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

Primary Purpose

Telemedicine, Emergency Medical Service

Status

Completed

Phase

Not Applicable

Locations

Czechia

Study Type

Interventional

Intervention

Mandatory phone call consultation

Mandatory audiovisual consultation

About this trial

This is an interventional supportive care trial for Telemedicine focused on measuring Pre-hospital care, Audiovisual consultation, Non-transport, Low urgency

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Exclusion criteria are:

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)

Sites / Locations

Zdravotnická záchranná služba Karlovarského kraje, p.o.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

CONTROL

PHONE

VIDEO

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04312321

First Posted

January 29, 2020

Last Updated

March 17, 2020

Sponsor

Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

1. Study Identification

Unique Protocol Identification Number

NCT04312321

Brief Title

Audiovisual Consultations in Prehospital Emergency Care: Randomised Controlled Trial

Acronym

Telemedicine

Official Title

Audiovisual Consultations by Paramedics With an Emergency Medical Service Physician in Low Urgency Events: Randomised Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

October 17, 2019 (Actual)

Primary Completion Date

November 30, 2019 (Actual)

Study Completion Date

March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Telemedicine, Emergency Medical Service

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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) .

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CONTROL

Arm Type

No Intervention

Arm Description

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

Arm Title

PHONE

Arm Type

Experimental

Arm Description

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

Arm Title

VIDEO

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Mandatory phone call consultation

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Mandatory audiovisual consultation

Other Intervention Name(s)

Mandatory video conference consultation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Non-transport of low urgency EMS case to hospital

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

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 Pre-specified Outcome Measures:

Title

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

Description

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. Exclusion criteria are: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiri Smetana, MD

Organizational Affiliation

Zdravotnická záchranná služba Karlovarskeho kraje, PO

Official's Role

Study Director

Facility Information:

Facility Name

Zdravotnická záchranná služba Karlovarského kraje, p.o.

City

Karlovy Vary

State/Province

Karlovarský Kraj

ZIP/Postal Code

360 06

Country

Czechia

12. IPD Sharing Statement

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Audiovisual Consultations in Prehospital Emergency Care: Randomised Controlled Trial

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