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.

Applicability and Validity of Second Victim Assessment Instruments among General Practitioners and Healthcare Assistants (SEVID-IX Study).

BACKGROUND: The second victim phenomenon and moral injury are acknowledged entities of psychological harm for healthcare providers. Both pose risks to patients, healthcare workers, and medical institutions, leading to further adverse events, economic burden, and dysfunctionality. Preceding studies in Germany and Austria showed a prevalence of second victim phenomena exceeding 53 percent among physicians, nurses, emergency physicians, and pediatricians. Using two German instruments for assessing moral injury and second victim phenomena, this study aimed to evaluate their feasibility for general practitioners and healthcare assistants. METHODS: We conducted a nationwide anonymous online survey in Germany among general practitioners and healthcare assistants utilizing the SeViD (Second Victims in Deutschland) questionnaire, the German version of the Second Victim Experience and Support Tool Revised Version (G-SVESTR), and the German version of the Moral Injury Symptom and Support Scale for Health Professionals (G-MISS-HP). RESULTS: Out of 108 participants, 67 completed the survey. In G-SVESTR, the collegial support items exhibited lower internal consistency than in prior studies, while all other scales showed good-quality properties. Personality traits, especially neuroticism, negatively correlated to age, seem to play a significant role in symptom count and warrant further evaluation. Multiple linear regression indicated that neuroticism, agreeableness, G-SVESTR, and G-MISS-HP were significant predictors of symptom count. Furthermore, moral injury partially mediated the relationship between second victim experience and symptom count. DISCUSSION: The results demonstrate the feasible use of the questionnaires, except for collegial support. With respect to selection bias and the cross-sectional design of the study, moral injury may be subsequent to the second victim phenomenon, strongly influencing symptom count in retrospect. This aspect should be thoroughly evaluated in future studies.

[17 years of the critical incident reporting and learning system "jeder-fehler-zaehlt.de" for primary care: Analysis of reports]. / 17 Jahre hausärztliches Fehlerberichts- und Lernsystem "jeder-fehler-zaehlt.de" ­ Analyse des Berichtsbestandes.

BACKGROUND: The topic of patient safety has been a subject of much discussion since the end of the last millennium. Ensuring patient safety is a central challenge in health care. An important tool to raise awareness for and learn from adverse events and thus promote patient safety are error-reporting and learning systems (Critical Incident Reporting System = CIRS). METHODS: More than 17 years after its establishment, the CIRS "jeder-fehler-zaehlt.de" (JFZ) for German primary care has undergone a revision in terms of content and technology. The revised web-based system can be used for reporting as well as for classifying and analyzing incident reports. During this process, a descriptive analysis of the current report inventory was carried out, with a focus on serious medication errors. This included all 781 valid incident reports received between September 2004 and December 2021. RESULTS: In 576 of the 781 reports (73.8%), the GP practice was directly involved in the critical incident. Among error types, process errors predominated (79.8% of the classifications, 99.1% of the reports) compared with knowledge and skills errors (20.2% of the classifications, 39.7% of the reports). Communication errors (63.0%) were the most common contributing factor to critical incidents, followed by flaws in tasks and measures (39.7%). Serious and permanent patient harm was rarely reported (8.3% of the reports), whereas temporary patient harm was more common (40.3% of the reports). Incident reports about medication errors with at least serious patient harm included, in particular, substances that affected blood clotting, corticosteroids, and opiates. DISCUSSION: Our results complement the rates that are reported internationally for error types, patient harm, and contributing factors. Serious but preventable adverse events, so-called never events, are frequently associated with the medication process in both JFZ reports and the literature. CONCLUSION: Critical incident reporting systems cannot provide accurate information about the frequency of errors in health care, but they can offer important insights into, for example, serious medication errors. Therefore, they offer both employees and healthcare institutions an opportunity for individual and institutional learning.

[General practitioners' perspectives on the perceived effectiveness of the disease management programs for type 2 diabetes and coronary heart disease: Results of a focus group study]. / Die wahrgenommene Effektivität der Disease Management Programme für Diabetes mellitus Typ 2 und Koronare Herzkrankheit aus Sicht von Hausärzt*innen ­ Ergebnisse einer Fokusgruppenstudie.

