Telemedical Support for Prehospital Emergency Medical Service

Study Overview
=================
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.

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

Conditions
-----------------
Emergency

Intervention / Treatment
-----------------
* Other: conventional EMS physician
* Other: tele-EMS physician


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional EMS physician<br>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<br>* A physically present conventional EMS physician on scene, will treat the patients according to the standard operating procedures.<br>|
| Other: Tele-EMS physician<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-hospital, Emergency medical system, Telemedicine, Tele consultation, Remote treatment