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

Balancing Standardization and Flexibility in National Complex Intervention Scale-Up: A Qualitative Study of Leadership Experiences and Management in the Implementation of Proactive Health Support (PaHS) 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 Standardization and Flexibility in National Complex Intervention Scale-Up: A Qualitative Study of Leadership Experiences and Management in the Implementation of Proactive Health Support (PaHS) in Denmark Mia Fredens, Morten Deleuran Terkildsen, Mette Grønkjær, Ulla Toft, and 2 more This is a preprint; it has not been peer reviewed by a journal.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-5677797/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Policymakers increasingly aim to expand small-scale healthcare interventions to a national level to maximize reach and impact. However, scaling complex interventions presents challenges, particularly in balancing national standardization 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, more than 25 hours of participant observations of leadership meetings and workshops, and 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 standardized 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—characterized by real-time adjustments and positive feedback loops—were pivotal for balancing standardization 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 such processes' non-linear and dynamic nature and the significant ongoing, real-time 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 standardized guidelines but on a co-adaptive process within a standardized yet flexible framework, where intervention and context are co-constructed through ongoing, leadership-driven negotiation. Trial registration: The implementation was studied as part of a multidisciplinary research program. The study is a follow-on study to a randomized controlled trial (ClinicalTrials.gov, NCT03628469). Implementation Complex intervention Large-scale implementation Leadership Fidelity Adaptation Context Contributions to the literature Implementation literature has evolved from framing fidelity and adaptation as opposing forces to exploring their complementarity. This study advances this trajectory by providing empirical insights into how leaders actively manage this interplay through collective leadership-driven feedback loops and real-time adjustmentsThis study emphasizes the need to focus on both core intervention and implementation components in the implementation of national interventions to achieve successful balances between adaptation and fidelity. This study empirically demonstrates that implementation should be studied as a longitudinal process to understand the ongoing adaptive implementation work required for integration between intervention and context. Background Policymakers focus increasingly on expanding successful small-scale healthcare interventions to a national scale to maximize 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 trialed 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 trialing 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 operationalization 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 standardization ( 10 ). Therefore, a key challenge in implementing large-scale national complex interventions is the inherent tension between striving for standardization and a complex system characterized 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 originally 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 emphasize that successful interventions rely both on core intervention components and implementation mechanisms. These mechanisms - such as training, coaching, and performance management - are thought to be crucial for achieving fidelity to core intervention components while allowing for adaptation in implementation strategies to ensure context fit across diverse settings ( 11 ). They suggest that flexibility in delivering implementation core components allows adaptation to local contexts without compromising intervention fidelity in large-scale national implementations. Building on this, recent studies increasingly suggest that flexibility in implementation processes can complement rather than compromise fidelity, enabling necessary adaptations to meet local contextual needs without necessarily undermining intervention integrity ( 15 , 16 , 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 largely focused on conceptual frameworks and theoretical discussions ( 21 ). This leaves a gap in understanding how leaders navigate this balance in real time, particularly in the dynamic and complex realities of large-scale, policy-driven implementation efforts. Leadership is increasingly recognized as a critical factor for successful implementation ( 22 – 24 ), and many implementation frameworks and theories in healthcare highlight the significance of organizational leadership in achieving high fidelity ( 24 ). Though recent research ( 24 ) 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 operationalizing the tension 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 are longitudinal, following 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 the role of leadership in navigating these dynamics. This study addresses this gap by investigating 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 and designed as a follow-on study to a trial. Further evaluation results are reported elsewhere ( 25 – 32 ). Methods This study utilizes a qualitative case study design based on interviews, observations, and documents. This study adheres to the SRQR guideline (33). 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 (34). 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 (34). 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. Registered nurses were trained to deliver the intervention, focusing on enhancing participants' self-management strategies and coping skills (30). The PaHS intervention is described in Table 1. INSERT Table 1 HERE In 2016, a national–regional political agreement was made to nationally upscale the PaHS intervention, previously tested and developed in Sweden. The policy-level processes and challenges related to the early implementation of PaHS have been addressed in a previous publication (27). The agreement emphasized 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 randomized clinical trial (30). Running from 2017 to 2020, the national program management oversaw the overall coordination, management, and implementation of PaHS. Each region employed a project leader and a nurse leader responsible for the implementation and operation of the intervention at both regional and cross-regional levels. This top-down government approach simultaneously allowed the authority of the regions to develop, implement, and organize the intervention, leading to a more bottom-up design and flexible implementation process (27). All regions established PaHS units, which varied in size, structure, and organizational anchoring. For example, some regions had two units with two nurse leaders, while others had only one unit (See Table 2 for the organization of PaHS in the regions). 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. Table 2 Regional Organization of the PaHS Intervention Organization Region 1 Region 2 Region 3 Region 4 Number of Call Centers 1 2 2 1 Nurses 9 20 20 34 Nurse Leaders 1 2 1 1 Project Leaders 1 1 1 1 INSERT Table 2 HERE 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 (35). The unit of analysis is the national PaHS implementation, while the embedded units consist of PaHS units in four regions. 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. 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 (31, 32). 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. Observation Participant observations were conducted (36) 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. 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. The aim of these observations was to gain valuable insights into the interactions, decision-making processes, and practical challenges faced during the implementation of the PaHS program and inform the interview guides. Document analysis Document analysis included a practice manual, workflow description, leadership meeting minutes, and a performance management catalog. 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 with input from frontline staff (nurses) to ensure practical relevance. These documents were adjusted several times during the implementation process to adjust implementation strategies. 