Development and validation of a short clinical risk management implementation (Short CRiMI) questionnaire.

Clinical Risk Management (CRM) is an important instrument to continuously improve safety of health care delivery. In Germany, hospitals are required by law to implement CRM and incidence reporting systems. Since 2010, nation-wide surveys have been conducted periodically to evaluate implementation of CRM in hospitals. The instrument used in these surveys is constantly being updated to reflect previous experiences, as well as to adapt to ongoing trends and developments in CRM practices. The survey instrument used in 2022 consisted of up to 200 items and took up to an hour to complete. In this study, we aimed to develop a short instrument to measure the level of CRM implementation in hospitals, evaluate its psychometric properties, and to offer benchmarking data for health care facilities of different sizes. We used data collected in 2022 as part of KHaSiMiR study, employing a cross-sectional self-reported online survey. The hospital administrations were invited to designate one CRM manager to participate in the study. Out of 1,411 general hospitals invited, 401 responses were collected (response rate of 28%). After removing the cases with excessive missings, we imputed remaining missing values using multiple imputation, and split the resulting sample (n=362) in two halves (i.e., exploratory and testing subsamples). A principal component analysis was applied on the first subsample. We validated the resulting model using confirmatory factor analysis in the testing subsample. We evaluated internal consistency, and tested external validity of the established instrument using correlation analysis with two single-item measures: subjective evaluation of CRM implementation compared to similar organizations and compared to own ideal level. The principal component analysis included 45 items from the full instrument. The analysis resulted in a three-factor model with 26 items. In the confirmatory factor analysis, the model demonstrated acceptable fit with the data according to the commonly used fit indices: Chi2/df=1.36, CFI=0.941, TLI=0.930, RMSEA=0.045 (90% CI=0.032-0.056), SRMR=0.049. Cronbach's alpha of all three factors was good (>0.70). All three factors had statistically significant positive correlations with each other (0.359-0.497) and with the two single items (0.282-0.532). None of the correlations were high enough (>0.7) to indicate multicollinearity. The proposed short clinical risk management implementation (Short CRiMI) questionnaire is psychometrically valid and can be used to rapidly evaluate CRM implementation in hospitals. Further research can provide evidence of its external validity and association with quality and safety outcomes. Benchmarking data can be used to compare the results with the data from the most recent Germany-wide survey.

[Discharge management strategies in German general hospitals : A nationwide survey of professionals responsible for clinical risk management]. / Strategien des Entlassmanagements in deutschen Allgemeinkrankenhäusern : Deutschlandweite Befragung von Verantwortlichen des klinischen Risikomanagements.

BACKGROUND: Transitions from inpatient care are associated with risks for the safety of patients. In 2017, the framework agreement on discharge management was legally defined. There is currently a lack of empirical data in Germany on the implementation of measures to ensure safe transitions of patients after inpatient care. The aim of this study is to provide an overview of the discharge management strategies implemented by German general hospitals. METHODS: Between March and May 2022, specific discharge management strategies as well as structural and organizational characteristics were assessed in a nationwide survey of 401 general hospitals, and descriptive statistics and group comparisons were performed. RESULTS: Seven of nine strategies surveyed were implemented in > 95% of all hospitals. The evaluation of discharge planning was only implemented in 61% of the hospitals, and systematic documentation, analysis, and evaluation of readmissions in 54%. Hospitals with a higher number of hospital beds reported significantly less often about "early contact with follow-up care providers" and "organization of a seamless transition to follow-up care." DISCUSSION: A large part of the strategies in discharge management from inpatient treatment is implemented in German general hospitals. However, measures for evaluation and the systematic analysis of discharge processes and readmissions of patients have only been partially implemented. However, these are necessary to systematically evaluate and potentially improve the discharge processes.

[Loss of information in cross-sectoral treatment: causes and solutions]. / Informationsverluste bei sektorübergreifender Behandlung: Ursachen und Lösungen.

Missing information on patients and their medication is a leading cause of medication errors and preventable harm. The TOP Projects uses pharmacy claim data and electronic decision support to improve quality and safety of care on hospital admission. In a survey 100 % of responding hospitals in Germany consider this approach helpful and important to improve availability of necessary information and medication safety and to reduce workload.