BACKGROUND: The majority of patients in disease management programs (DMPs) for type 2 diabetes (T2DM) and coronary heart disease (CHD) in Germany are enrolled by their general practitioner (GP). The aim of this study was, in the context of upcoming DMP expansions, to elicit GPs' current experiences and opinions regarding the perceived effectiveness and acceptance of the DMPs T2DM and CHD, as well as to determine beneficial and hindering aspects of the implementation of these programs from a GP's perspective. METHODS: In August and September 2020, 20 GPs of teaching practices of the University Hospital Cologne with experiences in DMPs were interviewed in semi-structured focus group discussions. Their expectations, attitudes and opinions regarding the DMPs T2DM and CHD were evaluated and analyzed according to the content-structuring qualitative content analysis by Kuckartz. RESULTS: The DMP T2DM was rated as generally positive by the respondents due to the structured treatment including regular foot and eye examinations, close patient contacts and perceptions of improved health outcomes. The DMP CHD was rated more negatively by the respondents because of a high and partly unnecessary documentation workload and limited therapeutic freedom, leading to a perceived ineffectiveness for patients' health outcomes. Thus, there was a discrepancy in the perceived effectiveness of the examined DMPs, causing a lower acceptance of the DMP CHD. Therefore, some of the respondents tended to enroll fewer patients into the DMP CHD or to drop out of the DMP CHD. DISCUSSION: In order to increase the acceptance and sustainability of DMPs some elements of the DMP CHD as well as the remuneration and the documentation need to be reconsidered. Additionally, future studies on the acceptance of DMPs should differentiate between different DMPs in order to generate valid results.

Initial User-Centred Design of an AI-Based Clinical Decision Support System for Primary Care.

A clinical decision support system based on different methods of artificial intelligence (AI) can support the diagnosis of patients with unclear diseases by providing tentative diagnoses as well as proposals for further steps. In a user-centred-design process, we aim to find out how general practitioners envision the user interface of an AI-based clinical decision support system for primary care. A first user-interface prototype was developed using the task model based on user requirements from preliminary work. Five general practitioners evaluated the prototype in two workshops. The discussion of the prototype resulted in categorized suggestions with key messages for further development of the AI-based clinical decision support system, such as the integration of intelligent parameter requests. The early inclusion of different user feedback facilitated the implementation of a user interface for a user-friendly decision support system.

Blackbox error management: how do practices deal with critical incidents in everyday practice? A qualitative interview study.

BACKGROUND: Error management plays a key role in patient safety. It is a systematic approach aimed at identifying and learning from critical incidents by reporting, documenting and analyzing them. Almost nothing is known about the incidents physicians in outpatient care consider to be critical and how they deal with them. We carried out an interview study to explore outpatient physicians' views on error management, discover what they regard as critical incidents, and find out how error management is put into practice in ambulatory care. METHODS: We conducted 72 semi-structured interviews with physicians from ambulatory practices. We asked participants what they considered to be a critical incident, how they reacted following an incident, how they discussed incidents with their coworkers, and whether they used critical incident reporting systems. The interviews were transcribed verbatim and analyzed using qualitative content analysis. RESULTS: Interviewed physicians defined the term "critical incident" differently. Most participants reported that they recorded information on incidents and discussed them in their teams. Several physicians reported taking a 'pay better attention next time-approach' to the analysis of incidents. Systematic error management involving incident documentation, analysis, preventive measure development, and follow-up, was the exception. CONCLUSIONS: To promote error management, medical training should include teaching on the topic, so that medical professionals can learn about critical incidents and how to deal with them in an open and structured manner. This would help establish the culture of safety that has long been called for internationally.

Evaluation of Patient-Reported Outcomes in Patients with Relapsing Multiple Sclerosis Treated with Cladribine Tablets in the CLAWIR Study: 12-Month Interim Analysis.

INTRODUCTION: Patient-reported outcomes (PROs) provide an insightful method of assessing the subjective impact of therapies for those affected by multiple sclerosis (MS), a chronic neurologic disease notable for symptoms of fatigue and reduced physical function. The ongoing CLAWIR study aims to assess the effect of cladribine tablets (3.5 mg/kg cumulative dose over 2 years) in patients with highly active relapsing MS focusing on PROs of fatigue, physical function, treatment satisfaction, and work productivity. Here, we report on a pre-planned analysis at 12 months after treatment initiation with cladribine tablets. METHODS: CLAWIR is a 2-year, multicenter, prospective, observational study of patients with relapsing MS newly initiating cladribine tablets. The following PROs were analyzed: PRO Measurement Information System (PROMIS®) Fatigue MS (v1.0) and Physical Function MS (v2.1), Treatment Satisfaction Questionnaire for Medication (TSQM, v1.4), and Work Productivity and Activity Impairment MS Questionnaire (WPAI-MS). Data were analyzed descriptively. RESULTS: In total, 128 patients were eligible for analysis: 95 females (74.2%); median (range) age 34.5 (29, 44) years; 34 patients (26.6%) were treatment-naïve, and 89 (69.5%) were early switchers from platform therapies (the remaining 5 patients [3.9%] switched from a high-efficacy disease-modifying therapy). PROMIS® Fatigue MS mean (± standard deviation [SD]) T-scores decreased from 54.6 (± 9.59) at baseline to 51.8 (± 10.30) at 12 months, indicating an alleviation of fatigue, whereas PROMIS® Physical Function MS mean T-scores remained stable over time [baseline: 49.4 (± 10.69); 12 months: 50.3 (± 10.88)]. TSQM v1.4 mean scores indicated an improvement over time, increasing from 52.2 (± 27.79) at baseline to 81.4 (± 17.06) at 12 months for global satisfaction. WPAI-MS scores also showed an improvement across all four domains over 12 months. CONCLUSION: This real-world study demonstrates the effect of cladribine tablets over 12 months on PROs of fatigue, physical function, treatment satisfaction, and work productivity. TRIAL REGISTRATION: The CLAWIR study is registered at the German Federal Institute for Drugs and Medical Devices with the internal NIS number 7469.

Are people interested in receiving advice from their general practitioner on how to protect their health during heatwaves? A survey of the German population.

OBJECTIVE: Climate change increases the frequency, intensity and length of heatwaves, which puts a particular strain on the health of vulnerable population groups. General practitioners (GPs) could reach these people and provide advice on protective health behaviour against heat. Data is lacking on whether and what topic of GP advice people are interested in, and whether specific person characteristics are associated with such interests. DESIGN: Cross-sectional, nationwide, face-to-face household survey, conducted during winter 2022/2023. SETTING: Germany. PARTICIPANTS: Population-based sample of 4212 respondents (aged 14-96 years), selected by using multistratified random sampling (50%) combined with multiquota sampling (50%). MAIN OUTCOME MEASURE: Interest in receiving GP advice on health protection during heatwaves (yes/no), and the topic people find most important (advice on drinking behaviour, nutrition, cooling, cooling rooms, physical activity or medication management). Associations between predefined person characteristics and the likelihood of interest were estimated using adjusted logistic regressions. RESULTS: A total of 4020 respondents had GP contact and provided data on the outcome measure. Of these, 23% (95% CI=22% to 25%) expressed interest in GP advice. The likelihood of expressing interest was positively associated with being female, older age (particularly those aged 75+ years: 38% were interested), having a lower level of educational attainment, having a migration background, living in a more urban area, and living in a single-person household. It was negatively associated with increasing income. Advice on medication management received highest interest (25%). CONCLUSIONS: During winter season 2022/2023, around one quarter of the German population with GP contact-and around 40% of those aged 75+ years-was estimated to have a stated interest in receiving GP advice on protective health behaviour during heatwaves, especially on medication management. Climate change is creating new demands for healthcare provision in general practice. This study provides initial relevant information for research and practice aiming to address these demands.

Requirements analysis for an AI-based clinical decision support system for general practitioners: a user-centered design process.

BACKGROUND: As the first point of contact for patients with health issues, general practitioners (GPs) are frequently confronted with patients presenting with non-specific symptoms of unclear origin. This can result in delayed, prolonged or false diagnoses. To accelerate and improve the diagnosis of diseases, clinical decision support systems would appear to be an appropriate tool. The objective of the project 'Smart physician portal for patients with unclear disease' (SATURN) is to employ a user-centered design process based on the requirements analysis presented in this paper to develop an artificial Intelligence (AI)-based diagnosis support system that specifically addresses the needs of German GPs. METHODS: Requirements analysis for a GP-specific diagnosis support system was conducted in an iterative process with five GPs. First, interviews were conducted to analyze current workflows and the use of digital applications in cases of diagnostic uncertainty (as-is situation). Second, we focused on collecting and prioritizing tasks to be performed by an ideal smart physician portal (to-be situation) in a workshop. We then developed a task model with corresponding user requirements. RESULTS: Numerous GP-specific user requirements were identified concerning the tasks and subtasks: performing data entry (open system, enter patient data), reviewing results (receiving and evaluating results), discussing results (with patients and colleagues), scheduling further diagnostic procedures, referring to specialists (select, contact, make appointments), and case closure. Suggested features particularly concerned the process of screening and assessing results: e.g., the system should focus more on atypical patterns of common diseases than on rare diseases only, display probabilities of differential diagnoses, ensure sources and results are transparent, and mark diagnoses that have already been ruled out. Moreover, establishing a means of using the platform to communicate with colleagues and transferring patient data directly from electronic patient records to the system was strongly recommended. CONCLUSIONS: Essential user requirements to be considered in the development and design of a diagnosis system for primary care could be derived from the analysis. They form the basis for mockup-development and system engineering.

