Telemedical support for prehospital emergency medical service in severe emergencies: an open-label randomised non-inferiority clinical trial

Abstract

Background A tele-emergency medical service with a remote emergency physician for severe prehospital emergencies may overcome the increasing number of emergency calls and shortage of emergency medical service providers. We analysed whether routine use of a tele-emergency medical service is non-inferior to a conventional physician-based one in the occurrence of intervention-related adverse events. Methods This open-label, randomised, controlled, parallel-group, non-inferiority trial included all routine severe emergency patients aged ≥ 18 years within the ground-based ambulance service of Aachen, Germany. Patients were randomised in a 1:1 allocation ratio to receive either tele-emergency medical service (n = 1764) or conventional physician-based emergency medical service (n = 1767). The primary outcome was the occurrence of intervention-related adverse events with suspected causality to the group assignment. The trial was registered with ClinicalTrials.gov (NCT02617875) on 30 November 2015 and is reported in accordance with the CONSORT statement for non-inferiority trials. Results Among 3531 randomised patients, 3220 were included in the primary analysis (mean age, 61.3 years; 53.8% female); 1676 were randomised to the conventional physician-based emergency medical service (control) group and 1544 to the tele-emergency medical service group. A physician was not deemed necessary in 108 of 1676 cases (6.4%) and 893 of 1544 cases (57.8%) in the control and tele-emergency medical service groups, respectively. The primary endpoint occurred only once in the tele-emergency medical service group. The Newcombe hybrid score method confirmed the non-inferiority of the tele-emergency medical service, as the non-inferiority margin of − 0.015 was not covered by the 97.5% confidence interval of − 0.0046 to 0.0025. Conclusions Among severe emergency cases, tele-emergency medical service was non-inferior to conventional physician-based emergency medical service in terms of the occurrence of adverse events.

Long-term effects of a prehospital telemedicine system on structural and process quality indicators of an emergency medical service

“…This was not manageable in Aachen, as ambulances still document in hand-written mission protocols. The decline of tele-EMS missions from 2018 to 2019 due to the TEMS-study has already been elaborated previously in the discussion 18 , 26 .…”

“…Strikingly, there is a recognizable peak of EMS physician missions in 2018 and 2019 and a drop of tele-EMS missions in 2019. Most likely this is related to the conduction of the randomized, controlled, parallel-group trial “TEMS” (“Telemedical support for prehospital Emergency Medical Service”, NCT02617875), which was the first RCT in this field to compare non-inferiority of patient treatment of a tele-EMS physician versus an onsite physician in 1500 missions 18 , 26 . The study design of the TEMS trial required a randomized alarm from an onsite physician for a potential tele-EMS indication from August 2018 until September 2019.…”

“…In the field of patient care research, tele-EMS physicians provide care for stroke, hypertensive crisis, acute coronary syndrome, analgesia, immobilization in mild trauma, diagnostic concordance of tele-EMS physicians, and life-threatening missions 10 , 13 – 17 . Furthermore, one randomized controlled trial has reported non-inferiority of tele-EMS physicians compared to onsite EMS physicians lately 18 .…”

Telemedicine for emergency patient rescue

“…As an extension to this concept, the use of telemedicine for prehospital emergent patient evaluation may also help overcome the rising numbers of emergency room (ER) visits and shortage of ER physicians. In an open-label trial, tele-emergency medical service was found to be noninferior compared to conventional physician-based emergency medical service in regard to adverse events such as respiratory insufficiency, cardiac arrest, and hypotension [34]. Similarly, prehospital evaluation of stroke patients has been practiced for several years.…”