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 (May 2017 to June 2019), 468 pages, were collected by the national program management secretary and forwarded to the first author. The performance management catalog was developed by the program management with input from leaders to establish joint standards and the scope for flexibility. The documents were reviewed in depth and analyzed flexibly, back and forth between the interview material, observations, and meeting minutes. The documents were mainly used to supplement and enrich the qualitative findings (37), with key themes and insights drawn from the material. 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 guide 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. Leaders were asked to reflect on their role and primary tasks with questions like, 'What are your main responsibilities as a leader in PaHS?' and 'How do you work day-to-day to lead the nursing PaHS team?' Interviews were digitally recorded and transcribed verbatim. Analysis A reflexive thematic analysis (38, 39) was used as it allowed for a flexible, abductive analytical process. The first step involved comprehensively reading interview transcripts, field notes, and documents. During this initial exploration of the data, the overarching themes of context , implementation processes , and outcomes were identified as essential aspects of the intervention's management across different regions. The first author then developed open codes within these broad themes. For example, within the theme of context , subcodes like standardization and flexibility began to take shape, reflecting early insights into how leaders 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 themes. The theme 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 among co-authors to ensure reflexivity, consistency, and depth in the analysis. Two co-authors (CPN and MDT) 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 (40). Through this approach, the analysis captured both the data-driven development of themes and the theory-informed structuring of these themes, leading to a comprehensive understanding of how leadership shaped the implementation of PaHS. A Large Language Model (ChatGPT, OpenAI) was used for language editing of quotes during the preparation of this manuscript. Results Three key themes emerged: 1) between national standardization and local implementation, 2) navigating flexibility within a national framework, and 3) managing national-local balances: vertical and horizontal leadership. Some of the themes 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 ( 31 , 32 ), 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 standardizing 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). Leaders reported observing changes in nursing practice, with nurses adopting more coaching-oriented, patient-centered roles, and that these practice changes were implemented consistently across regions. This shift marked a broader normative restructuring towards a coherent 'PaHS Professional Practice .' 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. Even though PaHS did not reach the desired outcomes ( 31 , 32 ), the implementation process was experienced a success, offering valuable lessons for forthcoming national implementation endeavors. The following analysis explores how the leaders experienced and managed the implementation process, leading to this unanimous experience of implementation success. Theme 1: Between National Standardization 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 randomized clinical trial protocol to be followed. Initially, leaders experienced the framework as restrictive, feeling constrained by standardized approaches and limited in their autonomy at the regional level. During observations, 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 faced when implementing a standardized intervention across diverse, dynamic local contexts. The framework necessitated adherence to set parameters, limiting autonomous decision-making. Over time, however, some recognized 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 standardization 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 operationalized flexibility to navigate the tension between standardization and local adaptation. Across all data material, leaders often 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 be able 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 favorable 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 standardization 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 and how we should screen, etc. […] There are 12 standards […] and we're discussing whether more standards are needed, both clinical standards and organizational, 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 standardize 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 catalog that was collaboratively developed by program management, project leaders, and nurse leaders. While certain standards were established to ensure consistency—such as standardized 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 catalog 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 catalog document) This collaborative effort allowed for the creation of a shared theory of change, outlining the expected relationships between the organizational 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 board 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 standardize 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: Vertical and Horizontal Leadership The analysis identified two key types of leadership in the PaHS implementation: vertical and horizontal. 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 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: 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 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 a general issue that needs to go to [project leader] 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 the 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 5 no-shows this week,' all that, just to keep a finger on the pulse with those things […].” (Leader 4) This real-time 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. Horizontal Leadership: Cross-regional Collaboration A national leadership structure was experienced 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) Formal cross-regional meetings were experienced as a cornerstone of this collaboration. Monthly, 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 project manager 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. 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. 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, standardization 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 longitudinal implementation processes ( 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 ( 41 ). 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 standardizations but depending on 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 to understand better 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 documents how the leaders’ reflexive practice—characterized by real-time adjustments and positive feedback loops—was crucial in managing this balance. Through this process, leaders did not simply follow national guidelines but actively mediated between standardization 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 documenting these real-time adaptive practices, this study provides a practical example of May’s theoretical concepts, demonstrating how leaders’ adaptive work, might support high fidelity implementation in policy-driven contexts. By leveraging the elasticity of the implementation strategies, leaders experienced 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 recognizes that adaptations can be made both in the intervention itself and in the implementation strategies ( 17 , 42 ). Schwarz et al. ( 17 ) suggest that implementation strategies can be seen as mechanisms for achieving a "fit" between intervention and context. Our findings extend this work by illustrating how leaders practically operationalize this "fit" in implementation strategies through real-time, context-sensitive adjustments. Also, a study by Rodriguez et al. ( 16 ) 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 were rather experienced as an essential part of the implementation process. Consistent with implementation science literature, which increasingly views adaptation and fidelity as complementary elements ( 16 , 17 , 43 ), 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. Inherent in this perspective is the understanding shared by scholars bridging implementation and complexity science ( 10 , 