Clinical Trials Directory

Trials / Completed

CompletedNCT03514173

Staff Acceptance of Remote Patient Monitoring on Intensive Care Unit

Analysis of Sociotechnical Acceptance and Workflow Integration of a Remote Patient Monitoring Device on an Intensive Care Unit

Status
Completed
Phase
Study type
Observational
Enrollment
208 (actual)
Sponsor
Charite University, Berlin, Germany · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICERemote Patient MonitoringUse of remote patient monitoring

Timeline

Start date
2018-04-04
Primary completion
2020-07-28
Completion
2023-12-31
First posted
2018-05-02
Last updated
2024-02-13

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03514173. Inclusion in this directory is not an endorsement.