Contact information
Type
Scientific
Primary contact
Dr Max Skorning
ORCID ID
Contact details
University Hospital Aachen
Department of Anaesthesiology
Pauwelsstr. 30
Aachen
52074
Germany
+49 (0)241 80 91194
mskorning@ukaachen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Project-No.: 01MB07022
Study information
Scientific title
T-EMS2-Trial: TEleMedical Support in Emergency Medical Services in a prospective controlled trial
Acronym
T-EMS2-Trial
Study hypothesis
The hypothesis is that the use of telemedical assistance (TMA) in a physician-powered Emergency Medical Service (EMS) will lead to
1. Improved guidelines coherence for stroke and acute coronary syndrome
2. Improved treatment time intervals for stroke and ST-Elevation myocardial infarction
3. Improved patient safety and patient outcome
4. Improved choice of appropriate hospital respiratory facility
5. Improved quality of pre-hospital diagnosis
and that the implementation of electronic documentation with integrated plausibility check will lead to
6. Improved quality of documentation in respect of medical and research purposes.
Secondary, the usability and feasibility of the system as well as the percentage of safe transferability of monitoring data will be observed and used for further improvement of the system.
Added 17/05/2011: We did not use electronic documentation as standard procedure. To ensure comparable data sources we used paper based documentation in both groups. Additionally we tested electronic documentation in some cases.
As of 19/05/2011 the study design has been updated. The previous study design was a 'Single centre prospective interventional randomised controlled trial'.
The patients were not randomised to ensure case numbers were high enough for the trial's purposes.
Ethics approval
Local ethics committee approved on the 24/032010 (ref: EK 141/09)
Study design
Prospective, controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Because of the fact, that patients receive at least standard EMS-care, no specific patient information material was developed. The community has been informed about the research project with local newspaper articles and with local TV. Patients may receive additional information via the project website: www.medonaix.de
Condition
Acute stroke; acute coronary syndrome; all other medical emergencies requiring Emergency Medical Service
Intervention
The study will be held in the EMS of Aachen. Within a period of five months totally, all inhabitants who have to make use of the EMS by calling the nationwide emergency phone number 112, will receive at least the recent standard in German EMS. This includes an EMS-physician staffed ambulance disposed according to predefined criteria given by the dispatch centre. There will be no special selection of patients at this stage of the study. The dispatcher decides which ambulance receives the mission on the basis of location and availableness. In this way patients receive either standard emergency care with or without additional telemedical assistance. Neither patients nor EMS-physicians or paramedics have influence over the dispatching.
Intervention group:
Use and documentation of Telemedical Assistance (TMA):
All monitoring data (ECG, blood pressure, pulseoximetry etc) is automatically transferred to a specialised computer workstation, where a TMA-physician observes the EMS-mission and advises the EMS-Team. Beside the monitoring data it is possible to transmit pictures (digital camera), 12-lead-ECG and video-stream (camera in ambulance) as and when required. The EMS-Team and the TMA-physician are able to communicate via a special, integrated mobile phones with headsets. All TMA-physicians are experienced, certified EMS-physicians. In the TMA-workstation they have access to several checklists, guidelines and medical online databases to provide additional information as needed.
All data transmission is carried out with a specifically developed transmission unit, using mobile phone networks. Up to date ciphering technologies are integrated to guaranty a maximum of data safety. (P3 communications, Aachen, Germany)
Agreement of the patient to transfer these data will be obtained in every case of a conscious patient.
Every EMS-Mission will be documented using an electronic documentation software with integrated plausibility check. For this purpose a specifically software was developed during the research project.
Hardware: Motion C5 Tablet PC, Motion Computing, Germany. Data of the EMS-documentation is used to evaluate coherence with medical guidelines.
All procedures are in accordance with national laws and guidelines as well as laws and guidelines of the European Union.
