For systematic development of the intervention, we used the logic model [23] as a structured framework and well-established tool in public health and quality improvement research, facilitating the systematic planning, implementation, and evaluation of interventions by mapping the relationships between inputs, activities, outputs, objectives, results, and goals [24,25]. Specifically, the model guided the derivation of necessary inputs to promote exchange and collaboration between the PFAC and the health care organization through the development of skill acquisition in terms of patient safety and communication among learners. The details of the model were developed iteratively by 2 members of the research team based on problem identification and objectives of the intervention. Figure 1 shows the general process and procedure for developing the P4PS program. This methodological approach ensured a goal-oriented intervention design based on key assumptions and evidence. An overview of the columns of the logic model relevant to the process of intervention development is provided in Table 1. The complete model can be found in Multimedia Appendix 1.

The target group of the P4PS program comprised members of PFACs affiliated with health care organizations. This included representatives of patient-oriented interests (eg, patients, relatives, patient advocates, and representatives of other patient-related organizations) as well as professionals of the health care organization who were responsible for leadership, general management, or administration of the respective PFAC (eg, coordinators and moderators). In line with the intervention’s objective of promoting collaboration between PFACs and health care organizations, program development was additionally geared toward the participation of senior professionals and leaders from collaborating health care organizations, such as senior physicians and head nurses, quality and risk managers, or members of hospital management and board of directors.

Two previous main sources informed the development of the P4PS program in terms of topics and formats: a needs and requirement analysis (a mixed methods study with a Delphi approach) and a literature review on existing educational resources for PFACs; both are reported elsewhere in detail [19]. However, a brief summary of the key findings from both studies is provided in Multimedia Appendix 2 [19].

The mixed methods study with a Delphi approach previously identified PFACs’ needs regarding competencies in patient safety and communication as well as PFAC engagement [19]. This approach ensured a high degree of participation in informing and developing this intervention. According to the continuum of patient engagement outlined by Carman et al [5], it actually achieved “active involvement” of PFAC members. According to the stages of participation described by Wright [26], the degree of participation in this study can be classified as medium, meaning participants had partial decision-making authority. A total of 19 participants from 6 nationwide PFACs took part in the two rounds of surveys, which consisted of (1) interviews and (2) questionnaires. The responses were evaluated descriptively and consensus-oriented (criterion: 85% agreement). The mixed methods analysis was performed sequentially and convergently. Among other findings, the results highlighted the need to address the following: (1) fundamentals of patient safety, error occurrence and error prevention, and knowledge on quality and risk management; (2) support in understanding and defining PFAC roles, responsibilities, and tasks; and (3) precise and clear communication of information, complaints, and problems. In terms of formats of intervention, participants desired a modularized program with theoretical and practical components, delivered online or on-site depending on the topics and organization, with opportunities for partial implementation in their respective settings [19].

To further inform the development of the P4PS program, we previously used peer-reviewed and relevant gray literature from various databases and search engines to conduct a parallel literature search in the form of a rapid scoping review of existing evidence and educational resources on patient safety for PFACs in health care organizations (reported elsewhere in detail). Although the number of the identified sources was limited, 13 articles and sources featuring various formats, content, and topics could be identified [16,27-38]. This information was extracted, and, together with the results of the needs and requirement analysis, used to inform the content and format of the intervention. In addition, other sources, such as previous projects and teaching materials, as well as those from various organizations, were used to generate intervention content [1,39-43].

While the general objectives of the intervention were defined on the basis of the logic model (refer to the Intervention Framework section), the specific learning objectives for the P4PS program on the core topics of patient safety, PFAC engagement, and communication (Textbox 1) were defined based on the taxonomy proposed by Bloom et al [44] and its later revision by Krathwohl [45].

A total of 5 patient safety researchers, consisting of psychologists, health scientists, and a physician, designed and developed the P4PS program. The research team received support from local institutional services (center for human resources development, university computer center, and faculty members), who provided technical and pedagogical advice regarding the digital realization, organization, and structure of the intervention. Finally, the P4PS program was informally reviewed by an external patient representative, whose user-oriented feedback was incorporated iteratively.

The e-learning module was designed based on the objective and core topics developed for the P4PS program (refer to the Content and Format of the Intervention section) with three chapters: (1) fundamentals of patient safety, (2) engagement of PFACs, and (3) communication and dialogue.

