Med-on-@ix: Telemedical support for prehospital Emergency Medicals Services in a prospective controlled trial
| ISRCTN | ISRCTN83270177 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83270177 |
| Secondary identifying numbers | Project-No.: 01MB07022 |
- Submission date
- 15/02/2010
- Registration date
- 18/05/2010
- Last edited
- 27/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Max Skorning
Scientific
Scientific
University Hospital Aachen, Department of Anaesthesiology
Pauwelsstr. 30
Aachen
52074
Germany
| Phone | +49 (0)241 80 91194 |
|---|---|
| mskorning@ukaachen.de |
Study information
| Study design | Prospective, controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant 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 |
| Scientific title | T-EMS2-Trial: TEleMedical Support in Emergency Medical Services in a prospective controlled trial |
| Study acronym | T-EMS2-Trial |
| Study objectives | 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(s) | Local ethics committee approved on the 24/032010 (ref: EK 141/09) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2010 |
| Completion date | 30/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 1000 patients (500 study group, 500 control group) |
| Key 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) |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/05/2010 |
| Date of final enrolment | 30/09/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
University Hospital Aachen, Department of Anaesthesiology
Aachen
52074
Germany
52074
Germany
Sponsor information
University Hospital Aachen (Germany)
Hospital/treatment centre
Hospital/treatment centre
Department of Anaesthesiology
Pauwelsstr. 30
Aachen
52074
Germany
| Website | http://www.anaesthesie.ukaachen.de |
|---|---|
"ROR" |
https://ror.org/02gm5zw39 |
Funders
Funder type
Government
Joint funding (Project-No.: 01MB07022)
No information available
German Federal Ministry of Economics and Technology (BMWi) (Germany)
No information available
German Aerospace Centre (DLR) (Germany)
No information available
Technical support and funding:
No information available
P3 Communications Engineering Company (Germany)
No information available
Philips Healthcare (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results of pilot study | 01/02/2012 | Yes | No |
Editorial Notes
27/09/2017: internal review.
