From Pilot to Region-wide Impact: A Hybrid Implementation and Evaluation Protocol for the LEX LOTSEN OWL Care and Case Management System

From Pilot to Region-wide Impact: A Hybrid Implementation and Evaluation Protocol for the LEX LOTSEN OWL Care and Case Management System | 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 Study protocol From Pilot to Region-wide Impact: A Hybrid Implementation and Evaluation Protocol for the LEX LOTSEN OWL Care and Case Management System Matthias Arnold, Sonja Gscheidle, Saskia Lange, Malte Haring, and 12 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8132959/v1 This work is licensed under a CC BY 4.0 License Status: Under Revision Version 1 posted 7 You are reading this latest preprint version Abstract Background: Care and case management (CCM) is considered a promising approach to bridging gaps in cross-sectoral coordination for high-needs patients, aiming to improve access, continuity, and overall care experiences. Despite promising pilot initiatives, comprehensive models that investigate both the “how” (implementation and sustainable scaling) and the “what” (patient outcomes) are lacking. To address this gap, the “LEX LOTSEN OWL” (LLO) project (registered under DRKS00034188) employs a hybrid study design, combining implementation research with a classic randomized controlled trial (RCT) across seven districts in the German East Westphalia-Lippe (Ostwestfalen-Lippe, OWL) region. By examining governance structures and organizational frameworks, LLO seeks to provide insights into the broader applicability and feasibility of CCM programs. Methods/Design: This study encompasses two interlinked components: (1) Implementation research via a process evaluation framework accompanying the establishment of “CCM offices” (Lotsenbüros) in seven districts, introduced in a staggered manner. Qualitative and quantitative methods (including interviews, document analysis, and process metrics) will be applied to identify facilitating factors and barriers, guided by a governance framework and rapid ethnographic assessments. (2) Outcome research via RCT at the patient level. Adults with complex care needs will be randomized into a care and case management group or a control group receiving usual care. The primary endpoints are relational coordination (system level), which is assessed via the Gittell Relational Coordination Questionnaire, and experienced quality of care (Patient Experience of Integrated Care Scale, PEICS). The secondary endpoints include (re)hospitalization, mortality, health-related quality of life, patient self-management, and caregiver self-efficacy, allowing a comprehensive assessment of clinical and patient-centered outcomes. Discussion: This dual design aims to generate evidence of both structural and process-related factors influencing implementation while evaluating the potential clinical effectiveness of CCM. The results may inform how an indication-independent CCM can be seamlessly integrated into diverse healthcare settings. By providing insights into governance, organizational strategies, and patient-specific benefits, LLO may inform future policy and practice, foster improved coordination, enhance continuity, and increase patient engagement in routine health systems. Additionally, the project explores scalability factors critical for decision-makers. Collectively, this initiative has the potential to contribute to the development of sustainable, patient-centered care models. Trial registration This study is prospectively registered in the German Clinical Trials Register (DRKS, DRKS00034188) on 17 May 2024. Full details are available at https//drks.de/search/de/trial/DRKS00034188. Mixed methods Implementation research Outcome evaluation Care and case management Care and case managers Integrated care Relational coordination Figures Figure 1 Figure 2 Figure 3 Introduction Patients with complex medical and psychosocial needs regularly encounter system fragmentation, multiple providers, limited coordination, and burdensome administrative hurdles. In recent years, both national and international initiatives have begun exploring the benefits of integrative programs that emphasize care and case management (CCM) [ 1 ]. These care and case managers act as central points of contact for patients, fostering communication, ensuring continuity, and advocating for patient interests across the care continuum [ 2 ]. Although previous pilot studies have demonstrated potential improvements in outcomes such as patient satisfaction, reduced hospital readmissions, and better adherence to treatment, many of these programs remain time limited or narrowly focused on specific populations [ 3 , 4 ]. Even fewer studies have examined broader governance frameworks that seek to institutionalize CCM within routine health systems. Moreover, the interplay between structural implementation (i.e., how an intervention is launched, maintained, and scaled) and clinical or patient-centered results (i.e., the tangible benefits in quality of care or quality of life) is rarely captured in a single study. Against this backdrop, the LEX LOTSEN OWL (LLO) initiative was developed to investigate whether an integrated approach—covering governance, organizational processes, and direct patient care—might address the needs of high-risk, high-need patients across multiple districts. Specifically, LLO introduces “CCM offices” (Lotsenbüros) in distinct geographic locations, intending to coordinate the efforts of care and case managers, connect stakeholders, and support data and billing structures. In parallel, we conduct a randomized controlled trial (RCT) to explore how the CCM intervention influences key outcomes, including relational coordination, patient-reported experiences, and clinical endpoints. By merging a process evaluation with an outcomes study, our project aims to generate evidence of both how the model is implemented and its potential benefit for patients and caregivers. For the concept of regional governance, no universally accepted definition exists [ 5 ]. It encompasses approaches ranging from self-organized coordination to cooperative or hierarchical steering. At its core, it reflects principles of transparency, participation, and accountability (“good governance”) and is shaped by the actors, institutions, and their interactions, including negotiation and decision-making processes [ 5 ]. In the LLO project, the governance arrangement arises from all the regional structures and actors connected to the central CCM offices. Our overarching objectives are as follows: To establish robust CCM offices across seven districts, documenting and analyzing the facilitators, barriers, and structural adaptations needed. This establishment process aims to develop a target vision for the CCM office, designed as a standardized yet adaptable operational framework that explicitly incorporates the diverse contexts of the implementation region. To evaluate the efficacy of CCM offices in improving relational coordination among providers and the efficacy of care and case managers in improving patient-reported quality of care. To investigate secondary outcomes such as (re)hospitalization, mortality, quality of life, self-management capacity, and caregiver self-efficacy. To derive insights into governance and policy implications to inform potential applicability for stakeholders regarding scalability of such a model in diverse contexts. Policymakers and healthcare managers continually seek cost-effective, patient-centered strategies to address the complex demands of aging populations and the increasing burden of chronic conditions. If preliminary findings support feasibility and benefit, the LLO model may serve as an informative example for widespread adoption, potentially alleviating system fragmentation and promoting value-based care. By embedding governance considerations and robust process evaluations, such a model can inform the creation of standardized but adaptable frameworks that cater to region-specific needs and ensure lasting impacts. Methods This study employs a hybrid design, combining an implementation research approach with a patient-level randomized controlled trial (RCT). The implementation component focuses on the staggered establishment of CCM offices across seven districts in the Ostwestfalen-Lippe region (Fig. 1). Process evaluation methods, including collection of process indicators, documentation of timelines, organizational readiness, staff training, budget allocation, stakeholder engagement, and governance quality, accompany the implementation. Qualitative data from semistructured interviews and observational field notes provide additional context regarding how local conditions influence the development and adaptation of each office. The LLO project not only establishes CCM offices but also actively models and implements their core functionalities and tasks. These are subject to continuous, iterative development and regional customization, driven by participatory methods. This continuous improvement process relies on capturing real-time operational experience through staff engagement, including systematic questioning and process workshops, thereby ensuring the adaptation of standard operating procedures on the basis of local operational needs. Initial structural development and the standardized protocol for the CCM offices were methodologically informed by insights from reviews and interviews with completed projects in care and case management, as well as regional network-building initiatives, to build on best practices and address identified implementation barriers. Moreover, the effects of the care and case managers are evaluated via an RCT (Fig. 2). Eligible patients, identified and enrolled by clinic staff at participating hospitals, are randomized into either an intervention group receiving CCM or a control group receiving usual care. Randomization is automated and conducted centrally via the electronic case report form (eCRF), using computer-generated block randomization stratified by district to balance potential site-specific differences in care delivery or resource availability. The interventional study is designed as a two-arm, parallel-group RCT with an allocation ratio of 1:1 and