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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional EMS physician | Other | A physically present conventional EMS physician on scene, will treat the patients according to the standard operating procedures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intervention-related adverse events |
| 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment associated quality indicator | Quality of medical history survey (adherence to the guidelines). | 1 day |
| Treatment quality | Adherence to the guidelines |
| Measure | Description | Time Frame |
|---|---|---|
| Dates and treatment durations | Time point of the first contact with a physician, time span between the emergency call and hospital arrival | 1 day |
| National Advisory Committee for Aeronautics (NACA) score |
Inclusion Criteria:
Exclusion Criteria:
All life-threatening emergency cases, where a physically present EMS physician on scene is obligatory required. These include:
Patient condition related indications:
Emergency case related indications
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| Name | Affiliation | Role |
|---|---|---|
| Rolf Rossaint, Professor | Department of Anesthesiology, University Hospital Aachen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, University Hospital Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19221700 | Background | 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. | |
| 26036316 | Background | Brokmann 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. |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| tele-EMS physician | Other | 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. |
|
| 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. | 1 day |
| Duration of the physician engagement-time | start: first contact time-point, end: termination of contact | 1 day |
| Fulfillment of predefined quality indicators for "Tracer" diagnoses | Tracer diagnoses
| 1 day |
| Death | Death within 24 hours and until day 30 of hospitalization, respectively until discharge from hospital. | 30 days |
| Intensive Care Unit (ICU) length of stay | start: ICU length of stay-end: ICU length of stay | 30 days |
| Hospital length of stay | start: Hospital length of stay-end: Hospital length of stay | 30 days |
| Correct pre-hospital diagnosis | Comparison to the hospital discharge diagnosis | 30 days |
| Adverse events independently of the kind of EMS care | The incidence of adverse events (AE) and serious adverse events (SAE) | 30 days |
| Premature termination of the telemedical or conventional EMS operation | Incidence of unnecessary EMS missions | 1 day |
| Conversion of the initial dispatched tele-EMS treatment | Required conversion from the primary dispatched tele-EMS physician to a conventional EMS physician | 1 day |
| Number of conventional EMS physician operations, which could be handled by a tele-EMS physician | Number of patients | 1 day |
NACA score 0-7
| 1 day |
| Conversion of the initial dispatched conventional EMS treatment | Proportion of conventional emergency cases, which were passed to a tele-EMS physician (differentiated into medical need and lack of capacity) | 1 day |
| Technical performance questionnaire | Questionnaire | 1 day |
| Satisfaction survey | Qusetionnaire | 30 days |
| 40370704 | Derived | Hess 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. |
| 37391836 | Derived | Kowark 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. |
| 28126019 | Derived | Stevanovic 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. |