it also gathers the supporting tools, like how the risk management tool works [\u0026hellip;] There are 12 standards [\u0026hellip;] and we're discussing whether more standards are needed, both clinical standards and organisational, structural ones, like how many patients we need to process [\u0026hellip;] We are currently discussing how to revise, some of the standards don't make sense anymore or are not meaningful enough, so we need to change them, but most of them still hold.\"\u003c/em\u003e (Leader 10).\u003c/p\u003e\u003cp\u003eThis collaborative flexibility allowed leaders to ensure that the national implementation standards were flexible enough to accommodate changes while still providing the structure needed for consistency across regions. This was the case, for example, when the prediction model suddenly did not include the necessary patients on the lists. Standards had to be adjusted to address this issue, as there was a requirement to process a certain number of patients for the regions to receive funding from the central Danish government.\u003c/p\u003e\u003cp\u003eThis collaboration and ongoing evaluation process was especially evident in discussions surrounding performance management, one of the national implementation core components. Leaders across regions were engaged in determining not only how to standardise the overall performance management system but also whether the specific methods used in the regions, such as team meetings and review processes, should be uniform or allow for variation:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;Various methods are being used across the regions to ensure a shared overview of production and progress within individual PaHS units, such as board meetings. There is a need to decide whether uniform methods should be applied, and if so, which ones\u0026rdquo;\u003c/em\u003e (Leadership Meeting Minute 10)\u003c/p\u003e\u003cp\u003eThis discussion exemplifies how the development of national implementation tools like performance management was not a one-size-fits-all process but rather a dynamic, adaptive, and collaborative effort.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec17\" class=\"Section2\"\u003e\u003ch2\u003eLocal Adaptation of Implementation Strategies\u003c/h2\u003e\u003cp\u003eLeaders collaborated at the national level to define where consistency was essential and where local variation could be permitted. At the local level, leaders extended flexibility to implementation strategies in response to specific PaHS unit needs. An example of this flexibility was the shared Performance Management catalogue that was collaboratively developed by program management, project leaders, and nurse leaders. While specific standards were established to ensure consistency, such as standardised registration practices within the M4 system, regional leaders were given the flexibility to develop and adapt the performance management implementation strategies to suit their local contexts best. The catalogue outlined a framework that leaders in the different regions were responsible for filling in based on their specific contexts, as stated in the document: \u003cem\u003e\u0026ldquo;The PaHS-units themselves have been responsible for filling out [the theoretical PM framework].\u0026rdquo;\u003c/em\u003e (Performance Management catalogue document)\u003c/p\u003e\u003cp\u003eThis collaborative effort allowed for the creation of a shared theory of change, outlining the expected relationships between the organisational structure of PaHS, its activities and resources, and the desired outcomes. Project leaders and nurse leaders received training on performance management, ensuring that the foundational principles were consistent across regions, while the practical implementation strategies or methods could vary. For example, while meetings were held across all regions and PaHS units to review performance data, the frequency, terminology, and specific content of these meetings varied depending on the regional context. As one leader remarked: \u003cem\u003e\u0026ldquo;But it probably also depends on the staff group because in [another region], you maybe can't gather 35 people around a board. It doesn't make sense. I do not know what they do over there.\u0026rdquo;\u003c/em\u003e (Leader 1). This illustrates how regional leaders adapted meetings to suit their specific team sizes and operational needs, ensuring that the national guidelines remained meaningful and practical within their local contexts. In this way, performance management, a core national implementation component, not only served to standardise practices but also became a dynamic space for regional and local adaptation, where strategies were monitored, shaped, and reshaped to fit local contexts.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec18\" class=\"Section2\"\u003e\u003ch2\u003eTheme 3: Managing National-Local Balances through Horizontal and Vertical Leadership\u003c/h2\u003e\u003cp\u003eThe analysis identified two key types of leadership in the PaHS implementation: horizontal and vertical. Horizontal leadership describes cross-regional collaboration, enabling leaders to share best practices and maintain consistency. This position enabled them to facilitate continuous dialogue, ensuring that adaptations in the implementation process remained aligned with the intervention's core components while allowing local insights to shape national core implementation components. Vertical leadership refers to the top-down and bottom-up processes where leaders translate national directives into local practice and communicate local insights back to the national level, acting as mediators, ensuring alignment between national goals and local realities.