Over the past two decades, medical education has undergone a global transformation toward a competency-based approach, aligning curricula with the abilities required for safe and effective clinical practice.¹ In Japan, the Model Core Curriculum for Medical Education was introduced to support this paradigm shift,² and its 2022 revision emphasizes the overarching goal of “providing safe and high-quality healthcare.”³ Within this framework, patient safety learning is no longer viewed as a discrete subject but as a crucial cross-cutting domain that should be systematically integrated into all stages of undergraduate education. The World Health Organization (WHO) also underscores the necessity for systematic patient safety learning at the undergraduate level to enable future healthcare professionals to deliver safe and effective care.⁴ Particular emphasis is placed on cultivating safety culture, encompassing reporting and learning, early in the educational trajectory, with the aim of fostering student attitudes and practices that support the enhancement of healthcare quality and safety.⁵ The introduction of the longitudinal competency framework overarching undergraduate and residency curricula has further reinforced the continuous quality improvement of care.

Despite this global and national emphasis, the implementation of patient safety education for undergraduates remains limited in Japan. Structural barriers include a shortage of educators trained in patient safety, a lack of standardized instructional models, and insufficient linkage between safety education and clinical practice.^6,7 A national survey reported that only around 30% of Japanese medical schools include certified patient safety specialists in their undergraduate curriculum planning,⁷ suggesting that most safety instruction is still delivered by faculty without formal training in safety science. In addition, undergraduate learning opportunities remain largely lecture-based, with few interactive or experiential activities. ⁸ However, these barriers are diverse and multi-faceted, spanning individual, interpersonal, and organizational levels. To develop effective dissemination strategies, a systematic understanding of implementation challenges across multiple domains is essential.

In this study, several key terms are operationally defined. “Educationally valid” refers to session designs that are grounded in established educational theory and aligned with learning outcomes specified in the Model Core Curriculum. “Model sessions” denote transferable, evidence-informed lesson plans that can serve as templates for instructors seeking to implement or adapt patient safety learning activities in their institutions. These sessions are mapped to the core patient safety competencies outlined in the Japanese curriculum, including quality improvement, safety management systems, and practical safety practices.²

From a theoretical perspective, the limited translation of patient safety principles into undergraduate education can be viewed as a gap in applying funda-mental learning principles. According to Merrill’s First Principles of Instruction, effective learning occurs when learners are engaged in authentic problem-solving and can integrate new knowledge into their prior experiences.⁹ This study therefore approached the implementation gap in patient safety education as an instructional design problem—where traditional lecture-based approaches fail to activate prior knowledge or provide opportunities for application and integration. Merrill's First Principles of Instruction, which emphasize authentic problem-solving, activation of prior knowledge, demonstration, application, and integration of learning, provided the theoretical basis for designing the model sessions. Guided by these principles, the study sought to develop educationally sound, interactive sessions that foster behavioral and attitudinal changes toward patient safety. To address these dual objectives, the study employed two complementary conceptual frameworks. First, to ensure systematic validation of the session plans, the Context-Input-Process-Product (CIPP) model¹⁰ was adopted as the conceptual framework. The CIPP model is a well-established approach to educational program evaluation that has been systematically applied across diverse contexts in higher education, including health professions education.¹¹ The model examines four critical dimensions: Context (needs and relevance), Input (resources and strategies), Process (implementation quality), and Product (outcomes and effectiveness). This comprehensive structure makes CIPP particularly suited for evaluating newly developed educational interventions prior to large-scale implementation. Second, to systematically identify and categorize implementation barriers, Steinert's framework for analyzing problems in educational practice¹² was employed, which distinguishes challenges across knowledge, attitude, skills, teacher, student, and system domains. This dual-framework approach enabled comprehensive assessment of both educational quality and implementation feasibility.

Accordingly, the present study had two interrelated aims: first, to develop and validate model session plans for patient safety learning that are educationally sound and feasible for undergraduate medical education in Japan; and second, to identify anticipated barriers to their implementation in real educational settings.

Of the 45 invited participants, 36 completed the evaluation (response rate: 80%), exceeding the minimum threshold and ensuring robust consensus findings. The panel comprised 14 physicians, 2 dentists, 14 nurses, and 6 pharmacists.

Table 2. Elements of the Steinert's framework¹² and their operational definitions created through the data analysis

Twenty respondents held nationally recognized certifications as general risk managers, reflecting dual expertise in education and safety administration. Among educational specialists (n=16), nine held certificates or master's degrees in health professions education.

Through the development and expert validation of four model session plans, this study demonstrated their educational validity and practical feasibility. As illustrated in the joint display, the integration of quantitative and qualitative findings revealed that the learning sessions are relevant to patient safety education but accompanied by structural obstacles and required implementation actions. These sessions, which emphasized experiential and collaborative learning, were aligned with expert perceptions and deemed suitable for implementation in educational settings. Active student engagement through role-play, simulations, and group discussions was particularly effective in fostering practical understanding and attitudinal shifts regarding patient safety. While the 2011 WHO Patient Safety Curriculum Guide recommended exploratory approaches such as problem-based learning, it did not provide detailed instructional strategies for each individual competency.⁵ This lack of guidance was later acknowledged by the WHO, which pointed out the need for more specific and practical educational approaches to support implementation.⁴ The present study addressed this gap by providing structured, theory-informed, and contextually adaptable session plans that concretize the WHO framework into reproducible teaching models. These findings extend previous research on patient safety curricula by demonstrating that practical, competency-linked sessions can be both educationally sound and feasible for nationwide implementation.^23,24 Although the models achieved strong consensus among panelists, practical considerations for implementation remain. Addressing these considerations and disseminating them to educational institutions and faculty may facilitate effective adoption of the sessions.

The session plans developed in this study were designed not merely for knowledge transmission but to promote behavioural change and ethical reflection. They also provided students—particularly those unfamiliar with peer learning or reflective practices—with structured exposure to key competencies rarely encountered in traditional curricula.” Activities such as sharing failure experiences and simulating conflict management were effective in reducing psychological barriers to incident reporting and fostering non-technical skills such as empathy and self-reflection.²⁵ These practices contributed to the cultivation of a safety culture and the enhancement of ethical medical behavior. Furthermore, as shared educational resources, the sessions can be adapted to the contextual needs of individual institutions and may contribute to elevating the national standards of patient safety education.⁴ By aligning each session with the Model Core Curriculum and the principles of competency-based medical education, the design ensured coherence between intended learning outcomes, instructional processes, and assessment strategies—an approach consistent with current global standards in medical education.

Table 5. Reported barriers to implementing patient safety learning sessions in this study

Note: No responses were classified under skills

Table 6. Joint Display integrating quantitative CIPP evaluation results with qualitative implementation barriers based on

Steinert’s framework

All quantitative findings met consensus criteria.

Note: Some subthemes, such as 'Difficulty securing curricular slots', have implications for both Input and Context dimensions but are categorized here based on their primary impact.

To enhance content validity, a modified Delphi method involving experts from multiple disciplines was employed during the development of the session plans.²⁶ For instance, the session on human error is well-suited for early-stage learners as part of foundational training in ethics or professionalism, while the sessions on incident reporting and conflict management are appropriate for integration into preclinical curricula. These sessions are also adaptable for post-graduate education, enabling residents to reinforce their non-technical patient safety competencies. The inclusion of multi-professional experts in the Delphi panel enhanced the credibility and transferability of the findings across diverse educational settings. Notably, insufficient teaching competence and shortage of teachers were the most frequently cited barriers, underscoring the critical need for systematic faculty development initiatives. Given that many general risk managers lack experience in curriculum design or active learning facilitation, targeted faculty development should address not only content knowledge but also instructional strategies.²⁷ Developing structured faculty development programs that focus on facilitation, feedback, and assessment techniques could further support effective dissemination of these model sessions. ²⁸

All four session plans were designed for class-room-based delivery and did not include workplace-based learning. This was for two main reasons. First, the timing and structure of workplace-based learning vary significantly across specialties, making standardization difficult.²⁹ Second, current curricula offer limited practical learning opportunities specifically focused on patient safety.^7,30 No barriers related to skills were identified in the qualitative analysis. This aligns with the nature of the patient safety competencies, which focused on cognitive and non-technical domains rather than technical skills used for clinical procedures. Developing patient-safety-oriented clinical rotations remains an important future direction. Future research should explore how these classroom-based sessions can be integrated with simulation-based and work-place-based learning to create a longitudinal learning continuum that strengthens behavioral outcomes in real clinical environments.

Moreover, a key feature of the proposed sessions is the integration of structured learner assessment strategies. In competency-based education, it is essential to assess whether learners can apply acquired skills in real-world practice.³¹ However, assessment of educational effectiveness remains a significant weakness in existing patient safety education.²⁸ By embedding assessment strategies into each session, this model addresses that gap and strengthens both the accountability and practical utility of patient safety instruction. Such embedded assessments can also facilitate program evaluation aligned with the CIPP framework used in this study, thereby linking instructional design and quality improvement in education.

