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Telemedical Support for Prehospital Emergency Medical Service (TEMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02617875
Recruitment Status : Active, not recruiting
First Posted : December 1, 2015
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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.


Condition or disease Intervention/treatment Phase
Emergency Other: conventional EMS physician Other: tele-EMS physician Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3534 participants
Allocation: Randomized
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
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Tele-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 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Germany
Department of Anesthesiology, University Hospital Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Rolf Rossaint, Professor Department of Anesthesiology, University Hospital Aachen, Germany
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02617875    
Other Study ID Numbers: 15-069
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RWTH Aachen University:
Pre-hospital
Emergency medical system
Telemedicine
Tele consultation
Remote treatment
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes