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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
3,534
A physically present conventional EMS physician on scene, will treat the patients according to the standard operating procedures.
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.
Department of Anesthesiology, University Hospital Aachen
Aachen, North Rhine-Westphalia, Germany
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
Time frame: 1 day
Treatment associated quality indicator
Quality of medical history survey (adherence to the guidelines).
Time frame: 1 day
Treatment quality
Adherence to the guidelines
Time frame: 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.
Time frame: 1 day
Duration of the physician engagement-time
start: first contact time-point, end: termination of contact
Time frame: 1 day
Fulfillment of predefined quality indicators for "Tracer" diagnoses
Tracer diagnoses * Stroke * Acute coronary syndrome * Pain therapy
Time frame: 1 day
Death
Death within 24 hours and until day 30 of hospitalization, respectively until discharge from hospital.
Time frame: 30 days
Intensive Care Unit (ICU) length of stay
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start: ICU length of stay-end: ICU length of stay
Time frame: 30 days
Hospital length of stay
start: Hospital length of stay-end: Hospital length of stay
Time frame: 30 days
Correct pre-hospital diagnosis
Comparison to the hospital discharge diagnosis
Time frame: 30 days
Adverse events independently of the kind of EMS care
The incidence of adverse events (AE) and serious adverse events (SAE)
Time frame: 30 days
Premature termination of the telemedical or conventional EMS operation
Incidence of unnecessary EMS missions
Time frame: 1 day
Conversion of the initial dispatched tele-EMS treatment
Required conversion from the primary dispatched tele-EMS physician to a conventional EMS physician
Time frame: 1 day
Number of conventional EMS physician operations, which could be handled by a tele-EMS physician
Number of patients
Time frame: 1 day