[The G-BA innovation fund's project "Avenue-Pal" - analysis and improvement of cross-sectoral and cross-departmental interface and relocation management in palliative care]. / Das G-BA-Innovationsfonds-Projekt "Avenue-Pal" : Analyse und Verbesserung des sektor- und bereichsübergreifenden Schnittstellen- und Verlegungsmanagements in der Palliativversorgung.

BACKGROUND: About 80% of all people in Germany die in inpatient care. Around every fifth person in inpatient care is relocated to another care area in the last phase of their life. That is more than 150,000 people being relocated, often without indication. 13 risk factors were identified for these non-indicated relocations. METHOD: With the support of the AWMF, two regionally effective guidelines were developed and implemented in a maximum care hospital and a care facility. A palliative consultation service has been established in the university hospital. Comprehensive personnel and organizational development was carried out in the care facility. Different collaborations with relevant regional partners of both model institutions were systematically expanded. RESULTS AND CONCLUSIONS: The relocations could be significantly reduced despite the short duration of the project. This was also possible through the establishment of decision-making aids and digital implementation support. The results of the accompanying ethical and social research justify the procedure: There is an increase in the satisfaction of relatives and employees.

Cluster-randomised trial evaluating a complex intervention to improve mental health and well-being of employees working in hospital - a protocol for the SEEGEN trial.

BACKGROUND: Health care employees in Germany and worldwide are exposed to a variety of stressors. However, most of the hospitals in Germany lack a systematic workplace health management. Thus, this study aims at the evaluation of the effects of a behavioural as well as organisational (´complex´) intervention on the mental health and well-being of hospital staff. METHODS: Mental health in the hospital workplace (SEElische GEsundheit am Arbeitsplatz KrankeNhaus - SEEGEN) is an unblinded, multi-centred cluster-randomised open trial with two groups (intervention group (IG) and waitlist control group (CG)). Study participants in the intervention clusters will receive the complex intervention; study participants in the waitlist control clusters will receive the complex intervention after the last follow-up measurement. The intervention consists of five behavioural and organisational intervention modules that are specifically tailored to hospital employees at different hierarchical and functional levels. Hospital staff may select one specific module according to their position and specific needs or interests. Towards the end of the intervention roundtable discussions with representatives from all professional groups will be held to facilitate organisational change. Primary outcome is the change in emotional and cognitive strain in the working environment, from baseline (T0) to 6 month-follow up (T1), between IG and CG. In addition, employees who do not participate in the modules are included in the trial by answering shorter questionnaires (cluster participants). Furthermore, using mixed methods, a process evaluation will identify uptake of the intervention, and mediators and moderators of the effect. DISCUSSION: There seems to be growing psychological strain on people working in the health care sector worldwide. This study will examine whether investing directly in the hospital staff and their interpersonal relationship may lead to measurable benefits in subjective well-being at the workplace and improved economic performance indicators of the hospital. In case of a positive outcome, health promotion strategies looking at behavioural as well as organisational components within the hospital may gain additional importance, especially in regard of the growing financial pressure within the health sector. TRIAL REGISTRATION DRKS: The SEEGEN study is registered at the German Clinical Trial Register (DRKS) under the DRKS-ID DRKS00017249. Registered 08 October 2019, URL. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017249.

[Staffing level: Survey among psychosomatic-psychotherapeutic institutions in Germany]. / Personalausstattung: Befragung psychosomatischpsychotherapeutischer Kliniken und Abteilungen in Deutschland.

Staffing level: Survey among psychosomatic-psychotherapeutic institutions in Germany Objectives: To establish the first nationwide hospital survey to assess the level of staffing for inpatient and daycare treatment in psychosomatic hospitals and specialist departments in Germany. METHODS: Using a standardized written hospital survey from the Deutsches Krankenhausinstitut (DKI), we invited a total of 218 psychosomatic-psychotherapeutic hospitals and specialist departments to participate. The participation rate of the institutions was 35%. RESULTS: In the overall sample, one psychotherapist (physician/clinical psychologist) was responsible for treating a median of 3.9 beds/patients (interquartile range 3.1-5.1) and one nurse a median of 2.9 beds/patients (interquartile range 2.3-3.9). There were significant differences for the nurse-patient ratio depending on the organizational size of the institution. To ensure quality treatment, professional experts saw increased staffing needs of about 12-17% across both professions. For the professional groups of specialist therapists and social workers, broad variances were observed for the therapist-patient ratio in the overall sample. CONCLUSIONS: The study provides an important and relevant data basis for the further discussion to determine mandatory minimal staffing levels in German psychosomatic-psychotherapeutic institutions.

