Clinical Requirements of Future Patient Monitoring in the Intensive Care Unit: Qualitative Study

BACKGROUND: In the intensive care unit (ICU), continuous patient monitoring is essential to detect critical changes in patients' health statuses and to guide therapy. The implementation of digital health technologies for patient monitoring may further improve patient safety. However, most monitoring devices today are still based on technologies from the 1970s. OBJECTIVE: The aim of this study was to evaluate statements by ICU staff on the current patient monitoring systems and their expectations for future technological developments in order to investigate clinical requirements and barriers to the implementation of future patient monitoring. METHODS: This prospective study was conducted at three intensive care units of a German university hospital. Guideline-based interviews with ICU staff-5 physicians, 6 nurses, and 4 respiratory therapists-were recorded, transcribed, and analyzed using the grounded theory approach. RESULTS: Evaluating the current monitoring system, ICU staff put high emphasis on usability factors such as intuitiveness and visualization. Trend analysis was rarely used; inadequate alarm management as well as the entanglement of monitoring cables were rated as potential patient safety issues. For a future system, the importance of high usability was again emphasized; wireless, noninvasive, and interoperable monitoring sensors were desired; mobile phones for remote patient monitoring and alarm management optimization were needed; and clinical decision support systems based on artificial intelligence were considered useful. Among perceived barriers to implementation of novel technology were lack of trust, fear of losing clinical skills, fear of increasing workload, and lack of awareness of available digital technologies. CONCLUSIONS: This qualitative study on patient monitoring involves core statements from ICU staff. To promote a rapid and sustainable implementation of digital health solutions in the ICU, all health care stakeholders must focus more on user-derived findings. Results on alarm management or mobile devices may be used to prepare ICU staff to use novel technology, to reduce alarm fatigue, to improve medical device usability, and to advance interoperability standards in intensive care medicine. For digital transformation in health care, increasing the trust and awareness of ICU staff in digital health technology may be an essential prerequisite

Creation of an Evidence-Based Implementation Framework for Digital Health Technology in the Intensive Care Unit: Qualitative Study

Background: Digital health technologies such as continuous remote monitoring and artificial intelligence–driven clinical decision support systems could improve clinical outcomes in intensive care medicine. However, comprehensive evidence and guidelines for the successful implementation of digital health technologies into specific clinical settings such as the intensive care unit (ICU) are scarce. We evaluated the implementation of a remote patient monitoring platform and derived a framework proposal for the implementation of digital health technology in an ICU. Objective: This study aims to investigate barriers and facilitators to the implementation of a remote patient monitoring technology and to develop a proposal for an implementation framework for digital health technology in the ICU. Methods: This study was conducted from May 2018 to March 2020 during the implementation of a tablet computer–based remote patient monitoring system. The system was installed in the ICU of a large German university hospital as a supplementary monitoring device. Following a hybrid qualitative approach with inductive and deductive elements, we used the Consolidated Framework for Implementation Research and the Expert Recommendations for Implementing Change to analyze the transcripts of 7 semistructured interviews with clinical ICU stakeholders and descriptive questionnaire data. The results of the qualitative analysis, together with the findings from informal meetings, field observations, and previous explorations, provided the basis for the derivation of the proposed framework. Results: This study revealed an insufficient implementation process due to lack of staff engagement and few perceived benefits from the novel solution. Further implementation barriers were the high staff presence and monitoring coverage in the ICU. The implementation framework includes strategies to be applied before and during implementation, targeting the implementation setting by involving all ICU stakeholders, assessing the intervention’s adaptability, facilitating the implementation process, and maintaining a vital feedback culture. Setting up a unit responsible for implementation, considering the guidance of an implementation advisor, and building on existing institutional capacities could improve the institutional context of implementation projects in the ICU. Conclusions: Implementation of digital health in the ICU should involve a thorough preimplementation assessment of the ICU’s need for innovation and its readiness to change, as well as an ongoing evaluation of the implementation conditions. Involvement of all stakeholders, transparent communication, and continuous feedback in an equal atmosphere are essential, but leadership roles must be clearly defined and competently filled. Our proposed framework may guide health care providers with concrete, evidence-based, and step-by-step recommendations for implementation practice, facilitating the introduction of digital health in intensive care. Trial Registration: ClinicalTrials.gov NCT03514173; https://clinicaltrials.gov/ct2/show/NCT0351417

A Remote Patient-Monitoring System for Intensive Care Medicine: Mixed Methods Human-Centered Design and Usability Evaluation

Background: Continuous monitoring of vital signs is critical for ensuring patient safety in intensive care units (ICUs) and is becoming increasingly relevant in general wards. The effectiveness of health information technologies such as patient-monitoring systems is highly determined by usability, the lack of which can ultimately compromise patient safety. Usability problems can be identified and prevented by involving users (ie, clinicians). Objective: In this study, we aim to apply a human-centered design approach to evaluate the usability of a remote patient-monitoring system user interface (UI) in the ICU context and conceptualize and evaluate design changes. Methods: Following institutional review board approval (EA1/031/18), a formative evaluation of the monitoring UI was performed. Simulated use tests with think-aloud protocols were conducted with ICU staff (n=5), and the resulting qualitative data were analyzed using a deductive analytic approach. On the basis of the identified usability problems, we conceptualized informed design changes and applied them to develop an improved prototype of the monitoring UI. Comparing the UIs, we evaluated perceived usability using the System Usability Scale, performance efficiency with the normative path deviation, and effectiveness by measuring the task completion rate (n=5). Measures were tested for statistical significance using a 2-sample t test, Poisson regression with a generalized linear mixed-effects model, and the N-1 chi-square test. P<.05 were considered significant. Results: We found 37 individual usability problems specific to monitoring UI, which could be assigned to six subcodes: usefulness of the system, response time, responsiveness, meaning of labels, function of UI elements, and navigation. Among user ideas and requirements for the UI were high usability, customizability, and the provision of audible alarm notifications. Changes in graphics and design were proposed to allow for better navigation, information retrieval, and spatial orientation. The UI was revised by creating a prototype with a more responsive design and changes regarding labeling and UI elements. Statistical analysis showed that perceived usability improved significantly (System Usability Scale design A: mean 68.5, SD 11.26, n=5; design B: mean 89, SD 4.87, n=5; P=.003), as did performance efficiency (normative path deviation design A: mean 8.8, SD 5.26, n=5; design B: mean 3.2, SD 3.03, n=5; P=.001), and effectiveness (design A: 18 trials, failed 7, 39% times, passed 11, 61% times; design B: 20 trials, failed 0 times, passed 20 times; P=.002). Conclusions: Usability testing with think-aloud protocols led to a patient-monitoring UI with significantly improved usability, performance, and effectiveness. In the ICU work environment, difficult-to-use technology may result in detrimental outcomes for staff and patients. Technical devices should be designed to support efficient and effective work processes. Our results suggest that this can be achieved by applying basic human-centered design methods and principles. Trial Registration: ClinicalTrials.gov NCT03514173; https://clinicaltrials.gov/ct2/show/NCT0351417