Charité - Universitätsmedizin, Klinik für Anästhesiologie m.S. operative Intensivmedizin
Berlin, 10117, Germany
NCT Number: NCT03514173
The subject of the observation study with accompanying employee survey is the evaluation of a patient remote monitoring system (Vital Sync from Medtronic, hereinafter abbreviated as "Vital Sync") in intensive care medicine.
The aim of this research project is to determine whether the use of Vital Sync on an intensive care unit is accepted by medical and nursing staff and can be integrated into everyday work as an additional visualisation and analysis tool.
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Notify Me18 year–65 year
All sexes
Observational
Berlin, 10117, Germany
In intensive care medicine, patient monitoring has become a standard that has led to a significant improvement in patient safety in recent decades. At the international level, minimum requirements for patient monitoring have been set out in guidelines and recommendations that represent milestones in patient safety, such as the Helsinki Declaration for Anaesthesiology and the Vienna Declaration for Intensive Care. With advances in digital health, there are new options for patient monitoring that may improve patient safety.
The concept of the Internet of Things has recently gained in importance. While the personal computer (PC) was long regarded as a prerequisite for making technologies accessible to people, the use of computer-supported electronic infrastructures has become ubiquitous. Today, more and more everyday devices are equipped with electronic circuits (microchip, memory chip), blurring earlier boundaries between hardware and software. In an intensive care unit - an environment with high operational reliability - ubiquitous computing means that the processing and visualization of medical data must not be limited to typical workstations at the patient's bedside. Instead, the accessibility of data relevant to medical decisions should result from clinical workflows, leading to the targeted provision of information as needed.
Although various remote patient monitoring systems from commercial providers are already available, little is known about how they can effectively support clinical processes. At the Charité, the working group "Data Science in Perioperative Care" of the Clinic for Anaesthesiology with focus on operative intensive care Charité - Universitätsmedizin Berlin, Campus Virchow and Campus Mitte is systematically evaluating the integration of such novel technologies with special consideration of the socio-technical dimension.
In the pre-implementation phase, 15 ICU staff members (physicians, nurses and respiratory therapists) will be involved into a semi-structured interview study. Results from this pre-implementation study will be validated via two independent surveys involving ICU staff members (n>100). In the post-implementation phase, two semi-structured interview studies will be conducted with key stakeholders of the ICU until data saturation is reached (n=5-10). The focus of this post-implementation interview studies will be to analyse the usability of the installed remote patient monitoring system as well as the success of the implementation and its contributing factors.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
From the Department for Anaesthesiology and operative Intensive Care, Charité - Universitätsmedizin Berlin, Campus Virchow- Klinikum and Campus Charité Mitte, Germany
Exclusion criteria
Use of remote patient monitoring
Time frame: One year
Acceptance of Remote Patient Monitoring Device (measured by the Likert scale on the question "What was the benefit of the new system for you?" 0=no benefit; 5=very high benefit)
Time frame: One year
Number and arrangement of ICU beds (in numbers e.g. 1,2,3,4....)
Time frame: One year
utilization of ICU (in percent e.g. 50%, 40%...)
Time frame: One year
number of ventilated patients
Time frame: One year
care per patient ratio (nurse per patient, e.g. 1:1)
Time frame: One year
doctor per patient (doctor per patient, e.g. 1:1)
Time frame: One year
working hours of staff (e.g. 7am until 8pm)
Time frame: One year
emotions when using Vital Sync (on a Likert Scale 0=very annoyed, 5=very happy)
Time frame: One year
Usability (Validated by John Brooke in 1986: System User Scale using Likert Scales) (0=bad usability, 100=very good usability)
Time frame: One year
usage time (in minutes) of Vital Sync (in min. per day)
Time frame: One year
usage frequency of Vital Sync (e.g. x time per day)
Charite University, Berlin, Germany
Other
Analysis of Sociotechnical Acceptance and Workflow Integration of a Remote Patient Monitoring Device on an Intensive Care Unit
Acronym: SARPI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.