Feasibility of Telemedicine Under Ambulance Station Conditions

Telemedicine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05388071
• Other study ID #: 22-130
• Secondary ID: Notice No. 03/20
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: June 6, 2023

Study information

• Verified date: September 2023
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: June 6, 2023
• Est. primary completion date: July 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disaster Medicine
• Emergencies
• Emergency Medicine
• Telemedicine

Intervention

Other:
• Usage of telemedicine and tele-consultation for treatment
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.

Locations

Country	Name	City	State
Germany	University Hospital RWTH Aachen	Aachen	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time for treatment	time needed for treatment using telemedicine, also regarding binding time for the physician and end of telemedicinal delegated treatment	through study completion, in total estimated 1 year
Other	Experience and education	Using surveys for the medical personnel, experience and education can be evaluated on the one hand for medical experience and education and on the other hand for experience an education concerning telemedicine	through study completion, in total estimated 1 year
Other	Acceptance of telemedicine	By analyzation of surveys an evaluation of the personnel's acceptance of telemedicine will be performed	through study completion, in total estimated 1 year
Other	Reasons for the usage of telemedicine	By analyzation of the medical protocols and in addition surveys and observation protocols, an evaluation of the reasons for the usage of telemedicine will be performed	through study completion, in total estimated 1 year
Other	Sense of security of the patients treated by teleconsultation	By analyzation of surveys and observation protocols, an evaluation of the sense of security of the patients treated by teleconsultation will be performed	through study completion, in total estimated 1 year
Other	Measures in the context of mass gathering medicine that can be delegated telemedically	By analyzing all mission logs, the measures carried out by telemedicine and those carried out by on-site personnel without telemedicine are recorded. Subsequently, a three-stage Delphi process is carried out in which experienced tele-EMS-physicians use case descriptions to decide whether the measure can be delegated via telemedicine in the context of this case description.	retrospectively after all protocols have been evaluated, estimated until September 2023
Other	Number of missions in the Accident Assistance Center that can be handled using telemedicine	The results of the Delphi process (described in Outcome 10) can be used to evaluate what proportion of all cases that occurred could have been handled using telemedicine.	retrospectively after all protocols have been evaluated, estimated until September 2023
Primary	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
Primary	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
Primary	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	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

External Links

•   project page with additional information presented for lay people