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Telemedical Support for Prehospital Emergency Medical Service (TEMS)

Primary Purpose

Emergency

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
conventional EMS physician
tele-EMS physician
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Emergency focused on measuring Pre-hospital, Emergency medical system, Telemedicine, Tele consultation, Remote treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Anesthesiology, University Hospital Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Conventional EMS physician

Tele-EMS physician

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 24, 2015
Last Updated
October 8, 2020
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT02617875
Brief Title
Telemedical Support for Prehospital Emergency Medical Service
Acronym
TEMS
Official Title
Telemedical Support for Prehospital Emergency Medical Service - a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
September 6, 2019 (Actual)
Study Completion Date
December 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency
Keywords
Pre-hospital, Emergency medical system, Telemedicine, Tele consultation, Remote treatment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3534 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional EMS physician
Arm Type
Active Comparator
Arm 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.
Arm Title
Tele-EMS physician
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
conventional EMS physician
Intervention Description
A physically present conventional EMS physician on scene, will treat the patients according to the standard operating procedures.
Intervention Type
Other
Intervention Name(s)
tele-EMS physician
Intervention Description
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 Measure Information:
Title
Intervention-related adverse events
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Treatment associated quality indicator
Description
Quality of medical history survey (adherence to the guidelines).
Time Frame
1 day
Title
Treatment quality
Description
Adherence to the guidelines
Time Frame
1 day
Title
Quality of the EMS-case data documentation
Description
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.
Time Frame
1 day
Title
Duration of the physician engagement-time
Description
start: first contact time-point, end: termination of contact
Time Frame
1 day
Title
Fulfillment of predefined quality indicators for "Tracer" diagnoses
Description
Tracer diagnoses Stroke Acute coronary syndrome Pain therapy
Time Frame
1 day
Title
Death
Description
Death within 24 hours and until day 30 of hospitalization, respectively until discharge from hospital.
Time Frame
30 days
Title
Intensive Care Unit (ICU) length of stay
Description
start: ICU length of stay-end: ICU length of stay
Time Frame
30 days
Title
Hospital length of stay
Description
start: Hospital length of stay-end: Hospital length of stay
Time Frame
30 days
Title
Correct pre-hospital diagnosis
Description
Comparison to the hospital discharge diagnosis
Time Frame
30 days
Title
Adverse events independently of the kind of EMS care
Description
The incidence of adverse events (AE) and serious adverse events (SAE)
Time Frame
30 days
Title
Premature termination of the telemedical or conventional EMS operation
Description
Incidence of unnecessary EMS missions
Time Frame
1 day
Title
Conversion of the initial dispatched tele-EMS treatment
Description
Required conversion from the primary dispatched tele-EMS physician to a conventional EMS physician
Time Frame
1 day
Title
Number of conventional EMS physician operations, which could be handled by a tele-EMS physician
Description
Number of patients
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
Dates and treatment durations
Description
Time point of the first contact with a physician, time span between the emergency call and hospital arrival
Time Frame
1 day
Title
National Advisory Committee for Aeronautics (NACA) score
Description
NACA score 0-7
Time Frame
1 day
Title
Conversion of the initial dispatched conventional EMS treatment
Description
Proportion of conventional emergency cases, which were passed to a tele-EMS physician (differentiated into medical need and lack of capacity)
Time Frame
1 day
Title
Technical performance questionnaire
Description
Questionnaire
Time Frame
1 day
Title
Satisfaction survey
Description
Qusetionnaire
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Rossaint, Professor
Organizational Affiliation
Department of Anesthesiology, University Hospital Aachen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, University Hospital Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19221700
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.
Results Reference
background
PubMed Identifier
26036316
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.
Results Reference
background
PubMed Identifier
28126019
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.
Results Reference
derived

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Telemedical Support for Prehospital Emergency Medical Service

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