Skip to main content
OpenTrials
Completed

NCT Number: NCT04312321

Audiovisual Consultations in Prehospital Emergency Care: Randomised Controlled Trial

This study investigates safety and efficacy of the use of audiovisual consultations of emergency medical service (EMS) doctor by paramedics for low urgency events in areas covered with paramedic crews only from emergency medical service stations with distant access to hospital.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Telemedicine Emergency Medical Service

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zdravotnická záchranná služba Karlovarského kraje, p.o.

Karlovy Vary, Carlsbad Region, 360 06, Czechia

About this study

The study will be realized on Karlovy Vary EMS areas covered with paramedic crews only from emergency medical service stations with distant access to hospital. Each call on emergency line during 6 weeks study period will be assessed for eligibility. If deemed as low urgency, the event will be randomised into 3 groups. CONTROL group: routine operation of paramedic crew with optional consultation with a doctor over the phone. In the PHONE group and in the VIDEO group, there will be a mandatory consultation of a doctor over the phone or by audiovisual constultation, respectively. The primary outcome of the study is the percent of patients treated on site without the need of hospital transfer. The secondary safety outcome is to evaluate repeated ambulance trips within 48 hours after the patient had been treated at home. Moreover, a qualitative analysis of subjective perception of the event by the patients, paramedic and consulting doctor using the Likert scales will be performed by survey at the end or immediately after the event.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Each call on emergency line (in action radius of actual position of 11 of 19 Karlovy Vary EMS paramedic crews) will be assessed for eligibility by EMS call-taker in Karlovy Vary region.

Inclusion criteria

are:

  • the call is evaluated as low urgency event (by criteria of Karlovy Vary EMS call-taker manual; the event is dedicated for paramedic crew only, without dispatchig doctor on site),
  • the case is determined for and will be served by one of 11 for study dedicated of total 19 paramedic crews in Karlovy Vary EMS,
  • dedicated doctor of Karlovy Vary EMS will be available for consultation during his shift.

Exclusion criteria

are:

  • need for escalation of the care: paramedics' requirement for the doctor to arrive at the scene of intervention,
  • consulting doctor is not available for the study at the moment of randomisation,
  • consultation with other than trained and for study dedicated doctors,
  • patient - crew language barrier,
  • study refusal by the patient or legal representative, or refusal of audiovisual consultation,
  • technical, logistic or other (agressive patient, patient detained by police) problems evaluated by paramedic crew (not to conduct a study in PHONE and especially VIDEO group)

Treatment and study plan

Mandatory phone call consultation

Device

Use of audio consultation (EMS crew smartphones, doctor smarphone) Smartphone (Xiaomi Redmi Note) and bluetooth handsfree headset (Jabra Talk)

Other names: mandatory phone consultation (via Czech mobile network provider O2 Czech, GSM), mandatory telephone consultation (via Czech mobile network provider O2 Czech, GSM)

Mandatory audiovisual consultation

Device

Smartphone (Xiaomi Redmi Note) and bluetooth handsfree headset (Jabra Talk) with installed Android application (VSee messenger, USA, HIPAA compliant software) for paramedic crews; personal computer (Windows 10) with desktop version of application VSee messenger for Windows and eqipped with webcamera (Logitech C922 PRO) and headset (Jabra Evolve 20) for consulting doctor.

Other names: Mandatory video conference consultation

Primary outcomes

  1. Non-transport of low urgency EMS case to hospital

    Time frame: until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study

    Based on Karlovy Vary EMS audit data, there is 10% of low urgency cases treated and left on site by paramedics so far. So the primary outcome is to evaluate the rate of non-transports in common daily routine, when the doctor provides phone call consultation on request of paramedics (based on Karlovy Vary EMS protocol) to mandatory phone call consultation and audiovisual consultation with a EMS doctor. Therefore, the primary objective is to evaluate potential benefit audiovisual consultation with EMS doctor on the rate of patients left at home after treatment on site by paramedics.

Secondary outcomes

  1. The rate of repeated trips within 48 hours after the patient had been treated at home.

    Time frame: until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study

    The co-primary safety outcome was repeated EMS trip within 48 hours after the patient had been treated at home. This outcome can confirm and compare the safety among study groups.

Other outcomes

  1. Qualitative analysis of subjective perception of phone call and audivisual consultation.

    Time frame: until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study

    This analysis of subjective perception of each event in all 3 groups will be evaluated. The inevstigators will use Likert scales (1-excellent, 2-good, 3-sufficient, 4-insufficient) to compare phone and audivisual consultation in following parameters: clinical information transfer, situational context, safety of care. Surveys have to be filled and the patient opinion should be asked at the and of an transport or befere the crew leaves the patient on site. The EMS doctor will fill the survey immediately after the phone or audiovisual consultation is provided.

Sponsors and collaborators

Lead sponsor

Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

Other

Registry information

Official study title

Audiovisual Consultations by Paramedics With an Emergency Medical Service Physician in Low Urgency Events: Randomised Controlled Trial

Acronym: Telemedicine

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 18, 2020
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.