In the admitting hospital standard patient care is provided. Relevant time intervals are measured with the hospital IT infrastructure (e.g. time of Computer Assisted Tomography [CAT] scan, time of Percutaneous Coronary Intervention [PCI]).
Control group:
Documentation in standard care:
All missions are documented on standardised paper based protocols fulfilling current recommended national standard of the German Interdisciplinary Association of Critical Care Medicine (DIVI 4.2). Standard patient care is provided in EMS. Data of the EMS-documentation is used to evaluate coherence with medical guidelines
In the admitting hospital standard patient care is provided. Relevant time intervals are measured with the hospital IT infrastructure (e.g. time of CAT scan, time of PCI).
Follow-up ends, when the last of these patients is discharged from hospital. There is no further follow-up planned after the hospital discharge.
Added 17/05/2011: Electronic documentation was used as an additional tool in some missions. Standard procedure in both groups was paper based documentation.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Guideline coherence for stroke and acute coronary syndrome: measured with data of the medical records / EMS-documentation
2. Improved treatment time intervals for stroke and ST-Elevation myocardial infarction
2.1. on scene time (all patients)
2.2. call to hospital arrival time (all patients)
2.3. call to PCI time (STEMI)
2.4. call to computed tomography time (stroke)
2.5. call to thrombolysis time (stroke)
All time intervals are measured with the computer system of the EMS dispatch centre and the computer systems of the hospitals. Both are synchronised.
3. improved patient safety and patient outcome
3.1. documentation of critical events, evaluated with medical records
3.2. length of hospital stay, evaluated with medical records
3.3. mortality, evaluated with medical records
4. Improved choice of appropriate hospital respiratory facility
comparison of the diagnosis and the level of the receiving hospital, evaluated with medical records
5. Improved quality of pre-hospital diagnosis
comparison between diagnosis in EMS and the diagnosis in hospital, evaluated with medical records
6. Improved quality of documentation in respect of medical and research purposes.
comparison between data quality in standard EMS (paper based documentation) and EMS with TMA (electronic documentation with integrated plausibility check)
Secondary outcome measures
The usability and feasibility of the system as well as the percentage of safe transferability of monitoring data will be observed and used for further improvement of the system. These criteria are measured with predefined checklists, which have to been completed after each mission with TMA.
Overall trial start date
01/05/2010
Overall trial end date
30/09/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients who calls EMS in Aachen, Germany from May 1st to September 30th 2010 (as of 17/05/2011; March 1st to July 31st 2010 at time of registration)
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
1000 patients (500 study group, 500 control group)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/05/2010
Recruitment end date
30/09/2010
Locations
Countries of recruitment
Germany
Trial participating centre
University Hospital Aachen, Department of Anaesthesiology
Aachen
52074
Germany
Sponsor information
Organisation
University Hospital Aachen (Germany)
Sponsor details
Department of Anaesthesiology
Pauwelsstr. 30
Aachen
52074
Germany
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Joint funding (Project-No.: 01MB07022)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
German Federal Ministry of Economics and Technology (BMWi) (Germany)
Alternative name(s)
Funding Body Type
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Location
Funder name
German Aerospace Centre (DLR) (Germany)
Alternative name(s)
Funding Body Type
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Location
Funder name
Technical support and funding:
Alternative name(s)
Funding Body Type
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Location
Funder name
P3 Communications Engineering Company (Germany)
Alternative name(s)
Funding Body Type
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Location
Funder name
Philips Healthcare (Germany)
Alternative name(s)
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Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results of pilot study in http://www.ncbi.nlm.nih.gov/pubmed/22629331
Publication citations
-
Pilot study
Bergrath S, Reich A, Rossaint R, Rörtgen D, Gerber J, Fischermann H, Beckers SK, Brokmann JC, Schulz JB, Leber C, Fitzner C, Skorning M, Feasibility of prehospital teleconsultation in acute stroke--a pilot study in clinical routine., PLoS ONE, 2012, 7, 5, e36796, doi: 10.1371/journal.pone.0036796.