EmergencyTEMSNCT02617875
Telemedical Support for Prehospital Emergency Medical Service
A study testing conventional EMS physician and tele-EMS physician in people with Emergency, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the safety and quality of a pre-hospital holistic multifunctional teleconsultation system. This system consists of on-line transmissions of vital parameters, audio- and video-signals from the scene to a telemedicine centre, where a trained emergency physician (tele-EMS… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency
- What is being tested?
- conventional EMS physician and tele-EMS physician
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,534 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jul 2018to 18 Dec 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All non-life-threatening emergency calls, which do not obligatory require an EMS physician on scene and which do not solely require an ambulance vehicle staffed with paramedics. study.
Who cannot join
- All life-threatening emergency cases, where a physically present EMS physician on scene is obligatory required. These include:
- Patient condition related indications:
- Apnea
- Acute respiratory failure
- Cardiocirculatory arrest
- ST-elevation myocardial infarction (STEMI)
Show all 26Show fewer
- Unconsciousness
- Persistent seizure
- Life- threatening rhythm disorder
- Major trauma
- Complex psychiatric disorders
- Age < 18 years
- Emergency case related indications
- Major vehicle accident
- (Traffic) accident with children
- Fall from a height (> 3m)
- Gunshot-, stab-, or blow injuries in the head, neck and torso area
- Fires with reference to personal injury
- Carbon monoxide intoxication
- Explosion-, thermic or chemical accidents with reference to personal injury
- High-voltage electrical accident
- Water connected accidents (drowning-, diving accident, fall through ice)
- Entrapment or accidental spillage
- Hostage-taking, rampage or other crimes with potential danger for human life (preventive deployment, police consultation)
- Immediate threatening suicide
- Immediate forthcoming delivery or preceding delivery
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Telemedical Support for Prehospital Emergency Medical Service - a Prospective Randomized Controlled Trial
The purpose of this study is to evaluate the safety and quality of a pre-hospital holistic multifunctional teleconsultation system. This system consists of on-line transmissions of vital parameters, audio- and video-signals from the scene to a telemedicine centre, where a trained emergency physician (tele-EMS physician) uses software-based guideline conform algorithms for diagnosis and treatment.
At the prehospital emergency scene half of the patients will receive this telemedicine-based approach and the other half the conventional emergency physician-based care.
Read the detailed description
The usual Emergency Medical Services (EMS) in Germany consists of a dual system with two paramedics and one EMS physician on scene.
Telemedicine networks between medical personnel and medical experts were shown to be beneficial for the quality of health care in many medical fields. The investigators have developed a holistic multifunctional mobile EMS teleconsultation system, as a complementary structural element to the ground based and air based EMS. This tele emergency system was evaluated and implemented during two third-party funded telemedicine projects (Med-on-@ix and TemRas) in the city of Aachen, Germany.
The EMS teleconsultation system was step-wise introduced in the clinical routine of Aachen. Several cases (hypertensive emergency cases, stroke, dislocated fractures etc.) with the primary indication for an EMS physician are already dispatched solely to the paramedics, who can demand support by a tele-EMS physician at any time.
Our aim is to demonstrate that the tele-EMS system is non-inferior in comparison to the conventional german EMS physician system with respect to safety. Moreover, the investigators want to evaluate which system provides a better quality with respect to recording important aspects of medical history and a more guideline conform treatment.
- Conditions
- Emergency
- Being tested
- conventional EMS physician, tele-EMS physician
- Keywords
- Pre-hospital, Emergency medical system, Telemedicine, Tele consultation, Remote treatment
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional EMS physicianOther
A physically present conventional EMS physician on scene, will treat the patients according to the standard operating procedures.
tele-EMS physicianOther
The patients will be treated by the paramedics, which are concurrently instructed by the tele-EMS physicians of the tele consultation center according to the software-based guideline conform algorithms for diagnosis and treatment.
| Study group | Role | What they receive |
|---|---|---|
| Conventional EMS physician | Active comparator | The dispatching personnel will evaluate the emergency call severity and after exclusion of the life-threatening cases listed in a written procedure instruction, they will dispatch a conventional EMS physician, if this is the result of the randomization software. Receives: Other: conventional EMS physician |
| Tele-EMS physician | Other | The dispatching personnel will evaluate the emergency call severity and after exclusion of the life-threatening cases listed in a written procedure instruction, they will dispatch a tele-EMS physician, if this is the result of the randomization software. Receives: Other: tele-EMS physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention-related adverse events
- Allergic reaction to drug application due to incorrect survey of patients' medical history
- Intervention-related and immediate treatment requiring blood pressure drop
- Intervention-related apnea or respiratory insufficiency
- Intervention-related circulatory arrest
Measured: 1 day
Secondary outcomes (13)
Treatment associated quality indicator
Quality of medical history survey (adherence to the guidelines).
Measured: 1 day
Treatment quality
Adherence to the guidelines
Measured: 1 day
Quality of the EMS-case data documentation
Completeness and correctness of the entered data in the standardized EMS documentation form/ the EMS documentation software.
Adherence to the guidelines for documentation in the EMS.
