Telemedical Support for Prehospital Emergency Medical Service (TEMS)

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

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.

Study Overview

• Status: Completed
• Conditions: Emergency
• Intervention / Treatment: Other: conventional EMS physician; Other: tele-EMS physician

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.

• Study Type: Interventional
• Enrollment (Actual): 3534
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • Department of Anesthesiology, University Hospital Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment associated quality indicator	Quality of medical history survey (adherence to the guidelines).	1 day
Treatment quality	Adherence to the guidelines	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.	1 day
Duration of the physician engagement-time	start: first contact time-point, end: termination of contact	1 day
Fulfillment of predefined quality indicators for "Tracer" diagnoses	Tracer diagnoses; Stroke; Acute coronary syndrome; Pain therapy	1 day
Death	Death within 24 hours and until day 30 of hospitalization, respectively until discharge from hospital.	30 days
Intensive Care Unit (ICU) length of stay	start: ICU length of stay-end: ICU length of stay	30 days
Hospital length of stay	start: Hospital length of stay-end: Hospital length of stay	30 days
Correct pre-hospital diagnosis	Comparison to the hospital discharge diagnosis	30 days
Adverse events independently of the kind of EMS care	The incidence of adverse events (AE) and serious adverse events (SAE)	30 days
Premature termination of the telemedical or conventional EMS operation	Incidence of unnecessary EMS missions	1 day
Conversion of the initial dispatched tele-EMS treatment	Required conversion from the primary dispatched tele-EMS physician to a conventional EMS physician	1 day
Number of conventional EMS physician operations, which could be handled by a tele-EMS physician	Number of patients	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dates and treatment durations	Time point of the first contact with a physician, time span between the emergency call and hospital arrival	1 day
National Advisory Committee for Aeronautics (NACA) score	NACA score 0-7	1 day
Conversion of the initial dispatched conventional EMS treatment	Proportion of conventional emergency cases, which were passed to a tele-EMS physician (differentiated into medical need and lack of capacity)	1 day
Technical performance questionnaire	Questionnaire	1 day
Satisfaction survey	Qusetionnaire	30 days

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Rolf Rossaint, Professor, Department of Anesthesiology, University Hospital Aachen, Germany

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): September 6, 2019
• Study Completion (Actual): December 18, 2019

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Telemedicine; Pre-hospital; Remote treatment; Emergency medical system; Tele consultation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 15-069

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No