13 , 14 ) that context is not a fixed organizational structure but an unstable, unfolding process. These scholars emphasize that implementation is dynamic and emergent, involving feedback loops and real-time adjustments that continuously shape and reshape fidelity and outcomes as contexts and implementation evolves ( 13 , 14 ). This understanding reframes implementation as a non-linear, ongoing process where interventions and contexts co-adapt over time ( 10 , 13 , 14 ). A non-linear view of implementation aligns with our findings, where significant leadership engagement was required to navigate the complexity of implementing PaHS. This finding echoes Greenhalgh and Papoutsi ( 13 ), who argue that the traditional quest for certainty and predictability must be supplemented by an ability to manage uncertainty and emergent causality in dynamic systems. By using substantial vertical and horizontal leadership, leaders in the present study fostered a collaborative environment where standardization and flexibility could coexist.. Our findings indicate that formal and informal collective leadership, actively involving multiple stakeholders, was critical to ensure consistency across regions while accommodating local implementation needs. This finding empirically supports Metz and Bartley ( 44 ) assertion 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 standardized implementation guideline; rather, it relied on a co-adaptive process within a national framework. This case reinforces the need for implementation frameworks to move beyond static and prescriptive implementation models, instead embracing a more fluid understanding of implementation, where intervention and context are co-constructed through ongoing, leadership-driven negotiation, as seen in this study. Limitation 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 preserved participant anonymity but may overlook nuances unique to different levels of leadership. Second, this study did not measure fidelity, relying instead on performance management measurering, adherence to the intervention's core components, and leaders' accounts of these aspects. Future research could benefit from incorporating objective fidelity assessments to measure fidelity alongside adaptive leadership strategies. 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, facilitating positive feedback loops and real-time adjustments, and ultimately ensuring what leaders perceived as a successful national implementation. It contributes empirically by demonstrating how fidelity and adaptation are not opposing forces but complementary in practice, with adaptation serving as a prerequisite for achieving fidelity. This dynamic interplay calls for moving beyond static, linear implementation models, recognizing 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 overall research program was approved by the Regional Committee on Health Research Ethics (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. Consent for publication Not applicable Availability of data and materials The datasets generated and analyzed during the current study are not publicly available due to the confidential nature of the qualitative data. 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 conceptualized 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 Jun 28;9:327. doi: 10.1186/s13104-016-2133-0. Organization WH. Everybody's business - strengthening health systems to improve health outcomes: WHO's framework for action. World Health Organization; 2007. Milat AJ, King L, Newson R, Wolfenden L, Rissel C, Bauman A, et al. Increasing the scale and adoption of population health interventions: Experiences and perspectives of policy makers, practitioners, and researchers. Health Res Policy Sys . 12, 18 (2014). https://doi.org/10.1186/1478-4505-12-18 Centre for Epidemiology and Evidence. Increasing the Scale of Population Health Interventions: A Guide. Evidence and Evaluation Guidance Series, Population and Public Health Division. Sydney: NSW Ministry of Health; 2023. Talboom-Kamp E, Ketelaar P, Versluis A. A national program to support self-management for patients with a chronic condition in primary care: A social return on investment analysis. Clinical ehealth. 2021;4:45-9. https://doi.org/10.1016/j.ceh.2021.02.001 Sarkies MN, Francis-Auton E, Long JC, Pomare C, Hardwick R, Braithwaite J. Making implementation science more real. BMC Med Res Methodol 22 , 178 (2022). https://doi.org/10.1186/s12874-022-01661-2 Moore G, Campbell M, Copeland L, Craig P, Movsisyan A, Hoddinott P, et al. Adapting interventions to new contexts—the ADAPT guidance. BMJ (Online). 2021;374:n1679-n. Hawe P, Shiell A, Riley T. Complex interventions: how “out of control” can a randomised controlled trial be? BMJ. 2004;328(7455):1561-3. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ (Online). 2021;374:n2061-n. May CR, Johnson M, Finch T. Implementation, context and complexity. Implementation Sci 11 , 141 (2016). https://doi.org/10.1186/s13012-016-0506-3 Fixsen DL, Naoom SF, Blase KA, Friedman, R. M. & Wallace F. Implementation Research: A Synthesis of the Literature. Tampa, Florida: University of South Florida, Louis de la Parte Florida Mental Health Institute, The National Implementation Research Network; 2005. Hawe P, Shiell A, Riley T. Theorising Interventions as Events in Systems. Am J Community Psychol. 2009;43(3-4):267-76. doi: 10.1007/s10464-009-9229-9. Greenhalgh T, Papoutsi C. Studying complexity in health services research: desperately seeking an overdue paradigm shift. BMC Med 16 , 95 (2018). https://doi.org/10.1186/s12916-018-1089-4 Braithwaite J, Churruca K, Long JC, Ellis LA, Herkes J. When complexity science meets implementation science: a theoretical and empirical analysis of systems change. BMC Med 16, 63 (2018). https://doi.org/10.1186/s12916-018-1057-z Aarons GA, Green AE, Palinkas LA, Self-Brown S, Whitaker DJ, Lutzker JR, et al. Dynamic adaptation process to implement an evidence-based child maltreatment intervention. Implementation Sci 7 , 32 (2012). https://doi.org/10.1186/1748-5908-7-32 Rodriguez SA, Lee SC, Higashi RT, Chen PM, Eary RL, Sadeghi N, et al. Factors influencing implementation of a care coordination intervention for cancer survivors with multiple comorbidities in a safety-net system: an application of the Implementation Research Logic Model. Implementation Sci 18 , 68 (2023). https://doi.org/10.1186/s13012-023-01326-8 Schwarz UvT, Aarons GA, Hasson H. The Value Equation: Three complementary propositions for reconciling fidelity and adaptation in evidence-based practice implementation. BMC Health Serv Res 19 , 868 (2019). https://doi.org/10.1186/s12913-019-4668-y Carroll C, Patterson M, Wood S, Booth A, Rick J, Balain S. A conceptual framework for implementation fidelity. Implementation Sci 2 , 40 (2007). https://doi.org/10.1186/1748-5908-2-40 Webster. New College Dictionary. Boston: Houghton Mifflin Company; 1995. Nilsen P. Making sense of implementation theories, models and frameworks. Implementation Sci 10 , 53 (2015). https://doi.org/10.1186/s13012-015-0242-0 Albers, B., Verweij, L., Blum, K. et al. Firm, yet flexible: a fidelity debate paper with two case examples. Implementation Sci 19 , 79 (2024). https://doi.org/10.1186/s13012-024-01406-3 Skovgaard T, Nielsen JV. The Role of Implementation Leadership in Driving Organizational Innovation – Revisiting a Classic. Collegium Antropologicum. 2023; 47(1):75-80. https://doi.org/10.5671/ca.47.1.10 Aarons 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;35:255-74. doi: 10.1146/annurev-publhealth-032013-182447. Williams 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. Implementation Sci 19 , 29 (2024). https://doi.org/10.1186/s13012-024-01356-w Winther S, Fredens M, Skov Benthien K, Konstantin Nissen N, Palmhøj Nielsen C, Grønkjær M. Exploring patient experiences of participating in a telephone‐based self‐management support intervention: Proactive Health Support (PaHS). J Adv Nurs. 2020 Dec;76(12):3563-3572. doi: 10.1111/jan.14590. Epub 2020 Oct 6. Winther S, Fredens M, Hansen MB, Benthien KS, Nielsen CP, Grønkjær 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 Jun 30;7:2333393620930026. doi: 10.1177/2333393620930026. Fredens M, Terkildsen MD, Stina B, Jens A, Nina Konstantin N, Susanne W, et al. The national implementation of 'Proactive Health Support' in Denmark since 2017: Expectations and challenges for the telephone-based self-management program. Health Policy. 