Telemedical Support for Prehospital Emergency Medical Service

Overview

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.

Full Title of Study: “Telemedical Support for Prehospital Emergency Medical Service – a Prospective Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 6, 2019

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.

Interventions

  • 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 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.

Arms, Groups and Cohorts

  • 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: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RWTH Aachen University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rolf Rossaint, Professor, Principal Investigator, Department of Anesthesiology, University Hospital Aachen, Germany

References

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.