Clinical trial NCT04127565: Implementation Strategy and Systemic Effects of Routine Telemedical Care in Prehospital Emergency Medicine
Official title: Implementation Strategy From Research to Routine Care of a Comprehensive Prehospital Telemedicine System and Pre-post Analysis of Systemic Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Telemedicine Usage
Teleconsultation Usage
Emergency Medical Service Missions
Keywords: Telemedicine
Emergency Medical Service
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 51649
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-intervention period:

Only standard care was provided. No patient data was obtained, only number of emergency calls and used resources were analyzed.

Post-intervention period:

Evaluation of conducted medical procedures in patients who received telemedical support (after given verbal consent). Number of emergency calls and used resources were compared to the pre-intervention period.

Brief summary: 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.

Detailed description: In two interdisciplinary research projects a comprehensive prehospital telemedicine system was developed and general feasibility as well as impact on guideline adherence were evaluated. Feasibility and general safety were demonstrated. These results allowed stepwise implementation into medical routine care during a one year phase. During implementation positive effects on guideline adherence were found. Despite positive results there are many barriers that prevent implementation of research projects into routine medical care. Therefore, the current study evaluated and interpreted all steps and milestones from the research idea to implementation and evaluated them descriptively. Using a pre-post intervention analysis the systemic effects of the implementation on change in emergency medical resource utilization were analyzed. Resource utilization of physician staffed emergency medical service units was compared between a pre-implementation period (12 months, April 2013 - March 2014) and a post-implementation period (12 months, April 2015 - March 2016). During the pre-implementation period only standard care was available.

Inclusion criteria: All emergency medical service (EMS) missions in both periods.

Data sources: Electronic health records of the EMS missions (data pseudonymity) and database of the regional EMS dispatch center.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in usage of physician staffed EMS units
timeFrame: Comparison between 1 year pre-implementation and 1 year post-implementation period.
Secondary outcomes:
measure: Usage of telemedical support in the post-implementation period
timeFrame: Through study completion in the post-implementation period (1 year)
measure: Provided medications during teleconsultation
timeFrame: Through study completion in the post-implementation period (1 year)
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Aachen, Germany
name: Rolf Rossaint, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Bergrath S, Muller 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.
citation: Brokmann JC, Rossaint R, Muller 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.
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.
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. doi: 10.2196/jmir.6358.
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.
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.
citation: Rortgen 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.
citation: Skorning M, Bergrath S, Rortgen 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.
citation: Bergrath S, Rortgen 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.
citation: Bergrath S, Brokmann JC, Beckers S, Felzen M, Czaplik M, Rossaint R. Implementation of a full-scale prehospital telemedicine system: evaluation of the process and systemic effects in a pre-post intervention study. BMJ Open. 2021 Mar 24;11(3):e041942. doi: 10.1136/bmjopen-2020-041942.