Our retrospective study showed a significant reduction of treatment-related harms following the introduction of CRM. The effect was visible in all hospital departments as well as on the level of the entire hospital. Despite the difficulties in measuring infrequent severe patient outcomes, such as treatment-related harms, data support an association between intervention and outcome.
Unlike many other projects to improve patient safety, this project took a comprehensive and systematic approach to clinical risk management. The German Patient Safety Coalition (Aktionsbündnis Patientensicherheit) defined the following requirements for clinical risk management systems in hospitals: 1. development and communication of a risk policy and risk management strategy; 2. definition of strategic and operative goals for clinical risk management; 3. definition of responsibilities and necessary resources; 4. development of competence and expertise for the identification, analysis, evaluation and management of risks; 5. establishment of a defined risk management process and integration of risk management into the management structures and processes of the organization; 6. participation, information and training of all professional groups; 7. continuous development and evaluation of the risk management system; 8. establishment of a positive safety culture [13]. A cross-sectional study of 138 Swiss hospitals identified the implementation of central coordination, established communication structures in and between the individual hospital facilities and the existence of a risk management strategy and strategic goals as key enablers for clinical risk management [22, 23].
In contrast, a survey of 572 German hospitals in 2015 revealed that, depending on the type of hospital, only 33% to 54% had systematically implemented a clinical risk management strategy and that in only 38% of hospitals the top management was involved in the project [24]. Only 13% of hospitals reported systematic use of information from the analysis of critical incidents, and only 14% reported the use of prospective risk analysis methods, although the vast majority had implemented a CIRS [24, 25]. These results show that, although the essential components of comprehensive clinical risk management are well defined, the extent and maturity of its implementation vary considerably between hospitals.
In this project, an attempt was already made at the planning stage to meet all the requirements of a comprehensive risk management system. Patient safety and clinical risk management were laid down in the corporate strategy, the risk policy and risk management strategy were described as part of the quality strategy, and the risk management processes were integrated into the management processes at corporate and hospital level. The development of expertise in the management of clinical risks was achieved by training a sufficiently large number of clinical risk managers and clinical risk management assistants. The recruitment of risk managers from different professional groups and the multi-professional composition of the risk management teams ensured a broad participation of all professional groups in the risk management process. In addition, the importance of patient safety and clinical risk management principles were communicated to employees through various communication channels, such as the intranet, newsletters, team meetings, training courses and lectures. The sustainability and continuous development of clinical risk management was ensured by annual internal and five-yearly external audits as well as by the annual determination of strategic goals and projects to increase patient safety.
This project used retrospective data, such as the analysis of CIRS reports, patient surveys, and the results of mobility and mortality conferences, as well as the systematic assessment, analysis and evaluation of clinical risks through risk audits. We classified the detected risks according to type and severity in order to get an overview of the hospital's risk profile. We could not find comparable data on risk profiles from other projects. Several studies reported on the number and type of adverse events detected by medical record review [4, 6, 26, 27]. However, the methods and classifications used are heterogeneous and not readily transferable to prospectively detected risks.
Among the risks identified in this project, risks due to organizational deficiencies were the most common (56.2%), with the highest proportion of serious risks (22.7%). This seems to be in contrast with a patient record study at 21 Dutch hospitals, which found that the majority of adverse events (61%) were caused by human factors, followed by patient-related factors with 39% and organizational factors with 14% [26]. However, active failures by people who are in direct contact with the patients and the medical system often only lead to damage in combination with latent conditions, that is weaknesses in the organization. Unlike active failures, whose specific forms are hard to predict, latent conditions can be identified and remedied before an adverse event occurs [28]. This is supported by the observation in the above-mentioned study, that the largest share of avoidable adverse events was among those with organizational causes (93%) [26].
There are hardly any previous reports on the outcome of CRM projects in hospitals. Cropper and colleagues reported on the implementation of a safety program in a large healthcare organization, which included some elements of clinical risk management, such as interprofessional risk management teams, a critical incident reporting system, safety critical policies and safety training. The authors reported a continuous decrease in the number of serious safety events recorded by the error reporting system after the introduction of the program [29]. Ramirez and colleagues reported on the introduction of an incident reporting system at a university hospital and evaluated the effectiveness of the resulting improvement actions through prospective real-time observations [17]. The authors found a significant reduction of patient safety incidents for 63.15% of the implemented safety measures. In contrast, a retrospective patient record review study at a department for cardiovascular surgery reported an increase in the rate of adverse events three years after the implementation of CRM from 21.1 to 42.8 events per 1,000 patient days [30].
Strengths and limitations
The strength of this study is that it reports on an extensive project carried out over nine years, which included all criteria and elements of a comprehensive risk management according to the current state of knowledge in a routine hospital setting. The detailed documentation of the prospective risk assessments allowed for the first time an assessment of the clinical risk profile of a tertiary care center. Together with the causes of adverse events with varying degrees of severity, as described in other studies, this can provide valuable information for future safety initiatives [9, 17, 26].
The study has some limitations. One limitation our study shares with many retrospective observational analyses is that the described intervention was carried out without the evaluation having been considered at the planning stage. The evaluation was therefore carried out retrospectively and had to be limited to the data available. For this reason, important aspects of a complex multiple intervention, such as effects on patient safety culture, could not be evaluated [31, 32].
Another limitation lies in the outcome measurements used for the evaluation. In our study, liability cases were used as a measure of treatment safety. This approach has some advantages and disadvantages. An advantage is the relatively high reliability of the data, since manifest damages are usually reported reliably. A retrospective review of 206 cases of medico-legal litigation showed that only 20% of adverse events were not reported to the hospital management [33]. Furthermore, liability cases usually concern serious adverse events with temporary or permanent damage or even fatal consequences, while 56% of adverse events detected with medical record review have no or only minimal consequences for patients [9]. In addition, reducing malpractice claims was a primary objective of this project, which could be measured directly by the assessment of liability cases.
One drawback is that liability cases, as compared to adverse events detected with chart review methods, represent a series of highly selected cases from which only limited conclusions can be drawn regarding general patient safety [34]. However, the effect of safety improvement measures on the reduction of litigation claims has been proven before, which suggests that liability cases can be used as surrogate parameters for patient safety [17].
Finally, our study design was observational, and therefore, outcomes may not only be affected by the intervention itself, but also by many other factors leading to a biased estimation of the intervention´s effect [35, 36]. In our study, the compared periods may vary in the number of inpatient and outpatient admissions, patient days, patient case mix, and internal and external cultural factors. We were not able to correct for these possible confounding factors. For the same reasons, generalizability is limited and our results may not be directly transferable to other hospitals, settings or countries. However, the close temporal relationship between the incidence of special cause variation in the control charts and the specific intervention makes it likely that the reduction in patient harm was at least partly due to the introduction of CRM.