2020. https://doi.org/10.1016/j.healthpol.2020.05.014. Fredens M, Palmhoj Nielsen C, Gronkjaer 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 Jun;80(6):2475-2486. doi: 10.1111/jan.15988. Epub 2023 Nov 27. Rasmussen MK, Fredens M, Nielsen CP, Toft U, Benthien KS, Rasmussen K, et al. Regional Disparities in Healthcare Costs: Insights from the Proactive Health Support Trial of Telephone-Based Self-management (forthcoming). 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 Jun;93:106004. doi: 10.1016/j.cct.2020.106004. Epub 2020 Apr 19. Benthien KS, Rasmussen K, Nielsen CP, Kidholm K, Gronkjaer 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 Oct 6;51(10):afac212. doi: 10.1093/ageing/afac212. Rasmussen MK, Benthien KS, Nielsen CP, Rasmussen K, Gronkjaer M, Toft U, et al. Cost-effectiveness of proactive health support-telephone-based self-management support compared with standard care for persons at risk of hospital admission. Age and ageing. 2024;53(3). O’Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for Reporting Qualitative Research: A Synthesis of Recommendations. Acad Med. 2014 Sep;89(9):1245-51. doi: 10.1097/ACM.0000000000000388. Olejaz M. Denmark : health system review. Copenhagen: European Observatory on Health Care Systems and Policies; 2012. Yin RK. Case study research : design and methods. Fifth edition. ed. Los Angeles: SAGE; 2014. Spradley JP. Participant observation. Reissued [i.e. New edition]. ed. Waveland Press.2023. Bowen GA. Document Analysis as a Qualitative Research Method. Qualitative research journal. 2009;9(2):27-40. Braun V, Clarke V. Reflecting on reflexive thematic analysis. Qualitative research in sport, exercise and health. 2019;11(4):589-97. Braun V, Clarke V. Thematic analysis : a practical guide. London: SAGE Publications Ltd; 2022. a Miles MB, Huberman AM, Saldaña J. Qualitative data analysis : a methods sourcebook. Third edition. ed. Thousand Oaks, Califorinia: SAGE Publications, Inc.; 2014. Waltz TJ, Powell BJ, Fernández ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implementation Sci 14 , 42 (2019). https://doi.org/10.1186/s13012-019-0892-4 Kirk MA, Moore JE, Wiltsey Stirman S, Birken SA. Towards a comprehensive model for understanding adaptations’ impact: the model for adaptation design and impact (MADI). Implementation Sci 15 , 56 (2020). https://doi.org/10.1186/s13012-020-01021-y Hawe P. Interventions tested in randomised controlled trials can and should adapt to context: here’s how. In: Jourdan D, Potvin L, editors. Global handbook of health promotion research, vol. 3. Cham: Springer; 2023. 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. https://doi.org/10.1007/978-3-030-03874-8_8 Table 1 Table 1 is available in the Supplementary Files section. Supplementary Files Table1.docx SRQRChecklist.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5677797","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":405184134,"identity":"dce374c0-f4d4-4651-aa56-fa2ea69e1a3a","order_by":0,"name":"Mia Fredens","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAy0lEQVRIiWNgGAWjYDACZiCuYGBgbADiB0A24wyitJyBaGE2IE4LA0ILmwRRWnTbmR8wHNxjI9sv3f6sujKHQXZmAwEtZofZDBgOPEsznjnnjNnNs9sYjGcTssXsMIMB84cDhxM33Mhhu9m4jSFxHmEt7B8YDhz4n7j/RvqzQiK18AAdduBA4gaJBDNGkBYiHMZTANSRbDzjRo6xZOM2CWPC3j9/fOODAwfsZPtnpD/82LjNRnbGAULWAAGyGgki1I+CUTAKRsEoIAgA4OFHsnd0uP4AAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-3602-8879","institution":"Central Denmark Region Center for Public Health and Quality Improvement: Defactum","correspondingAuthor":true,"prefix":"","firstName":"Mia","middleName":"","lastName":"Fredens","suffix":""},{"id":405184135,"identity":"e99c4266-2c1c-4a11-89b0-b5f342695135","order_by":1,"name":"Morten Deleuran Terkildsen","email":"","orcid":"","institution":"Central Denmark Region Center for Public Health and Quality Improvement: Defactum","correspondingAuthor":false,"prefix":"","firstName":"Morten","middleName":"Deleuran","lastName":"Terkildsen","suffix":""},{"id":405184136,"identity":"fec8e0cd-bafc-48cc-831e-629aa691bce2","order_by":2,"name":"Mette Grønkjær","email":"","orcid":"","institution":"Aalborg University: Aalborg Universitet","correspondingAuthor":false,"prefix":"","firstName":"Mette","middleName":"","lastName":"Grønkjær","suffix":""},{"id":405184137,"identity":"21963443-5ce5-473a-8a5a-25d42d997f43","order_by":3,"name":"Ulla Toft","email":"","orcid":"","institution":"Steno Diabetes Center Copenhagen","correspondingAuthor":false,"prefix":"","firstName":"Ulla","middleName":"","lastName":"Toft","suffix":""},{"id":405184138,"identity":"12b0cb30-5c71-4671-88c9-c95ee9216d0e","order_by":4,"name":"Jemma Hawkins","email":"","orcid":"","institution":"Centre for Development Evaluation Complexity and Implementation in Public Health Improvement","correspondingAuthor":false,"prefix":"","firstName":"Jemma","middleName":"","lastName":"Hawkins","suffix":""},{"id":405184139,"identity":"89e36c0b-276d-4df0-b461-30699ed97b26","order_by":5,"name":"Camilla Palmhøj Nielsen","email":"","orcid":"","institution":"Central Denmark Region Center for Public Health and Quality Improvement: Defactum","correspondingAuthor":false,"prefix":"","firstName":"Camilla","middleName":"Palmhøj","lastName":"Nielsen","suffix":""}],"badges":[],"createdAt":"2024-12-19 14:56:59","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5677797/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5677797/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":94442638,"identity":"f32ba8da-e99a-49d2-a5e2-4c30c17543b4","added_by":"auto","created_at":"2025-10-27 14:29:03","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":806121,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5677797/v1/67c37243-1a93-46f4-9243-e6c53c3524ad.pdf"},{"id":74523233,"identity":"23ae3c18-6d8b-423e-ae05-7de406d51771","added_by":"auto","created_at":"2025-01-23 06:19:08","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":38445,"visible":true,"origin":"","legend":"","description":"","filename":"Table1.docx","url":"https://assets-eu.researchsquare.com/files/rs-5677797/v1/4af5038502e860dd3387f9a2.docx"},{"id":74523232,"identity":"a097e002-f0b0-4a1b-8af9-42438c4ba317","added_by":"auto","created_at":"2025-01-23 06:19:08","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":24277,"visible":true,"origin":"","legend":"","description":"","filename":"SRQRChecklist.docx","url":"https://assets-eu.researchsquare.com/files/rs-5677797/v1/0967d53e3f9d2f4fcab75ed3.docx"}],"financialInterests":"","formattedTitle":"Balancing Standardization and Flexibility in National Complex Intervention Scale-Up: A Qualitative Study of Leadership Experiences and Management in the Implementation of Proactive Health Support (PaHS) in Denmark","fulltext":[{"header":"Contributions to the literature","content":"\u003cul type=\"disc\"\u003e\n \u003cli\u003eImplementation literature has evolved from framing fidelity and adaptation as opposing forces to exploring their complementarity. This study advances this trajectory by providing empirical insights into how leaders actively manage this interplay through collective leadership-driven feedback loops and real-time adjustmentsThis study emphasizes the need to focus on both core intervention and implementation components in the implementation of national interventions to achieve successful balances between adaptation and fidelity.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eThis study empirically demonstrates that implementation should be studied as a longitudinal process to understand the ongoing adaptive implementation work required for integration between intervention and context. \u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Background","content":"\u003cp\u003ePolicymakers focus increasingly on expanding successful small-scale healthcare interventions to a national scale to maximize 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 trialed 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 trialing 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 'practical problem of context' cannot be handled by treating it as a pure operationalization 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 standardization (\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 standardization and a complex system characterized 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 originally 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 emphasize that successful interventions rely both on core intervention components and implementation mechanisms. These mechanisms - such as training, coaching, and performance management - are thought to be crucial for achieving fidelity to core intervention components while allowing for adaptation in implementation strategies to ensure context fit across diverse settings (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). They