Telemedical Support for Prehospital Emergency Medical Service

Emergency Clinical Trial

— TEMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617875
• Other study ID #: 15-069
• Status: Completed
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: December 18, 2019

Study information

• Verified date: October 2020
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3534
• Est. completion date: December 18, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency

Intervention

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 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.

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, University Hospital Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

Skorning M, Bergrath S, Rörtgen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dates and treatment durations	Time point of the first contact with a physician, time span between the emergency call and hospital arrival	1 day
Other	National Advisory Committee for Aeronautics (NACA) score	NACA score 0-7	1 day
Other	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
Other	Technical performance questionnaire	Questionnaire	1 day
Other	Satisfaction survey	Qusetionnaire	30 days
Primary	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	Treatment associated quality indicator	Quality of medical history survey (adherence to the guidelines).	1 day
Secondary	Treatment quality	Adherence to the guidelines	1 day
Secondary	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
Secondary	Duration of the physician engagement-time	start: first contact time-point, end: termination of contact	1 day
Secondary	Fulfillment of predefined quality indicators for "Tracer" diagnoses	Tracer diagnoses; Stroke; Acute coronary syndrome; Pain therapy	1 day
Secondary	Death	Death within 24 hours and until day 30 of hospitalization, respectively until discharge from hospital.	30 days
Secondary	Intensive Care Unit (ICU) length of stay	start: ICU length of stay-end: ICU length of stay	30 days
Secondary	Hospital length of stay	start: Hospital length of stay-end: Hospital length of stay	30 days
Secondary	Correct pre-hospital diagnosis	Comparison to the hospital discharge diagnosis	30 days
Secondary	Adverse events independently of the kind of EMS care	The incidence of adverse events (AE) and serious adverse events (SAE)	30 days
Secondary	Premature termination of the telemedical or conventional EMS operation	Incidence of unnecessary EMS missions	1 day
Secondary	Conversion of the initial dispatched tele-EMS treatment	Required conversion from the primary dispatched tele-EMS physician to a conventional EMS physician	1 day
Secondary	Number of conventional EMS physician operations, which could be handled by a tele-EMS physician	Number of patients	1 day