Non-contact monitoring of agitation and use of a sheltering device in patients with dementia in emergency departments: a feasibility study.

BACKGROUND: Agitation is common in geriatric patients with cognitive impairment, e.g. in persons with dementia (PWD), who are admitted to an emergency department (ED). It might be a first sign of upcoming delirium and is associated with a higher risk of an unfavorable clinical course. Hence, monitoring of vital signs and enhanced movement as indicators of upcoming agitation is essential in these patients during their stay in the ED. Since PWD rarely tolerate fixed monitoring devices, a novel developed non-contact monitoring system (NCMSys) might represent an appropriate alternative. Aim of this feasibility study was to test the validity of a NCMSys and of the tent-like "Charité Dome" (ChD), aimed to shelter PWD from the busy ED environment. Furthermore, effects of the ChD on wellbeing and agitation of PWD were investigated. METHODS: Both devices were attached to patient's bed. Tests on technical validity and safety issues of NCMSys and ChD were performed at the iDoc institute with six healthy volunteers. A feasibility study evaluating the reliability of the NCMSys with and without the ChD was performed in the real-life setting of an ED and on a geriatric-gerontopsychiatric ward. 19 patients were included, ten males and nine females; mean age: 77.4 (55-93) years of which 14 were PWD. PWD inclusion criteria were age ≥ 55 years, a dementia diagnosis and a written consent (by patients or by a custodian). Exclusion criteria were acute life-threatening situations and a missing consent. RESULTS: Measurements of heart rate, changes in movement and sound emissions by the NCMSys were valid, whereas patient movements affected respiratory rate measurements. The ChD did not impact patients' vital signs or movements in our study setting. However, 53% of the PWD (7/13) and most of the patients without dementia (4/5) benefited from its use regarding their agitation and overall wellbeing. CONCLUSIONS: The results of this feasibility study encourage a future controlled clinical trial in geriatric ED patients, including PWD, to further evaluate if our concept of non-contact measurement of vital signs and movement combined with the "Charité Dome" helps to prevent upcoming agitation in this vulnerable patient group in the ED. TRIAL REGISTRATION: ICTRP: "Charité-Dome-Study - DRKS00014737" (retrospectively registered).

Investigation of the Usability of Computerized Critical Care Information Systems in Germany.

INTRODUCTION: The term "usability" describes how effectively, efficiently, and with what level of user satisfaction an information system can be used to accomplish specific goals. Computerized critical care information systems (CCISs) with high usability increase quality of care and staff satisfaction, while reducing medication errors. Conversely, systems lacking usability can interrupt clinical workflow, facilitate errors, and increase charting time. The aim of this study was to investigate and compare usability across CCIS currently used in Germany. METHODS: In this study, German intensive care unit (ICU) nurses and physicians completed a specialized, previously validated, web-based questionnaire. The questionnaire assessed CCIS usability based on three rating models: an overall rating of the systems, a model rating technical usability, and a model rating task-specific usability. RESULTS: We analyzed results from 535 survey participants and compared eight different CCIS commonly used in Germany. Our results showed that usability strongly differs across the compared systems. The system ICUData had the best overall rating and technical usability, followed by the platforms ICM and MetaVision. The same three systems performed best in the rating of task-specific usability without significant differences between each other. Across all systems, overall ratings were more dependent on ease-of-use aspects than on aspects of utility/functionality, and the general scope of the functions offered was rated better than how well the functions are realized. DISCUSSION: Our results suggest that manufacturers should shift some of their effort away from the development of new features and focus more on improving the ease-of-use and quality of existing features.

Design and validation of a questionnaire to evaluate the usability of computerized critical care information systems.

The implementation of computerized critical care information systems (CCIS) can improve the quality of clinical care and staff satisfaction, but also holds risks of disrupting the workflow with consecutive negative impacts. The usability of CCIS is one of the key factors determining their benefits and weaknesses. However, no tailored instrument exists to measure the usability of such systems. Therefore, the aim of this study was to design and validate a questionnaire that measures the usability of CCIS. Following a mixed-method design approach, we developed a questionnaire comprising two evaluation models to assess the usability of CCIS: (1) the task-specific model rates the usability individually for several tasks which CCIS could support and which we derived by analyzing work processes in the ICU; (2) the characteristic-specific model rates the different aspects of the usability, as defined by the international standard "ergonomics of human-system interaction". We tested validity and reliability of the digital version of the questionnaire in a sample population. In the sample population of 535 participants both usability evaluation models showed a strong correlation with the overall rating of the system (multiple correlation coefficients ≥0.80) as well as a very high internal consistency (Cronbach's alpha ≥0.93). The novel questionnaire is a valid and reliable instrument to measure the usability of CCIS and can be used to study the influence of the usability on their implementation benefits and weaknesses.