From niche topic to inclusion in the curriculum - design and evaluation of the elective course "climate change and health".

Objective: At the Medical Faculty of the Goethe University Frankfurt am Main, the elective course "climate change and health" was offered to students in the clinical phase of their medical studies for the first time in the winter semester 2021/22 (any unfilled places were made available to interested students studying other subjects). Despite attracting considerable attention, this topic has not yet been incorporated into the curriculum of medical studies. Our aim was therefore to teach students about climate change and discuss its effects on human health. The students evaluated the elective in terms of various factors relating to knowledge, attitudes and behavior. Project description: The elective focused on the concept of Planetary Health, with an emphasis on the health consequences of climate change, as well as possibilities for action and adaptation in clinical and practical settings. The course took place in three live, online sessions (with inputs, discussion, case studies and work in small groups), as well as online preparation and a final written assignment for which students were asked to reflect on the subject. The standardized teaching evaluation questionnaire (=didactic dimension) of Goethe University was used online to evaluate the elective, whereby the questionnaire was extended to include the measurement of changes in students' agreement with items (dimensions) relating to knowledge, attitudes and behavior (personal behavior and behavior as physicians) before and after the course (pre/post comparison). Results: Students expressed high levels of satisfaction with the course content, the presentation of the course, and the organization of the elective. This was reflected in very good to good overall ratings. The pre/post comparisons further showed a significant, positive shift in agreement ratings in almost all dimensions. The majority of respondents also wanted the topic to be firmly embedded in the medical curriculum. Conclusion: The evaluation shows that with respect to the impact of climate change on human health, the elective course had a clear influence on the knowledge, attitudes, and behaviors of the students. In view of the relevance of the topic, it is therefore important that this subject is included in medical curricula in the future.

Complex implementation mechanisms in primary care: do physicians' beliefs about the effectiveness of innovation play a mediating role? Applying a realist inquiry and structural equation modeling approach in a formative evaluation study.

BACKGROUND: The adoption of digital health technologies can improve the quality of care for polypharmacy patients, if the underlying complex implementation mechanisms are better understood. Context effects play a critical role in relation to implementation mechanisms. In primary care research, evidence on the effects of context in the adoption of digital innovation for polypharmacy management is lacking. STUDY AIM: This study aims to identify contextual factors relevant to physician behavior and how they might mediate the adoption process. METHODS: The physicians who participated in this formative evaluation study (n = 218) were part of the intervention group in a cluster-randomized controlled trial (AdAM). The intervention group implemented a digital innovation for clinical decision making in polypharmacy. A three-step methodological approach was used: (1) a realist inquiry approach, which involves the description of a context-mechanism-outcome configuration for the primary care setting; (2) a belief elicitation approach, which involves qualitative content analysis and the development of a quantitative latent contextualized scale; and (3) a mediation analysis using structural equation modeling (SEM) based on quantitative survey data from physicians to assess the mediating role of the contextualized scale (n = 179). RESULTS: The key dimensions of a (1) context-mechanism-outcome model were mapped and refined. A (2) latent construct of the physicians' innovation beliefs related to the effectiveness of polypharmacy management practices was identified. Innovation beliefs play a (3) mediating role between the organizational readiness to implement change (p < 0.01) and the desired behavioral intent of physicians to adopt digital innovation (p < 0.01; R2 = 0.645). Our contextualized model estimated significant mediation, with a relative size of 38% for the mediation effect. Overall, the model demonstrated good fit indices (CFI = 0.985, RMSEA = 0.034). CONCLUSION: Physician adoption is directly affected by the readiness of primary care organizations for the implementation of change. In addition, the mediation analysis revealed that this relationship is indirectly influenced by primary care physicians' beliefs regarding the effectiveness of digital innovation. Both individual physician beliefs and practice organizational capacity could be equally prioritized in developing implementation strategies. The methodological approach used is suitable for the evaluation of complex implementation mechanisms. It has been proven to be an advantageous approach for formative evaluation. TRIAL REGISTRATION: NCT03430336 . First registration: 12/02/2018. CLINICALTRIALS: gov.