Based on the findings from the qualitative content analysis, several practical considerations emerged regarding the implementation of these sessions in real-world educational contexts. These implementations challenges aligned with barriers identified through content analysis, particularly in the categories of teacher, student, and system. The results clarified limited instructional experience among safety educators and a lack of prior exposure among students to activities such as peer assessment or reflective discussion.^5,32 Structural constraints—such as shortages in teaching staff, absence of formal teaching roles for safety officers, and limited curricular space—also emerged as key concerns. Addressing these multi-level barriers is essential for the sustainable integration of safety education into health professions curricula. For example, a co-facilitation model involving both clinical educators and safety officers, or the development of brief training modules for facilitators, may help overcome structural barriers.³³ Furthermore, it is reported that job descriptions may act as barriers for education in the work-place.³⁴ Aligning the educational responsibilities of general risk managers with their job descriptions could promote more sustainable integration of these sessions into routine educational practice. These findings reinforce the importance of institutional commitment and leadership support for patient safety education, suggesting that organizational culture change must accompany pedagogical innovation to achieve long-term sustainability.³⁵

In some cases, these structural and educational challenges may reflect perceptions towards patient safety management practices. Traditional approaches often emphasise strict procedural compliance and focus on individual deviations. While recent directions in patient safety increasingly integrate insights from safety engineering and cognitive psychology, our findings suggest that some practices may still be rooted in classical, rule-based understandings of safety management.³⁷ Some participants questioned whether conflict management fits within patient safety education. This reflects a common divide between clinical responsibilities for patient safety and the educational roles of safety departments. While patient safety offices often focus on system oversight, they also have a duty to support education that enables safer clinical practice. Teaching conflict management is a prime example. It builds communication and de-escalation skills essential for patient-centered care. By contributing to such educational efforts, patient safety staff help develop future professionals who can act safely and collaboratively in complex clinical environments. At the same time, involvement in undergraduate curriculum offers a valuable lifelong learning opportunity for general risk managers themselves. This dual benefit—educating students while simultaneously enhancing educators’ own reflective practice—illustrates how patient safety education can serve as a platform for mutual professional growth and organizational learning.

This study had several limitations. First, although the validity and feasibility of the session plan were demonstrated based on expert opinions, future studies should verify educational outcomes through practical implementation. Second, a methodological limitation is that the Delphi process concluded in the first round as all items met the strict pre-determined consensus criteria immediately. Consequently, the iterative feedback and re-evaluation loop—a hallmark of the Delphi method—was not utilized, meaning the results reflect initial expert agreement rather than opinion convergence over time. Third, because all panelists were affiliated with university hospitals, the generalizability of the findings to other medical professional education facilities (e.g., junior colleges and vocational schools) is limited. These facilities are often constrained by shorter curricula, which may limit the opportunity to introduce new opportunities for a deeper understanding of patient safety. In addition, this study did not assess long-term retention or behavioral change among learners, which represents a key area for further research. Repeating the cycle of evaluation and design improvement when implementing the sessions proposed in this study is necessary to enhance session quality. Future multi-institutional or longitudinal studies will be necessary to verify transferability and sustainability across different educational contexts. Longitudinal studies that verify behavioral outcomes can support the establishment of evidence-based patient safety learning. Despite these limitations, this study contributes to a replicable and theory-informed model that can inform future curriculum development and strengthen the foundation for patient safety education in Japan and beyond.

This study developed four model session plans for undergraduate patient safety learning in Japan and verified their validity and feasibility through expert evaluations involving general risk managers and faculty members from national university hospitals. All sessions met the consensus criteria in the first evaluation round and were educationally sound. Covering key themes, namely, human error, incident reporting, RCA, and conflict management, the sessions promoted experiential and collaborative learning to support behavioral and attitudinal change. Future practical research should test the sessions’ effectiveness and impact on student behavior, along with efforts to enhance faculty facilitation skills. Longitudinal and multi-institutional evaluations are warranted to confirm the transferability, sustainability, and behavioral outcomes of these sessions in diverse educational contexts. In addition, faculty development programs that strengthen facilitation, feedback, and assessment skills are essential to maximize educational impact and ensure quality implementation. These efforts are expected to support the national adoption and institutionalization of patient safety education. In parallel, the findings from our qualitative analysis indicate that several barriers must be addressed to ensure sustainable implementation. Practical solutions to target identified barriers are expected to support the national adoption and institutionalization of patient safety education.