follows a superiority framework to assess whether the intervention may lead to improvements in outcomes compared with standard care. The study is conducted as an open-label trial, meaning that neither participants nor investigators are blinded to group assignment. The Ostwestfalen-Lippe region encompasses rural, suburban, and urban contexts, allowing examination of how CCM functions under various demographic and infrastructural conditions. District authorities, local health networks, and associated providers collaborate to create regionally adapted CCM offices. Each office oversees daily operations, finance, data management, and stakeholder outreach. This structural support includes networking and the continuous maintenance of a comprehensive map of regional care providers and services (“Versorgungslandkarte”) to systematically document the regional care landscape. Crucially, CCM offices aim to connect stakeholders and facilitate multistakeholder collaboration to strengthen relational coordination. This organizational infrastructure is intended to relieve care and case managers of the ongoing burden of gathering situational information, enabling them to focus more intensively on direct case management. The region’s diverse geographic and socioeconomic contexts also make it possible to examine whether the CCM model can be effectively scaled across areas with differing healthcare densities, patient demographics, and resource availability. A detailed list of participating study sites is available in the trial registry entry ( https://drks.de/search/en/trial/DRKS00034188 ). Study recruitment We recruit stroke or heart disease patients who fulfill the following requirements (Table 1 ): Table 1 Inclusion criteria for the study population Category Stroke CCM Cardiology CCM ICD Diagnosis Confirmed stroke diagnosis (ICD codes I60–I64 or G45 for TIA) Confirmed cardiac diagnosis (ICD codes I20–I25, I47–I49, I50) Minimum Age ≥ 18 years ≥ 18 years Insurance Active membership in a statutory health insurance fund Active membership in a statutory health insurance fund Consent Informed consent provided Informed consent provided Residence Residence within the catchment area of the responsible CCM Residence within the catchment area of the responsible CCM Care Level No existing care level or care level 1–4 prior to the current stroke, or care level 5 if initiated by the stroke No existing care level or care level 1–4 Language Sufficient German language skills or guaranteed language support throughout the intervention period to understand and provide informed consent Sufficient German language skills or guaranteed language support throughout the intervention period to understand and provide informed consent We exclude patients who are unreachable by phone or post, have severe cognitive impairment without a representative, or refuse to participate. Recruitment strategies include direct referrals from clinics, outreach through primary care networks, and information campaigns in local communities. Care and case management intervention The CCM approach follows a standardized protocol informed by the guidelines of the German Care and Case Management Association (DGCC) [ 6 ]. Additionally, the concept of CCM grades (“Lotsengrade”) (I-III) is implemented [ 7 ]. The core components are as follows: Initial assessment: Collecting medical and psychosocial information, establishing baseline functionality, and identifying primary care gaps. Individualized care planning: Defining goals, matching patients with resources, scheduling follow-up calls, and clarifying roles among providers. Coordination activities: The care and case managers engaged with general practitioners, specialists, social workers, rehabilitation facilities, and community agencies to ensure aligned and timely service delivery. Ongoing monitoring: Regular check-ins (phone or in person), adjusting care plans as needed, and documenting progress. Closure and transition: Conducting a final review of patient status, bridging any pending referrals, and promoting self-management strategies where feasible. Patients assigned to the control group receive the usual care available within their local health system. No additional CCM services are provided; however, standard hospital discharge planning or existing community programs may be utilized, as is typical for their district. Data collection strategy All outcome data are gathered prospectively at three time points—baseline (t 0 , after enrollment but before the start of the intervention), six months (t 1 ) and twelve months (t 2 )—in both the intervention and control groups. Quantitative assessments are complemented by qualitative interviews every six months, or sooner if a CCM office reaches full operational maturity, to document organizational evolution and staff perspectives on how the new structures mesh with existing health and social-care services. The first coprimary endpoint is relational coordination among regional providers. It is assessed with an adaptation of Gittell’s Relational Coordination Scale [ 8 – 11 ], which captures the frequency, quality and timeliness of communication; the extent of shared goals; and the degree of mutual respect across professional teams. The second coprimary endpoint is patient-reported quality of care, measured with the Patient Experience of Integrated Care Scale (PEICS) [ 12 ]. This instrument reflects patients’ perceptions of how well services are integrated, the clarity and sufficiency of the information they receive, and the continuity of their care journeys. To obtain a broader picture of effectiveness, several secondary outcomes are monitored. Hospitalization was recorded through patient self-reports. Mortality follow-up relies on local registry checks, which are subject to data protection legislation. Health-related quality of life is captured with the EQ-5D-5L [ 13 ], which includes both the five-domain descriptive system and the visual analog scale. Patient activation—the knowledge, skills and confidence needed for effective self-management—is evaluated with the 13-item Patient Activation Measure (PAM-13) [ 14 ]. For informal caregivers who provide daily or frequent support, self-efficacy is assessed via the eight-item Caregiver Self-Efficacy Scale (CSES-8) [ 15 ]. Together, this mixed-methods approach allows the study to track not only clinical and utilization outcomes but also the relational, experiential and behavioral dimensions that underpin successful integrated care. To ensure the completeness of the data and the whereabouts of the participants throughout the study, the care and case managers and study nurses maintain constant contact with the participants. For those who drop out of the study (e.g., quit, become unavailable) or deviate from the protocol, outcome data will continue to be recorded via the eCRF to minimize missing information. This electronic system for data entry and management allows for a significant improvement in data quality. The schedule of enrolment, interventions, and assessments is presented in Fig. 3, following SPIRIT 2025 recommendations [ 16 ]. Sample size and statistical analysis The required sample size was driven by two coprimary endpoints: (i) changes in relational coordination among regional stakeholders and (ii) improvements in patients’ experiences with integrated care. All calculations were performed via the assumptions detailed below. Relational coordination: Existing German data indicate a mean relational coordination score of 2.62 ± 1.00 on a 1–5 scale [ 17 ]. Although a previous study reported a nonsignificant mean of 2.95 (Cohen’s d = 0.33) [ 17 ], we defined the minimal important difference as a medium effect (d = 0.50). Assuming a one-sided matched-pairs t test with α = 0.05 and power = 80% (β = 0.20), 27 completed questionnaires per district are required to detect this effect. Patient experience of integrated care: In an unnavigated population, the mean patient experience score is 53 ± 10 on a 68-point scale [ 12 ]. A clinically meaningful improvement of 5 points corresponds to d = 0.50 and is expected in the subgroup exposed to the highest CCM intensity (grade III). Because lower intensity grades are anticipated to yield smaller effects, the overall expected effect size across all CCM grades was conservatively set to d = 0.20. For a two-sided t test with α = 0.05 and power = 85% (β = 0.15), 450 patients per group are necessary within each of the three analytic strata (two stroke-CCM iterations, one cardio-CCM iteration), yielding 2 700 patients in total. The primary endpoint relies on primary data collection; therefore, 27% loss to follow-up was projected. Consequently, the aim is to recruit 3 700 patients (1 850 intervention patients and 1 850 control patients). The calculated numbers apply exclusively to patients; participating informal caregivers are not included in the sample size estimate. We employed multiple regression or mixed-effects models for continuous outcomes, adjusting for confounders (e.g., age, sex), and logistic models for binary outcomes (e.g., readmission yes/no). The primary analysis will follow the intention-to-treat principle and include all randomized participants regardless of protocol adherence. Missing data will be addressed by mean imputation to minimize bias. Qualitative data (interview transcripts and observational logs) will be analyzed thematically and triangulated with quantitative data [ 18 ]. This mixed-methods approach will enable us to interpret quantitative findings in light of contextual factors identified qualitatively. Ethical considerations Ethical approval was secured from the Ethics Committee of the Medical Association of Ostwestfalen-Lippe (Reference Number: 2024-057-f-S). All participants provide informed consent, which is obtained by the case managers, with confidentiality maintained via pseudonymized identifiers. Personal information about the enrolled participants is collected and managed via the eCRF. Access to identifiable data is restricted to authorized personnel only (i.e., care and case managers and study nurses), ensuring confidentiality throughout and after the trial. Data storage complies with the General Data Protection Regulation (GDPR) and applicable national regulations. The