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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

Telemedical support for prehospital Emergency Medical Service (TEMS trial): study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Ana Stevanovic, Stefan Kurt Beckers, Michael Czaplik, Sebastian Bergrath, Mark Coburn, Jörg Christian Brokmann, Ralf-Dieter Hilgers, Rolf Rossaint, TEMS Collaboration Group
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-1781-2) contains supplementary material, which is available to authorized users.

Abstract

Background

Increasing numbers of emergency calls, shortages of Emergency Medical Service (EMS), physicians, prolonged emergency response times and regionally different quality of treatment by EMS physicians require improvement of this system. Telemedical solutions have been shown to be beneficial in different emergency projects, focused on specific disease patterns. Our previous pilot studies have shown that the implementation of a holistic prehospital EMS teleconsultation system, between paramedics and experienced tele-EMS physicians, is safe and feasible in different emergency situations. We aim to extend the clinical indications for this teleconsultation system. We hypothesize that the use of a tele-EMS physician is noninferior regarding the occurrence of system-induced patient adverse events and superior regarding secondary outcome parameters, such as the quality of guideline-conforming treatment and documentation, when compared to conventional EMS-physician treatment.

Methods/design

Three thousand and ten patients will be included in this single-center, open-label, randomized controlled, noninferiority trial with two parallel arms. According to the inclusion criteria, all emergency cases involving adult patients who require EMS-physician treatment, excluding life-threatening cases, will be randomly assigned by the EMS dispatching center into two groups. One thousand five hundred and five patients in the control group will be treated by a conventional EMS physician on scene, and 1505 patients in the intervention group will be treated by paramedics who are concurrently instructed by the tele-EMS physicians at the teleconsultation center. The primary outcome measure will include the rate of treatment-specific adverse events in relation to the kind of EMS physician used. The secondary outcome measures will record the specific treatment-associated quality indicators.

Discussion

The evidence underlines the better quality of service using telemedicine networks between medical personnel and medical experts in prehospital emergency care, as well as in other medical areas. The worldwide unique EMS teleconsultation system in Aachen has been optimized and evaluated in pilot studies and subsequently integrated into routine use for a broad spectrum of indications. It has enabled prompt, safe and efficient patient treatment with optimized use of the “resource” EMS physician. There is, however, a lack of evidence as to whether the advantages of the teleconsultation system can be replicated in wider-ranging EMS-physician indications (excluding life-threatening emergency calls).

Trial registration

ClinicalTrials.gov, identifier: NCT02617875. Registered on 24 November 2015.
Zusatzmaterial
Additional file 1: SPIRIT Checklist. (DOC 123 kb)
13063_2017_1781_MOESM1_ESM.doc
Additional file 2: Participant timeline: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram. (PDF 123 kb)
13063_2017_1781_MOESM2_ESM.pdf
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