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec19\" class=\"Section2\"\u003e\u003ch2\u003eHorizontal Leadership: Cross-regional Collaboration\u003c/h2\u003e\u003cp\u003eMany leaders described a national leadership structure as a key precondition for successful, cohesive, and consistent national implementation:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;We are completely dependent on having such a well-functioning cross-regional leadership. In that sense, having a group of project leaders and a group of nurse leaders [\u0026hellip;] has in many ways practically functioned as part of the [national] leadership.\u0026rdquo;\u003c/em\u003e (Leader 10)\u003c/p\u003e\u003cp\u003eThe ongoing cross-regional collaboration among leaders allowed them to maintain a shared focus and uniform implementation while also facilitating the exchange of best practices and problem-solving strategies:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;We have become very aware that we can only ensure a unified and consistent effort, both across and within the regions, by continuously being curious and communicating with each other.\u0026rdquo;\u003c/em\u003e (Leader 8)\u003c/p\u003e\u003cp\u003e Leaders commonly experienced formal cross-regional meetings as a cornerstone of this collaboration. Regular in-person meetings created a space for regional leaders to discuss national strategies and to share local experiences. One leader described the structure of these meetings:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;We have these joint meetings first, and then we each go our separate ways[...] I think our [leadership role] meetings have been good and constructive[...] it's a forum where we are equal and where you get the chance to talk about some of the things you've been thinking about.\u0026rdquo;\u003c/em\u003e (Leader 3)\u003c/p\u003e\u003cp\u003eMuch of the collaboration also occurred through informal networks. Several leaders described frequently reaching out to their peers across regions to seek advice or share solutions to practical challenges:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;Personally, I do it if I have something I feel I can\u0026rsquo;t solve myself or something that puzzles me, or if I\u0026rsquo;m in doubt whether I\u0026rsquo;m doing it right, then I write to the others and ask, 'How do you see this?' 'Do you have a challenge here, because I do?' and 'How did you solve it?' Or vice versa, if I notice something that we discussed in a meeting, I can say, 'This is how it\u0026rsquo;s done,' and maybe they can use that.\u0026rdquo;\u003c/em\u003e (Leader 6)\u003c/p\u003e\u003cp\u003eThese informal networks were an essential support system, enabling leaders access to expertise and to discuss implementation challenges:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;[name of a leader from another region] is incredibly skilled with our M4 system, which extracts data... If there\u0026rsquo;s something we really need... it\u0026rsquo;s her who can help with that.\u0026rdquo;\u003c/em\u003e (Leader 1)\u003c/p\u003e\u003cp\u003eThis example illustrates how informal collaborations were experienced as valuable for sharing technical expertise and resources, helping leaders manage the implementation process despite variations in skills and capacities among the regional leaders.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec20\" class=\"Section2\"\u003e\u003ch2\u003eVertical Leadership: Mediating Between National and Regional Levels\u003c/h2\u003e\u003cp\u003eWithin regions, the leaders demonstrated shared responsibility for both implementing and guiding the intervention to translate national decisions into local practice. A leader reflected:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;So it\u0026rsquo;s me who can explain the history and make sense of why sometimes the things they [the nurses] have to do may not immediately seem meaningful in daily practice. What\u0026rsquo;s the reason behind it, and why does it still make sense?\u0026rdquo;\u003c/em\u003e (Leader 3)\u003c/p\u003e\u003cp\u003eThis illustrates how some leaders ensured that national directives were understood and meaningfully applied in daily practice. The focus was not only on issuing instructions but on creating a shared understanding of why certain practices were necessary, which supported smoother implementation.\u003c/p\u003e\u003cp\u003eLeaders saw themselves as having a critical role in managing upward communication by ensuring that frontline staff concerns and insight were brought to the attention of higher leadership levels, e.g. the overarching cross-regional leadership group and program management:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;I believe that the way we communicate is the most important part and that I listen a lot to their [the nurses'] inputs. There can be problems that I don't immediately understand or see as a problem, so I listen to them and try to figure out whether this is an issue at a staff level, something that needs to be raised with the team [\u0026hellip;] or the close leadership group [cross-regional leadership group].