Mandatory quality reports in Germany from the hospitals' point of view: a cross-sectional observational study.

BACKGROUND: Public reporting of hospital quality is to enable providers, patients and the public to make comparisons regarding the quality of care and thus contribute to informed decisions. It stimulates quality improvement activities in hospitals and thus positively impacts treatment results. Hospitals often use publicly reported data for further internal or external purposes.As of 2005, German hospitals are obliged to publish structured quality reports (QR) every two years. This gives them the opportunity to demonstrate their performance by number, type and quality in a transparent way. However, it constitutes a major burden to hospitals to generate and publish data required, and it is yet unknown if hospitals feel adequately represented and at the same time consider the effort appropriate.This study assesses hospital leaders' judgement about the capability of QR to put legally defined aims effectively and efficiently into practice. It also explores the additional purposes hospitals use their QR for. METHODS: In a cross-sectional observational study, a representative random sample out of 2,064 German hospitals (N=748) was invited to assess QR via questionnaire; 333 hospitals participated. We recorded the suitability of QR for representing number, type and quality of services, the adequacy of cost and benefits (6-level Likert scales) and additional purposes QR are used for (free text question). For representation purposes, the net sample was weighted for hospital size and hospital ownership (direct standardization). Data was analyzed descriptively and using inferential statistics (chi-2 test) or for the purpose of generating hypotheses. RESULTS: German hospitals rated the QR as suitable to represent the number of services but less so for the type and quality of services. The cost-benefit ratio was seen as inadequate. There were no significant differences between hospitals of different size or ownership.Public hospitals additionally used their reports for mostly internal purposes (e.g. comparison with competitors, quality management) whereas private ones used them externally (e.g. communication, marketing) (p=0.024, chi-2 test, hypotheses-generating level). CONCLUSIONS: German hospitals consider the mandatory QR as only partially capable to put the legally defined aims effectively and efficiently into practice. In order for public reporting to achieve its potentially positive effects, the QR must be more closely aligned to the needs of hospitals.

Psychosocial stress at work and perceived quality of care among clinicians in surgery.

BACKGROUND: Little is known about the association between job stress and job performance among surgeons, although physicians' well-being could be regarded as an important quality indicator. This paper examines associations between psychosocial job stress and perceived health care quality among German clinicians in surgery. METHODS: Survey data of 1,311 surgeons from 489 hospitals were analysed. Psychosocial stress at work was measured by the effort-reward imbalance model (ERI) and the demand-control model (job strain). The quality of health care was evaluated by physicians' self-assessed performance, service quality and error frequency. Data were collected in a nationwide standardised mail survey. 53% of the contacted hospitals sent back the questionnaire; the response rate of the clinicians in the participating hospitals was about 65%. To estimate the association between job stress and quality of care multiple logistic regression analyses were conducted. RESULTS: Clinicians exposed to job stress have an increased risk of reporting suboptimal quality of care. Magnitude of the association varies depending on the respective job stress model and the indicator of health care quality used. Odds ratios, adjusted for gender, occupational position and job experience vary between 1.04 (CI 0.70-1.57) and 3.21 (CI 2.23-4.61). CONCLUSION: Findings indicate that theoretical models of psychosocial stress at work can enrich the analysis of effects of working conditions on health care quality. Moreover, results suggest interventions for job related health promotion measures to improve the clinicians' working conditions, their quality of care and their patients' health.

Burnout and perceived quality of care among German clinicians in surgery.