trial was registered with the German Clinical Trial Register (DRKS00034188), ensuring transparency and adherence to recognized standards of research reporting. Any important protocol modifications (e.g., changes to eligibility criteria, outcomes, or analysis plans) will be communicated to the responsible ethics committee and updated in the German Clinical Trial Register. The study was also published on the WHO portal ( https://trialsearch.who.int ). Discussion Interpretation This study aims to unify the theoretical and practical domains of the CCM by implementing CCM offices and assessing their potential impact through a rigorously designed RCT. The early-stage CCM offices suggest that local context plays a critical role in determining how quickly and effectively such offices can be launched. Some offices appear to benefit from existing community networks and supportive policy environments, whereas others struggle to secure the necessary infrastructure or overcome administrative hurdles. Comparison with existing literature By extending beyond disease-specific CCM and focusing on a broad range of complex health needs, LLO builds on international evidence that indicates potential benefits for integrated, patient-centered care. Programs in stroke, cardiac or oncological CCM have shown promising but often siloed results [ 3 , 19 , 20 ]. LLO conceptualizes CCM as a flexible, indication-independent function performed by qualified healthcare professionals, allowing adaptation to diverse healthcare contexts. Region-wide CCM offices may support scalability, though formal conclusions about effectiveness await study results. Our approach also contributes to the literature on governance, as few studies have addressed how decisions, financial structures, and multistakeholder partnerships influence the long-term success of CCM [ 5 , 21 ]. Strengths and Limitations A central strength of this study is its hybrid design, which captures both process data related to implementation and outcome data from the embedded RCT. The staggered introduction of CCM offices across multiple districts enables controlled comparisons and provides opportunities for real-time learning and iterative adaptation. Furthermore, the deliberate inclusion of a wide range of stakeholders—including primary care providers, specialists, social services, municipal authorities, and payers—allows observation of how each group adapts to and influences the CCM implementation. Nevertheless, several limitations should be noted. First, the heterogeneity of local infrastructure and resources across districts may lead to variability in office performance. Second, self-reported outcomes, such as hospital readmissions and patient experience, may be influenced by recall bias or social desirability. Third, the relatively short follow-up period of 12 months may not capture long-term benefits or potential cost offsets associated with improved care coordination. Additional limitations include the restriction of participation to patients with sufficient German language proficiency or access to language support, which may limit generalizability, and variations in CCM intensity by CCM grade, which could result in differential effects among participants. Finally, external factors, such as policy changes or regional [ Policy Implications If the final analysis suggests improvements in patient experiences and relational coordination, policymakers may consider adopting CCM offices as a potential model for coordinating care in regions facing similar fragmentation issues. Funding strategies could be adapted to reimburse care and case managers’ time and overhead. Participants’ requirement for sufficient German language skills or access to language support should be noted, as it may influence both informed consent and collaboration among stakeholders. Over the longer term, the data generated by these CCM offices may help inform health-economic evaluations and provide insights into whether improved coordination could translate into fewer unnecessary admissions, reduced duplication of diagnostic services, and enhanced patient satisfaction. In the context of an aging population and rising rates of multimorbidity, integrated CCM models might offer a systematic approach to bridging gaps, optimizing resource use, and enhancing both patient and provider experiences. The LLO project combines implementation science with a formal RCT, aiming to explore how CCM can be operationalize effectively and whether it can improve patient-centered measures. By systematically tracking the establishment and function of CCM offices while simultaneously assessing outcome measures among high-need patients, this initiative may provide valuable evidence to inform future care models. The ultimate success of such approaches will likely depend not only on evidence-based protocols but also on strong governance, adequate financing, and the willingness of diverse stakeholders to collaborate in shaping a more coordinated and patient-centered continuum of care. Abbreviations CCM Care and case management CSES-8 Caregiver Self-Efficacy Scale DGCC German Care and Case Management Association DRKS German Clinical Trial Register eCRF Electronic case report form EQ-5D-5L European Quality of Life 5 Dimensions 5 Level Version GDPR General Data Protection Regulation LLO LEX LOTSEN OWL PAM-13 13-item Patient Activation Measure PEICS Patient Experience of Integrated Care Scale RCT Randomized controlled trial Declarations Trial status: Recruitment for this study is ongoing. Recruitment started on 17 May 2024. The current protocol version is 1.1 (Protocol version date: 2025-12-05). The study protocol has been prepared in accordance with the SPIRIT 2025 guidelines [16], and the completed SPIRIT 2025 checklist is provided as an additional file (see Supplementary Material). Ethics approval and consent to participate: The work described has been carried out in accordance with the Declaration of Helsinki. All participants provided written informed consent. The study was approved by the Ethics Committee of the Medical Association of Ostwestfalen-Lippe (Reference Number: 2024-057-f-S). Consent for publication: Not applicable. Availability of data and materials: The data supporting the results of this study are available from the evaluation institute (inav GmbH, Berlin, Germany), but there are restrictions on the availability of these data, which were used under license for the current study and are therefore not publicly available. However, the data are available from the corresponding author upon reasonable request and with the approval of the G-BA (Gemeinsamer Bundesausschuss, Germany). Dissemination policy: Trial results will be communicated to participants in an accessible format. Healthcare professionals and relevant stakeholders will be informed through peer-reviewed publications, conference presentations, and reports to appropriate institutions. Publications will preferably be open access. Additionally, the results will be posted in the trial registry to ensure transparency. Competing interests: The authors declare that they have no competing interests. Funding: The study is supported by funding from the Joint Federal Committee of the Federal Republic of Germany: 01NVF22116. The Joint Federal Committee (G-BA, Gutenbergstraße 13, 10587 Berlin) is the highest decision-making body of the joint self-administration of doctors, dentists, hospitals, and health insurance companies in Germany. It issues guidelines for the catalog of services covered by statutory health insurance (GKV) for more than 73 million insured people, thereby determining which medical care services are reimbursed by the GKV. The Joint Federal Committee is subject to the statutory supervision of the Federal Ministry of Health. The Innovation Committee established within the G-BA defines the priorities and criteria for funding in funding announcements, expresses interest procedures, and determines the funding applications received. Funding is administered by the DLR Project Management Agency. Project managers must submit a factual and financial report every four months and prepare an annual interim report, which is reviewed by the DLR Project Management Agency. All protocol changes must be approved by the DLR Project Management Agency. The results of the study will be published by the G-BA six months after the end of the project. Authors' contributions: Conceptualization: M.B., G.G., U.B., C.K., E.S., M.A., S.G.; Data curation: M.A., S.G., S.L., E.S., H.K.; Methodology: M.A., S.G., S.L., E.S., C.K., M.S.; Project administration: M.B., G.G., J.M., R.P.; Supervision: M.B., G.G., M.A., A.v.S. U.B., C.K., E.S; Writing – original draft: M.A., S.G.; Writing – review & editing: S.L., M.H., E.S., C.K., M.S., U.B., J.H.S., A.v.S., R.P., J.M., G.G., M.B. All the authors have read and agreed to publish this version of the manuscript. The authors adhered to SPIRIT guidelines/methodology. Acknowledgement: We thank the statutory health insurance providers AOK Nordost, AOK Nordwest, Techniker Krankenkasse Landesvertretung Nordrein-Westfalen, IKK classic, and Bertelsmann BKK for their support and advice during the project. Data Monitoring Committee (DMC): A formal Data Monitoring Committee (DMC) was not established for this study. The decision is based on the low-risk nature of the intervention, which consists of care coordination and case management activities without the use of experimental drugs or invasive procedures. The study does not involve any foreseeable physical harm or significant clinical risk to participants. In addition, internal quality assurance processes—including centralized data monitoring, regular review of protocol adherence, and oversight by the project coordination team—are in place to ensure the integrity of the trial. Any serious adverse events or ethical concerns will be reported to the responsible ethics committee in accordance with regulatory requirements. References DGCC e.V.: Case Management Leitlinien – Rahmenempfehlungen, Standards und ethische Grundlagen, vol. 2. Heidelberg: medhochzwei Verlag; 2020. Ex P, Behmer, M. & Amelung, V.: Mit Patientenlotsen Managed Care ermöglichen Monitor Versorgungsforschung 2020, 13 (4), 33–38. Greiner W, Düvel J, Elkenkamp S, Gensorowsky D: Evaluationsbericht gemäß Nr. 14.1 ANBest-IF: Sektorenübergreifend organisierte Versorgung komplexer chronischer Erkrankungen: Schlaganfall-Lotsen in Ostwestfalen-Lippe (STROKE OWL). In. Bielefeld: Stiftung Deutsche Schlaganfall-Hilfe; 2023. 