Remote Patient Monitoring on Intensive Care UnitSARPINCT03514173
Staff Acceptance of Remote Patient Monitoring on Intensive Care Unit
An observational study of Remote Patient Monitoring on Intensive Care Unit, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Remote Patient Monitoring on Intensive Care Unit
- What is being tested?
- Remote Patient Monitoring
- Type of treatment
- Medical device
- How many people
- 208 participants
- Where
- 1 siteGermany
- Study dates
- 4 Apr 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Rejection of participation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin, Klinik für Anästhesiologie m.S. operative Intensivmedizin
Berlin, 10117
About this study
Official title: 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.
Read the 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.
- Being tested
- Remote Patient Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Patient MonitoringDevice
Use of remote patient monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: One year
Secondary outcomes (10)
Structural Data of Intensive Care Unit
Number and arrangement of ICU beds (in numbers e.g. 1,2,3,4....)
Measured: One year
Structural Data of Intensive Care Unit
utilization of ICU (in percent e.g. 50%, 40%...)
Measured: One year
Structural Data of Intensive Care Unit
number of ventilated patients
Measured: One year
Structural Data of Intensive Care Unit
care per patient ratio (nurse per patient, e.g. 1:1)
Measured: One year
Structural Data of Intensive Care Unit
doctor per patient (doctor per patient, e.g. 1:1)
Measured: One year
Structural Data of Intensive Care Unit
working hours of staff (e.g. 7am until 8pm)
Measured: 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)
Measured: 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)
Measured: One year
Usage of Vital Sync
usage time (in minutes) of Vital Sync (in min. per day)
Measured: One year
Usage of Vital Sync
usage frequency of Vital Sync (e.g. x time per day)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start4 Apr 2018
- Primary completion28 Jul 2020
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Remote Patient Monitoring on Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Balzer, Charite University, Berlin, Germany
- Investigators
- Felix Balzer, Prof., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514173
- Sponsor's protocol ID
- SARPI
- Acronym
- SARPI
- Status last verified
- Feb 2024
- First submitted
- 27 Mar 2018
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Balzer F, Agha-Mir-Salim L, Ziemert N, Schmieding M, Mosch L, Prendke M, Wunderlich MM, Memmert B, Spies C, Poncette AS. Staff perspectives on the influence of patient characteristics on alarm management in the intensive care unit: a cross-sectional survey study. BMC Health Serv Res. 2023 Jul 5;23(1):729. doi: 10.1186/s12913-023-09688-x.
PubMed 37407989Mosch 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.
PubMed 35394445Poncette 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.
PubMed 35275071Poncette 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.
PubMed 32459655Poncette 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.
PubMed 31038467
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Sociotechnical Acceptance and Workflow Integration of a Remote Patient Monitoring Device on an Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03514173
- Acronym / sponsor ID
- SARPI / SARPI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Rejection of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Patient MonitoringUse of remote patient monitoring | Device | – |
Primary outcome
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)
10 secondary outcomes
Structural Data of Intensive Care Unit
Time frame: One year
Structural Data of Intensive Care Unit
Time frame: One year
Structural Data of Intensive Care Unit
Time frame: One year
Structural Data of Intensive Care Unit
Time frame: One year
Structural Data of Intensive Care Unit
Time frame: One year
Structural Data of Intensive Care Unit
Time frame: One year
Use of medical technology on Intensive Care Unit
Time frame: One year
Use of medical technology on Intensive Care Unit
Time frame: One year
Usage of Vital Sync
Time frame: One year
Usage of Vital Sync
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 37407989Balzer F, Agha-Mir-Salim L, Ziemert N, Schmieding M, Mosch L, Prendke M, Wunderlich MM, Memmert B, Spies C, Poncette AS. Staff perspectives on the influence of patient characteristics on alarm management in the intensive care unit: a cross-sectional survey study. BMC Health Serv Res. 2023 Jul 5;23(1):729. doi: 10.1186/s12913-023-09688-x.
- Derived from this study: PubMed 35394445Mosch 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.
- Derived from this study: PubMed 35275071Poncette 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.
- Derived from this study: PubMed 32459655Poncette 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.
- Derived from this study: PubMed 31038467Poncette 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Balzer, Prof. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Remote Patient Monitoring on Intensive Care Unit, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of Remote Patient Monitoring Device on Intensive Care Unit (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03514173, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.