\u0026rdquo;\u003c/em\u003e (Leader 7)\u003c/p\u003e\u003cp\u003eBy bringing up these issues, the leaders facilitated the recognition and timely attention of potential challenges in the implementation process, helping to resolve local concerns and preventing them from affecting the program's overall success.\u003c/p\u003e\u003cp\u003eThis mediating leader role, based on vertical leadership, also encompassed managing uncertainties and reducing potential unwarranted turbulence within the local context:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;Sometimes, I'm also kind of brought in as someone who has the professional authority when there is too much uncertainty about certain things. I'm used to setting the framework and saying, 'This is how it is done.'\u0026rdquo;\u003c/em\u003e (Leader 8)\u003c/p\u003e\u003cp\u003eThis balancing act was only possible because these leaders were embedded \u0026ldquo;on the ground,\u0026rdquo; close to the nurses and the local contexts they were trying to influence:\u003c/p\u003e\u003cp\u003e\u003cem\u003e\"We should only focus on things that we find interesting to look at and can learn from, and I really like to use all the breaks to have dialogues with the staff in the break room and try to bring up the professional dialogue about how things are going, how many we have in the process, and 'Oh, now there were five no-shows this week,' all that, just to keep a finger on the pulse with those things [\u0026hellip;].\"\u003c/em\u003e (Leader 4)\u003c/p\u003e\u003cp\u003eThis interaction with frontline staff was used as an informal opportunity to gather feedback, track progress, and identify potential issues early. By being embedded in the local context, leaders knew when to \u0026ldquo;step in\u0026rdquo; or \u0026ldquo;keep out\u0026rdquo; and trust the staff to manage daily operations effectively.\u003c/p\u003e\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study aims to investigate how leaders experience and manage the national implementation of a complex SMS intervention (PaHS) in Denmark.\u003c/p\u003e\u003cp\u003eImplementation is always a meeting between the new and the old, between intervention and context, stability and change, standardisation and adaptation. This intersection, where critical tensions and synergies arise, is essential for understanding the complexities of implementation. While these tensions, especially between intervention and context (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) and between fidelity and adaptation (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e), are well-known in implementation research, few studies have explored the implementation processes over time (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e), including the role of leaders in navigating these tensions during large-scale national implementations.\u003c/p\u003e\u003cp\u003eProspectively identified factors can certainly play an important role in finding contextual determinants for implementation (i.e. facilitators and barriers) and thereby guide decisions about the appropriate implementation strategies for matching the needs of local contexts (\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e). However, they also imply a somewhat static, formulaic, predictable understanding of the implementation context and process (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Our findings demonstrate that leaders experienced the implementation process as unpredictable, and that the experienced successful PaHS implementation was not a result of simply following top-down directives and standardisations, but instead of embracing the complexity of a dynamic and ongoing process. Leaders managed this process by balancing stable, nationally defined intervention and implementation core components with adaptive, context-sensitive implementation strategies. May's concepts of plasticity and elasticity (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) provide valuable tools for a better understanding of the degree to which leaders could navigate this balance (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Plasticity refers to the degree to which an intervention can be adapted to fit varying contexts. Elasticity describes the flexibility of the implementation strategies and the context's ability to accommodate the intervention. In our study, the leaders experienced the PaHS intervention to have limited plasticity \u003cem\u003e\u0026ndash; \u0026ldquo;a heavy logic\u0026rdquo;-\u003c/em\u003e due to its tightly coupled intervention core components. Leaders navigated these constraints by leveraging the elasticity of the implementation strategies, ensuring both fidelity and responsiveness to the unique demands of local realities. This required leaders to engage in significant adaptive work, aligning with May's proposition that the more tightly coupled the intervention components are, the less discretion participants have, and the more adaptive work is required for integration (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eOur analysis illustrates how the leaders\u0026rsquo; reflexive practice, characterised by real-time adjustments and feedback loops (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e), was crucial in managing this balance. Through this process, leaders did not simply follow national guidelines but actively mediated between standardisation and local realities, resulting in an experienced successful implementation with fidelity across the regions. This dynamic process aligns with May's notion of understanding context as a process rather than a place where continuous interaction and adaptation are necessary to ensure effective implementation (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). By demonstrating these real-time adaptive practices, this study provides a practical example of May\u0026rsquo;s theoretical concepts, showing how leaders\u0026rsquo; adaptive work might support high-fidelity implementation in policy-driven contexts.