Clinical trial NCT04312321: Audiovisual Consultations in Prehospital Emergency Care: Randomised Controlled Trial
Official title: Audiovisual Consultations by Paramedics With an Emergency Medical Service Physician in Low Urgency Events: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Emergency Medical Service
Keywords: Pre-hospital care
Audiovisual consultation
Non-transport
Low urgency
Lead sponsor: Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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) .
Primary purpose: SUPPORTIVE_CARE

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.

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:

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)

Primary outcomes:
measure: Non-transport of low urgency EMS case to hospital
timeFrame: until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study
Secondary outcomes:
measure: The rate of repeated trips within 48 hours after the patient had been treated at home.
timeFrame: until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study
Other outcomes:
measure: Qualitative analysis of subjective perception of phone call and audivisual consultation.
timeFrame: until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study
Locations:
city: Karlovy Vary
country: Czechia
facility: Zdravotnická záchranná služba Karlovarského kraje, p.o.
state: Karlovarský Kraj
Study officials:
affiliation: Zdravotnická záchranná služba Karlovarskeho kraje, PO
name: Jiri Smetana, MD
role: STUDY_DIRECTOR
References: