Susann May, Felix Muehlensiepen, Gina Barzen, Frances Seifert, Manuela Marquardt, Charly Bunar, Lena Dimde, Dennis Kipping, Peter Gocke, Philipp Stachwitz, Katrin Hahn, Liane Schenk, Sebastian Spethmann
Background: This manuscript presents the study protocol for a planned mixed-methods study on the transition to an opt-out approach for the electronic health record (elektronische Patientenakte, ePA) in Germany in 2025. This change represents a paradigm shift in the healthcare system and aims to promote broad adoption. While the ePA has the potential to improve cross-sectoral care and patient empowerment, structural and individual barriers may hinder successful implementation. Understanding these factors is crucial to developing strategies for effective integration and long-term utilization of the ePA. Objective: This study aims to systematically investigate the barriers and facilitators influencing the adoption and use of the ePA among various user groups, including both patients and healthcare providers, in Germany. It seeks to identify sociodemographic and contextual factors affecting acceptance and usage while also exploring the ePAs potential to optimize healthcare processes, patient satisfaction, and empowerment. Methods: This mixed-methods exploratory study employs the Consolidated Framework for Implementation Research to examine the structural, organizational, and individual determinants of ePA implementation. Data will be collected in four modules: (1) patient interviews and surveys with ePA users and nonusers, (2) analysis of aggregated usage data from all ePAs in Germany, (3) interviews and surveys with stakeholders in outpatient and emergency care, and (4) focus groups for validation and synthesis of findings. Quantitative analyses include descriptive statistics and regression models, whereas qualitative data will be analyzed using structured content analysis. Discussion: This study is expected to provide a comprehensive understanding of the factors that affect ePA adoption and use in Germany. Insights from different perspectives will inform targeted strategies to overcome barriers, strengthen health literacy, and enhance system usability. These insights will contribute to recommendations for optimizing the implementation of the ePA in Germany and promoting the digital transformation of the German healthcare system.