\u003c/p\u003e\u003cp\u003eBy leveraging the elasticity of implementation strategies, leaders experienced that they were able to preserve the core intervention components with fidelity by creating a \"fit\" between intervention and context. This insight aligns well with the recent implementation science literature, which recognises that adaptations can be made both in the intervention itself and in the implementation strategies (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e). Schwarz et al. (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e) suggest that implementation strategies can be viewed as mechanisms for achieving a \"fit\" between intervention and context. Our findings extend this work by illustrating how leaders practically operationalise this \"fit\" in implementation strategies through real-time, context-sensitive adjustments. A study by Rodriguez et al. (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e) likewise underscores that flexibility in implementation does not necessarily reduce fidelity but can enhance the adoption and penetration of interventions in real-world settings. Our findings further suggest that adaptations were not experienced as conflicting with fidelity, but rather as an essential part of the implementation process. Consistent with implementation science literature, which increasingly views adaptation and fidelity as complementary elements (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e), we suggest that context-sensitive adaptation in implementation strategies enabled leaders to increase fidelity as it allowed the intervention to function in diverse local contexts.\u003c/p\u003e\u003cp\u003eBraithwaite et al. (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e) support this finding by highlighting that achieving system-level change necessitates moving beyond a narrow focus on intervention fidelity to embrace iterative, recursive adaptation to context, working closely with local stakeholders and embracing contextual complexity. Among the concepts he introduces as important in such processes are feedback loops (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Feedback loops are described as recursive mechanisms that create reciprocal behaviours in which outputs feed back as new inputs. In a positive self-reinforcing feedback loop, the rate of change is amplified, resulting in the production of more of its own output. In a negative, self-correcting feedback loop, outputs dampen change or adjust their direction (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). In our study, these mechanisms became visible through leaders\u0026rsquo; reflexive practices: reinforcing loops when successful practices were shared and amplified across regions, and stabilising loops when feedback from practice and performance management data led to the revision of standards or correction of misalignments. Together, these dynamics illustrate implementation as a non-linear and ongoing process, where interventions and contexts co-adapt over time (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). In such a system, Greenhalgh and Papoutsi (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e) argue that the traditional quest for certainty and predictability must be supplemented by the capacity to manage uncertainty and emergent causality in dynamic systems. In our study, this capacity was enacted through both formal and informal vertical and horizontal leadership, where leaders collaborated to foster an environment in which reinforcing loops could spread successful practices and stabilising loops could correct misalignments. Our findings indicate that this collective approach to leadership was critical not only for ensuring consistency and accommodating local needs but also for maintaining momentum in the implementation process. This finding empirically supports Metz and Bartley (\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e), who argue that successful implementation is inherently collaborative and relies on shared responsibilities rather than individual leadership.\u003c/p\u003e\u003cp\u003e Altogether, these findings illustrate that the experienced successful national implementation of PaHS required much more than strict adherence to a standardised implementation guideline; instead, it relied on a co-adaptive process within a national framework. This case highlights the need for implementation frameworks to move beyond static and prescriptive models, embracing a more fluid understanding of implementation where intervention and context are co-constructed through ongoing, leadership-driven negotiation, as seen in this study.