suggest that flexibility in delivering implementation core components allows adaptation to local contexts without compromising intervention fidelity in large-scale national implementations. Building on this, recent studies increasingly suggest that flexibility in implementation processes can complement rather than compromise fidelity, enabling necessary adaptations to meet local contextual needs without necessarily undermining intervention integrity (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\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 largely focused on conceptual frameworks and theoretical discussions (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). This leaves a gap in understanding how leaders navigate this balance in real time, particularly in the dynamic and complex realities of large-scale, policy-driven implementation efforts. Leadership is increasingly recognized as a critical factor for successful implementation (\u003cspan additionalcitationids=\"CR23\" citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e), and many implementation frameworks and theories in healthcare highlight the significance of organizational leadership in achieving high fidelity (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). Though recent research (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\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 operationalizing the tension 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 are longitudinal, following 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 the role of leadership in navigating these dynamics. This study addresses this gap by investigating 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 and designed as a follow-on study to a trial. Further evaluation results are reported elsewhere (\u003cspan additionalcitationids=\"CR26 CR27 CR28 CR29 CR30 CR31\" citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e). \u003c/p\u003e "},{"header":"Methods","content":"\u003cp\u003eThis study utilizes a qualitative case study design based on interviews, observations, and documents. This study adheres to the SRQR guideline (33).\u003c/p\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 (34). 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 (34).\u003c/p\u003e\n\u003cdiv id=\"Sec3\"\u003e\n \u003ch2\u003eThe PaHS Intervention\u003c/h2\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. Registered nurses were trained to deliver the intervention, focusing on enhancing participants\u0026apos; self-management strategies and coping skills (30). The PaHS intervention is described in Table 1.\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eINSERT\u003c/em\u003e Table 1 \u003cem\u003eHERE\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003eIn 2016, a national\u0026ndash;regional political agreement was made to nationally upscale the PaHS intervention, previously tested and developed in Sweden. The policy-level processes and challenges related to the early implementation of PaHS have been addressed in a previous publication (27). The agreement emphasized 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 randomized clinical trial (30). Running from 2017 to 2020, the national program management oversaw the overall coordination, management, and implementation of PaHS. Each region employed a project leader and a nurse leader responsible for the implementation and operation of the intervention at both regional and cross-regional levels. This top-down government approach simultaneously allowed the authority of the regions to develop, implement, and organize the intervention, leading to a more bottom-up design and flexible implementation process (27). All regions established PaHS units, which varied in size, structure, and organizational anchoring. For example, some regions had two units with two nurse leaders, while others had only one unit (See Table 2 for the organization of PaHS in the regions). While the implementation involved leadership at different levels, this study investigates leadership collectively to protect the participants\u0026apos; anonymity by avoiding identifying specific leadership roles and regional distinctions. \u0026nbsp;\u003c/p\u003e\n \u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv\u003eTable 2\u003c/div\u003e\n \u003cdiv\u003e\n \u003cp\u003eRegional Organization of the PaHS Intervention\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eOrganization\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eRegion 1\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eRegion 2\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eRegion 3\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eRegion 4\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNumber of Call Centers\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNurses\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e34\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNurse Leaders\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eProject Leaders\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003cp\u003e\u003cem\u003eINSERT\u003c/em\u003e Table 2 \u003cem\u003eHERE\u003c/em\u003e\u003c/p\u003e\n\u003c/div\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 (35). The unit of analysis is the national PaHS implementation, while the embedded units consist of PaHS units in four regions.\u003c/p\u003e\n\u003ch3\u003eParticipants\u003c/h3\u003e\n\u003cp\u003eThe 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.\u003c/p\u003e\n\u003ch3\u003eData Collection\u003c/h3\u003e\n\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 (31, 32). 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.\u003c/p\u003e\n\u003ch3\u003eObservation\u003c/h3\u003e\n\u003cp\u003eParticipant observations were conducted (36) 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. 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. The aim of these observations was to gain valuable insights into the interactions, decision-making processes, and practical challenges faced during the implementation of the PaHS program and inform the interview guides.\u003c/p\u003e\n\u003cdiv id=\"Sec8\"\u003e\n \u003ch2\u003eDocument analysis\u003c/h2\u003e\n \u003cp\u003eDocument analysis included a practice manual, workflow description, leadership meeting minutes, and a performance management catalog. 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 with input from frontline staff (nurses) to ensure practical relevance. These documents were adjusted several times during the implementation process to adjust implementation strategies. 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 (May 2017 to June 2019), 468 pages, were collected by the national program management secretary and forwarded to the first author. The performance management catalog was developed by the program management with input from leaders to establish joint standards and the scope for flexibility. The documents were reviewed in depth and analyzed flexibly, back and forth between the interview material, observations, and meeting minutes. The documents were mainly used to supplement and enrich the qualitative findings (37), with key themes and insights drawn from the material.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eSemi-Structured individual Interviews\u003c/h3\u003e\n\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 guide 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. Leaders were asked to reflect on their role and primary tasks with questions like, \u0026apos;What are your main responsibilities as a leader in PaHS?\u0026apos; and \u0026apos;How do you work day-to-day to lead the nursing PaHS team?\u0026apos; Interviews were digitally recorded and transcribed verbatim.\u003c/p\u003e\n\u003cp\u003eAnalysis\u003c/p\u003e\n\u003cp\u003eA reflexive thematic analysis (38, 39) was used as it allowed for a flexible, abductive analytical process.\u003c/p\u003e\n\u003cp\u003eThe first step involved comprehensively reading interview transcripts, field notes, and documents. During this initial exploration of the data, the overarching themes 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 intervention\u0026apos;s management across different regions.