Clinical trial NCT02617875: Telemedical Support for Prehospital Emergency Medical Service
Official title: Telemedical Support for Prehospital Emergency Medical Service - a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergency
Keywords: Pre-hospital
Emergency medical system
Telemedicine
Tele consultation
Remote treatment
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 3534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention-related adverse events
timeFrame: 1 day
Secondary outcomes:
measure: Treatment associated quality indicator
timeFrame: 1 day
measure: Treatment quality
timeFrame: 1 day
measure: Quality of the EMS-case data documentation
timeFrame: 1 day
measure: Duration of the physician engagement-time
timeFrame: 1 day
measure: Fulfillment of predefined quality indicators for "Tracer" diagnoses
timeFrame: 1 day
measure: Death
timeFrame: 30 days
measure: Intensive Care Unit (ICU) length of stay
timeFrame: 30 days
measure: Hospital length of stay
timeFrame: 30 days
measure: Correct pre-hospital diagnosis
timeFrame: 30 days
measure: Adverse events independently of the kind of EMS care
timeFrame: 30 days
measure: Premature termination of the telemedical or conventional EMS operation
timeFrame: 1 day
measure: Conversion of the initial dispatched tele-EMS treatment
timeFrame: 1 day
measure: Number of conventional EMS physician operations, which could be handled by a tele-EMS physician
timeFrame: 1 day
Other outcomes:
measure: Dates and treatment durations
timeFrame: 1 day
measure: National Advisory Committee for Aeronautics (NACA) score
timeFrame: 1 day
measure: Conversion of the initial dispatched conventional EMS treatment
timeFrame: 1 day
measure: Technical performance questionnaire
timeFrame: 1 day
measure: Satisfaction survey
timeFrame: 30 days
Locations:
city: Aachen
country: Germany
facility: Department of Anesthesiology, University Hospital Aachen
state: NRW
Study officials:
affiliation: Department of Anesthesiology, University Hospital Aachen, Germany
name: Rolf Rossaint, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.