OBJECTIVE: Burnout is highly prevalent among clinicians but there is not much known about the association between burnout and quality of care. In this paper, burnout, perceived quality of care and medical errors among German clinicians in surgery are explored. DESIGN: Data were collected during 2008 by a cross-sectional, standardized mail survey. PARTICIPANTS: and SETTING: A total of 1311 clinicians in surgery in 489 German hospitals. Measure(s) Burnout was measured by using the Copenhagen Burnout Inventory (CBI). The measurement of self-rated patient care was based on a 13 item instrument (Chirurgisches Qualitätssiegel) and two questions assessing the frequency of medical errors. RESULTS: About 48.7% of the clinicians meet the criteria for burnout according to the CBI. Moreover, in multivariate logistic regression analyses, burnout is significantly associated with perceived quality of care among male (odds ratios vary from 1.5 to 2.6) but not among female surgeons (odds ratios vary from 1.3 to 1.5). CONCLUSIONS: The high prevalence of burnout in our study corresponds with former studies of burnout among physicians. Furthermore, the results of the study suggest a relationship between burnout and perceived quality of care among men. Thus, reducing burnout among surgeons could not only improve their health and well-being but also the quality of care.

Psychosocial stress among hospital doctors in surgical fields: results of a nationwide survey in Germany.

BACKGROUND: The aim of this paper is to analyze psychosocial stress in the workplace among hospital doctors working in surgical fields in Germany with the aid of the demand-control model, the effort-reward imbalance model, and selected additional indicators. METHODS: A written questionnaire was answered by a stratified random sample consisting of 1311 hospital doctors working in surgical fields in 489 hospitals in Germany. Validated instruments were used to make measurements according to the demand-control and effort-reward imbalance models. RESULTS: The working conditions of about a quarter of the hospital doctors surveyed were characterized by an effort-reward imbalance. 22% of them have "job strain" according to the demand-control model, i.e., they are confronted with high demands, yet have a low degree of control. Residents and assistant physicians not occupying training positions were both found to have an especially high degree of psychosocial stress. Furthermore, about one-fifth of the hospital doctors surveyed thought about giving up their profession at least a few times per month. 44% of them considered that the quality of patient care was sometimes or often impaired by an excessive physician workload. CONCLUSION: An investigation of psychosocial stress in the workplace among hospital doctors in surgical fields in Germany indicates that this group suffers from more severe stress at work than other occupational groups. Such working conditions pose a threat to these physicians' own health and to the quality of the health care that they provide.

Two short-term outcomes after instituting a national regulation regarding minimum procedural volumes for total knee replacement.

BACKGROUND: Several studies have demonstrated positive relationships between high hospital volume and improved outcome following total knee replacement. To our knowledge, it has not been demonstrated whether improved outcomes are causally determined by selective referral to high-volume hospitals. We therefore evaluated the effect of a national regulation regarding minimum hospital volume for total knee replacement on two short-term outcome parameters. METHODS: We performed a comparison of the years before (2004, 2005) and after (2006) the implementation of a national regulation on minimum hospital volume for total knee replacement through a secondary analysis of a national database on the quality of inpatient care in Germany as reflected by the number of cases per hospital and the postoperative rates of wound infection and wound hematoma or secondary hemorrhage. RESULTS: We analyzed 110,349 cases from 2004, 118,922 cases from 2005, and 125,322 cases from 2006. Implementation of the regulation had a significant effect on the number of cases per hospital. Of the hospitals that had performed one to forty-nine cases in 2005, 35.6% moved to higher-volume categories and 21.2% dropped out in 2006. Multiple logistic regression analysis adjusting for patient characteristics demonstrated risk reductions of 22.5% (odds ratio, 0.775; 95% confidence interval, 0.700 to 0.857) for postoperative wound infection and of 44% (odds ratio, 0.562; 95% confidence interval, 0.531 to 0.596) for wound hematoma or secondary hemorrhage from 2005 to 2006. For wound infection, approximately half of the improvement was attributable to the effects of the minimum-volume regulation. For wound hematoma and secondary hemorrhage, the improvement could not be explained by the minimum-volume regulation. CONCLUSIONS: Implementation of the minimum-volume regulation for total knee replacement resulted in more patients being managed at higher-volume hospitals than expected. Following the implementation of a minimum-volume regulation, effects on two short-term outcome parameters were observed, but definite conclusions could only be made regarding wound infection, with the minimum-volume regulation resulting in a decreased rate of infection.