\u003c/p\u003e\n\u003cp\u003eThe first author then developed open codes within these broad themes. For example, within the theme of \u003cem\u003econtext\u003c/em\u003e, subcodes like \u003cem\u003estandardization\u003c/em\u003e and \u003cem\u003eflexibility\u003c/em\u003e began to take shape, reflecting early insights into how leaders 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\n\u003cp\u003eAs the analysis progressed, theoretical concepts from the implementation science literature were gradually introduced to inform and refine the preliminary themes. The theme 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\n\u003cp\u003eThe coding process was iterative and collaborative. The first author led the coding, with continuous discussions among co-authors to ensure reflexivity, consistency, and depth in the analysis. Two co-authors (CPN and MDT) 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 (40). Through this approach, the analysis captured both the data-driven development of themes and the theory-informed structuring of these themes, leading to a comprehensive understanding of how leadership shaped the implementation of PaHS.\u003c/p\u003e\n\u003cp\u003eA Large Language Model (ChatGPT, OpenAI) was used for language editing of quotes during the preparation of this manuscript.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eThree key themes emerged: 1) between national standardization and local implementation, 2) navigating flexibility within a national framework, and 3) managing national-local balances: vertical and horizontal leadership. Some of the themes 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=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e, \u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\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 standardizing 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\u003eLeaders reported observing changes in nursing practice, with nurses adopting more coaching-oriented, patient-centered 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.' 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. Even though PaHS did not reach the desired outcomes (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e, \u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e), the implementation process was experienced a success, offering valuable lessons for forthcoming national implementation endeavors. The following analysis explores how the leaders experienced and managed the implementation process, leading to this unanimous experience of implementation success.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eTheme 1: Between National Standardization 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 randomized clinical trial protocol to be followed. Initially, leaders experienced the framework as restrictive, feeling constrained by standardized approaches and limited in their autonomy at the regional level. During observations, 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 faced when implementing a standardized intervention across diverse, dynamic local contexts. The framework necessitated adherence to set parameters, limiting autonomous decision-making. Over time, however, some recognized 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 standardization 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=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eTheme 2: Navigating Flexibility within a Structured Framework\u003c/h2\u003e \u003cp\u003eThis theme focuses on how leaders operationalized flexibility to navigate the tension between standardization and local adaptation. Across all data material, leaders often 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 be able 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 favorable 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=\"Sec13\" 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 standardization 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\u0026ldquo;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 and how we should screen, etc. [\u0026hellip;] There are 12 standards [\u0026hellip;] and we're discussing whether more standards are needed, both clinical standards and organizational, structural ones, like how many patients we need to process [\u0026hellip;] We are currently discussing how to revise\u0026mdash;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.\u0026rdquo;\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 standardize the overall performance management system but also whether the specific methods used in the regions\u0026mdash;such as team meetings and review processes\u0026mdash;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=\"Sec14\" 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 catalog that was collaboratively developed by program management, project leaders, and nurse leaders. While certain standards were established to ensure consistency\u0026mdash;such as standardized registration practices within the M4 system \u0026mdash; regional leaders were given the flexibility to develop and adapt the performance management implementation strategies to suit their local contexts best. The catalog 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 catalog document)\u003c/p\u003e \u003cp\u003eThis collaborative effort allowed for the creation of a shared theory of change, outlining the expected relationships between the organizational 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 board 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 standardize 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=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eTheme 3: Managing National-Local Balances: Vertical and Horizontal Leadership\u003c/h2\u003e \u003cp\u003eThe analysis identified two key types of leadership in the PaHS implementation: vertical and horizontal. 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 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.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" 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 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, or a general issue that needs to go to [project leader] 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 the 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\u0026ldquo;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 5 no-shows this week,' all that, just to keep a finger on the pulse with those things [\u0026hellip;].\u0026rdquo;\u003c/em\u003e (Leader 4)\u003c/p\u003e \u003cp\u003eThis real-time 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 \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eHorizontal Leadership: Cross-regional Collaboration\u003c/h2\u003e \u003cp\u003eA national leadership structure was experienced 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\u0026mdash;both across and within the regions\u0026mdash;by continuously being curious and communicating with each other.\u0026rdquo;\u003c/em\u003e (Leader 8)\u003c/p\u003e \u003cp\u003eFormal cross-regional meetings were experienced as a cornerstone of this collaboration. Monthly, 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 project manager 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. 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"},{"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\u0026mdash;between intervention and context, stability and change, standardization and adaptation. This intersection, where critical tensions and synergies arise, is essential for understanding the complexities of implementation. While these tensions\u0026mdash;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)\u0026mdash;are well-known in implementation research, few studies have explored the longitudinal implementation processes (\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=\"CR41\" class=\"CitationRef\"\u003e41\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 standardizations but depending on 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 to understand better 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 documents how the leaders\u0026rsquo; reflexive practice\u0026mdash;characterized by real-time adjustments and positive feedback loops\u0026mdash;was crucial in managing this balance. Through this process, leaders did not simply follow national guidelines but actively mediated between standardization 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 documenting these real-time adaptive practices, this study provides a practical example of May\u0026rsquo;s theoretical concepts, demonstrating how leaders\u0026rsquo; adaptive work, might support high fidelity implementation in policy-driven contexts.