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

Sponsor
Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O. (Other)
Overall Status
Completed
CT.gov ID
NCT04312321
Collaborator
(none)
600
Enrollment
1
Location
3
Arms
4.9
Actual Duration (Months)
121.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Mandatory phone call consultation
  • Device: Mandatory audiovisual consultation
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Low urgency emergency calls are randomised by call-taker of dispatching center to 3 groups: routine prehospital emergency care without optional phone call consultation (1), with mandatory phone call consultation with base physician (2), with mandatory audivisual consultation with base physician (3). Power analysis. Based on available data prior to the initiation of the study, 10% of patients after low acuity calls were treated on site. The hypothesis that the video consult would lead to doubling this percentage will be investigated. In order to have 80% probability to confirm this at p < 0.05, we would need 200 subjects per group. Planned interim analysis will be after 4 weeks of study (aprox. after 600 eligible cases) .Low urgency emergency calls are randomised by call-taker of dispatching center to 3 groups: routine prehospital emergency care without optional phone call consultation (1), with mandatory phone call consultation with base physician (2), with mandatory audivisual consultation with base physician (3). Power analysis. Based on available data prior to the initiation of the study, 10% of patients after low acuity calls were treated on site. The hypothesis that the video consult would lead to doubling this percentage will be investigated. In order to have 80% probability to confirm this at p < 0.05, we would need 200 subjects per group. Planned interim analysis will be after 4 weeks of study (aprox. after 600 eligible cases) .
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Audiovisual Consultations by Paramedics With an Emergency Medical Service Physician in Low Urgency Events: Randomised Controlled Trial
Actual Study Start Date :
Oct 17, 2019
Actual Primary Completion Date :
Nov 30, 2019
Actual Study Completion Date :
Mar 15, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    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 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zdravotnická záchranná služba Karlovarského kraje, p.o. Karlovy Vary Karlovarský Kraj Czechia 360 06

    Sponsors and Collaborators

    • Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roman Sýkora, MD, Ph.D., Principal Investigator, Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
    ClinicalTrials.gov Identifier:
    NCT04312321
    Other Study ID Numbers:
    • Telemedicina_10/11/2019
    First Posted:
    Mar 18, 2020
    Last Update Posted:
    Mar 20, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Roman Sýkora, MD, Ph.D., Principal Investigator, Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
    Pre-hospital care
    Audiovisual consultation
    Non-transport
    Low urgency
    Additional relevant MeSH terms:
    Emergencies

    Study Results

    No Results Posted as of Mar 20, 2020