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| Med-on-@ix: Telemedical support for prehospital Emergency Medical Services in a randomised controlled trial |
| ISRCTN | ISRCTN83270177 |
| ClinicalTrials.gov identifier | |
| Public title | Med-on-@ix: Telemedical support for prehospital Emergency Medical Services in a randomised controlled trial |
| Scientific title | T-EMS2-Trial: TEleMedical Support in Emergency Medical Services in a prospective controlled trial |
| Acronym | T-EMS2-Trial |
| Serial number at source | Project-No.: 01MB07022 |
| 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. |
| Ethics approval | Local ethics committee approved on the 24th of March 2010 (ref: EK 141/09) |
| Study design | Single centre prospective interventional randomised controlled trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Acute stroke; acute coronary syndrome; all other medical emergencies requiring Emergency Medical Service |
| Participants - inclusion criteria | All patients who calls EMS in Aachen, Germany from March 1st to July 31st 2010 |
| Participants - exclusion criteria | Does not match inclusion criteria |
| Anticipated start date | 01/05/2010 |
| Anticipated end date | 30/09/2010 |
| Status of trial | Ongoing |
| Patient information material | 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 |
| Target number of participants | 1000 patients (500 study group, 500 control group) |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) | 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. |
| Sources of funding |
Joint funding (Project-No.: 01MB07022)
1. German Federal Ministry of Economics and Technology (BMWi) (Germany) 2. German Aerospace Centre (DLR) (Germany) Technical support and funding: 3. P3 Communications Engineering Company (Germany) 4. Philips Healthcare (Germany) |
| Trial website | http://www.medonaix.de |
| Publications | |
| Contact name | Dr Max Skorning |
| Address |
University Hospital Aachen, Department of Anaesthesiology
Pauwelsstr. 30 |
| City/town | Aachen |
| Zip/Postcode | 52074 |
| Country | Germany |
| Tel | +49 (0)241 80 91194 |
| Fax | +49 (0)241 80 82406 |
| mskorning@ukaachen.de | |
| Sponsor | University Hospital Aachen (Germany) |
| Address |
Department of Anaesthesiology
Pauwelsstr. 30 |
| City/town | Aachen |
| Zip/Postcode | 52074 |
| Country | Germany |
| Sponsor website: | http://www.anaesthesie.ukaachen.de |
| Date applied | 15/02/2010 |
| Last edited | 18/05/2010 |
| Date ISRCTN assigned | 18/05/2010 |
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