Quality of Telemedically Guided Prehospital Analgesia

Comparison of Analgesic Treatment Quality Between Prehospital Emergency Care of Telemedically Guided Paramedics and On-scene Physicians - a Retrospective Longitudinal Study

The purpose of this retrospective study is to analyze quality and adverse events of analgesia by telemedically supported paramedics in comparison to conventional treatment by on-scene emergency medical service (EMS) physicians in the EMS of the city of Aachen, Germany.

Study Overview

• Status: Completed
• Conditions: Analgesia; Telemedicine; Adverse Events; Prehospital; Ambulance; Opioids; Teleconsultation; Tele-emergency Medical Services; City of Aachen; Prehospital Emergency Medical Service Physician
• Intervention / Treatment: Procedure: physician operated telemedical prehospital analgesia; Procedure: prehospital analgesia by on-scene EMS physicians

Detailed Description

The standard emergency medical service (EMS) in Germany consists of a two-tiered system with ambulances (paramedics) and prehospital EMS physician units. For example, legal conditions restrict opioid-based analgesia to physicians. Based on pre-defined standards regional emergency dispatch centers deploy both kinds of emergency units.

In recent years telemedicine emerged as a complementary system in EMS that may provide remote medical expertise and sustain or even improve quality of medical treatment on-scene. Particularly, based on the results of the projects Med-on-@ix and TemRas (telemedical rescue assistance system), emergency telemedical services were gradually implemented in daily routine of the EMS of the city of Aachen, Germany.

In this retrospective study the quality and adverse events of analgesia by telemedically supported paramedics shall be compared to conventional treatment by on-scene EMS physicians in the EMS of the city of Aachen, Germany.

• Study Type: Observational
• Enrollment (Actual): 381

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • University Hospital Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients requiring prehospital pain treatment in the EMS of the city of Aachen

Description

Inclusion Criteria:

• Initial Numerical Rating Scale ≥ 5 and
• Documented administration of analgesics

Exclusion Criteria:

• Missing consent for telemedical consultation (in teleconsultation group)
• Initial NRS < 5
• Analgesia in non-ST-segment elevation acute coronary syndrome (Non-STEMI-ACS) and ST-elevating myocardial infarction (STEMI)
• Initially unconscious patient
• Inter-hospital transfer missions
• Cases involving both on-scene and telemedical-EMS physicians

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
telemedicine group; physician operated telemedical prehospital analgesia	Procedure: physician operated telemedical prehospital analgesia; Ambulances in the EMS of the city of Aachen are equipped with a portable telemedicine system. In emergencies requiring intravenous analgesia paramedics can use this system to contact the tele-EMS physician with an audio-connection. Vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) can be transferred in real-time. The transmission of still pictures - taken with an official smartphone - and video streaming from the inside of the ambulance are also possible. The tele-EMS physician supports the paramedics and can delegate the application of morphine and other analgesics based on two predefined algorithms for trauma and non-trauma cases that are displayed on a context-sensitive telemedical documentation system in the teleconsultation center.
historical control group; prehospital analgesia by on-scene EMS physicians	Procedure: prehospital analgesia by on-scene EMS physicians; This (control) group represents the conventional treatment in German emergency medical service (EMS). In addition to an ambulance manned with paramedics, a prehospital EMS physician is deployed to conduct analgesic treatment on-scene. Treatment data for this group are selected from the time period before implementing teleconsultation in routine and therefore represent a historical control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of analgesia	Decrease of value on the Numerical Rating Scale (NRS; 0-10). The NRS is applied at initial contact with the patient and at the end of the mission.	Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of adverse events	Respiratory and/or circulatory insufficiency and/or severe allergic reactions	Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.
Administered analgesics and their dosages		Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.
Number of patients with documented analgesia related (safety-) parameters (evaluated for each safety parameter separately)	Documentation of analgesia related parameters: heart rate (beats per minute), blood pressure (mmHg), oxygen saturation (0-100%), respiratory rate (respirations per minute), Glasgow coma scale (Numerical values 3 to 15), The above named parameters should be documented by EMS teams at first medical contact and at patient handover in the emergency room.	Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.
Occurrence of nausea and vomiting		Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Study Chair: Rolf Rossaint, Professor, MD, University Hospital RWTH Aachen; Principal Investigator: Sebastian Bergrath, MD, University Hospital RWTH Aachen

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: October 6, 2016
• First Posted (Estimate): October 10, 2016

Study Record Updates

• Last Update Posted (Estimate): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: telemedicine; adverse events; analgesia; opioids; ambulance; prehospital; teleconsultation; tele-emergency medical services; prehospital emergency medical service physician
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: Quality of Tele-Analgesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No additional research benefits.