Integrated therapy safety management system.

AIMS: The aim is to demonstrate the benefit of the medico-ergonomic approach for the redesign of clinical work systems. Based on the six layer model, a concept for an 'integrated therapy safety management' is drafted. This concept could serve as a basis to improve resilience. METHODS: The concept is developed through a concept-based approach. The state of the art of safety and complexity research in human factors and ergonomics forms the basis. The findings are synthesized to a concept for 'integrated therapy safety management'. The concept is applied by way of example for the 'medication process' to demonstrate its practical implementation. RESULTS: The 'integrated therapy safety management' is drafted in accordance with the six layer model. This model supports a detailed description of specific work tasks, the corresponding responsibilities and related workflows at different layers by using the concept of 'bridge managers'. 'Bridge managers' anticipate potential errors and monitor the controlled system continuously. If disruptions or disturbances occur, they respond with corrective actions which ensure that no harm results and they initiate preventive measures for future procedures. The concept demonstrates that in a complex work system, the human factor is the key element and final authority to cope with the residual complexity. The expertise of the 'bridge managers' and the recursive hierarchical structure results in highly adaptive clinical work systems and increases their resilience. CONCLUSIONS: The medico-ergonomic approach is a highly promising way of coping with two complexities. It offers a systematic framework for comprehensive analyses of clinical work systems and promotes interdisciplinary collaboration.

Functional requirements of critical care information systems (CCIS) from the users' perspective.

INTRODUCTION: Critical care information systems (CCIS) are computer software systems specialized for supporting the data processing tasks of clinical staff in intensive care units (ICUs). Reports on the impact of CCIS vary strongly from large benefits to harmful impact. One factor causing these inconsistent results is a large functional heterogeneity of the currently available systems, as no standards exist. Therefore, the aim of this study was to derive recommendations for a minimum range of functions that CCIS should incorporate from the perspective of clinical users. MATERIALS AND METHODS: We performed a web-based survey targeting clinical ICU staff in Germany. Participants rated the usefulness of pre-defined CCIS functions (36 for physicians / 31 for nurses) between 0-5. To capture confounders that might influence the ratings, we recorded 18 individual and workplace characteristics. RESULTS: The 912 participants rated all but three of the investigated functions as useful with median scores of 4-5. A multivariable analysis showed that the ratings were influenced by whether CCIS were used on the participants' wards, by the rating of the function quality of the used CCIS, the years of work experience and whether the participant was a physician or a nurse. CONCLUSIONS: Clinical ICU staff considers all but three of the here investigated CCIS functions as useful. Even though we identified a variety of factors influencing the usefulness ratings, their influence is rather small and thus does not limit the validity of our findings. Accordingly, we commend the functions identified as useful to be incorporated in CCIS.

[Medical device use errors]. / Fehlerhafter Umgang mit Medizingeräten.

Medical devices define our everyday patient treatment processes. But despite the beneficial effect, every use can also lead to damages. Use errors are thus often explained by human failure. But human errors can never be completely extinct, especially in such complex work processes like those in medicine that often involve time pressure. Therefore we need error-tolerant work systems in which potential problems are identified and solved as early as possible. In this context human engineering uses the TOP principle: technological before organisational and then person-related solutions. But especially in everyday medical work we realise that error-prone usability concepts can often only be counterbalanced by organisational or person-related measures. Thus human failure is pre-programmed. In addition, many medical work places represent a somewhat chaotic accumulation of individual devices with totally different user interaction concepts. There is not only a lack of holistic work place concepts, but of holistic process and system concepts as well. However, this can only be achieved through the co-operation of producers, healthcare providers and clinical users, by systematically analyzing and iteratively optimizing the underlying treatment processes from both a technological and organizational perspective. What we need is a joint platform like medilab V of the TU Berlin, in which the entire medical treatment chain can be simulated in order to discuss, experiment and model--a key to a safe and efficient healthcare system of the future.