\u003c/p\u003e\u003cdiv id=\"Sec22\" class=\"Section2\"\u003e\u003ch2\u003eLimitations\u003c/h2\u003e\u003cp\u003eWhen assessing the results, some limitations should be acknowledged. First, while leadership was involved at multiple levels, we chose to treat it collectively rather than distinguishing between specific roles. This approach highlighted the collective leadership practice and preserved participant anonymity but may overlook nuances unique to different levels of leadership. Second, this study did not measure fidelity; instead, it relied on performance management measures, adherence to the intervention's core components, and leaders' accounts of these aspects. Future research could incorporate objective fidelity assessments to measure fidelity alongside adaptive leadership strategies. Third, a limitation relates to the temporal variation in data collection. While interviews were conducted during a more mature phase of implementation, observations and documents spanned the whole implementation period from 2017 to 2020. This variation may have shaped how experiences were expressed and understood at different stages. However, triangulation across data sources helped mitigate this limitation by enabling interpretation of interview accounts in relation to documented and observed implementation practices over time.\u003c/p\u003e\u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study highlights the complexity of scaling and implementing healthcare interventions across diverse contexts. The study underscores the crucial role of collaborative leadership in fostering vertical and horizontal leadership and facilitating feedback loops \u0026ndash; both reinforcing (positive) and stabilising (negative) \u0026ndash; together with real-time adjustments, ultimately ensuring what leaders perceived as a successful national implementation. It contributes empirically by demonstrating how fidelity and adaptation can, in practice, function not as opposing forces but complementary, with adaptation serving as a prerequisite for achieving fidelity. This dynamic interplay calls for moving beyond static, linear implementation models, recognising that success in implementing national complex interventions lies in continuous adaptation and real-time leadership-driven adjustments, where stability and flexibility co-evolve with complex and unfolding contexts. By providing empirical insights into the adaptive mechanisms, this study addresses calls for a deeper understanding of the processes that underpin successful implementation in complex systems.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003ePaHS\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eProactive Health Support\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eSMS\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eSelf-management support\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cem\u003eEthics approval and consent to participate\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe randomized controlled trial in the overall research program was approved by the Regional Committee on Health Research Ethics for the Region of Zealand, Denmark (SJ-677). According to Danish legislation, this kind of qualitative research does not require separate approval by the Biomedical Research Ethics Committee. All informants have given informed consent. The study was conducted in accordance with the principles outlined in the Declaration of Helsinki.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003cem\u003eTrial registration\u003cbr\u003e\u003c/em\u003eNot applicable. This qualitative study is part of a larger multidisciplinary research programme that includes a randomised controlled trial registered at ClinicalTrials.gov (NCT03628469).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003cem\u003eConsent for publication\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAvailability of data and materials\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe qualitative datasets generated and analysed during the current study are not publicly available due to the confidential nature of the material and data protection obligations under the General Data Protection Regulation (GDPR).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eCompeting interests\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAn unrestricted research grant from the Danish Ministry of Health funds the PaHS research program. The funding source was not involved in conducting the research program or preparing this article. JH works for the Centre for Development, Evaluation, Complexity, and Implementation in Public Health Improvement, funded by the Welsh Government via Health and Care Research Wales.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAuthors\u0026rsquo; contribution\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eMF conceptualised the study, designed the methodology, conducted data collection, performed the analysis, and drafted the manuscript. CPN and MDT provided substantial input during data interpretation and contributed to critical revisions of the manuscript. UT, MG, and JH contributed intellectual input and provided critical feedback to improve the manuscript\u0026apos;s clarity and structure.\u003c/p\u003e\n\u003cp\u003eAll authors reviewed and approved the manuscript\u0026apos;s final version and agreed to be personally accountable for their respective contributions to the study.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAcknowledgments\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eWe want to express our gratitude to the leaders for their participation in the study. Additionally, we would like to thank Associate Professor and Senior Researcher Stina Lou for her thorough review of the article.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eWutzke S, Benton M, Verma R. Towards the implementation of large scale innovations in complex health care systems: views of managers and frontline personnel. BMC Res Notes. 2016;9:327. \u003c/li\u003e\n\u003cli\u003eWorld Health Organization. 