\u003c/p\u003e \u003cp\u003eBy leveraging the elasticity of the implementation strategies, leaders experienced 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 recognizes 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=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e). Schwarz et al. (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e) suggest that implementation strategies can be seen as mechanisms for achieving a \"fit\" between intervention and context. Our findings extend this work by illustrating how leaders practically operationalize this \"fit\" in implementation strategies through real-time, context-sensitive adjustments. Also, a study by Rodriguez et al. (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e) 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 were rather experienced 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=\"CR43\" class=\"CitationRef\"\u003e43\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. Inherent in this perspective is the understanding shared by scholars bridging implementation and complexity science (\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) that context is not a fixed organizational structure but an unstable, unfolding process. These scholars emphasize that implementation is dynamic and emergent, involving feedback loops and real-time adjustments that continuously shape and reshape fidelity and outcomes as contexts and implementation evolves (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). This understanding reframes implementation as a non-linear, 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).\u003c/p\u003e \u003cp\u003eA non-linear view of implementation aligns with our findings, where significant leadership engagement was required to navigate the complexity of implementing PaHS. This finding echoes Greenhalgh and Papoutsi (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e), who argue that the traditional quest for certainty and predictability must be supplemented by an ability to manage uncertainty and emergent causality in dynamic systems. By using substantial vertical and horizontal leadership, leaders in the present study fostered a collaborative environment where standardization and flexibility could coexist.. Our findings indicate that formal and informal collective leadership, actively involving multiple stakeholders, was critical to ensure consistency across regions while accommodating local implementation needs. This finding empirically supports Metz and Bartley (\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e) assertion 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 standardized implementation guideline; rather, it relied on a co-adaptive process within a national framework. This case reinforces the need for implementation frameworks to move beyond static and prescriptive implementation models, instead 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 \u003cp\u003eLimitation\u003c/p\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 preserved participant anonymity but may overlook nuances unique to different levels of leadership. Second, this study did not measure fidelity, relying instead on performance management measurering, adherence to the intervention's core components, and leaders' accounts of these aspects. Future research could benefit from incorporating objective fidelity assessments to measure fidelity alongside adaptive leadership strategies.\u003c/p\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, facilitating positive feedback loops and real-time adjustments, and ultimately ensuring what leaders perceived as a successful national implementation. It contributes empirically by demonstrating how fidelity and adaptation are not opposing forces but complementary in practice, with adaptation serving as a prerequisite for achieving fidelity. This dynamic interplay calls for moving beyond static, linear implementation models, recognizing 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":"\u003cp\u003ePaHS: Proactive Health Support\u003c/p\u003e\n\u003cp\u003eSMS: Self-management support\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eEthics approval and consent to participate\u003c/p\u003e\n\u003cp\u003eThe overall research program was approved by the Regional Committee on Health Research Ethics (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.\u003c/p\u003e\n\n\u003cp\u003eConsent for publication\u003c/p\u003e\n\u003cp\u003eNot applicable \u003c/p\u003e\n\n\u003cp\u003eAvailability of data and materials\u003c/p\u003e\n\u003cp\u003eThe datasets generated and analyzed during the current study are not publicly available due to the confidential nature of the qualitative data. \u003c/p\u003e\n\n\u003cp\u003eCompeting interests\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\n\u003cp\u003eFunding\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\n\u003cp\u003eAuthors\u0026rsquo; contribution\u003c/p\u003e\n\u003cp\u003eMF conceptualized 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\u0026rsquo;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\n\u003cp\u003eAcknowledgments\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 Jun 28;9:327. doi: 10.1186/s13104-016-2133-0. \u003c/li\u003e\n\u003cli\u003eOrganization WH. Everybody\u0026apos;s business - strengthening health systems to improve health outcomes: WHO\u0026apos;s framework for action. World Health Organization; 2007.\u003c/li\u003e\n\u003cli\u003eMilat AJ, King L, Newson R, Wolfenden L, Rissel C, Bauman A, et al. Increasing the scale and adoption of population health interventions: Experiences and perspectives of policy makers, practitioners, and researchers. \u003cem\u003eHealth Res Policy Sys\u003c/em\u003e. 12, 18 (2014). https://doi.org/10.1186/1478-4505-12-18\u003c/li\u003e\n\u003cli\u003eCentre for Epidemiology and Evidence. Increasing the Scale of Population Health Interventions: A Guide. Evidence and Evaluation Guidance Series, Population and Public Health Division. Sydney: NSW Ministry of Health; 2023.\u003c/li\u003e\n\u003cli\u003eTalboom-Kamp E, Ketelaar P, Versluis A. A national program to support self-management for patients with a chronic condition in primary care: A social return on investment analysis. Clinical ehealth. 2021;4:45-9. https://doi.org/10.1016/j.ceh.2021.02.001\u003c/li\u003e\n\u003cli\u003eSarkies MN, Francis-Auton E, Long JC, Pomare C, Hardwick R, Braithwaite J. Making implementation science more real. \u003cem\u003eBMC Med Res Methodol\u003c/em\u003e \u003cstrong\u003e22\u003c/strong\u003e, 178 (2022). https://doi.org/10.1186/s12874-022-01661-2 \u003c/li\u003e\n\u003cli\u003eMoore G, Campbell M, Copeland L, Craig P, Movsisyan A, Hoddinott P, et al. Adapting interventions to new contexts\u0026mdash;the ADAPT guidance. BMJ (Online). 2021;374:n1679-n.\u003c/li\u003e\n\u003cli\u003eHawe P, Shiell A, Riley T. Complex interventions: how \u0026ldquo;out of control\u0026rdquo; can a randomised controlled trial be? BMJ. 2004;328(7455):1561-3.\u003c/li\u003e\n\u003cli\u003eSkivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ (Online). 2021;374:n2061-n.\u003c/li\u003e\n\u003cli\u003eMay CR, Johnson M, Finch T. Implementation, context and complexity. \u003cem\u003eImplementation Sci \u003c/em\u003e\u003cstrong\u003e11\u003c/strong\u003e, 141 (2016). https://doi.org/10.1186/s13012-016-0506-3\u003c/li\u003e\n\u003cli\u003eFixsen DL, Naoom SF, Blase KA, Friedman, R. M. \u0026amp; Wallace F. Implementation Research: A Synthesis of the Literature. Tampa, Florida: University of South Florida, Louis de la Parte Florida Mental Health Institute, The National Implementation Research Network; 2005. \u003c/li\u003e\n\u003cli\u003eHawe P, Shiell A, Riley T. Theorising Interventions as Events in Systems. Am J Community Psychol. 2009;43(3-4):267-76. doi: 10.1007/s10464-009-9229-9.\u003c/li\u003e\n\u003cli\u003eGreenhalgh T, Papoutsi C. Studying complexity in health services research: desperately seeking an overdue paradigm shift. \u003cem\u003eBMC Med\u003c/em\u003e \u003cstrong\u003e16\u003c/strong\u003e, 95 (2018). https://doi.org/10.1186/s12916-018-1089-4 \u003c/li\u003e\n\u003cli\u003eBraithwaite J, Churruca K, Long JC, Ellis LA, Herkes J. When complexity science meets implementation science: a theoretical and empirical analysis of systems change. BMC Med 16, 63 (2018). https://doi.org/10.1186/s12916-018-1057-z\u003c/li\u003e\n\u003cli\u003eAarons GA, Green AE, Palinkas LA, Self-Brown S, Whitaker DJ, Lutzker JR, et al. Dynamic adaptation process to implement an evidence-based child maltreatment intervention. \u003cem\u003eImplementation Sci\u003c/em\u003e \u003cstrong\u003e7\u003c/strong\u003e, 32 (2012). https://doi.org/10.1186/1748-5908-7-32\u003c/li\u003e\n\u003cli\u003eRodriguez SA, Lee SC, Higashi RT, Chen PM, Eary RL, Sadeghi N, et al. Factors influencing implementation of a care coordination intervention for cancer survivors with multiple comorbidities in a safety-net system: an application of the Implementation Research Logic Model. \u003cem\u003eImplementation Sci\u003c/em\u003e \u003cstrong\u003e18\u003c/strong\u003e, 68 (2023). https://doi.org/10.1186/s13012-023-01326-8\u003c/li\u003e\n\u003cli\u003eSchwarz UvT, Aarons GA, Hasson H. The Value Equation: Three complementary propositions for reconciling fidelity and adaptation in evidence-based practice implementation. \u003cem\u003eBMC Health Serv Res\u003c/em\u003e \u003cstrong\u003e19\u003c/strong\u003e, 868 (2019). https://doi.org/10.1186/s12913-019-4668-y\u003c/li\u003e\n\u003cli\u003eCarroll C, Patterson M, Wood S, Booth A, Rick J, Balain S. A conceptual framework for implementation fidelity. \u003cem\u003eImplementation Sci\u003c/em\u003e \u003cstrong\u003e2\u003c/strong\u003e, 40 (2007). https://doi.org/10.1186/1748-5908-2-40\u003c/li\u003e\n\u003cli\u003eWebster. New College Dictionary. Boston: Houghton Mifflin Company; 1995.