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Audiovisual Consultations in Prehospital Emergency Care: Randomised Controlled Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04312321
Acronym
Telemedicine
Enrollment
600
Registered
2020-03-18
Start date
2019-10-17
Completion date
2020-03-15
Last updated
2020-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency Medical Service, Telemedicine

Keywords

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

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.

Interventions

DEVICEMandatory phone call consultation

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

DEVICEMandatory 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.

Sponsors

Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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) .

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion 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: 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)

Design outcomes

Primary

MeasureTime frameDescription
Non-transport of low urgency EMS case to hospitaluntil 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the studyBased 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

MeasureTime frameDescription
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 studyThe 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

MeasureTime frameDescription
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 studyThis 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.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026