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Implement Sci. 2015;10:53.\u003c/li\u003e\n\u003cli\u003eAlbers B, Verweij L, Blum K, et al. Firm, yet flexible: a fidelity debate paper with two case examples. Implement Sci. 2024;19:79.\u003c/li\u003e\n\u003cli\u003eMazmanian DA, Sabatier PA. Effective policy implementation. Lexington (MA): Lexington Books; 1981.\u003c/li\u003e\n\u003cli\u003eNilsen P, Stahl C, Roback K, Cairney P. Never the twain shall meet? A comparison of implementation science and policy implementation research. Implement Sci. 2013;8:63.\u003c/li\u003e\n\u003cli\u003eSkovgaard T, Nielsen JV. The role of implementation leadership in driving organizational innovation \u0026ndash; revisiting a classic. Coll Antropol. 2023;47(1):75\u0026ndash;80.\u003c/li\u003e\n\u003cli\u003eAarons GA, Ehrhart MG, Farahnak LR, Sklar M. Aligning leadership across systems and organizations to develop a strategic climate for evidence-based practice implementation. Annu Rev Public Health. 2014;35:255\u0026ndash;74.\u003c/li\u003e\n\u003cli\u003eWilliams NJ, Ehrhart MG, Aarons GA, Esp S, Sklar M, Carandang K, et al. Improving measurement-based care implementation in youth mental health through organizational leadership and climate: a mechanistic analysis within a randomized trial. Implement Sci. 2024;19:29.\u003c/li\u003e\n\u003cli\u003eWinther S, Fredens M, Skov Benthien K, Konstantin Nissen N, Palmh\u0026oslash;j Nielsen C, Gr\u0026oslash;nkj\u0026aelig;r M. Exploring patient experiences of participating in a telephone-based self-management support intervention: Proactive Health Support (PaHS). J Adv Nurs. 2020;76(12):3563\u0026ndash;72.\u003c/li\u003e\n\u003cli\u003eWinther S, Fredens M, Hansen MB, Benthien KS, Nielsen CP, Gr\u0026oslash;nkj\u0026aelig;r M. Proactive Health Support: exploring face-to-face start-up sessions between participants and registered nurses at the onset of telephone-based self-management support. Glob Qual Nurs Res. 2020;7:2333393620930026.\u003c/li\u003e\n\u003cli\u003eFredens M, Terkildsen MD, Bollerup S, Alb\u0026aelig;k J, Nissen NK, Winther S, et al. The national implementation of \u0026lsquo;Proactive Health Support\u0026rsquo; in Denmark since 2017: expectations and challenges for the telephone-based self-management program. Health Policy. 2020;124(7):674\u0026ndash;678.\u003c/li\u003e\n\u003cli\u003eFredens M, Palmh\u0026oslash;j Nielsen C, Gr\u0026oslash;nkj\u0026aelig;r M, Kjaerside Nielsen B, Konstantin Nissen N, Benthien KS, et al. Nurses\u0026apos; perspectives on challenges and facilitators when implementing a self-management support intervention as an everyday healthcare practice: a qualitative study. J Adv Nurs. 2024;80(6):2475\u0026ndash;86.\u003c/li\u003e\n\u003cli\u003eBenthien KS, Rasmussen K, Nielsen CP, Hjarnaa L, Rasmussen MK, Kidholm K, et al. Proactive health support (PaHS) \u0026ndash; telephone-based self-management support for persons at risk of hospital admission: study protocol for a randomized controlled trial. Contemp Clin Trials. 2020;93:106004.\u003c/li\u003e\n\u003cli\u003eBenthien KS, Rasmussen K, Nielsen CP, Kidholm K, Gr\u0026oslash;nkj\u0026aelig;r M, Toft U. Proactive Health Support: a randomised controlled trial of telephone-based self-management support for persons at risk of hospital admission. Age Ageing. 2022;51(10):afac222.\u003c/li\u003e\n\u003cli\u003eRasmussen MK, Benthien KS, Nielsen CP, Rasmussen K, Gr\u0026oslash;nkj\u0026aelig;r M, Toft U, et al. Cost-effectiveness of proactive health support \u0026ndash; telephone-based self-management support compared with standard care for persons at risk of hospital admission. Age Ageing. 2024;53(3):afae036.\u003c/li\u003e\n\u003cli\u003eO\u0026rsquo;Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: a synthesis of recommendations. Acad Med. 2014;89(9):1245\u0026ndash;51.\u003c/li\u003e\n\u003cli\u003eOlejaz M. Denmark: health system review. Copenhagen: European Observatory on Health Care Systems and Policies; 2012.\u003c/li\u003e\n\u003cli\u003eYin RK. Case study research: design and methods. 5th ed. Los Angeles: SAGE; 2014.\u003c/li\u003e\n\u003cli\u003ePaparini S, Papoutsi C, Murdoch J, Green J, Petticrew M, Greenhalgh T, et al. Evaluating complex interventions in context: systematic, meta-narrative review of case study approaches. BMC Med Res Methodol. 2021;21:225.\u003c/li\u003e\n\u003cli\u003eSpradley JP. Participant observation. Long Grove (IL): Waveland Press; 2016\u003c/li\u003e\n\u003cli\u003eBraun V, Clarke V. Reflecting on reflexive thematic analysis. Qual Res Sport Exerc Health. 2019;11(4):589\u0026ndash;97.\u003c/li\u003e\n\u003cli\u003eBraun V, Clarke V. Thematic analysis: a practical guide. London: SAGE Publications; 2022.\u003c/li\u003e\n\u003cli\u003eTimmermans S, Tavory I. Data analysis in qualitative research: theorizing with abductive analysis. Chicago: University of Chicago Press; 2022.\u003c/li\u003e\n\u003cli\u003eMiles MB, Huberman AM, Salda\u0026ntilde;a J. Qualitative data analysis: a methods sourcebook. 3rd ed. Thousand Oaks (CA): SAGE Publications; 2014.\u003c/li\u003e\n\u003cli\u003eWaltz TJ, Powell BJ, Fern\u0026aacute;ndez ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implement Sci. 2019;14:42.\u003c/li\u003e\n\u003cli\u003eKirk MA, Moore JE, Wiltsey Stirman S, Birken SA. Towards a comprehensive model for understanding adaptations\u0026rsquo; impact: the model for adaptation design and impact (MADI). Implement Sci. 2020;15:56.