NCT02617875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,534

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
2.6 years until next milestone

Study Start

First participant enrolled

July 9, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2019

Completed
Last Updated

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

November 24, 2015

Last Update Submit

October 8, 2020

Conditions

Emergency

Keywords

Pre-hospitalEmergency medical systemTelemedicineTele consultationRemote treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Treatment associated quality indicator

    1 day

  • Treatment quality

    1 day

  • Quality of the EMS-case data documentation

    1 day

  • Duration of the physician engagement-time

    1 day

  • Fulfillment of predefined quality indicators for "Tracer" diagnoses

    1 day

  • +8 more secondary outcomes

Other Outcomes (5)

  • Dates and treatment durations

    1 day

  • National Advisory Committee for Aeronautics (NACA) score

    1 day

  • Conversion of the initial dispatched conventional EMS treatment

    1 day

  • +2 more other outcomes

Study Arms (2)

Conventional EMS physician

ACTIVE COMPARATOR

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

Tele-EMS physician

OTHER

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

Interventions

conventional EMS physicianOTHER

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

Conventional EMS physician
tele-EMS physicianOTHER

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.

Tele-EMS physician

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (5)

  • 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.

    PMID: 19221700BACKGROUND

  • 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.

    PMID: 26036316BACKGROUND

  • Hess PP, Czaplik M, Hess J, Schroder H, Beckers SK, Follmann A, Pitsch M, Felzen M. Comparison of the diagnostic concordance of tele-EMS and EMS physicians in the emergency medical service-a subanalysis of the TEMS-trial. Front Digit Health. 2025 Apr 30;7:1519619. doi: 10.3389/fdgth.2025.1519619. eCollection 2025.

    PMID: 40370704DERIVED

  • Kowark A, Felzen M, Ziemann S, Wied S, Czaplik M, Beckers SK, Brokmann JC, Hilgers RD, Rossaint R; TEMS-study group. Telemedical support for prehospital emergency medical service in severe emergencies: an open-label randomised non-inferiority clinical trial. Crit Care. 2023 Jun 30;27(1):256. doi: 10.1186/s13054-023-04545-z.

    PMID: 37391836DERIVED

  • 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.

    PMID: 28126019DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rolf Rossaint, Professor

    Department of Anesthesiology, University Hospital Aachen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 1, 2015

Study Start

July 9, 2018

Primary Completion

September 6, 2019

Study Completion

December 18, 2019

Last Updated

October 9, 2020

Record last verified: 2020-10

Locations

DE(1)