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

October 12, 2019 updated by: Dr. med. Sebastian Bergrath, RWTH Aachen University

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

51649

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pre-implementation period

All 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 period

All 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in usage of physician staffed EMS units
Time Frame: Comparison between 1 year pre-implementation and 1 year post-implementation period.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usage of telemedical support in the post-implementation period
Time Frame: Through study completion in the post-implementation period (1 year)
Number of ambulance calls using telemedical support
Through study completion in the post-implementation period (1 year)
Provided medications during teleconsultation
Time Frame: Through study completion in the post-implementation period (1 year)
Number of delegated medications including opioids in the post-implementation phase
Through study completion in the post-implementation period (1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Study Director: Rolf Rossaint, Prof. Dr., University Hospital Aachen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

March 31, 2016

Study Completion (Actual)

March 31, 2016

Study Registration Dates

First Submitted

October 4, 2019

First Submitted That Met QC Criteria

October 12, 2019

First Posted (Actual)

October 15, 2019

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 12, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNA2019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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