Measured: 1 day
Duration of the physician engagement-time
start: first contact time-point, end: termination of contact
Measured: 1 day
Fulfillment of predefined quality indicators for "Tracer" diagnoses
Tracer diagnoses
- Stroke
- Acute coronary syndrome
- Pain therapy
Measured: 1 day
Death
Death within 24 hours and until day 30 of hospitalization, respectively until discharge from hospital.
Measured: 30 days
Intensive Care Unit (ICU) length of stay
start: ICU length of stay-end: ICU length of stay
Measured: 30 days
Hospital length of stay
start: Hospital length of stay-end: Hospital length of stay
Measured: 30 days
Correct pre-hospital diagnosis
Comparison to the hospital discharge diagnosis
Measured: 30 days
Adverse events independently of the kind of EMS care
The incidence of adverse events (AE) and serious adverse events (SAE)
Measured: 30 days
Premature termination of the telemedical or conventional EMS operation
Incidence of unnecessary EMS missions
Measured: 1 day
Conversion of the initial dispatched tele-EMS treatment
Required conversion from the primary dispatched tele-EMS physician to a conventional EMS physician
Measured: 1 day
Number of conventional EMS physician operations, which could be handled by a tele-EMS physician
Number of patients
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start9 Jul 2018
- Primary completion6 Sep 2019
- Study completion18 Dec 2019
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 EmergencyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,534 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rolf Rossaint, Professor, Principal investigator, Department of Anesthesiology, University Hospital Aachen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617875
- Sponsor's protocol ID
- 15-069
- Acronym
- TEMS
- Status last verified
- Oct 2020
- First submitted
- 24 Nov 2015
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Skorning M, Bergrath S, Rortgen D, Brokmann JC, Beckers SK, Protogerakis M, Brodziak T, Rossaint R. [E-health in emergency medicine - the research project Med-on-@ix]. Anaesthesist. 2009 Mar;58(3):285-92. doi: 10.1007/s00101-008-1502-z. German.
PubMed 19221700Brokmann JC, Rossaint R, Bergrath S, Valentin B, Beckers SK, Hirsch F, Jeschke S, Czaplik M. [Potential and effectiveness of a telemedical rescue assistance system. Prospective observational study on implementation in emergency medicine]. Anaesthesist. 2015 Jun;64(6):438-45. doi: 10.1007/s00101-015-0039-1. Epub 2015 Jun 3. German.
PubMed 26036316Hess PP, Czaplik M, Hess J, Schroder H, Beckers SK, Follmann A, Pitsch M, Felzen M. Comparison of the diagnostic concordance of tele-EMS and EMS physicians in the emergency medical service-a subanalysis of the TEMS-trial. Front Digit Health. 2025 Apr 30;7:1519619. doi: 10.3389/fdgth.2025.1519619. eCollection 2025.
PubMed 40370704Kowark A, Felzen M, Ziemann S, Wied S, Czaplik M, Beckers SK, Brokmann JC, Hilgers RD, Rossaint R; TEMS-study group. Telemedical support for prehospital emergency medical service in severe emergencies: an open-label randomised non-inferiority clinical trial. Crit Care. 2023 Jun 30;27(1):256. doi: 10.1186/s13054-023-04545-z.
PubMed 37391836Stevanovic A, Beckers SK, Czaplik M, Bergrath S, Coburn M, Brokmann JC, Hilgers RD, Rossaint R; TEMS Collaboration Group. Telemedical support for prehospital Emergency Medical Service (TEMS trial): study protocol for a randomized controlled trial. Trials. 2017 Jan 26;18(1):43. doi: 10.1186/s13063-017-1781-2.
PubMed 28126019
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedical Support for Prehospital Emergency Medical Service - a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02617875
- Acronym / sponsor ID
- TEMS / 15-069
- Conditions
- Emergency
- Keywords
- Pre-hospital, Emergency medical system, Telemedicine, Tele consultation, Remote treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,534 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 1 Dec 2015 (estimated)
- 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 purpose of this study is to evaluate the safety and quality of a pre-hospital holistic multifunctional teleconsultation system. This system consists of on-line transmissions of vital parameters, audio- and video-signals from the scene to a telemedicine centre, where a trained emergency physician (tele-EMS physician) uses software-based guideline conform algorithms for diagnosis and treatment.
At the prehospital emergency scene half of the patients will receive this telemedicine-based approach and the other half the conventional emergency physician-based care.
Detailed description
The usual Emergency Medical Services (EMS) in Germany consists of a dual system with two paramedics and one EMS physician on scene.
Telemedicine networks between medical personnel and medical experts were shown to be beneficial for the quality of health care in many medical fields. The investigators have developed a holistic multifunctional mobile EMS teleconsultation system, as a complementary structural element to the ground based and air based EMS. This tele emergency system was evaluated and implemented during two third-party funded telemedicine projects (Med-on-@ix and TemRas) in the city of Aachen, Germany.
The EMS teleconsultation system was step-wise introduced in the clinical routine of Aachen. Several cases (hypertensive emergency cases, stroke, dislocated fractures etc.) with the primary indication for an EMS physician are already dispatched solely to the paramedics, who can demand support by a tele-EMS physician at any time.