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Ritter PL, Sheth K, Stewart AL, Gallagher-Thompson D, Lorig K: Development and Evaluation of the Eight-Item Caregiver Self-Efficacy Scale (CSES-8). Gerontologist 2022, 62(3):e140-e149. Chan A-W, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA et al : SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ 2025, 389:e081477. Wild EM, Schreyögg J, Go-lubinski V, Ress V, Schmidt H: Evaluationsbericht. Hamburg Billstedt/Horn als Prototyp für eine Integrierte gesundheitliche Vollversorgung in deprivierten großstädtischen Regionen 2022:108. Mayring P, Fenzl T: Qualitative Inhaltsanalyse. In: Handbuch Methoden der empirischen Sozialforschung. edn. Edited by Baur N, Blasius J. Wiesbaden: Springer VS; 2022. Schneider N, Altmann U, Bäcker A, Strauß B: Evaluationsbericht gemäß Nr. 14.1 ANBest-IF: Patienteninformation, -kommunikation und Kompetenzförderung in der Onkologie (PIKKO). In. Jena: Institut für Psychosoziale Medizin, Psychotherapie und Psychoonkologie, Universitätsklinikum Jena; 2021. Schuttig W, Darius H, Reber KC, Coors M, Flothow A, Holzgreve A, Karmann S, Sturtz A, Zoller R, Kropp S et al : Reducing rehospitalization in cardiac patients: a randomized, controlled trial of a cardiac care management program ("Cardiolotse") in Germany. BMC Med 2024, 22(1):480. Bolton R, Logan C, Gittell JH: Revisiting Relational Coordination: A Systematic Review. The Journal of Applied Behavioral Science 2021, 57(3):290–322. Additional Declarations No competing interests reported. Supplementary Files SPIRITOutcomes2022checklistLLO.pdf SPIRIT2025editablechecklistLLO.pdf Cite Share Download PDF Status: Under Revision Version 1 posted Editorial decision: Revision requested 12 May, 2026 Reviews received at journal 12 May, 2026 Reviewers agreed at journal 02 Feb, 2026 Reviewers invited by journal 02 Feb, 2026 Editor assigned by journal 13 Jan, 2026 Submission checks completed at journal 07 Dec, 2025 First submitted to journal 05 Dec, 2025 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. 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Arnold","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA5ElEQVRIiWNgGAWjYLCCB2w2PCCaGYhl2ICEBEEtCWxpcC08xGo5zADXwkBIC//sswcfJJSdlzFnP2PAXFBxj4dPuoHxxgc8WiTO5SUbJJy7zWPZk2PAPONMMQ+bzAFmyxn4rDnDYyaR2Habx+BAWvpv3rYEHjaJBDZpHjw65CFazvEYnH+WwMz7D6rlDx4tBhAtB3gMbiQfYOZtgGrB5y7DMzzGQL8kA7U8PsA84xhIS2KzZQ8eLXJneAwffCizszc4n9jAXFCTICc/I/ngjR/4rMECGBtI1DAKRsEoGAWjAB0AAAdRQkSiYg7DAAAAAElFTkSuQmCC","orcid":"","institution":"inav GmbH","correspondingAuthor":true,"prefix":"","firstName":"Matthias","middleName":"","lastName":"Arnold","suffix":""},{"id":584281782,"identity":"f34c6397-266a-453f-b32a-17760bc6ce41","order_by":1,"name":"Sonja Gscheidle","email":"","orcid":"","institution":"inav GmbH","correspondingAuthor":false,"prefix":"","firstName":"Sonja","middleName":"","lastName":"Gscheidle","suffix":""},{"id":584281784,"identity":"b6a914c6-0701-4d99-a385-98779a6edb51","order_by":2,"name":"Saskia Lange","email":"","orcid":"","institution":"inav GmbH","correspondingAuthor":false,"prefix":"","firstName":"Saskia","middleName":"","lastName":"Lange","suffix":""},{"id":584281786,"identity":"5e97919d-f69e-4341-a6e0-5295da9f926a","order_by":3,"name":"Malte Haring","email":"","orcid":"","institution":"inav GmbH","correspondingAuthor":false,"prefix":"","firstName":"Malte","middleName":"","lastName":"Haring","suffix":""},{"id":584281787,"identity":"a546150c-9966-4682-9abe-6030d15661db","order_by":4,"name":"Elmar Stegmeier","email":"","orcid":"","institution":"Social Impactor GbR","correspondingAuthor":false,"prefix":"","firstName":"Elmar","middleName":"","lastName":"Stegmeier","suffix":""},{"id":584281788,"identity":"2be315dc-4d14-4af9-968c-97a5475ea1b0","order_by":5,"name":"Helena Klampfleitner","email":"","orcid":"","institution":"Social Impactor GbR","correspondingAuthor":false,"prefix":"","firstName":"Helena","middleName":"","lastName":"Klampfleitner","suffix":""},{"id":584281789,"identity":"fdf20359-3e5d-495a-953b-fbf91cc6d301","order_by":6,"name":"Clarissa Kurscheid","email":"","orcid":"","institution":"figus GmbH","correspondingAuthor":false,"prefix":"","firstName":"Clarissa","middleName":"","lastName":"Kurscheid","suffix":""},{"id":584281790,"identity":"58dd87b1-eb4b-468b-8f81-f2b00b2600b3","order_by":7,"name":"Marie Schluttig","email":"","orcid":"","institution":"figus GmbH","correspondingAuthor":false,"prefix":"","firstName":"Marie","middleName":"","lastName":"Schluttig","suffix":""},{"id":584281791,"identity":"99d4e067-0de7-4726-99a0-d649187f6754","order_by":8,"name":"Uwe Borchers","email":"","orcid":"","institution":"ZIG OWL","correspondingAuthor":false,"prefix":"","firstName":"Uwe","middleName":"","lastName":"Borchers","suffix":""},{"id":584281792,"identity":"924f1955-f11f-4f1f-a94c-5309a2fda862","order_by":9,"name":"Susanne Stampa","email":"","orcid":"","institution":"ZIG OWL","correspondingAuthor":false,"prefix":"","firstName":"Susanne","middleName":"","lastName":"Stampa","suffix":""},{"id":584281793,"identity":"d199e8f6-3e3d-4a0e-acf8-b972847f652c","order_by":10,"name":"Jan Hendrik Schnecke","email":"","orcid":"","institution":"ZIG OWL","correspondingAuthor":false,"prefix":"","firstName":"Jan","middleName":"Hendrik","lastName":"Schnecke","suffix":""},{"id":584281794,"identity":"b9ae44aa-ab19-4bdc-82a0-a7a8327d9ec3","order_by":11,"name":"Andreas von Schell","email":"","orcid":"","institution":"HELP GmbH","correspondingAuthor":false,"prefix":"","firstName":"Andreas","middleName":"","lastName":"von Schell","suffix":""},{"id":584281795,"identity":"5520ca4c-86f6-4645-a399-85accc794daa","order_by":12,"name":"Rebecca Pries","email":"","orcid":"","institution":"Stiftung Deutsche Schlaganfall-Hilfe","correspondingAuthor":false,"prefix":"","firstName":"Rebecca","middleName":"","lastName":"Pries","suffix":""},{"id":584281796,"identity":"1b81916f-d9c7-4d73-bb3b-cbbe800339bc","order_by":13,"name":"Johannes Miethe","email":"","orcid":"","institution":"Stiftung Deutsche Schlaganfall-Hilfe","correspondingAuthor":false,"prefix":"","firstName":"Johannes","middleName":"","lastName":"Miethe","suffix":""},{"id":584281797,"identity":"72768b83-3271-4aef-b15c-44f5c56555a1","order_by":14,"name":"Georg Galle","email":"","orcid":"","institution":"Stiftung Deutsche Schlaganfall-Hilfe","correspondingAuthor":false,"prefix":"","firstName":"Georg","middleName":"","lastName":"Galle","suffix":""},{"id":584281798,"identity":"d0b5299f-09ce-4084-9316-d166d5e58347","order_by":15,"name":"Michael Brinkmeier","email":"","orcid":"","institution":"Stiftung Deutsche Schlaganfall-Hilfe","correspondingAuthor":false,"prefix":"","firstName":"Michael","middleName":"","lastName":"Brinkmeier","suffix":""}],"badges":[],"createdAt":"2025-11-17 08:53:27","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8132959/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8132959/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":101861659,"identity":"a4c515ef-44a6-496a-bbe8-82d078a965f5","added_by":"auto","created_at":"2026-02-04 11:47:42","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":426134,"visible":true,"origin":"","legend":"\u003cp\u003eImplementation timeline for the CCM offices in Ostwestfalen-Lippe. Sequential establishment of seven CCM offices; stroke iteration during months 0–12, combined stroke and cardio iterations during months 12–24; interim evaluation at month 12; process workshops every 6 months.\u003c/p\u003e","description":"","filename":"Figure1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-8132959/v1/3037d2f9f2a5e34f9c6fd8d0.jpeg"},{"id":101861661,"identity":"d3f99a44-d363-413b-be48-2a01be8e8017","added_by":"auto","created_at":"2026-02-04 11:47:42","extension":"jpeg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":368815,"visible":true,"origin":"","legend":"\u003cp\u003ePatient pathway in the LLO project. Patients are enrolled in the clinic and randomized into groups. The control phase represents standard care for patients with stroke or cardiac disease in Germany. The intervention phase represents care delivered using the CCM model.]\u003c/p\u003e","description":"","filename":"Figure2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-8132959/v1/5150213e6b7ae0938faf4f3a.jpeg"},{"id":101861663,"identity":"85e8841a-dfb9-4d79-9aba-500804061133","added_by":"auto","created_at":"2026-02-04 11:47:42","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":174826,"visible":true,"origin":"","legend":"\u003cp\u003eSchedule of Enrolment, Interventions, and Assessments\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-8132959/v1/d199ba3cc8664d496660783c.png"},{"id":101861666,"identity":"76ac6edd-6a5e-4b87-9139-2e6e7e0e1e43","added_by":"auto","created_at":"2026-02-04 11:47:51","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1533789,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8132959/v1/92f6d568-2775-475a-8939-cd0a450f42a5.pdf"},{"id":101861660,"identity":"2d8e7eb9-4cf8-44d7-8903-8ba911cecf45","added_by":"auto","created_at":"2026-02-04 11:47:42","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":161483,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRITOutcomes2022checklistLLO.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8132959/v1/9e87c093f344e82546348739.pdf"},{"id":101861662,"identity":"01760075-3a1e-454d-ab7b-c4e8b96a1d5c","added_by":"auto","created_at":"2026-02-04 11:47:42","extension":"pdf","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":205417,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRIT2025editablechecklistLLO.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8132959/v1/7c4df96c855e90bef9942ec1.