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Completed

NCT Number: NCT03514173

Staff Acceptance of Remote Patient Monitoring on 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Universitätsmedizin, Klinik für Anästhesiologie m.S. operative Intensivmedizin

Berlin, 10117, Germany

About this study

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.

Who can participate

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

  • physicians
  • specialist nurses
  • respiratory therapists or respiratory therapists

Exclusion criteria

  • Rejection of participation

Treatment and study plan

Remote Patient Monitoring

Device

Use of remote patient monitoring

Primary outcomes

  1. Acceptance of Remote Patient Monitoring Device on Intensive Care Unit

    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)

Secondary outcomes

  1. Structural Data of Intensive Care Unit

    Time frame: One year

    Number and arrangement of ICU beds (in numbers e.g. 1,2,3,4....)

  2. Structural Data of Intensive Care Unit

    Time frame: One year

    utilization of ICU (in percent e.g. 50%, 40%...)

  3. Structural Data of Intensive Care Unit

    Time frame: One year

    number of ventilated patients

  4. Structural Data of Intensive Care Unit

    Time frame: One year

    care per patient ratio (nurse per patient, e.g. 1:1)

  5. Structural Data of Intensive Care Unit

    Time frame: One year

    doctor per patient (doctor per patient, e.g. 1:1)

  6. Structural Data of Intensive Care Unit

    Time frame: One year

    working hours of staff (e.g. 7am until 8pm)

  7. Use of medical technology on Intensive Care Unit

    Time frame: One year

    emotions when using Vital Sync (on a Likert Scale 0=very annoyed, 5=very happy)

  8. Use of medical technology on Intensive Care Unit

    Time frame: One year

    Usability (Validated by John Brooke in 1986: System User Scale using Likert Scales) (0=bad usability, 100=very good usability)

  9. Usage of Vital Sync

    Time frame: One year

    usage time (in minutes) of Vital Sync (in min. per day)

  10. Usage of Vital Sync

    Time frame: One year

    usage frequency of Vital Sync (e.g. x time per day)

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: SARPI

Important dates

Study start
2018
Primary completion
2020
Study completion
2023
First posted
May 2, 2018
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.