Our aim is to demonstrate that the tele-EMS system is non-inferior in comparison to the conventional german EMS physician system with respect to safety. Moreover, the investigators want to evaluate which system provides a better quality with respect to recording important aspects of medical history and a more guideline conform treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional EMS physician | Active comparator | Other: conventional EMS physicianThe dispatching personnel will evaluate the emergency call severity and after exclusion of the life-threatening cases listed in a written procedure instruction, they will dispatch a conventional EMS physician, if this is the result of the randomization software. |
| Tele-EMS physician | Other | Other: tele-EMS physicianThe dispatching personnel will evaluate the emergency call severity and after exclusion of the life-threatening cases listed in a written procedure instruction, they will dispatch a tele-EMS physician, if this is the result of the randomization software. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All non-life-threatening emergency calls, which do not obligatory require an EMS physician on scene and which do not solely require an ambulance vehicle staffed with paramedics. study.
Key exclusion criteria (26 listed)
- All life-threatening emergency cases, where a physically present EMS physician on scene is obligatory required. These include:
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 |
|---|---|---|
| conventional EMS physicianA physically present conventional EMS physician on scene, will treat the patients according to the standard operating procedures. | Other | Conventional EMS physician |
| tele-EMS physicianThe patients will be treated by the paramedics, which are concurrently instructed by the tele-EMS physicians of the tele consultation center according to the software-based guideline conform algorithms for diagnosis and treatment. | Other | Tele-EMS physician |
Primary outcome
Intervention-related adverse events
Time frame: 1 day
* Allergic reaction to drug application due to incorrect survey of patients' medical history * Intervention-related and immediate treatment requiring blood pressure drop * Intervention-related apnea or respiratory insufficiency * Intervention-related circulatory arrest
13 secondary outcomes
Treatment associated quality indicator
Time frame: 1 day
Treatment quality
Time frame: 1 day
Quality of the EMS-case data documentation
Time frame: 1 day
Duration of the physician engagement-time
Time frame: 1 day
Fulfillment of predefined quality indicators for "Tracer" diagnoses
Time frame: 1 day
Death
Time frame: 30 days
Intensive Care Unit (ICU) length of stay
Time frame: 30 days
Hospital length of stay
Time frame: 30 days
Correct pre-hospital diagnosis
Time frame: 30 days
Adverse events independently of the kind of EMS care
Time frame: 30 days
Premature termination of the telemedical or conventional EMS operation
Time frame: 1 day
Conversion of the initial dispatched tele-EMS treatment
Time frame: 1 day
Number of conventional EMS physician operations, which could be handled by a tele-EMS physician
Time frame: 1 day
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 9 Oct 2020.
- Background: PubMed 19221700Skorning M, Bergrath S, Rortgen D, Brokmann JC, Beckers SK, Protogerakis M, Brodziak T, Rossaint R. [E-health in emergency medicine - the research project Med-on-@ix]. Anaesthesist. 2009 Mar;58(3):285-92. doi: 10.1007/s00101-008-1502-z. German.
- Background: PubMed 26036316Brokmann JC, Rossaint R, Bergrath S, Valentin B, Beckers SK, Hirsch F, Jeschke S, Czaplik M. [Potential and effectiveness of a telemedical rescue assistance system. Prospective observational study on implementation in emergency medicine]. Anaesthesist. 2015 Jun;64(6):438-45. doi: 10.1007/s00101-015-0039-1. Epub 2015 Jun 3. German.
- Derived from this study: PubMed 40370704Hess PP, Czaplik M, Hess J, Schroder H, Beckers SK, Follmann A, Pitsch M, Felzen M. Comparison of the diagnostic concordance of tele-EMS and EMS physicians in the emergency medical service-a subanalysis of the TEMS-trial. Front Digit Health. 2025 Apr 30;7:1519619. doi: 10.3389/fdgth.2025.1519619. eCollection 2025.
- Derived from this study: PubMed 37391836Kowark A, Felzen M, Ziemann S, Wied S, Czaplik M, Beckers SK, Brokmann JC, Hilgers RD, Rossaint R; TEMS-study group. Telemedical support for prehospital emergency medical service in severe emergencies: an open-label randomised non-inferiority clinical trial. Crit Care. 2023 Jun 30;27(1):256. doi: 10.1186/s13054-023-04545-z.
- Derived from this study: PubMed 28126019Stevanovic A, Beckers SK, Czaplik M, Bergrath S, Coburn M, Brokmann JC, Hilgers RD, Rossaint R; TEMS Collaboration Group. Telemedical support for prehospital Emergency Medical Service (TEMS trial): study protocol for a randomized controlled trial. Trials. 2017 Jan 26;18(1):43. doi: 10.1186/s13063-017-1781-2.
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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.
Rolf Rossaint, Professor principal investigator
Department of Anesthesiology, University Hospital Aachen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional EMS physician and tele-EMS physician in people with Emergency, run by RWTH Aachen University 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 1 inclusion and 26 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 9 Oct 2020. 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?
Intervention-related adverse events (time frame: 1 day). 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 NCT02617875, 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 9 Oct 2020.