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"From Pilot to Region-wide Impact: A Hybrid Implementation and Evaluation Protocol for the LEX LOTSEN OWL Care and Case Management System","fulltext":[{"header":"Introduction","content":"\u003cp\u003ePatients with complex medical and psychosocial needs regularly encounter system fragmentation, multiple providers, limited coordination, and burdensome administrative hurdles. In recent years, both national and international initiatives have begun exploring the benefits of integrative programs that emphasize care and case management (CCM) [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. These care and case managers act as central points of contact for patients, fostering communication, ensuring continuity, and advocating for patient interests across the care continuum [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAlthough previous pilot studies have demonstrated potential improvements in outcomes such as patient satisfaction, reduced hospital readmissions, and better adherence to treatment, many of these programs remain time limited or narrowly focused on specific populations [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Even fewer studies have examined broader governance frameworks that seek to institutionalize CCM within routine health systems. Moreover, the interplay between structural implementation (i.e., how an intervention is launched, maintained, and scaled) and clinical or patient-centered results (i.e., the tangible benefits in quality of care or quality of life) is rarely captured in a single study.\u003c/p\u003e \u003cp\u003eAgainst this backdrop, the LEX LOTSEN OWL (LLO) initiative was developed to investigate whether an integrated approach—covering governance, organizational processes, and direct patient care—might address the needs of high-risk, high-need patients across multiple districts. Specifically, LLO introduces “CCM offices” (Lotsenbüros) in distinct geographic locations, intending to coordinate the efforts of care and case managers, connect stakeholders, and support data and billing structures. In parallel, we conduct a randomized controlled trial (RCT) to explore how the CCM intervention influences key outcomes, including relational coordination, patient-reported experiences, and clinical endpoints. By merging a process evaluation with an outcomes study, our project aims to generate evidence of both how the model is implemented and its potential benefit for patients and caregivers.\u003c/p\u003e \u003cp\u003eFor the concept of regional governance, no universally accepted definition exists [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. It encompasses approaches ranging from self-organized coordination to cooperative or hierarchical steering. At its core, it reflects principles of transparency, participation, and accountability (“good governance”) and is shaped by the actors, institutions, and their interactions, including negotiation and decision-making processes [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. In the LLO project, the governance arrangement arises from all the regional structures and actors connected to the central CCM offices.\u003c/p\u003e \u003cp\u003eOur overarching objectives are as follows:\u003c/p\u003e \u003cp\u003e \u003c/p\u003e\u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo establish robust CCM offices across seven districts, documenting and analyzing the facilitators, barriers, and structural adaptations needed. This establishment process aims to develop a target vision for the CCM office, designed as a standardized yet adaptable operational framework that explicitly incorporates the diverse contexts of the implementation region.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo evaluate the efficacy of CCM offices in improving relational coordination among providers and the efficacy of care and case managers in improving patient-reported quality of care.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo investigate secondary outcomes such as (re)hospitalization, mortality, quality of life, self-management capacity, and caregiver self-efficacy.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo derive insights into governance and policy implications to inform potential applicability for stakeholders regarding scalability of such a model in diverse contexts.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003cp\u003e\u003c/p\u003e \u003cp\u003ePolicymakers and healthcare managers continually seek cost-effective, patient-centered strategies to address the complex demands of aging populations and the increasing burden of chronic conditions. If preliminary findings support feasibility and benefit, the LLO model may serve as an informative example for widespread adoption, potentially alleviating system fragmentation and promoting value-based care. By embedding governance considerations and robust process evaluations, such a model can inform the creation of standardized but adaptable frameworks that cater to region-specific needs and ensure lasting impacts.\u003c/p\u003e "},{"header":"Methods","content":"\u003cp\u003eThis study employs a hybrid design, combining an implementation research approach with a patient-level randomized controlled trial (RCT). The implementation component focuses on the staggered establishment of CCM offices across seven districts in the Ostwestfalen-Lippe region (Fig.\u0026nbsp;1). Process evaluation methods, including collection of process indicators, documentation of timelines, organizational readiness, staff training, budget allocation, stakeholder engagement, and governance quality, accompany the implementation. Qualitative data from semistructured interviews and observational field notes provide additional context regarding how local conditions influence the development and adaptation of each office.\u003c/p\u003e\n\u003cp\u003eThe LLO project not only establishes CCM offices but also actively models and implements their core functionalities and tasks. These are subject to continuous, iterative development and regional customization, driven by participatory methods. This continuous improvement process relies on capturing real-time operational experience through staff engagement, including systematic questioning and process workshops, thereby ensuring the adaptation of standard operating procedures on the basis of local operational needs. Initial structural development and the standardized protocol for the CCM offices were methodologically informed by insights from reviews and interviews with completed projects in care and case management, as well as regional network-building initiatives, to build on best practices and address identified implementation barriers.\u003c/p\u003e\n\u003cp\u003eMoreover, the effects of the care and case managers are evaluated via an RCT (Fig.\u0026nbsp;2). Eligible patients, identified and enrolled by clinic staff at participating hospitals, are randomized into either an intervention group receiving CCM or a control group receiving usual care. Randomization is automated and conducted centrally via the electronic case report form (eCRF), using computer-generated block randomization stratified by district to balance potential site-specific differences in care delivery or resource availability. The interventional study is designed as a two-arm, parallel-group RCT with an allocation ratio of 1:1 and follows a superiority framework to assess whether the intervention may lead to improvements in outcomes compared with standard care. The study is conducted as an open-label trial, meaning that neither participants nor investigators are blinded to group assignment.\u003c/p\u003e\n\u003cp\u003eThe Ostwestfalen-Lippe region encompasses rural, suburban, and urban contexts, allowing examination of how CCM functions under various demographic and infrastructural conditions. District authorities, local health networks, and associated providers collaborate to create regionally adapted CCM offices. Each office oversees daily operations, finance, data management, and stakeholder outreach. This structural support includes networking and the continuous maintenance of a comprehensive map of regional care providers and services (\u0026ldquo;Versorgungslandkarte\u0026rdquo;) to systematically document the regional care landscape. Crucially, CCM offices aim to connect stakeholders and facilitate multistakeholder collaboration to strengthen relational coordination. This organizational infrastructure is intended to relieve care and case managers of the ongoing burden of gathering situational information, enabling them to focus more intensively on direct case management. The region\u0026rsquo;s diverse geographic and socioeconomic contexts also make it possible to examine whether the CCM model can be effectively scaled across areas with differing healthcare densities, patient demographics, and resource availability. A detailed list of participating study sites is available in the trial registry entry (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://drks.de/search/en/trial/DRKS00034188\u003c/span\u003e\u003c/span\u003e).