\u003c/li\u003e\n\u003cli\u003eHawe P. Interventions tested in randomised controlled trials can and should adapt to context: here\u0026rsquo;s how. In: Jourdan D, Potvin L, editors. Global handbook of health promotion research. Vol 3: Doing health promotion research. Cham: Springer International Publishing; 2023. p. 141\u0026ndash;9.\u003c/li\u003e\n\u003cli\u003eMetz A, Bartley L. Implementation teams: a stakeholder view of leading and sustaining change. In: Albers B, Shlonsky A, Mildon R, editors. Implementation science 3.0. Cham: Springer; 2020. p. 199\u0026ndash;225.\u003c/li\u003e\n\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":"Implementation, Complex intervention, Large-scale implementation, Leadership, Fidelity, Adaptation, Context, up-scaling","lastPublishedDoi":"10.21203/rs.3.rs-7977843/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7977843/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\u003ePolicymakers increasingly aim to expand small-scale healthcare interventions to a national level to maximise reach and impact. However, scaling complex interventions presents challenges, particularly in balancing national standardisation with flexibility in local implementation across contexts. This study investigates how leaders experience and manage the national implementation of Proactive Health Support, a large-scale self-management support intervention in Denmark.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study employed a single-case study design with embedded units to examine the national implementation of the Proactive Health support intervention. Data were collected through 10 semi-structured interviews with leaders from the five Danish regions, over 25 hours of participant observation of leadership meetings and workshops, and a document analysis of 468 pages of leadership meeting minutes and reports.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eImplementing Proactive Health Support required leaders to balance the tension between fidelity and adaptation within a standardised framework. While the national framework provided stability, leaders leveraged the flexibility of implementation strategies to preserve the core intervention components while enabling local adjustments to fit diverse contexts. Reflexive practices, characterised by real-time adjustments and operating through feedback loops, both reinforcing and stabilising, were pivotal for balancing standardisation with flexibility. Vertical leadership mediated alignment between national and regional levels, while horizontal collaboration fostered shared learning across regions.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study demonstrates the complexity of scaling healthcare interventions across diverse contexts, underscoring the non-linear and dynamic nature of such processes and the significant ongoing leadership engagement required to navigate complexity and manage uncertainty. It highlights collaborative leadership as crucial for enabling real-time responsiveness, fostering alignment across levels, and balancing fidelity and adaptation in national implementations. The findings empirically demonstrate that fidelity and adaptation are not opposing forces but complementary in practice, with adaptation in implementation strategies supporting fidelity by allowing interventions to be applied meaningfully across diverse contexts. The findings further suggest that successful national implementation relies not on strict adherence to standardised guidelines but on a co-adaptive process within a standardised yet flexible framework, where intervention and context are co-constructed through ongoing, leadership-driven negotiation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration: Part of\u003c/strong\u003e a research programme including a registered randomised controlled trial (ClinicalTrials.gov, NCT03628469). Not applicable to this study.\u003c/p\u003e","manuscriptTitle":"Balancing Standardisation and Flexibility in National Complex Intervention Scale-Up: A Qualitative Study of Leadership Experiences and Management in the Implementation of Proactive Health Support in Denmark","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-12-01 12:12:47","doi":"10.21203/rs.3.rs-7977843/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-03-03T15:19:03+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-12-23T14:59:48+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-12-15T13:08:36+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"73017980902725088864163876431365594456","date":"2025-12-11T20:24:17+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"78083264346826513565912199273196657332","date":"2025-12-06T00:35:07+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-11-28T13:35:20+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-11-26T11:01:29+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-11-04T15:07:18+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-11-04T14:05:35+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Health Services Research","date":"2025-11-04T13:52:25+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":"74f4ff33-08dd-4ba4-8cb6-32313604891b","owner":[],"postedDate":"December 1st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-03-13T12:08:25+00:00","versionOfRecord":[],"versionCreatedAt":"2025-12-01 12:12:47","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7977843","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7977843","identity":"rs-7977843","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}