Harmonization and standardization of personalized oncology care within the German network for personalized medicine (DNPM): methods of a controlled observational study employing an adapted stepped-wedge design

Background: The goal of personalized medicine (PM) is to provide tailored diagnostics and therapies for individual patients, primarily in oncology. However, significant regional disparities exist in its implementation. The Deutsches Netzwerk für Personalisierte Medizin (DNPM; German Network for Personalized Medicine) project aims to harmonize and network the implementation of PM in Germany. Methods: The DNPM project is evaluated as a Hybrid Type 3 implementation study using a non-randomized, modified stepped-wedge design. Twenty-one university hospital sites across Germany will transition from standard, non-harmonized care to a harmonized personalized medicine intervention at different time points, based on administrative readiness indicated by certification. The primary outcome is change in patient management due to molecular tumor board (MTB) decisions, assessed on three tiers using prospectively collected primary data entered by clinical staff: (1) number of patients with access to an MTB, (2) proportion with revised diagnostic or therapeutic recommendations, and (3) proportion with implemented changes. Therefore, the study aims to include 4,807 patients (intervention group: 3.507). A mixed-methods approach is employed to evaluate further aspects of the implementation process including patient and staff satisfaction, perceived quality of care, and the degree of harmonization and collaboration within the network. Health economic outcomes include health-related quality of life, healthcare utilization costs, and intervention-related costs. Discussion: The study's wide range of outcome parameters and mixed-methods approach yield robust results for implementation insights. A limitation of the study design is the lack of a clear cutoff for transitioning from the control to the intervention group and the lack of randomization. Additionally, the health economic evaluation is limited by the absence of health insurance claims data, as no insurance company is involved in the project. Trial registration: This trial is registered with the German Clinical Trials Register (DRKS) under the trial number DRKS00031622 (registration date: 23 May 2023).