[Effort-reward imbalance, job strain and burnout among clinicians in surgery]. / Berufliche Gratifikationskrisen, Job Strain und Burnout bei chirurgisch tätigen Krankenhausärzten.

The aim of the study is to analyse the association between psychosocial stress at work and burnout among clinicians in surgery in Germany. For the conceptualisation of work stress the demand-control model (job strain) and the effort-reward imbalance model (ERI) were used. Based on a stratified probability sample a mail survey of 1 311 clinicians from 489 hospitals was conducted. Burnout was measured by the Copenhagen Burnout Inventory. Results of logistic regressions show that both models are significantly associated with burnout (odds ratio job strain: 6.53 (95% confidence interval 4.50-9.46), odds ratio ERI: 5.39 (95% confidence interval 3.94-7.36). Clinicians who are exposed to both, job strain and ERI, have an additionally increased risk. The demand-control model and the effort-reward imbalance model suggest theory-driven interventions for job related health promotion measures which aim for improved working conditions and a decrease of health risks among clinicians in surgery.

Implementation and effects of Germany's minimum volume regulations: results of the accompanying research.

INTRODUCTION: Since 2004, Germany has had legal minimum volumes for five surgical interventions (kidney, liver, and stem cell transplantations and complex pancreatic and esophageal interventions). In 2006, minimum volumes for total knee replacement were added. On behalf of the Federal Joint Committee we evaluated the implementation of the minimum volumes and their effects on health service structure, hospitals, and outcome quality. METHODS: We analyzed hospital surveys and secondary data from quality reports for 2004, the Institute for the Hospital Remuneration System, and the Federal Agency for Quality Assurance. RESULTS: In 2006, the minimum volume regulations affected about half of all acute-care hospitals and about 146 000 hospital cases. Depending on the intervention, 10% to 60% of the hospitals with 1% to 31% of the patients performed the procedures yet failed to attain the minimum volumes. The number of hospitals providing the services did not change between 2004 and 2006, so nationwide coverage remained virtually unchanged. Regarding outcomes, only data for total knee replacement were available. One of three analyzed indicators of outcome, wound infections, showed the introduction of the minimum volumes to be associated with better results for higher numbers of cases. DISCUSSION: To date, the minimum volumes have affected health care only marginally. Further monitoring of the effects of the minimum volumes requires prospective definition of essential indicators of outcome and access.

Evaluating compulsory minimum volume standards in Germany: how many hospitals were compliant in 2004?

BACKGROUND: Minimum hospital procedure volumes are discussed as an instrument for quality assurance. In 2004 Germany introduced such annual minimum volumes nationwide on five surgical procedures: kidney, liver, stem cell transplantation, complex oesophageal, and pancreatic interventions. The present investigation is the first part of a study evaluating the effects of these minimum volumes on health care provision. Research questions address how many hospitals and cases were affected by minimum volume regulations in 2004, how affected hospitals were distributed according to minimum volumes, and how many hospitals within the 16 German states complied with the standards set for 2004. METHODS: The evaluation is based on the mandatory hospital quality reports for 2004. In the reports, all hospitals are statutorily obliged to state the number of procedures performed for each minimum volume. The data were analyzed descriptively. RESULTS: In 2004, 485 out of 1710 German hospitals providing acute care and approximately 0.14% of all hospital cases were affected by minimum volume regulations. Liver, kidney, and stem cell transplantation affected from 23 to hospitals; complex oesophageal and pancreatic interventions affected from 297 to 455 hospitals. The inter-state comparison of the average hospital care area demonstrates large differences between city states and large area states and the eastern and western German states ranging from a minimum 51 km2 up to a maximum 23.200 km2, varying according to each procedure. A range of 9% - 16% of the transplantation hospitals did not comply with the standards affecting 1% - 2% of the patients whereas 29% and 18% of the hospitals treating complex oesophageal and pancreatic interventions failed the standards affecting 2% - 5% of the prevailing cases. CONCLUSION: In 2004, the newly introduced minimum volume regulations affected only up to a quarter of German acute care hospitals and few cases. However, excluding the hospitals not meeting the minimum volume standards from providing the respective procedures deserves considering two aspects: the hospital health care provision concepts by the German states as being responsible and from a patient perspective the geographically equal access to hospital care.