Audiovisual Consultations in Prehospital Emergency Care: Randomised Controlled Trial

NCT04312321 | Completed

• 1 other identifier: Telemedicina_10/11/2019
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Telemedicine; Emergency Medical Service

Keywords

Pre-hospital care; Audiovisual consultation; Non-transport; Low urgency

Outcome Measures

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.

  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.

  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.

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

Study Arms (3)

CONTROL

NO INTERVENTION

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

PHONE

EXPERIMENTAL

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

VIDEO

EXPERIMENTAL

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

Mandatory phone call consultation DEVICE

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)

PHONE

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.

Also known as: Mandatory video conference consultation

VIDEO

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.: lead

Study Sites (1)

Zdravotnická záchranná služba Karlovarského kraje, p.o.

Karlovy Vary, Karlovarský kraj, 360 06, Czechia

Location

Study Officials

• Jiri Smetana, MD

  Zdravotnická záchranná služba Karlovarskeho kraje, PO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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) .

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: March 18, 2020
• Study Start: October 17, 2019
• Primary Completion: November 30, 2019
• Study Completion: March 15, 2020
• Last Updated: March 20, 2020

Record last verified: 2020-03

Locations

CZ (1)