Audiovisual Consultations in Prehospital Emergency Care: Randomised Controlled Trial

Telemedicine Clinical Trial

— Telemedicine  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312321
• Other study ID #: Telemedicina_10/11/2019
• Status: Completed
• Phase: N/A
• Start date: October 17, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: March 2020
• Source: Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 15, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Emergencies
• Emergency Medical Service
• Telemedicine

Intervention

Device:
• Mandatory phone call consultation
Use of audio consultation (EMS crew smartphones, doctor smarphone) Smartphone (Xiaomi Redmi Note) and bluetooth handsfree headset (Jabra Talk)
• 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.

Locations

Country	Name	City	State
Czechia	Zdravotnická záchranná služba Karlovarského kraje, p.o.	Karlovy Vary	Karlovarský Kraj

Sponsors (1)

Lead Sponsor	Collaborator
Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative analysis of subjective perception of phone call and audivisual consultation.	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
Primary	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	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.	until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study