Audiovisual Consultations in Prehospital Emergency Care: Randomised Controlled Trial

NCT ID: NCT04312321

Last Updated: 2020-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-17

Study Completion Date

2020-03-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Telemedicine Emergency Medical Service

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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) .
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CONTROL

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

Group Type NO_INTERVENTION

No interventions assigned to this group

PHONE

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

Group Type EXPERIMENTAL

Mandatory phone call consultation

Intervention Type DEVICE

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

VIDEO

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

Group Type EXPERIMENTAL

Mandatory audiovisual consultation

Intervention Type 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.

Interventions

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Mandatory phone call consultation

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

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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mandatory phone consultation (via Czech mobile network provider O2 Czech, GSM) mandatory telephone consultation (via Czech mobile network provider O2 Czech, GSM) Mandatory video conference consultation

Eligibility Criteria

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Inclusion Criteria

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

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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

OTHER

Sponsor Role lead

Responsible Party

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Roman Sýkora, MD, Ph.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiri Smetana, MD

Role: STUDY_DIRECTOR

Zdravotnická záchranná služba Karlovarskeho kraje, PO

Locations

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Zdravotnická záchranná služba Karlovarského kraje, p.o.

Karlovy Vary, Karlovarský kraj, Czechia

Site Status

Countries

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Czechia

Other Identifiers

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Telemedicina_10/11/2019

Identifier Type: -

Identifier Source: org_study_id

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