\u003c/p\u003e\n\u003ch3\u003eStudy recruitment\u003c/h3\u003e\n\u003cp\u003eWe recruit stroke or heart disease patients who fulfill the following requirements (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e):\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab1\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eInclusion criteria for the study population\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eCategory\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eStroke CCM\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eCardiology CCM\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\u003eICD Diagnosis\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eConfirmed stroke diagnosis (ICD codes I60\u0026ndash;I64 or G45 for TIA)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eConfirmed cardiac diagnosis (ICD codes I20\u0026ndash;I25, I47\u0026ndash;I49, I50)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMinimum Age\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026ge;\u0026thinsp;18 years\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026ge;\u0026thinsp;18 years\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eInsurance\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eActive membership in a statutory health insurance fund\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eActive membership in a statutory health insurance fund\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eConsent\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eInformed consent provided\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eInformed consent provided\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eResidence\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eResidence within the catchment area of the responsible CCM\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eResidence within the catchment area of the responsible CCM\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCare Level\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNo existing care level or care level 1\u0026ndash;4 prior to the current stroke, or care level 5 if initiated by the stroke\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNo existing care level or care level 1\u0026ndash;4\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLanguage\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSufficient German language skills or guaranteed language support throughout the intervention period to understand and provide informed consent\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSufficient German language skills or guaranteed language support throughout the intervention period to understand and provide informed consent\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003eWe exclude patients who are unreachable by phone or post, have severe cognitive impairment without a representative, or refuse to participate. Recruitment strategies include direct referrals from clinics, outreach through primary care networks, and information campaigns in local communities.\u003c/p\u003e\n\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n\u003ch2\u003eCare and case management intervention\u003c/h2\u003e\n\u003cp\u003eThe CCM approach follows a standardized protocol informed by the guidelines of the German Care and Case Management Association (DGCC) [\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e]. Additionally, the concept of CCM grades (\u0026ldquo;Lotsengrade\u0026rdquo;) (I-III) is implemented [\u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e]. The core components are as follows:\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003eInitial assessment: Collecting medical and psychosocial information, establishing baseline functionality, and identifying primary care gaps.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eIndividualized care planning: Defining goals, matching patients with resources, scheduling follow-up calls, and clarifying roles among providers.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eCoordination activities: The care and case managers engaged with general practitioners, specialists, social workers, rehabilitation facilities, and community agencies to ensure aligned and timely service delivery.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eOngoing monitoring: Regular check-ins (phone or in person), adjusting care plans as needed, and documenting progress.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eClosure and transition: Conducting a final review of patient status, bridging any pending referrals, and promoting self-management strategies where feasible.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003ePatients assigned to the control group receive the usual care available within their local health system. No additional CCM services are provided; however, standard hospital discharge planning or existing community programs may be utilized, as is typical for their district.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eData collection strategy\u003c/h3\u003e\n\u003cp\u003eAll outcome data are gathered prospectively at three time points\u0026mdash;baseline (t\u003csub\u003e0\u003c/sub\u003e, after enrollment but before the start of the intervention), six months (t\u003csub\u003e1\u003c/sub\u003e) and twelve months (t\u003csub\u003e2\u003c/sub\u003e)\u0026mdash;in both the intervention and control groups. Quantitative assessments are complemented by qualitative interviews every six months, or sooner if a CCM office reaches full operational maturity, to document organizational evolution and staff perspectives on how the new structures mesh with existing health and social-care services.\u003c/p\u003e\n\u003cp\u003eThe first coprimary endpoint is relational coordination among regional providers. It is assessed with an adaptation of Gittell\u0026rsquo;s Relational Coordination Scale [\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e11\u003c/span\u003e], which captures the frequency, quality and timeliness of communication; the extent of shared goals; and the degree of mutual respect across professional teams.\u003c/p\u003e\n\u003cp\u003eThe second coprimary endpoint is patient-reported quality of care, measured with the Patient Experience of Integrated Care Scale (PEICS) [\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e]. This instrument reflects patients\u0026rsquo; perceptions of how well services are integrated, the clarity and sufficiency of the information they receive, and the continuity of their care journeys.\u003c/p\u003e\n\u003cp\u003eTo obtain a broader picture of effectiveness, several secondary outcomes are monitored. Hospitalization was recorded through patient self-reports. Mortality follow-up relies on local registry checks, which are subject to data protection legislation. Health-related quality of life is captured with the EQ-5D-5L [\u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e], which includes both the five-domain descriptive system and the visual analog scale. Patient activation\u0026mdash;the knowledge, skills and confidence needed for effective self-management\u0026mdash;is evaluated with the 13-item Patient Activation Measure (PAM-13) [\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e]. For informal caregivers who provide daily or frequent support, self-efficacy is assessed via the eight-item Caregiver Self-Efficacy Scale (CSES-8) [\u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003eTogether, this mixed-methods approach allows the study to track not only clinical and utilization outcomes but also the relational, experiential and behavioral dimensions that underpin successful integrated care.\u003c/p\u003e\n\u003cp\u003eTo ensure the completeness of the data and the whereabouts of the participants throughout the study, the care and case managers and study nurses maintain constant contact with the participants. For those who drop out of the study (e.g., quit, become unavailable) or deviate from the protocol, outcome data will continue to be recorded via the eCRF to minimize missing information. This electronic system for data entry and management allows for a significant improvement in data quality.\u003c/p\u003e\n\u003cp\u003eThe schedule of enrolment, interventions, and assessments is presented in Fig.\u0026nbsp;3, following SPIRIT 2025 recommendations [\u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003eSample size and statistical analysis\u003c/p\u003e\n\u003cp\u003eThe required sample size was driven by two coprimary endpoints: (i) changes in relational coordination among regional stakeholders and (ii) improvements in patients\u0026rsquo; experiences with integrated care. All calculations were performed via the assumptions detailed below.\u003c/p\u003e\n\u003cp\u003eRelational coordination: Existing German data indicate a mean relational coordination score of 2.62\u0026thinsp;\u0026plusmn;\u0026thinsp;1.00 on a 1\u0026ndash;5 scale [\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e]. Although a previous study reported a nonsignificant mean of 2.95 (Cohen\u0026rsquo;s d\u0026thinsp;=\u0026thinsp;0.33) [\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e], we defined the minimal important difference as a medium effect (d\u0026thinsp;=\u0026thinsp;0.50). Assuming a one-sided matched-pairs t test with \u0026alpha;\u0026thinsp;=\u0026thinsp;0.05 and power\u0026thinsp;=\u0026thinsp;80% (\u0026beta;\u0026thinsp;=\u0026thinsp;0.20), 27 completed questionnaires per district are required to detect this effect.\u003c/p\u003e\n\u003cp\u003ePatient experience of integrated care: In an unnavigated population, the mean patient experience score is 53\u0026thinsp;\u0026plusmn;\u0026thinsp;10 on a 68-point scale [\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e]. A clinically meaningful improvement of 5 points corresponds to d\u0026thinsp;=\u0026thinsp;0.50 and is expected in the subgroup exposed to the highest CCM intensity (grade III). Because lower intensity grades are anticipated to yield smaller effects, the overall expected effect size across all CCM grades was conservatively set to d\u0026thinsp;=\u0026thinsp;0.20. For a two-sided t test with \u0026alpha;\u0026thinsp;=\u0026thinsp;0.05 and power\u0026thinsp;=\u0026thinsp;85% (\u0026beta;\u0026thinsp;=\u0026thinsp;0.15), 450 patients per group are necessary within each of the three analytic strata (two stroke-CCM iterations, one cardio-CCM iteration), yielding 2 700 patients in total.\u003c/p\u003e\n\u003cp\u003eThe primary endpoint relies on primary data collection; therefore, 27% loss to follow-up was projected. Consequently, the aim is to recruit 3 700 patients (1 850 intervention patients and 1 850 control patients). The calculated numbers apply exclusively to patients; participating informal caregivers are not included in the sample size estimate.\u003c/p\u003e\n\u003cp\u003eWe employed multiple regression or mixed-effects models for continuous outcomes, adjusting for confounders (e.g., age, sex), and logistic models for binary outcomes (e.g., readmission yes/no). The primary analysis will follow the intention-to-treat principle and include all randomized participants regardless of protocol adherence. Missing data will be addressed by mean imputation to minimize bias. Qualitative data (interview transcripts and observational logs) will be analyzed thematically and triangulated with quantitative data [\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e]. This mixed-methods approach will enable us to interpret quantitative findings in light of contextual factors identified qualitatively.