Involvement of patients to promote patient safety in healthcare facilities in Germany

Patient safety in healthcare has increasingly become the focus of global attention. It is defined as the "avoidance, prevention, and improvement of adverse events or injuries resulting from healthcare processes" (Campbell et al., 2020). At the 74th World Health Assembly (2021), the World Health Organization (WHO) presented a global action plan to prevent health threats and harm to patients arising from healthcare (World Health Organization, 2021). Strategic Goal 4 of this action plan explicitly calls for active patient involvement (PD) in the further development of healthcare. Given the continued significant number of preventable adverse events in medical healthcare, even in Germany, the tenth National Health Goal on Patient Safety was established in 2022 (Holtz & Jonitz, 2023). This goal also calls for the active involvement of patients, their families, or representatives, e.g., through patient-centered care. B. by promoting patient safety competence and supporting patients in their active participation in the development of measures.

>> The health goal is based on the principle that patient safety requires a joint effort of all stakeholders and that patient experiences are important for shaping safe healthcare.
While healthcare professionals rely on structured and learned competencies for safe patient care, patients have lived experiences and can therefore contribute valuable insights to safe and high-quality healthcare (Abid et al., 2021; Bergerum et al., 2020; Canadian Patient Safety Institute, 2018). From the literature, the following patient safety-relevant areas of action in healthcare facilities can be derived that can significantly benefit from patient safety training measures (Ahmadi et al., 2022; Anderson et al., 2022; Holtz & Jonitz, 2023; Sahlström et al., 2016; Saut et al., 2022):
(1) Information: Patient-friendly design of information material for patients (e.g. information sheets for interventions and treatments, explanations of procedures),
(2) Process design and design: Identification of error-promoting influences and causal weaknesses (e.g. lack of communication between different departments),
(3) Accessibility: Identifying problem areas in structural measures (e.g. accessible lifts, including sanitary facilities) and barrier-free design of processes,
(4) Quality assurance and risk management: development and monitoring of quality criteria and objectives.

One of the most frequently cited barriers in the literature is the funding of participatory or collaborative measures (Herrin et al., 2016; Hughes, 2020; Zerbe et al., 2020). Resources such as time, organizational infrastructure, contact persons, and experience are also relevant (APS e. V., 2022). Since many institutions have little experience with HRD, developing and fostering a participatory mindset and a relationship of trust is also necessary (Elsner, 2021; Zerbe et al., 2020).
Framework model: three levels of patient involvement in the strategic promotion of patient safety
Building on a model by Carman et al. (Carman et al., 2013), we propose the following framework for classifying PE measures (Fig. 1):
Each level of engagement brings with it its own advantages and disadvantages, as well as different application possibilities. The goal is not to reach the highest level, but rather to find the appropriate PD method for needs and areas of action (Carman et al., 2013). A flexibly adapted and needs-oriented approach is likely to contribute most to the effective and meaningful engagement of patient safety knowledge (Anderson et al., 2021).
Question
Given the lack of an overview of patient safety measures for strategically promoting patient safety in Germany, in-depth research is necessary. To better leverage patient experiences to effectively identify and address safety risks in healthcare in the future, an evaluation of the current implementation status in Germany is necessary with the following objectives:
(1) Exploration of institutional PE activities carried out in Germany, taking into account the different conditions of different utility sectors.
(2) Development of a preliminary agenda for future research projects and initial recommendations for clinical practice.
methodology
An exploratory, unsystematic online search and analysis of German-language (professional) literature and website information was conducted (Koch et al., 2022). Relevant scientific databases (e.g., PubMed) and search engines (e.g., Google/Scholar) were used for this purpose.
The following terms were used for the online research, among others: patient, interview, survey, questionnaire, perspective, complaint (management), risk (management), quality (assurance), experience, feedback, suggestion (box), praise & criticism, advocates, representatives, participation, involvement, inclusion, exchange, communication, cooperation, expert, dialogue, co-determination, representation, commitment,
Advice, security.
Relevant search results were screened for secondary literature, i.e., the cited literature was screened. In addition, websites of various healthcare institutions (e.g., clinics, doctor's offices) were randomly searched for relevant content.
In addition to the online research described above, we consulted a total of five experts who had practical experience in the areas of patient advocacy, leading a self-help group, and serving on the Federal Joint Committee (G-BA). All research results were structured and processed.
Results
The most commonly established method for incorporating patient experiences as feedback for evaluation and further development in healthcare facilities is through surveys, which are frequently used in the context of quality management (Satzinger, 2002). The goal of a survey can be both to identify problem areas to prioritize (e.g., cleanliness) and to identify concrete ideas and suggestions. It appears that most hospitals have such a survey and have established it as a standard. Patient surveys are significantly less common in outpatient medical practices (Pfaff et al., 2007). Some differences and factors are described for the survey methods (Schmidt et al., 2013):
• Systematics and scope (e.g.: Are the surveys conducted regularly at appropriate intervals or sporadically? Do the surveys cover as diverse patient groups as possible and on an appropriately large scale?)
• Type of survey (e.g., questionnaire or oral interviews? Are questionnaires distributed on-site, mailed, or available online? Are surveys combined?)
• User-friendliness (e.g., are the questions clearly formulated and readable for specific groups of people such as children, seniors, and people with visual impairments?)
• Use of the results (e.g.: Are results publicly accessible? Are results sufficiently evaluated, analyzed, communicated internally and used for further development?).

The praise and complaint management system used by some institutions also involves retrospective information collection and surveys. Patients can provide suggestions and ideas for improvement, but this approach is less proactive (i.e., patients are not actively approached for input, and the design is not systematic and representative).
The next well-established measure in hospitals and clinics is patient advocates. These mostly volunteer and independent advocates fulfill several functions: They act as contact persons, provide emotional support, serve as a link between the facility and patients, and can act as mediators due to their subject-specific and contextual knowledge (Office of the Federal Government Commissioner for Patient Affairs, 2018). Advocates make an important contribution to patient-centered care. However, they are only an effective measure in promoting patient safety and quality improvement under certain circumstances and cases (Hamann et al., 2008). They generally do not work proactively. This creates a kind of filtering effect, so that only the perspectives of those patients who actively report themselves are taken into account. At the same time, patient concerns and feedback can only be utilized if a regular, constructive dialogue between facility management and the advocates is ensured.
The well-established self-help groups and organizations in Germany (Kofahl, 2019), some of which are affiliated with clinical institutions, often have a liaison or other communication channel to the respective clinics or practices. Cooperation between healthcare institutions and self-help groups also offers the potential to utilize the patient experiences gathered and collected there to promote patient safety (Trojan, 2014). However, there is no solid knowledge of the extent to which this actually happens in practice. Patient councils, known internationally as patient advisory boards, are still relatively unestablished in Germany. Such activities were briefly mentioned in our research, but a systematic presentation and cross-institutional description of these patient councils or advisory boards is currently lacking for Germany.
A more detailed presentation of the results can be found in the project report, which is available on the website of the Federal Ministry of Health (Koch et al., 2022).

discussion
What do the results mean with regard to the WHO Patient Safety Action Plan and the National Health Goal for Patient Safety? The measures identified in Germany for involving patients in the strategic promotion of patient safety already partially meet the requirements of the WHO Patient Safety Action Plan and the National Health Goal. Nevertheless, there is a great potential for patient experience and knowledge that is not yet fully utilized.
Further measures are needed to systematically and structuredly consider patient perspectives at the leadership and management levels (e.g., quality management, risk management) in healthcare facilities; also to ensure safe and effective healthcare through cooperative collaboration on equal terms. The active role of patients in strengthening the patient safety culture in Germany, as envisioned in the National Health Goal of Patient Safety, is only partially reflected in the currently implemented measures. In particular, dialogic collaboration between patients or their representatives and healthcare facility staff is rarely realized. Further action is needed here.

Proposals for the agenda for empirical surveys and further research
The results of this research show that – considering the three levels of PD presented in the framework model (Fig. 1) – patient surveys (Level 1) are primarily conducted in clinical and non-clinical settings in Germany. Projects and initiatives for dialogic engagement or even shared leadership (Levels 2 and 3) are far less established (Wild & Weltermann, 2020). At the same time, there are hardly any systematic reports and research studies evaluating existing strategic approaches to PD and patient safety (Bergerum et al., 2019). We therefore propose the following priorities for future surveys in Germany:
(1) In-depth empirical recording of already implemented or planned PE activities and their acceptance by patients, staff and facility management.
(2) Analysis of existing obstacles and barriers and identification of necessary framework conditions and realization potential for PE in the strategic promotion of patient safety.
(3) Evaluation of the effectiveness of PE measures through accompanying health services research in order to generate evidence in everyday in- and out-of-hospital care.
(4) Development of recommendations for practical work in health care facilities to enable the transfer of the knowledge gained and the sustainable establishment of further approaches at all levels of PE.

Limitations of this research and reporting
The overview of PE measures presented here is based on an exploratory and non-systematic online search. Therefore, it cannot be ruled out that individual established projects may not be mentioned here because they could not be covered by this type of research. This also includes measures that were not reported or are currently being planned. Furthermore, future overviews should also address the various stakeholders in the healthcare system (such as those involved in the Federal Joint Committee (G-BA) procedure, quality institutions in the healthcare system, such as the ÄZQ (German Association of Health Insurance Physicians), IQTIG (Institute of Quality Assurance), IQWiG (Institute of Quality Assurance), AWMF (Institute of Medical Sciences and Research), or the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds).

Conclusion
Recognizing and incorporating the patient perspective as an important resource for advancing safe healthcare is essential. Both research and measures to involve patients in the strategic promotion of patient safety in healthcare are still in their infancy compared to Scandinavian and Anglo-American countries. Therefore, the status reported here and an initial systematic approach can serve as a basis for future developments to further strengthen the role of patients and their representatives in the strategic promotion of patient safety in German-speaking healthcare settings.