Feasibility of Telemedicine Under Ambulance Station Conditions

Study Overview
=================
Brief Summary
-----------------
Our aim is to evaluate the feasibility of telemedicine in context of medical service in an ambulance station and in a further step in context of civil defense situations. The conditions in those situations are different to the usual usage of telemedicine in context of emergency medical services (EMS) like the Telenotarzt in Aachen. The medical personnel who are performing the medical treatment in ambulance stations or civil defense situations are most volunteers and are ordinarily not as experienced and educated as professional medical personnel in EMS. In case of civil defense situations, the personnel also must deal with shortage in material which we are not going to simulate in our study. The study will be realized at each one ambulance station at four large-scale events. Every time there will be a telemedicine workspace with an EMS-physician educated in telemedicine who can be contacted by briefed and equipped medical personnel according to the TeleSAN-standard. The emergency personnel start the patient's treatment according to their known standards and decide on their own whether they want to contact the tele-EMS-physician or not. Before starting the tele-consultation, every patient must declare his consent to the tele-consultation, otherwise tele-consultation cannot be realized, and the patient needs to be treated according to common standards. Due to spatial proximity of the telemedicine workspace and the ambulance station, the tele-EMS-physician can also work as an EMS-physician in the ambulance station if necessary. As a hypothesis we declare that telemedicine is feasible in context of an ambulance station. To evaluate the feasibility, we use patient's medical protocols, observations and surveys.

Detailed Description
-----------------
To evaluate the feasibility of telemedicine in context of an ambulance station with all the given restrictions compared to usage of telemedicine in emergency medical services (EMS), we will set up each one ambulance station at four large-scale events in Germany with a telemedicine infrastructure. The ambulance stations at such events are the primary place to go for visitors to get a primary medical care and is also used as a primary place for the patients of medical service providers on feet. As part of the telemedicine infrastructure, educated personnel is required. The study protocol defines that any medical personnel with the ability to use telemedicine must be declared as a Rettungssanitäter/in, a special paramedic qualification in Germany comparable to an EMT-I/85 (Intermediate) in the USA. These emergency personnel are called TeleSAN. Before the assignment in the ambulance station starts, every TeleSAN will be educated and briefed in the usage of the telemedical devices. The used equipment has been evaluated in context of the research project TeleSAN at the AcuteCare InnovationHub, University Hospital Aachen, Germany and is composed of a smartphone with a TeleSAN-app, a headset, and a camera. In addition to that, every TeleSAN in the ambulance station will be equipped with a Bluetooth-medical-device-set consisting of a mini-ECG, a blood glucose meter, a blood pressure cuff and a bluetooth-stethoscope which can stream all data in real-time to the tele-EMS-physician. To stream the data and as a communication platform, the TeleDoc-App for video-consultation and the TeleSAN-App which is based on the TeleDoc-App with a focus on disaster medicine, both developed by Docs in Clouds TeleCare GmbH, Aachen, Germany, will be used. Every patient who enters the ambulance station will be informed that a telemedicine-study is going on. In addition to that, the protocol defines a separate enlightenment for every patient who will be treated by telemedicine through the TeleSAN-operator before the teleconsultation starts. Whether telemedicine will be used for patient's treatment or not is at the discretion of the TeleSAN, who will always start the treatment on his / her own and evaluates if the patient meets any exclusion criteria which would lead to not-usage of telemedicine. In case of a none-given consent or in case of medical or technical necessity of termination of the teleconsultation, the tele-EMS-physician can work as a regular EMS-physician in the ambulance station thanks to spatial proximity. Therefore, we can guarantee a treatment according to the current medical standards all the time. In addition to the already listed medical devices, we will also have a defibrillator/ECG-monitor, a ventilator and a suction pump available for emergency situations. The aim is to evaluate if telemedicine is feasible in context of an ambulance station regarding medical protocols, observations, and surveys. In a further step an assessment of a possible usage of telemedicine in context of civil defense situations will be done.

Official Title
-----------------
The Tele-senior EMS Physician as a Strategy for the Future of Disaster Medicine - a Study Testing the Feasibility of Telemedicine in Civil Defense: Feasibility of Telemedicine Under Ambulance Station Conditions

Conditions
-----------------
Telemedicine, Disaster Medicine, Emergency Medicine

Intervention / Treatment
-----------------
* Other: Usage of telemedicine and tele-consultation for treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: full legal age capacity to consent Exclusion Criteria: apnea acute failure of breathing cardiac arrest STEMI unconsciousness status epilepticus life-threatening arrhythmia polytrauma non-manageable symptoms of a mental illness, self-endangerment, danger to others imminent birth serious traffic accident or traffic accident with children involved fall from a great height (>3m) gunshot or knife wounds to the head, neck or torso fire with personal damage high-voltage accident water accidents (drowning, swimming accidents, breaking in the ice) accidents with involvement of hazardous substances killing spree, hostage situations or other situations which endanger the lives of the medical personnel imminent threat of suizide non-consent

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention: Treatment with the aid of telemedicine<br>Telemedicine will be used to treat patients at an ambulance station. The medical interventions will be performed by a TeleSAN after delegation through a tele-EMS-physician if possible. | Other: Usage of telemedicine and tele-consultation for treatment<br>* Telemedicine will be used to treat patients at an ambulance station. The medical interventions will be performed by a TeleSAN after delegation through a tele-EMS-physician if possible.<br>|
| No intervention: Usual treatment<br>Treatment will be performed as usual without the usage of telemedicine. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of triage category using the German PRIOR algorithm (Primäres Ranking zur initialen Orientierung im Rettungsdienst) | Changes of the patient's medical condition will be measured using the german PRIOR algorithm which is used to triage patients in three categories: red, yellow and green. A change of triage category from red to yellow/green or from yellow to green means a better outcome, a change from green to yellow/red means a worse outcome. | through study completion, in total estimated 1 year | 
| Improvement of vital signs | Changes of the patient's medical condition will be measured by analyzing changes in the patient's vital signs. Changes from unphysiological to physiological vital signs mean a better outcome. | through study completion, in total estimated 1 year | 
| Improvement of NACA-Score (National Advisory Committee for Aeronautics) | Changes of the patient's medical condition will be measured using the NACA-Score. Changes from a lower to a higher score means a worse outcome. | through study completion, in total estimated 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of the telemedicine-devices and infrastructure and their reliable function | By analyzation of observation protocols, patient-surveys and personnel-surveys, the usability and the reliability can be evaluated | through study completion, in total estimated 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TeleSAN, Telemedicine, Remote Consultation, Remote Treatment, Emergency Medical Services, Disaster Medicine, Emergency Medicine, Teleconsultation, Tele-emergency physician, Quality of Health Care