\u003c/p\u003e\n\u003cp\u003eEthical considerations\u003c/p\u003e\n\u003cp\u003eEthical approval\u0026nbsp;was secured from the Ethics Committee of the Medical Association of Ostwestfalen-Lippe (Reference Number: 2024-057-f-S). All participants provide informed consent, which is obtained by the case managers, with confidentiality maintained via pseudonymized identifiers. Personal information about the enrolled participants is collected and managed via the eCRF. Access to identifiable data is restricted to authorized personnel only (i.e., care and case managers and study nurses), ensuring confidentiality throughout and after the trial. Data storage complies with the General Data Protection Regulation (GDPR) and applicable national regulations. The trial was registered with the German Clinical Trial Register (DRKS00034188), ensuring transparency and adherence to recognized standards of research reporting. Any important protocol modifications (e.g., changes to eligibility criteria, outcomes, or analysis plans) will be communicated to the responsible ethics committee and updated in the German Clinical Trial Register. The study was also published on the WHO portal (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://trialsearch.who.int\u003c/span\u003e\u003c/span\u003e).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eInterpretation\u003c/h2\u003e \u003cp\u003eThis study aims to unify the theoretical and practical domains of the CCM by implementing CCM offices and assessing their potential impact through a rigorously designed RCT. The early-stage CCM offices suggest that local context plays a critical role in determining how quickly and effectively such offices can be launched. Some offices appear to benefit from existing community networks and supportive policy environments, whereas others struggle to secure the necessary infrastructure or overcome administrative hurdles.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eComparison with existing literature\u003c/h2\u003e \u003cp\u003eBy extending beyond disease-specific CCM and focusing on a broad range of complex health needs, LLO builds on international evidence that indicates potential benefits for integrated, patient-centered care. Programs in stroke, cardiac or oncological CCM have shown promising but often siloed results [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. LLO conceptualizes CCM as a flexible, indication-independent function performed by qualified healthcare professionals, allowing adaptation to diverse healthcare contexts. Region-wide CCM offices may support scalability, though formal conclusions about effectiveness await study results. Our approach also contributes to the literature on governance, as few studies have addressed how decisions, financial structures, and multistakeholder partnerships influence the long-term success of CCM [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eStrengths and Limitations\u003c/h3\u003e\n\u003cp\u003eA central strength of this study is its hybrid design, which captures both process data related to implementation and outcome data from the embedded RCT. The staggered introduction of CCM offices across multiple districts enables controlled comparisons and provides opportunities for real-time learning and iterative adaptation. Furthermore, the deliberate inclusion of a wide range of stakeholders\u0026mdash;including primary care providers, specialists, social services, municipal authorities, and payers\u0026mdash;allows observation of how each group adapts to and influences the CCM implementation.\u003c/p\u003e \u003cp\u003eNevertheless, several limitations should be noted. First, the heterogeneity of local infrastructure and resources across districts may lead to variability in office performance. Second, self-reported outcomes, such as hospital readmissions and patient experience, may be influenced by recall bias or social desirability. Third, the relatively short follow-up period of 12 months may not capture long-term benefits or potential cost offsets associated with improved care coordination. Additional limitations include the restriction of participation to patients with sufficient German language proficiency or access to language support, which may limit generalizability, and variations in CCM intensity by CCM grade, which could result in differential effects among participants. Finally, external factors, such as policy changes or regional [\u003c/p\u003e\n\u003ch3\u003ePolicy Implications\u003c/h3\u003e\n\u003cp\u003eIf the final analysis suggests improvements in patient experiences and relational coordination, policymakers may consider adopting CCM offices as a potential model for coordinating care in regions facing similar fragmentation issues. Funding strategies could be adapted to reimburse care and case managers\u0026rsquo; time and overhead. Participants\u0026rsquo; requirement for sufficient German language skills or access to language support should be noted, as it may influence both informed consent and collaboration among stakeholders. Over the longer term, the data generated by these CCM offices may help inform health-economic evaluations and provide insights into whether improved coordination could translate into fewer unnecessary admissions, reduced duplication of diagnostic services, and enhanced patient satisfaction.\u003c/p\u003e \u003cp\u003eIn the context of an aging population and rising rates of multimorbidity, integrated CCM models might offer a systematic approach to bridging gaps, optimizing resource use, and enhancing both patient and provider experiences. The LLO project combines implementation science with a formal RCT, aiming to explore how CCM can be operationalize effectively and whether it can improve patient-centered measures. By systematically tracking the establishment and function of CCM offices while simultaneously assessing outcome measures among high-need patients, this initiative may provide valuable evidence to inform future care models. The ultimate success of such approaches will likely depend not only on evidence-based protocols but also on strong governance, adequate financing, and the willingness of diverse stakeholders to collaborate in shaping a more coordinated and patient-centered continuum of care.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eCCM\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Care and case management\u003c/p\u003e\n\u003cp\u003eCSES-8\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Caregiver Self-Efficacy Scale\u003c/p\u003e\n\u003cp\u003eDGCC\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;German Care and Case Management Association\u003c/p\u003e\n\u003cp\u003eDRKS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;German Clinical Trial Register\u003c/p\u003e\n\u003cp\u003eeCRF\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Electronic case report form\u003cbr\u003eEQ-5D-5L\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;European Quality of Life 5 Dimensions 5 Level Version\u003c/p\u003e\n\u003cp\u003eGDPR\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;General Data Protection Regulation\u003c/p\u003e\n\u003cp\u003eLLO\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;LEX LOTSEN OWL\u003cbr\u003ePAM-13\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;13-item Patient Activation Measure\u003cbr\u003ePEICS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Patient Experience of Integrated Care Scale\u0026nbsp;\u003cbr\u003eRCT Randomized controlled trial\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eTrial status: Recruitment for this study is ongoing. Recruitment started on 17 May 2024. The current protocol version is 1.1 (Protocol version date: 2025-12-05).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe study protocol has been prepared in accordance with the SPIRIT 2025 guidelines [16], and the completed SPIRIT 2025 checklist is provided as an additional file (see Supplementary Material).\u003c/p\u003e\n\u003cp\u003eEthics approval and consent to participate: The work described has been carried out in accordance with the Declaration of Helsinki. All participants provided written informed consent. The study was approved by the Ethics Committee of the Medical Association of Ostwestfalen-Lippe (Reference Number: 2024-057-f-S).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eConsent for publication: Not applicable.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAvailability of data and materials: The data supporting the results of this study are available from the evaluation institute (inav GmbH, Berlin, Germany), but there are restrictions on the availability of these data, which were used under license for the current study and are therefore not publicly available. However, the data are available from the corresponding author upon reasonable request and with the approval of the G-BA (Gemeinsamer Bundesausschuss, Germany).\u003c/p\u003e\n\u003cp\u003eDissemination policy: Trial results will be communicated to participants in an accessible format. Healthcare professionals and relevant stakeholders will be informed through peer-reviewed publications, conference presentations, and reports to appropriate institutions. Publications will preferably be open access. Additionally, the results will be posted in the trial registry to ensure transparency.\u003c/p\u003e\n\u003cp\u003eCompeting interests: The authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003eFunding: The study is supported by funding from the Joint Federal Committee of the Federal Republic of Germany: 01NVF22116. The Joint Federal Committee (G-BA, Gutenbergstra\u0026szlig;e 13, 10587 Berlin) is the highest decision-making body of the joint self-administration of doctors, dentists, hospitals, and health insurance companies in Germany. It issues guidelines for the catalog of services covered by statutory health insurance (GKV) for more than 73 million insured people, thereby determining which medical care services are reimbursed by the GKV. The Joint Federal Committee is subject to the statutory supervision of the Federal Ministry of Health. The Innovation Committee established within the G-BA defines the priorities and criteria for funding in funding announcements, expresses interest procedures, and determines the funding applications received.