Staff Acceptance of Remote Patient Monitoring on Intensive Care Unit (SARPI)

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

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.

Study Overview

• Status: Completed
• Conditions: Remote Patient Monitoring on Intensive Care Unit
• Intervention / Treatment: Device: Remote Patient Monitoring

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.

• Study Type: Observational
• Enrollment (Actual): 208

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin, Klinik für Anästhesiologie m.S. operative Intensivmedizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural Data of Intensive Care Unit	Number and arrangement of ICU beds (in numbers e.g. 1,2,3,4....)	One year
Structural Data of Intensive Care Unit	utilization of ICU (in percent e.g. 50%, 40%...)	One year
Structural Data of Intensive Care Unit	number of ventilated patients	One year
Structural Data of Intensive Care Unit	care per patient ratio (nurse per patient, e.g. 1:1)	One year
Structural Data of Intensive Care Unit	doctor per patient (doctor per patient, e.g. 1:1)	One year
Structural Data of Intensive Care Unit	working hours of staff (e.g. 7am until 8pm)	One year
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
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
Usage of Vital Sync	usage time (in minutes) of Vital Sync (in min. per day)	One year
Usage of Vital Sync	usage frequency of Vital Sync (e.g. x time per day)	One year

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Felix Balzer, Prof., Charite University, Berlin, Germany

Publications and helpful links

General Publications

• Mosch LK, Poncette AS, Spies C, Weber-Carstens S, Schieler M, Krampe H, Balzer F. Creation of an Evidence-Based Implementation Framework for Digital Health Technology in the Intensive Care Unit: Qualitative Study. JMIR Form Res. 2022 Apr 8;6(4):e22866. doi: 10.2196/22866.
• Poncette AS, Mosch LK, Stablo L, Spies C, Schieler M, Weber-Carstens S, Feufel MA, Balzer F. A Remote Patient-Monitoring System for Intensive Care Medicine: Mixed Methods Human-Centered Design and Usability Evaluation. JMIR Hum Factors. 2022 Mar 11;9(1):e30655. doi: 10.2196/30655.
• Poncette AS, Mosch L, Spies C, Schmieding M, Schiefenhovel F, Krampe H, Balzer F. Improvements in Patient Monitoring in the Intensive Care Unit: Survey Study. J Med Internet Res. 2020 Jun 19;22(6):e19091. doi: 10.2196/19091.
• Poncette AS, Spies C, Mosch L, Schieler M, Weber-Carstens S, Krampe H, Balzer F. Clinical Requirements of Future Patient Monitoring in the Intensive Care Unit: Qualitative Study. JMIR Med Inform. 2019 Apr 30;7(2):e13064. doi: 10.2196/13064.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): July 28, 2020
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 2, 2018

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SARPI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No