Staff Acceptance of Remote Patient Monitoring on Intensive Care Unit

Remote Patient Monitoring on Intensive Care Unit Clinical Trial

— SARPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514173
• Other study ID #: SARPI
• Status: Completed
• Start date: April 4, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 31, 2023
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

From the Department for Anaesthesiology and operative Intensive Care, Charité - Universitätsmedizin Berlin, Campus Virchow- Klinikum and Campus Charité Mitte, Germany

• physicians

• specialist nurses

• respiratory therapists or respiratory therapists

Exclusion criteria:

• Rejection of participation

Related Conditions & MeSH terms

• Remote Patient Monitoring on Intensive Care Unit

Intervention

Device:
• Remote Patient Monitoring
Use of remote patient monitoring

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin, Klinik für Anästhesiologie m.S. operative Intensivmedizin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance of Remote Patient Monitoring Device on Intensive Care Unit	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)	One year
Secondary	Structural Data of Intensive Care Unit	Number and arrangement of ICU beds (in numbers e.g. 1,2,3,4....)	One year
Secondary	Structural Data of Intensive Care Unit	utilization of ICU (in percent e.g. 50%, 40%...)	One year
Secondary	Structural Data of Intensive Care Unit	number of ventilated patients	One year
Secondary	Structural Data of Intensive Care Unit	care per patient ratio (nurse per patient, e.g. 1:1)	One year
Secondary	Structural Data of Intensive Care Unit	doctor per patient (doctor per patient, e.g. 1:1)	One year
Secondary	Structural Data of Intensive Care Unit	working hours of staff (e.g. 7am until 8pm)	One year
Secondary	Use of medical technology on Intensive Care Unit	emotions when using Vital Sync (on a Likert Scale 0=very annoyed, 5=very happy)	One year
Secondary	Use of medical technology on Intensive Care Unit	Usability (Validated by John Brooke in 1986: System User Scale using Likert Scales) (0=bad usability, 100=very good usability)	One year
Secondary	Usage of Vital Sync	usage time (in minutes) of Vital Sync (in min. per day)	One year
Secondary	Usage of Vital Sync	usage frequency of Vital Sync (e.g. x time per day)	One year