The first chapter covered definitions of patient safety and adverse events, key patient safety domains, the significance of the topic (eg, adverse event rates and mismanaged conditions), and the sociotechnical complexities that affect patient safety and contribute to errors. Learners were informed about patients’ rights (eg, World Health Organization Patient Safety Rights Charter) and methods for identifying and reducing errors (eg, Swiss cheese model, standardization, hygiene measures, and critical incident reporting).

The second chapter captured engagement of PFACs and provided basic information on patient engagement (ie, levels of engagement, legal requirements, and practical examples of positive influence of PFAC engagement). Learners were presented with videos and various downloadable content covering internal role understanding, examples of high-functioning PFACs organization and structure, and other materials (eg, meeting minutes, PFAC charter, and orientation manual for new members).

The third chapter focused on communication and dialogue for patient safety and included the Speak Up initiative [46] and communication models that fostered respectful dialogue (eg, 4-side model, nonviolent communication, and sandwich method [47-49]). To improve collaboration between PFACs and health care facilities, 2 frameworks were introduced: the facts, options, risks and benefits, decision, execution, and check (FORDEC) decision-making method [50] and the specific, measurable, attainable, realistic, and time-bound (SMART) goal-setting framework [51]. The FORDEC method was selected due to its potential for team decision support and preplanning of risks and failures in complex situations [52,53]. The SMART method is an established approach that has been successfully applied in various disciplines, including medical education [54-57].

The e-learning module concluded with a practice example that demonstrated how a hospital addressed a patient safety issue related to an error, linking it to the course content. More specifically, in this example, a fictitious PFAC collaborated with hospital management to reduce readmission rates. To this end, they set common goals and design strategies to achieve these goals using the SMART and FORDEC methods, which were introduced in earlier chapters of the e-learning module. The developed strategies included informing patients about the Speak Up initiative and providing them with a logbook to record medication changes, questions, and contact information after discharge. This logbook is made available to learners as a downloadable document.

The e-learning module provided various didactic elements, allowing learners to choose suitable options for obtaining information. Options included audio texts, labeled graphics with extra content, and short videos. Learners also engaged with diagrams, graphs, matching exercises, and scenario-based tasks. The intensity of the content delivered increased over the course of the e-learning module, such that basic information on patient safety was followed by in-depth information on strategies, activities, and tasks to promote the engagement of PFACs in patient safety in health care organizations. Learners received downloadable files with information, checklists, and templates for application to their PFAC. Each topic concluded with a short quiz intended to reinforce learning.

We used Rise 360 software (Articulate Global, LLC) to create the e-learning module. Embedded, self-created videos were generated using Microsoft PowerPoint and edited in the DaVinci Resolve editing program (Blackmagic Design Pty Ltd). Audio tracks were generated using the ElevenLabs’ artificial intelligence Text to Speech software. The final e-learning module [58] has been made available on the home page of the Institute for Patient Safety.

Prior to the introduction of the first chapter, learners received instructions on software management, an overview of topics, learning objectives (Textbox 1), and information on taking breaks.

The e-learning module was designed to be flexible and completed by each learner independently at their own pace. It was accessible via a link and was to be completed before the workshop module (module 2) to aid knowledge retention. It worked on any device (PC, smartphone, tablet, or laptop) with a stable internet connection. A larger device was recommended for better visibility. This module had a duration of approximately 120 minutes.

The activities carried out in the workshop module were based on completion of the previous e-learning module (module 1). The workshop module addressed the individual situation of each PFAC and health care organization as well as the respective circumstances. While the e-learning module provided a theoretical foundation, the workshop module focused on translation and contextualization to locally promote mutual communication and collaborative goal development.

On the basis of the formulated learning objectives (Textbox 1), 4 different activities were performed by the participants during the workshop module:

In the beginning, the moderators introduced the topic with a short presentation outlining the learning objectives (Textbox 1). Learners were then informed about the course of the workshop module and presented reminders on the preceding e-learning module (eg, communication techniques).

All tasks were performed using different methodological approaches (eg, individual assignments, small or whole group tasks, discussions, and short presentations) and different media (eg, interactive queries, working papers, handouts, and flipcharts). Learners were encouraged by the moderators to apply the communication techniques and models presented in the e-learning module (refer to the e-Learning section). Collaborative development and statement or refinements of objectives were carried out by the learners using the FORDEC and SMART methods, learned in the e-learning module (refer to the e-Learning section). Learners receive additional handouts and worksheets for this purpose. A tabular overview of the workshop activities, methodology, and scheduling can be found in Multimedia Appendix 3.

The results of the workshop modules were documented and shared with participants in a summary. The workshop modules were organized as one-time and on-site events that lasted approximately 4 hours.