Implementing digital health technologies in intensive care: a mixed methods study with development of an implementation framework

Background: In the context of the digital transformation of healthcare, technologies such as tablet-based remote patient monitoring systems promise to improve patient-related outcomes and reduce workload of healthcare staff. However, the introduction of novel digital technologies into routine clinical practice, e.g. in intensive care units (ICUs), is still lagging behind. In the context of implementing a remote patient monitoring system, we aimed to explore expectations of ICU staff regarding patient monitoring, validate them, and develop an implementation framework for digital health technologies in the ICU. Methods: We followed an exploratory research approach using mixed methods. The data collection included semi-structured interviews, field visits and focus groups; and an online cross-sectional survey to validate the insights gained. We derived the implementation framework applying inductive and deductive analysis. The deduction was oriented towards the categories of the Consolidated Framework for Implementation Research and the Expert Recommendations for Implementing Change. Results: Staff expectations regarding novel patient monitoring solutions included introducing wireless sensors, enhanced usability and optimized alarm management. Many false positive alarms due to poor alarm hygiene were considered problematic, more training with new devices was demanded. In the validation study, staff members stated that high rates of false-positive alarms (n=60, 70% chose “Strongly agree” or “Agree”) and too many sensor cables (n=66, 77%) would disturb patient care. They supported using remote patient monitoring for earlier alerts (n=55, 65%) and artificial-intelligence-powered clinical decision support systems for early detection of complications (n=67, 79%). To promote usage of such systems, respondents suggested more interoperability (n=79, 93%), high usability (n=78, 93%) and more training with technologies (n=75, 90%). High quality and regular staff training, clear leadership commitment and feedback opportunities for staff should be installed for improved implementation. The presented framework compiles strategies to apply before, during and in the general context of the implementation, focussing on usability and adaptability of the intervention, staff involvement, communication, and evaluation strategies. Conclusions: The implementation of digital health technology in specialized settings like the ICU requires a high level of staff resources and commitment. It is important to test the adaptability of the technology and improve it with a user-centered approach in design and implementation. The implementation involves interdisciplinary staff engagement, clear communication of the project, and continuous assessment of implementation requirements and conditions should be continuously reassessed. The presented framework may guide implementation leaders towards sustainable and user-centered introduction of digital health technology in the ICU.Neue digitale Gesundheitstechnologien könnten patientenbezogene Out-comes verbessern und die Arbeitsbelastung des Personals reduzieren. Ihre Einführung in die klinische Routinepraxis auf Intensivstationen verläuft jedoch schleppend. Im Kontext der Implementierung eines neuen Patientenmonitoringsystems auf einer Intensivstation untersuchten wir Erwartungen des Personals an die Monitoring-Technologie, validierten sie und entwickelten ein Implementierungsframework für digitale Gesundheitstechnologien auf Intensivstationen. Methoden: Wir verfolgten einen explorativen Mixed-Methods Forschungsansatz. Die Datenerhebung umfasste semistrukturierte Interviews, Feldbeobachtungen und Fokusgruppen, die induktiv und deduktiv analysiert wurden, sowie einen Onlinefragebogen, der deskriptiv ausgewertet wurde. Das Implementierungsframework wurde induktiv und deduktiv aus der Datengrundlage heraus sowie aufbauend auf evidenzbasierten Rahmenwerken entwickelt. Ergebnisse: Das Personal wünschte sich für ein zukünftiges Patientenmonitoring drahtlose Sensoren, höhere Benutzerfreundlichkeit und ein optimiertes Alarmmanagement. Sie bewerteten viele falsch-positive Alarme problematisch und forderten mehr Training mit neuen Geräten. Auch in der Validierungsstudie wurden zu viele falsch-positive Alarme (n=60, 70% wählten "stimme voll zu" oder "stimme zu") und zu viele Sensorkabel (n=66, 77%) bemängelt. Das Personal befürwortete den Einsatz von Patientenfernüberwachung um früher alarmiert zu werden (n=55, 65%), und von durch Künstliche Intelligenz gestützte Entscheidungshilfesystemen für die Früherkennung von Komplikationen (n=67, 79%). Für eine höhere Nutzung solcher Systeme seien Interoperabilität (n=79, 93%), Benutzerfreundlichkeit (n=78, 93%) und mehr Schulungen (n=75, 90%) sinnvoll. Zur Verbesserung der Implementierung sollten qualitativ hochwertige und regelmäßige Mitarbeiterschulungen, ein klares Leitungsengagement für das Projekt und Feedbackmöglichkeiten vorhanden sein. Das Implementierungsframework für digitale Gesundheitstechnologien auf Intensivstationen enthält Strategien, die vor, während und im allgemeinen Kontext der Implementierung angewandt werden können, wobei die Benutzerfreundlichkeit und Anpassungsfähigkeit der Intervention, die Einbeziehung des Personals, die Kommunikation und die Evaluierungsstrategien im Mittelpunkt stehen. Schlussfolgerungen: Die Implementierung digitaler Gesundheitstechnologien in spezialisierten Settings wie Intensivstationen muss sorgfältig geplant werden. Im Fokus steht die Einschätzung der Anpassungsfähigkeit der Technologie, die mit nutzerzentrierten Methoden verbessert werden sollte, u.a. durch die Einbeziehung des interdisziplinären Personals und eine klare Kommunikation des Projekts. Zudem sollten Anforderungen für die Implementierung kontinuierlich neu eingeschätzt werden. Das Framework kann Verantwortlichen in der Implementierungspraxis als Leitfaden dienen

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