Telemedical Support for Prehospital Emergency Medical Service (TEMS)

RWTH Aachen University

Status: Completed

Conditions: Emergency

Treatments: Other: conventional EMS physician; Other: tele-EMS physician

Study type: Interventional

Funder types: Other

Identifiers

NCT02617875

15-069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,534 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• All life-threatening emergency cases, where a physically present EMS physician on scene is obligatory required. These include:

  1. Patient condition related indications:

     • Apnea
     • Acute respiratory failure
     • Cardiocirculatory arrest
     • ST-elevation myocardial infarction (STEMI)
     • Unconsciousness
     • Persistent seizure
     • Life- threatening rhythm disorder
     • Major trauma
     • Complex psychiatric disorders
     • Age < 18 years

  2. 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 design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,534 participants in 2 patient groups

Conventional EMS physician

Active Comparator group

Description:

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.

Treatment:

Other: conventional EMS physician

Tele-EMS physician

Other group

Description:

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.

Treatment:

Other: tele-EMS physician