Audiovisual Consultations in Prehospital Emergency Care: Randomised Controlled Trial (Telemedicine)

March 17, 2020 updated by: Roman Sýkora, MD, Ph.D., Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

Audiovisual Consultations by Paramedics With an Emergency Medical Service Physician in Low Urgency Events: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Karlovarský Kraj
      • Karlovy Vary, Karlovarský Kraj, Czechia, 360 06
        • Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

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

Description

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:

  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 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)

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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)
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study

Collaborators and Investigators

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

Sponsor

Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

Investigators

  • Study Director: Jiri Smetana, MD, Zdravotnická záchranná služba Karlovarskeho kraje, PO

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)

October 17, 2019

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

March 15, 2020

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

March 14, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Telemedicina_10/11/2019

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.

Clinical Trials on Telemedicine

Clinical Trials on Mandatory phone call consultation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe