Supporting Error Management and Safety Climate in Ambulatory Care Practices: The CIRSforte Study.

BACKGROUND: To improve patient safety, it is important that healthcare facilities learn from critical incidents. Tools such as reporting and learning systems and team meetings structure error management and promote learning from incidents. To enhance error management in ambulatory care practices, it is important to promote a climate of safety and ensure personnel share views on safety policies and procedures. In contrast to the hospital sector, little research has been dedicated to developing feasible approaches to supporting error management and safety climate in ambulatory care. In this study, we developed, implemented, and evaluated a multicomponent intervention to address how error management and safety climate can be improved in ambulatory care practices. METHODS: In a prospective 1-group pretest-posttest implementation study, we sought to encourage teams in German ambulatory practices to use proven methods such as guidelines, workshops, e-learning, (online) meetings, and e-mail newsletters. A pretest-posttest questionnaire was used to evaluate level and strength of safety climate and psychological behavioral determinants for systematic error management. Using 3 short surveys, we also assessed the state of error management in the participating practices. In semistructured interviews, we asked participants for their views on our intervention measures. RESULTS: Overall, 184 ambulatory care practices nationwide agreed to participate. Level of safety climate and safety climate strength (rwg) improved significantly. Of psychological behavioral determinants, significant improvements could be seen in "action/coping planning" and "action control." Seventy-six percent of practices implemented a new reporting and learning system or modified their existing system. The exchange of information between practices also increased over time. Interviews showed that the introductory workshop and provided materials such as report forms or instructions for team meetings were regarded as helpful. CONCLUSIONS: A significant improvement in safety climate level and strength, as well as participants' knowledge of how to analyze critical incidents, derive preventive measures and develop concrete plans suggest that it is important to train practice teams, to provide practical tips and tools, and to facilitate the exchange of information between practices. Future randomized and controlled intervention trials should confirm the effectiveness of our multicomponent intervention.Trial registration: Retrospectively registered on 18. November 2019 in German Clinical Trials Register No. DRKS00019053.

Strength of Safety Measures Introduced by Medical Practices to Prevent a Recurrence of Patient Safety Incidents: An Observational Study.

OBJECTIVE: The aim of this study was to analyze the strength of safety measures described in incident reports in outpatient care. METHODS: An incident reporting project in German outpatient care included 184 medical practices with differing fields of specialization. The practices were invited to submit anonymous incident reports to the project team 3 times for 17 months. Using a 14-item coding scheme based on international recommendations, we deductively coded the incident reports and safety measures. Safety measures were classified as "strong" (likely to be effective and sustainable), "intermediate" (possibly effective and sustainable), or "weak" (less likely to be effective and sustainable). RESULTS: The practices submitted 245 incident reports. In 160 of them, 243 preventive measures were described, or an average of 1.5 per report. The number of documented measures varied from 1 in 67% to 4 in 5% of them. Four preventive measures (2%) were classified as strong, 37 (15%) as intermediate, and 202 (83%) as weak. The most frequently mentioned measures were "new procedure/policy" (n = 121) and "information/notification/warning" (n = 45). CONCLUSIONS: The study provides examples of critical incidents in medical practices and for the first time examines the strength of ensuing measures introduced in outpatient care. Overall, the proportion of weak measures is (too) high, indicating that practices need more support in identifying strong measures.

Moving towards patient-centered care and shared decision-making in Germany.

The main focus of this paper is to describe the development and current state of policy, research and implementation of patient-centered care (PCC) and shared decision-making (SDM) in Germany. What is the current state in health policy? Since 2013, the Law on Patients' Rights has standardized all rights and responsibilities regarding medical care for patients in Germany. This comprises the right to informed decisions, comprehensive and comprehensible information, and decisions based on a clinician-patient partnership. In addition, reports and action plans such as the German Ethics Council's report on patient well-being, the National Health Literacy Action Plan, or the National Cancer Plan emphasize and foster PCC and SDM on a policy level. There are a number of public organizations in Germany that support PCC and SDM. How are patients and the public involved in health policy and research? Publishers and funding agencies increasingly demand patient and public involvement. Numerous initiatives and organizations are involved in publicizing ways to engage patients and the public. Also, an increasing number of public and research institutions have established patient advisory boards. How is PCC and SDM taught? Great progress has been made in introducing SDM into the curricula of medical schools and other health care providers' (HCPs) schools (e.g., nursing, physical therapy). What is the German research agenda? The German government and other public institutions have constantly funded research programs in which PCC and SDM are important topics. This yielded several large-scale funding initiatives and helped to develop SDM training programs for HCPs in different fields of health care and information materials. Recently, two implementation studies on SDM have been conducted. What is the current uptake of PCC and SDM in routine care, and what implementation efforts are underway? Compared to the last country report from 2017, PCC and SDM efforts in policy, research and education have been intensified. However, many steps are still needed to reliably implement SDM in routine care in Germany. Specifically, the further development and uptake of decision tools and countrywide SDM trainings for HCPs require further efforts. Nevertheless, an increasing number of decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care. Also, recent implementation efforts are promising. For example, reimbursement by health insurance companies of hospital-wide SDM implementation is being piloted. A necessary next step is to nationally coordinate the gathering and provision of the many PCC and SDM resources available.

[Patient perspectives on patient safety: Results of a population-based survey in Germany]. / Subjektive Informiertheit von Patient*innen zum Thema Patientensicherheit: Ergebnisse einer Bevölkerungsbefragung in Deutschland.

INTRODUCTION: The growing number of people with multimorbidity and polypharmacy in Germany has led to increasing complexity in health care and risks to patient safety. A high priority should therefore be placed on identifying and preventing avoidable adverse events. The patient perspective plays an important role in improving patient safety. In this study, we conducted a representative, population-based survey of knowledge, perceptions and experiences of patient safety, especially of subjectively experienced errors in health care. Our aim was, in particular, to assess patient safety from the patients' point of view, and to analyze differences in assessments of risk and preventability between persons that felt well or poorly informed about patient safety topics. METHODS: In 2019, computer-assisted telephone interviews were conducted nationwide as part of the "TK-Monitor Patient Safety" project. Recruitment was carried out by using multistage selection and forming a stratified random sample. Adults (18 years and older) with sufficient knowledge of German were included. The survey was conducted using a structured guideline containing 21 questions concerning perceptions and experiences of patient safety, and 12 questions on sociodemographic factors. The results were analyzed both descriptively and using inferential statistical methods. RESULTS: Of a total of 1,000 respondents (51% female), approx. half (52%) were gainfully employed, and 57% rated their state of health as "very good" or "good". The patients regarded data protection, medication errors, hospital infections and diagnostic (un)certainty as of major relevance to patient safety. Overall, 55% of the respondents rated their knowledge of patient safety as "very good" or "good". The results showed that subjective knowledge was negatively associated with important outcome parameters such as having experience of medication errors or suspecting errors had been made in a medical examination or treatment. Patients that considered themselves well-informed also reckoned they could contribute towards increasing safety in health care. DISCUSSION: The respondents considered diagnostic uncertainty to be one of the greatest risks to their person. This shows that they recognized a need for further information and felt this need was inadequately satisfied in the German research landscape. With regard to the correlation between subjective knowledge and outcome parameters, it is also necessary to analyze whether the respondents' subjective knowledge reflects their actual knowledge, as this would be necessary for preventive measures to be effective. This question will be the subject of further studies. CONCLUSION: The patient perspective is an important addition to the study of the safety of medical care in Germany. Factors influencing subjective knowledge should be investigated. Furthermore, regular surveys would be desirable in order to gain greater insight into the topic.

The long way of implementing patient-centered care and shared decision making in Germany.

The main focus of the paper is on the description of the development and current state of research and implementation of patient-centered care (PCC) and shared decision making (SDM) after fifteen years of substantial advances in health policy and health services research. What is the current state of SDM in health policy? The "Patients' Rights Act" from 2013 standardizes all rights and responsibilities within the framework of medical treatment for German citizens and legal residents. This comprises the right to informed decisions, comprehensive and comprehensible information for patients, and decisions based on a clinician-patient-partnership. What is the current state of SDM interventions and patient decision support tools? SDM training programs for healthcare professionals have been developed. Their implementation in medical schools has been successful. Several decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care, specifically for national cancer screening programs. What is the current state of research and routine implementation? The German government and other public institutions are constantly funding research programs in which patient-centered care and shared decision-making are important topics. The development and implementation of decision tools for patients and professionals as well as the implementation of CME trainings for healthcare professionals require future efforts. What does the future look like? With the support of health policy and scientific evidence, transfer of PCC and SDM to practice is regarded as meaningful. Research can help to assess barriers, facilitators, and needs, and subsequently to develop and evaluate corresponding strategies to successfully implement PCC and SDM in routine care, which remains challenging.

[jeder-fehler-zaehlt.de: Content of and prospective benefits from a critical incident reporting and learning system (CIRS) for primary care]. / Das hausärztliche Fehlerberichts- und Lernsystem 'jeder-fehler-zaehlt.de' - Berichtsbestand und Nutzungsperspektiven.

Critical incident reporting and learning systems (CIRS) have been recommended as an instrument to promote patient safety for a long time. However, both their scientific value and their actual impact have been disputed. The nationwide German CIRS for primary care has been in operation since September 2004. Incident reports are available online, and the question is how to make use of this large database to promote patient safety. A descriptive analysis of the content was performed, classifying, in particular, types of error and contributing factors. Its usage is presented for the period from 2004 to 2013 where a total of 483 complete reports have been recorded. Their severity ranges from 35.6 % with no tangible harm to patients to 14.6 % with important harm (or errors contributing to mortality). The majority of them (74.2 %) were process errors, compared to 25.8 % knowledge/skills errors. The main areas involved were treatment/medication (54.2 %) and diagnosis/tests (16.4 %). The results of the analysis of the CIRS cannot be used as an epidemiological data source. And yet they will generate hypotheses for further research in the field of patient safety. Moreover, they will enable practice teams to make themselves familiar with and learn from critical incident analysis. In spite of the specific difficulties in ambulatory care, CIRS should be promoted in this sector to enable learning. Participation in CIRS can be increased by enhanced feedback.

Replacement of endoprosthetic implants within a two years follow-up period: a statutory health insurance routine data analysis.

BACKGROUND: The statutory health insurance system embodies a large amount of data on the treatments of their members. Depending on joint, prosthesis type, patient activity and comorbidity, knee and hip replacements can last up to 20 years. Based on statutory health insurance data the main object of this analysis was to investigate how high the early revision rate of replacements actually is. METHODS: The number of replacements in the years 2005 and 2006 has been extracted from the TK database for hip (OPS-Code 5-820, n = 20,875), knee (OPS 5-822, n = 13,466), upper limbs (OPS 5-824, n = 901), and lower limbs (OPS 5-826) replacements. This data has then been related to each consecutive operation (i. e. change or excision of joint endoprosthesis) over a joint-specific observation period of two years. RESULTS: In 3.7% of the cases joint replacements stood for less than 2 years (hip 3.5%, knee 3.8%, upper limbs 6.5%, and lower limbs 5.5%). There is a significantly positive correlation between the treatment data of the hospitals and the outcome as to low rates of reoperations at early stages. The main reason for short lifetime (76 - 81%) is mechanical failure. CONCLUSION: The percentage of joint endoprostheses with significantly short lifetimes has been unexpectedly high. The de facto lifetimes of joint endoprostheses thus often do not match the manufacturers' information. The authors strongly support the idea of a national endoprosthesis register as such a register could give detailed information on firstly whether these deficits are due to material defects, osteolysis or dislocation and secondly which products are mainly affected.

Patient participation and shared decision making in Germany - history, agents and current transfer to practice.

The main focus of the present paper is to describe 1) the healthcare system specific influences on patient participation in medical decision making and 2) the current state of research and implementation of shared decision making (SDM) after ten years of substantial advances in health policy and research in this field. WHAT ABOUT POLICY REGARDING SDM? The "Medical Patients Rights Act" is to standardise all the rights and responsibilities within the scope of medical treatment. This also comprises the right to informed decisions, comprehensive and comprehensible information for patients, and decisions based on the partnership of clinicians and patients. WHAT ABOUT TOOLS - DECISION SUPPORT FOR PATIENTS? SDM training programmes for healthcare professionals have been developed and partly implemented. Several decision support interventions - primarily with support from health insurance funds - have been developed and evaluated. WHAT ABOUT PROFESSIONAL INTEREST AND IMPLEMENTATION? Against the background of the German health policy's endorsement of patient participation, the German government and other public institutions are currently funding different research programmes in which shared decision making is playing a substantial role. The development and implementation of decision support tools for patients and professionals as well as the implementation of trainings for healthcare professionals require stronger efforts. WHAT DOES THE FUTURE LOOK LIKE? With the support of health policy and with the utilisation of scientific evidence, the transfer of shared decision making into practice is considered to be meaningful in the German healthcare system. The translation into routine care will remain an important task for the future.

[Medical centers--from a Statutory Health Insurance Company's perspective]. / Medizinische Zentren--Anforderungen aus Sicht der GKV.

In the course of recent activities involving the bundling of healthcare institutions into so-called "Centers", many kinds of Healthcare Centers, Breast Centers, Comprehensive Cancer Centers etc. have been established. The term "Center" suggests expertise and superiority, and, without doubt, centers take medical care closer to higher quality and cost efficiency at the same time. However, there are preconditions which need to be fulfilled, such as the compliance with certain structural and process-oriented criteria in patient care. From the perspective of the compulsory health insurance funds, this raises questions regarding the type of centers that should be supported, the requirements that must be met, and the role that centers are assigned within the complex of our healthcare system. For health insurance purposes, Medical Centers provide innovative structural conditions for group-balanced concepts. Since the Statutory Health Insurance System Modernization Act (GKV-Modernisierungsgesetz and 140 a ff. SGB V) has provided individual contract options and inpatient oriented institutions have opened up to offer highly specialized ambulatory treatment (and 116b SGB V), centers have become attractive contractual partners for health insurance companies. The present article describes expectations and requirements in relation to the formation of Medical Centers from the perspective of a compulsory health insurance company, focusing on oncological centers.