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

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.