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Completed

NCT Number: NCT02617875

Telemedical Support for Prehospital Emergency Medical Service

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.

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Key information

Conditions

Emergency Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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
  • 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

Treatment and study plan

conventional EMS physician

Other

A physically present conventional EMS physician on scene, will treat the patients according to the standard operating procedures.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Treatment associated quality indicator

    Time frame: 1 day

    Quality of medical history survey (adherence to the guidelines).

  2. Treatment quality

    Time frame: 1 day

    Adherence to the guidelines

  3. 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.

  4. Duration of the physician engagement-time

    Time frame: 1 day

    start: first contact time-point, end: termination of contact

  5. Fulfillment of predefined quality indicators for "Tracer" diagnoses

    Time frame: 1 day

    Tracer diagnoses

    • Stroke
    • Acute coronary syndrome
    • Pain therapy

  6. Death

    Time frame: 30 days

    Death within 24 hours and until day 30 of hospitalization, respectively until discharge from hospital.

  7. Intensive Care Unit (ICU) length of stay

    Time frame: 30 days

    start: ICU length of stay-end: ICU length of stay

  8. Hospital length of stay

    Time frame: 30 days

    start: Hospital length of stay-end: Hospital length of stay

  9. Correct pre-hospital diagnosis

    Time frame: 30 days

    Comparison to the hospital discharge diagnosis

  10. Adverse events independently of the kind of EMS care

    Time frame: 30 days

    The incidence of adverse events (AE) and serious adverse events (SAE)

  11. Premature termination of the telemedical or conventional EMS operation

    Time frame: 1 day

    Incidence of unnecessary EMS missions

  12. 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

  13. Number of conventional EMS physician operations, which could be handled by a tele-EMS physician

    Time frame: 1 day

    Number of patients

Other outcomes

  1. 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

  2. National Advisory Committee for Aeronautics (NACA) score

    Time frame: 1 day

    NACA score 0-7

  3. 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)

  4. Technical performance questionnaire

    Time frame: 1 day

    Questionnaire

  5. Satisfaction survey

    Time frame: 30 days

    Qusetionnaire

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

Telemedical Support for Prehospital Emergency Medical Service - a Prospective Randomized Controlled Trial

Acronym: TEMS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 1, 2015
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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