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.

[Implementing a secure instant messaging app in the COVID-19 pandemic: Usage experiences of primary care physicians and local health authorities]. / Implementierung einer Secure Instant Messaging-App in der COVID-19 Pandemie: Nutzungserfahrungen von Hausärzt*innen und Mitarbeiter*innen von Gesundheitsämtern.

BACKGROUND: At the onset of the COVID-19 pandemic general practitioners complained about feeling uninformed and lacking a sufficient flow of information from the local health authorities. Secure instant messaging describes a digital, chat-based form of communication enabling ambulatory care providers to connect in real-time and share information across medial sectors. KomPan, a proof-of-concept study, established a secure instant messaging structure in two model regions in Germany to improve communication between general practitioners and local health authorities via an additional communication pathway. This paper presents results of a qualitative user survey. METHODS: We recruited general practitioners (n = 43) and staff of local health authorities (n=10) in two Hessian model regions for using the secure instant messaging (SIM) app of the Famedly GmbH, starting in December 2020 (2nd COVID-19 wave). We asked participants to share their usage experiences after a usage time of multiple months. In guided telephone interviews, we primarily asked how communication between the two user groups had changed while using secure instant messaging. The interviews were transcribed verbatim and analysed using thematic analysis. RESULTS: We conducted ten interviews with general practitioners and two with staff of the participating local health authorities. Using our SIM-based platform promoted professional exchange between general practitioners. In contrast, the app had little impact on communication between local health authorities and general practitioners. Opposing expectations and usage patterns of the two user groups, among other reasons, probably led to a reduced direct trans-sectoral communication via secure instant messaging. CONCLUSION: Establishing local chat groups for general practitioners was welcomed, especially during the pandemic situation, to improve professional exchange while experiencing challenging working conditions. To use secure instant messaging effectively for trans-sectoral communication a more comprehensive approach seems to be needed, such as digitalisation of institutional communication structures and improved networks of local healthcare providers.

Providing an interactive undergraduate elective on safety culture online - concept and evaluation.

BACKGROUND: The COVID-19 pandemic has made it more difficult to maintain high quality in medical education. As online formats are often considered unsuitable, interactive workshops and seminars have particularly often been postponed or cancelled. To meet the challenge, we converted an existing interactive undergraduate elective on safety culture into an online event. In this article, we describe the conceptualization and evaluation of the elective. METHODS: The learning objectives of the safety culture elective remained unchanged, but the teaching methods were thoroughly revised and adapted to suit an online setting. The online elective was offered as a synchronous two-day course in winter semester 2020/21 during the "second wave" of the COVID-19 pandemic in Germany. At the end of each day, participating students evaluated the elective by completing an online survey. Items were rated on a six-point Likert scale. We used SPSS for data analysis. RESULTS: Twenty medical undergraduates completed the elective and rated it extremely positively (1.1 ± 0.2). Students regard safety culture as very important and felt the learning objectives had been achieved. Moreover, they were very satisfied with the design and content of the elective, and especially with interactive elements like role-play. Around 55% of participants would recommend continuing to offer the online elective after the pandemic. CONCLUSIONS: It makes sense to offer undergraduate medical students online elective courses on safety culture, especially during a pandemic. The elective described here can serve as a best practice example of how to teach safety culture to undergraduates, especially when physical presence is unfeasible. Electives requiring a high degree of interaction can also function well online.

A scoping review of mHealth monitoring of pediatric bronchial asthma before and during COVID-19 pandemic.

Mobile (m) Health technology is well-suited for Remote Patient Monitoring (RPM) in a patient's habitual environment. In recent years there have been fast-paced developments in mHealth-enabled pediatric RPM, especially during the COVID-19 pandemic, necessitating evidence synthesis. To this end, we conducted a scoping review of clinical trials that had utilized mHealth-enabled RPM of pediatric asthma. MEDLINE, Embase and Web of Science were searched from September 1, 2016 through August 31, 2021. Our scoping review identified 25 publications that utilized synchronous and asynchronous mHealth-enabled RPM in pediatric asthma, either involving mobile applications or via individual devices. The last three years has seen the development of evidence-based, multidisciplinary, and participatory mHealth interventions. The quality of the studies has been improving, such that 40% of included study reports were randomized controlled trials. In conclusion, there exists high-quality evidence on mHealth-enabled RPM in pediatric asthma, warranting future systematic reviews and/or meta-analyses of the benefits of such RPM.