\u003c/li\u003e\n\u003cli\u003eNilsen P. Making sense of implementation theories, models and frameworks. \u003cem\u003eImplementation Sci\u003c/em\u003e \u003cstrong\u003e10\u003c/strong\u003e, 53 (2015). https://doi.org/10.1186/s13012-015-0242-0\u003c/li\u003e\n\u003cli\u003eAlbers, B., Verweij, L., Blum, K. \u003cem\u003eet al.\u003c/em\u003e Firm, yet flexible: a fidelity debate paper with two case examples. \u003cem\u003eImplementation Sci\u003c/em\u003e \u003cstrong\u003e19\u003c/strong\u003e, 79 (2024). https://doi.org/10.1186/s13012-024-01406-3\u003c/li\u003e\n\u003cli\u003eSkovgaard T, Nielsen JV. The Role of Implementation Leadership in Driving Organizational Innovation \u0026ndash; Revisiting a Classic. Collegium Antropologicum. 2023; 47(1):75-80. https://doi.org/10.5671/ca.47.1.10\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;35:255-74. doi: 10.1146/annurev-publhealth-032013-182447.\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. \u003cem\u003eImplementation Sci\u003c/em\u003e \u003cstrong\u003e19\u003c/strong\u003e, 29 (2024). https://doi.org/10.1186/s13012-024-01356-w\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 Dec;76(12):3563-3572. doi: 10.1111/jan.14590. Epub 2020 Oct 6.\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 Jun 30;7:2333393620930026. doi: 10.1177/2333393620930026.\u003c/li\u003e\n\u003cli\u003eFredens M, Terkildsen MD, Stina B, Jens A, Nina Konstantin N, Susanne W, et al. The national implementation of \u0026apos;Proactive Health Support\u0026apos; in Denmark since 2017: Expectations and challenges for the telephone-based self-management program. Health Policy. 2020. https://doi.org/10.1016/j.healthpol.2020.05.014.\u003c/li\u003e\n\u003cli\u003eFredens M, Palmhoj Nielsen C, Gronkjaer 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 Jun;80(6):2475-2486. doi: 10.1111/jan.15988. Epub 2023 Nov 27.\u003c/li\u003e\n\u003cli\u003eRasmussen MK, Fredens M, Nielsen CP, Toft U, Benthien KS, Rasmussen K, et al. Regional Disparities in Healthcare Costs: Insights from the Proactive Health Support Trial of Telephone-Based Self-management (forthcoming).\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 Jun;93:106004. doi: 10.1016/j.cct.2020.106004. Epub 2020 Apr 19. \u003c/li\u003e\n\u003cli\u003eBenthien KS, Rasmussen K, Nielsen CP, Kidholm K, Gronkjaer 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 Oct 6;51(10):afac212. doi: 10.1093/ageing/afac212.\u003c/li\u003e\n\u003cli\u003eRasmussen MK, Benthien KS, Nielsen CP, Rasmussen K, Gronkjaer M, Toft U, et al. Cost-effectiveness of proactive health support-telephone-based self-management support compared with standard care for persons at risk of hospital admission. Age and ageing. 2024;53(3). \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 Sep;89(9):1245-51. doi: 10.1097/ACM.0000000000000388.\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. Fifth edition. ed. Los Angeles: SAGE; 2014.\u003c/li\u003e\n\u003cli\u003eSpradley JP. Participant observation. Reissued [i.e. New edition]. ed. Waveland Press.2023.\u003c/li\u003e\n\u003cli\u003eBowen GA. Document Analysis as a Qualitative Research Method. Qualitative research journal. 2009;9(2):27-40.\u003c/li\u003e\n\u003cli\u003eBraun V, Clarke V. Reflecting on reflexive thematic analysis. Qualitative research in sport, exercise and health. 2019;11(4):589-97.\u003c/li\u003e\n\u003cli\u003eBraun V, Clarke V. Thematic analysis : a practical guide. London: SAGE Publications Ltd; 2022.\u003c/li\u003e\n\u003cli\u003ea Miles MB, Huberman AM, Salda\u0026ntilde;a J. Qualitative data analysis : a methods sourcebook. Third edition. ed. Thousand Oaks, Califorinia: SAGE Publications, Inc.; 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. \u003cem\u003eImplementation Sci\u003c/em\u003e \u003cstrong\u003e14\u003c/strong\u003e, 42 (2019). https://doi.org/10.1186/s13012-019-0892-4\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). \u003cem\u003eImplementation Sci\u003c/em\u003e \u003cstrong\u003e15\u003c/strong\u003e, 56 (2020). https://doi.org/10.1186/s13012-020-01021-y\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. Cham: Springer; 2023. \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. https://doi.org/10.1007/978-3-030-03874-8_8\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Table 1","content":"\u003cp\u003eTable 1 is available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"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":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Implementation, Complex intervention, Large-scale implementation, Leadership, Fidelity, Adaptation, Context","lastPublishedDoi":"10.21203/rs.3.rs-5677797/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5677797/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eBackground\u003c/b\u003e\u003c/p\u003e \u003cp\u003ePolicymakers increasingly aim to expand small-scale healthcare interventions to a national level to maximize reach and impact. However, scaling complex interventions presents challenges, particularly in balancing national standardization 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\u003cp\u003e\u003cb\u003eMethods\u003c/b\u003e\u003c/p\u003e \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, more than 25 hours of participant observations of leadership meetings and workshops, and document analysis of 468 pages of leadership meeting minutes and reports.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e\u003c/p\u003e \u003cp\u003eImplementing Proactive Health Support required leaders to balance the tension between fidelity and adaptation within a standardized 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\u0026mdash;characterized by real-time adjustments and positive feedback loops\u0026mdash;were pivotal for balancing standardization with flexibility. Vertical leadership mediated alignment between national and regional levels, while horizontal collaboration fostered shared learning across regions.\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusion\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThis study demonstrates the complexity of scaling healthcare interventions across diverse contexts, underscoring such processes' non-linear and dynamic nature and the significant ongoing, real-time 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 standardized guidelines but on a co-adaptive process within a standardized yet flexible framework, where intervention and context are co-constructed through ongoing, leadership-driven negotiation.\u003c/p\u003e\u003cp\u003e\u003cb\u003eTrial registration:\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThe implementation was studied as part of a multidisciplinary research program. The study is a follow-on study to a randomized controlled trial (ClinicalTrials.gov, NCT03628469).\u003c/p\u003e","manuscriptTitle":"Balancing Standardization and Flexibility in National Complex Intervention Scale-Up: A Qualitative Study of Leadership Experiences and Management in the Implementation of Proactive Health Support (PaHS) in Denmark","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-01-23 06:19:03","doi":"10.21203/rs.3.rs-5677797/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"74f4ff33-08dd-4ba4-8cb6-32313604891b","owner":[],"postedDate":"January 23rd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-10-27T11:02:49+00:00","versionOfRecord":[],"versionCreatedAt":"2025-01-23 06:19:03","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5677797","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5677797","identity":"rs-5677797","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}