\u003c/p\u003e\n\u003cp\u003eFunding is administered by the DLR Project Management Agency. Project managers must submit a factual and financial report every four months and prepare an annual interim report, which is reviewed by the DLR Project Management Agency. All protocol changes must be approved by the DLR Project Management Agency. The results of the study will be published by the G-BA six months after the end of the project.\u003c/p\u003e\n\u003cp\u003eAuthors\u0026apos; contributions: Conceptualization: M.B., G.G., U.B., C.K., E.S., M.A., S.G.; Data curation: M.A., S.G., S.L., E.S., H.K.; Methodology: M.A., S.G., S.L., E.S., C.K., M.S.; Project administration: M.B., G.G., J.M., R.P.; Supervision: M.B., G.G., M.A., A.v.S. U.B., C.K., E.S; Writing \u0026ndash; original draft: M.A., S.G.; Writing \u0026ndash; review \u0026amp; editing: S.L., M.H., E.S., C.K., M.S., U.B., J.H.S., A.v.S., R.P., J.M., G.G., M.B. All the authors have read and agreed to publish this version of the manuscript. The authors adhered to SPIRIT guidelines/methodology.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAcknowledgement: We thank the statutory health insurance providers AOK Nordost, AOK Nordwest, Techniker Krankenkasse Landesvertretung Nordrein-Westfalen, IKK classic, and Bertelsmann BKK for their support and advice during the project.\u003c/p\u003e\n\u003cp\u003eData Monitoring Committee (DMC): A formal Data Monitoring Committee (DMC) was not established for this study. The decision is based on the low-risk nature of the intervention, which consists of care coordination and case management activities without the use of experimental drugs or invasive procedures. The study does not involve any foreseeable physical harm or significant clinical risk to participants. In addition, internal quality assurance processes\u0026mdash;including centralized data monitoring, regular review of protocol adherence, and oversight by the project coordination team\u0026mdash;are in place to ensure the integrity of the trial. Any serious adverse events or ethical concerns will be reported to the responsible ethics committee in accordance with regulatory requirements.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eDGCC e.V.: Case Management Leitlinien \u0026ndash; Rahmenempfehlungen, Standards und ethische Grundlagen, vol. 2. 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New York, NY: McGraw-Hill Education; 2018.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJoober H, Chouinard MC, King J, Lambert M, Hudon \u0026Eacute;, Hudon C: The Patient Experience of Integrated Care Scale: A Validation Study among Patients with Chronic Conditions Seen in Primary Care. \u003cem\u003eInt J Integr Care\u003c/em\u003e 2018, 18(4):1.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLudwig K, Graf von der Schulenburg JM, Greiner W: German Value Set for the EQ-5D-5L. \u003cem\u003ePharmacoEconomics\u003c/em\u003e 2018, 36(6):663\u0026ndash;674.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHibbard JH, Mahoney ER, Stockard J, Tusler M: Development and testing of a short form of the patient activation measure. \u003cem\u003eHealth Serv Res\u003c/em\u003e 2005, 40(6 Pt 1):1918\u0026ndash;1930.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRitter PL, Sheth K, Stewart AL, Gallagher-Thompson D, Lorig K: Development and Evaluation of the Eight-Item Caregiver Self-Efficacy Scale (CSES-8). \u003cem\u003eGerontologist\u003c/em\u003e 2022, 62(3):e140-e149.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChan A-W, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA \u003cem\u003eet al\u003c/em\u003e: SPIRIT 2025 statement: updated guideline for protocols of randomised trials. \u003cem\u003eBMJ\u003c/em\u003e 2025, 389:e081477.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWild EM, Schrey\u0026ouml;gg J, Go-lubinski V, Ress V, Schmidt H: Evaluationsbericht. Hamburg Billstedt/Horn als Prototyp f\u0026uuml;r eine Integrierte gesundheitliche Vollversorgung in deprivierten gro\u0026szlig;st\u0026auml;dtischen Regionen 2022:108.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMayring P, Fenzl T: Qualitative Inhaltsanalyse. In: \u003cem\u003eHandbuch Methoden der empirischen Sozialforschung.\u003c/em\u003e edn. Edited by Baur N, Blasius J. Wiesbaden: Springer VS; 2022.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSchneider N, Altmann U, B\u0026auml;cker A, Strau\u0026szlig; B: Evaluationsbericht gem\u0026auml;\u0026szlig; Nr. 14.1 ANBest-IF: Patienteninformation, -kommunikation und Kompetenzf\u0026ouml;rderung in der Onkologie (PIKKO). In. Jena: Institut f\u0026uuml;r Psychosoziale Medizin, Psychotherapie und Psychoonkologie, Universit\u0026auml;tsklinikum Jena; 2021.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSchuttig W, Darius H, Reber KC, Coors M, Flothow A, Holzgreve A, Karmann S, Sturtz A, Zoller R, Kropp S \u003cem\u003eet al\u003c/em\u003e: Reducing rehospitalization in cardiac patients: a randomized, controlled trial of a cardiac care management program (\"Cardiolotse\") in Germany. \u003cem\u003eBMC Med\u003c/em\u003e 2024, 22(1):480.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBolton R, Logan C, Gittell JH: Revisiting Relational Coordination: A Systematic Review. \u003cem\u003eThe Journal of Applied Behavioral Science\u003c/em\u003e 2021, 57(3):290\u0026ndash;322.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Mixed methods, Implementation research, Outcome evaluation, Care and case management, Care and case managers, Integrated care, Relational coordination","lastPublishedDoi":"10.21203/rs.3.rs-8132959/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8132959/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e Care and case management (CCM) is considered a promising approach to bridging gaps in cross-sectoral coordination for high-needs patients, aiming to improve access, continuity, and overall care experiences. Despite promising pilot initiatives, comprehensive models that investigate both the “how” (implementation and sustainable scaling) and the “what” (patient outcomes) are lacking. To address this gap, the “LEX LOTSEN OWL” (LLO) project (registered under DRKS00034188) employs a hybrid study design, combining implementation research with a classic randomized controlled trial (RCT) across seven districts in the German East Westphalia-Lippe (Ostwestfalen-Lippe, OWL) region. By examining governance structures and organizational frameworks, LLO seeks to provide insights into the broader applicability and feasibility of CCM programs.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods/Design:\u003c/strong\u003e This study encompasses two interlinked components: (1) Implementation research via a process evaluation framework accompanying the establishment of “CCM offices” (Lotsenbüros) in seven districts, introduced in a staggered manner. Qualitative and quantitative methods (including interviews, document analysis, and process metrics) will be applied to identify facilitating factors and barriers, guided by a governance framework and rapid ethnographic assessments. (2) Outcome research via RCT at the patient level. Adults with complex care needs will be randomized into a care and case management group or a control group receiving usual care. The primary endpoints are relational coordination (system level), which is assessed via the Gittell Relational Coordination Questionnaire, and experienced quality of care (Patient Experience of Integrated Care Scale, PEICS). The secondary endpoints include (re)hospitalization, mortality, health-related quality of life, patient self-management, and caregiver self-efficacy, allowing a comprehensive assessment of clinical and patient-centered outcomes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e This dual design aims to generate evidence of both structural and process-related factors influencing implementation while evaluating the potential clinical effectiveness of CCM. The results may inform how an indication-independent CCM can be seamlessly integrated into diverse healthcare settings. By providing insights into governance, organizational strategies, and patient-specific benefits, LLO may inform future policy and practice, foster improved coordination, enhance continuity, and increase patient engagement in routine health systems. Additionally, the project explores scalability factors critical for decision-makers. Collectively, this initiative has the potential to contribute to the development of sustainable, patient-centered care models.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study is prospectively registered in the German Clinical Trials Register (DRKS, DRKS00034188) on 17 May 2024. Full details are available at https//drks.de/search/de/trial/DRKS00034188.\u003c/p\u003e","manuscriptTitle":"From Pilot to Region-wide Impact: A Hybrid Implementation and Evaluation Protocol for the LEX LOTSEN OWL Care and Case Management System","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-04 11:47:26","doi":"10.21203/rs.3.rs-8132959/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-05-12T10:12:30+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-12T10:11:42+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"272480617282096619413427578662499559814","date":"2026-02-02T11:11:55+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-02-02T10:54:20+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-01-13T12:11:05+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-12-07T09:17:54+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-12-05T10:43:37+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"7612275d-a392-4b39-9566-ddce40967416","owner":[],"postedDate":"February 4th, 2026","published":true,"recentEditorialEvents":[{"type":"decision","content":"Revision requested","date":"2026-05-12T10:12:30+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-12T10:11:42+00:00","index":15,"fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"in-revision","subjectAreas":[],"tags":[],"updatedAt":"2026-05-12T10:54:47+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-04 11:47:26","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8132959","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8132959","identity":"rs-8132959","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}