Emergency Medical Service Missions Clinical Trial
Official title:
Implementation Strategy From Research to Routine Care of a Comprehensive Prehospital Telemedicine System and Pre-post Analysis of Systemic Effects
| NCT number | NCT04127565 |
| Other study ID # | TNA2019-01 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2013 |
| Est. completion date | March 31, 2016 |
| Verified date | October 2019 |
| Source | RWTH Aachen University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
In two research projects a comprehensive prehospital telemedicine system was developed and
general feasibility as well as impact on guideline adherence were evaluated. These results
allowed stepwise implementation into medical routine care.
All steps and milestones from the research idea to implementation were analyzed and evaluated
descriptively in this study. Using a pre-post intervention analysis the systemic effects of
the implementation on change in emergency medical resource utilization were analyzed.
| Status | Completed |
| Enrollment | 51649 |
| Est. completion date | March 31, 2016 |
| Est. primary completion date | March 31, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: All patients treated by emergency medical service during the pre- and post-implementation period. Post-implementation period: Patients had to give verbal consent prior to teleconsultation. Exclusion Criteria: Pre-implementation period: none Post-implementation period: Patients who refused teleconsultation. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| RWTH Aachen University |
Bergrath S, Müller M, Rossaint R, Beckers SK, Uschner D, Brokmann JC. Guideline adherence in acute coronary syndromes between telemedically supported paramedics and conventional on-scene physician care: A longitudinal pre-post intervention cohort study. Health Informatics J. 2019 Dec;25(4):1528-1537. doi: 10.1177/1460458218775157. Epub 2018 Jun 4. — View Citation
Bergrath S, Rörtgen D, Rossaint R, Beckers SK, Fischermann H, Brokmann JCh, Czaplik M, Felzen M, Schneiders MT, Skorning M. Technical and organisational feasibility of a multifunctional telemedicine system in an emergency medical service - an observational study. J Telemed Telecare. 2011;17(7):371-7. doi: 10.1258/jtt.2011.110203. Epub 2011 Sep 20. — View Citation
Brokmann JC, Conrad C, Rossaint R, Bergrath S, Beckers SK, Tamm M, Czaplik M, Hirsch F. Treatment of Acute Coronary Syndrome by Telemedically Supported Paramedics Compared With Physician-Based Treatment: A Prospective, Interventional, Multicenter Trial. J Med Internet Res. 2016 Dec 1;18(12):e314. — View Citation
Brokmann JC, Rossaint R, Bergrath S, Valentin B, Beckers SK, Hirsch F, Jeschke S, Czaplik M. [Potential and effectiveness of a telemedical rescue assistance system. Prospective observational study on implementation in emergency medicine]. Anaesthesist. 2015 Jun;64(6):438-45. doi: 10.1007/s00101-015-0039-1. Epub 2015 Jun 3. German. — View Citation
Brokmann JC, Rossaint R, Müller M, Fitzner C, Villa L, Beckers SK, Bergrath S. Blood pressure management and guideline adherence in hypertensive emergencies and urgencies: A comparison between telemedically supported and conventional out-of-hospital care. J Clin Hypertens (Greenwich). 2017 Jul;19(7):704-712. doi: 10.1111/jch.13026. Epub 2017 May 30. — View Citation
Felzen M, Brokmann JC, Beckers SK, Czaplik M, Hirsch F, Tamm M, Rossaint R, Bergrath S. Improved technical performance of a multifunctional prehospital telemedicine system between the research phase and the routine use phase - an observational study. J Telemed Telecare. 2017 Apr;23(3):402-409. doi: 10.1177/1357633X16644115. Epub 2016 Apr 13. — View Citation
Lenssen N, Krockauer A, Beckers SK, Rossaint R, Hirsch F, Brokmann JC, Bergrath S. Quality of analgesia in physician-operated telemedical prehospital emergency care is comparable to physician-based prehospital care - a retrospective longitudinal study. Sci Rep. 2017 May 8;7(1):1536. doi: 10.1038/s41598-017-01437-5. — View Citation
Rörtgen D, Bergrath S, Rossaint R, Beckers SK, Fischermann H, Na IS, Peters D, Fitzner C, Skorning M. Comparison of physician staffed emergency teams with paramedic teams assisted by telemedicine--a randomized, controlled simulation study. Resuscitation. 2013 Jan;84(1):85-92. doi: 10.1016/j.resuscitation.2012.06.012. Epub 2012 Jun 30. — View Citation
Skorning M, Bergrath S, Rörtgen D, Beckers SK, Brokmann JC, Gillmann B, Herding J, Protogerakis M, Fitzner C, Rossaint R; Med-on-@ix-Working Group. Teleconsultation in pre-hospital emergency medical services: real-time telemedical support in a prospective controlled simulation study. Resuscitation. 2012 May;83(5):626-32. doi: 10.1016/j.resuscitation.2011.10.029. Epub 2011 Nov 22. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in usage of physician staffed EMS units | Change in usage of physician staffed EMS units (ground based and helicopter based). Comparison between the pre- and post-implementation period. | Comparison between 1 year pre-implementation and 1 year post-implementation period. | |
| Secondary | Usage of telemedical support in the post-implementation period | Number of ambulance calls using telemedical support | Through study completion in the post-implementation period (1 year) | |
| Secondary | Provided medications during teleconsultation | Number of delegated medications including opioids in the post-implementation phase | Through study completion in the post-implementation period (1 year) |