Telemedical Support for Prehospital Emergency Medical Service (TEMS)
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|ClinicalTrials.gov Identifier: NCT02617875|
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : October 9, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Emergency||Other: conventional EMS physician Other: tele-EMS physician||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3534 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Telemedical Support for Prehospital Emergency Medical Service - a Prospective Randomized Controlled Trial|
|Actual Study Start Date :||July 9, 2018|
|Actual Primary Completion Date :||September 6, 2019|
|Actual Study Completion Date :||December 18, 2019|
Active Comparator: Conventional EMS physician
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.
Other: conventional EMS physician
A physically present conventional EMS physician on scene, will treat the patients according to the standard operating procedures.
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.
Other: tele-EMS physician
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.
- 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
- Treatment associated quality indicator [ Time Frame: 1 day ]Quality of medical history survey (adherence to the guidelines).
- Treatment quality [ Time Frame: 1 day ]Adherence to the guidelines
- Quality of the EMS-case data documentation [ Time Frame: 1 day ]
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.
- Duration of the physician engagement-time [ Time Frame: 1 day ]start: first contact time-point, end: termination of contact
- Fulfillment of predefined quality indicators for "Tracer" diagnoses [ Time Frame: 1 day ]
- Acute coronary syndrome
- Pain therapy
- Death [ Time Frame: 30 days ]Death within 24 hours and until day 30 of hospitalization, respectively until discharge from hospital.
- Intensive Care Unit (ICU) length of stay [ Time Frame: 30 days ]start: ICU length of stay-end: ICU length of stay
- Hospital length of stay [ Time Frame: 30 days ]start: Hospital length of stay-end: Hospital length of stay
- Correct pre-hospital diagnosis [ Time Frame: 30 days ]Comparison to the hospital discharge diagnosis
- Adverse events independently of the kind of EMS care [ Time Frame: 30 days ]The incidence of adverse events (AE) and serious adverse events (SAE)
- Premature termination of the telemedical or conventional EMS operation [ Time Frame: 1 day ]Incidence of unnecessary EMS missions
- Conversion of the initial dispatched tele-EMS treatment [ Time Frame: 1 day ]Required conversion from the primary dispatched tele-EMS physician to a conventional EMS physician
- Number of conventional EMS physician operations, which could be handled by a tele-EMS physician [ Time Frame: 1 day ]Number of patients
- Dates and treatment durations [ Time Frame: 1 day ]Time point of the first contact with a physician, time span between the emergency call and hospital arrival
- National Advisory Committee for Aeronautics (NACA) score [ Time Frame: 1 day ]NACA score 0-7
- Conversion of the initial dispatched conventional EMS treatment [ Time Frame: 1 day ]Proportion of conventional emergency cases, which were passed to a tele-EMS physician (differentiated into medical need and lack of capacity)
- Technical performance questionnaire [ Time Frame: 1 day ]Questionnaire
- Satisfaction survey [ Time Frame: 30 days ]Qusetionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617875
|Department of Anesthesiology, University Hospital Aachen|
|Aachen, NRW, Germany, 52074|
|Principal Investigator:||Rolf Rossaint, Professor||Department of Anesthesiology, University Hospital Aachen, Germany|