AzTrials
AzTrials

Telemedicine UsageNCT04127565

Implementation Strategy and Systemic Effects of Routine Telemedical Care in Prehospital Emergency Medicine

An observational study of Telemedicine Usage and Teleconsultation Usage, run by RWTH Aachen University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
How many people
51,649 participants
Where
No sites listed yet
Study dates
1 Apr 2013to 31 Mar 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Pre-implementation period: none Post-implementation period: Patients who refused teleconsultation.

About this study

Official title: Implementation Strategy From Research to Routine Care of a Comprehensive Prehospital Telemedicine System and Pre-post Analysis of Systemic Effects

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.

Read the 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.

Keywords
Telemedicine, Emergency Medical Service

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04127565
Study groupRoleWhat they receive
Pre-implementation periodAll emergency medical service missions (EMS) in the city of Aachen (Germany) from April 2013 to March 2014. Analysis of all ambulance calls and fraction of calls with support by an physician-staffed EMS unit, help of neighboring EMS units and helicopter emergency medical service units.
Post-implementation periodAll emergency medical service missions (EMS) in the city of Aachen (Germany) from April 2015 to March 2016. Analysis of all ambulance calls and fraction of calls with support by an physician-staffed EMS unit, help of neighboring EMS units and helicopter emergency medical service units. Additionally analysis of all ambulance calls with telemedical support.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Comparison between 1 year pre-implementation and 1 year post-implementation period.

Secondary outcomes (2)

  1. Usage of telemedical support in the post-implementation period

    Number of ambulance calls using telemedical support

    Measured: Through study completion in the post-implementation period (1 year)

  2. Provided medications during teleconsultation

    Number of delegated medications including opioids in the post-implementation phase

    Measured: Through study completion in the post-implementation period (1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2019
  2. Study start1 Apr 2013
  3. Primary completion31 Mar 2016
  4. Study completion31 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
51,649 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04127565
Sponsor's protocol ID
TNA2019-01
Status last verified
Oct 2019
First submitted
4 Oct 2019
Last updated
15 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29865891

  • 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.

    PubMed 28560799

  • 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.

    PubMed 28484212

  • 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.

    PubMed 27908843

  • 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.

    PubMed 27080747

  • 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.

    PubMed 26036316

  • 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.

    PubMed 22750663

  • 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.

    PubMed 22115932

  • 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.

    PubMed 21933897

  • 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.

    PubMed 33762230

Questions about this trial

What is this clinical trial studying?

An observational study of Telemedicine Usage and Teleconsultation Usage, run by RWTH Aachen University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in usage of physician staffed EMS units (time frame: Comparison between 1 year pre-implementation and 1 year post-implementation period.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04127565, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in