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CompletedNCT04312321TelemedicineUpdated Mar 20, 2020

Audiovisual Consultations in Prehospital Emergency Care: Randomised Controlled Trial

An interventional study of Mandatory phone call consultation and Mandatory audiovisual consultation in Telemedicine and Emergency Medical Service, sponsored by Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.. Completed at 1 site in Czechia. Per ClinicalTrials.gov, last updated 2020-03-20.

Sponsored by Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O. · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Oct 2019, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Telemedicine
  • Emergency Medical Service

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Keywords

  • Pre-hospital care
  • Audiovisual consultation
  • Non-transport
  • Low urgency
03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 600 is above the median of 145 across 931 interventional studies indexed under Emergencies.

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Lead sponsor

Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

Inclusion criteria are:

  1. 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),
  2. 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,
  3. dedicated doctor of Karlovy Vary EMS will be available for consultation during his shift.

Exclusion criteria

Exclusion criteria are:

  1. need for escalation of the care: paramedics' requirement for the doctor to arrive at the scene of intervention,
  2. consulting doctor is not available for the study at the moment of randomisation,
  3. consultation with other than trained and for study dedicated doctors,
  4. patient - crew language barrier,
  5. study refusal by the patient or legal representative, or refusal of audiovisual consultation,
  6. 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)
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (actual)

Study arms

  • No intervention
    CONTROL

    CONTROL group: low urgency cases with routine operation of paramedic crew with optional consultation with a doctor over the phone.

  • Experimental
    PHONE

    In the PHONE group, there will be a mandatory consultation of a doctor over the phone in all low urgency cases.

    Device: Mandatory phone call consultation

  • Experimental
    VIDEO

    In the VIDEO group, there will be a mandatory consultation of a doctor over the audiovisual consultation in low urgency cases

    Device: Mandatory audiovisual consultation

Interventions

  • DeviceMandatory phone call consultation

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

    Also known as: mandatory phone consultation (via Czech mobile network provider O2 Czech, GSM), mandatory telephone consultation (via Czech mobile network provider O2 Czech, GSM)

  • DeviceMandatory audiovisual consultation

    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.

    Also known as: Mandatory video conference consultation

06

What researchers measure

Primary outcomes

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

    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.

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

Secondary outcomes

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

    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.

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

Other outcomes

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

    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.

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

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Study locations

1 site
  • Zdravotnická záchranná služba Karlovarského kraje, p.o.
    Karlovy Vary, Karlovarský Kraj 360 06, Czechia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04312321
Lead sponsor
Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
Responsible party
Roman Sýkora, MD, Ph.D. (Principal Investigator, Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.) — Principal investigator
First posted
Mar 18, 2020
Start date
Oct 17, 2019
Primary completion
Nov 30, 2019
Completion
Mar 15, 2020
Last update
Mar 20, 2020

Study contacts

Jiri Smetana, MD
study director · Zdravotnická záchranná služba Karlovarskeho kraje, PO

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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