TelemedicineTelemedicineNCT04312321
Audiovisual Consultations in Prehospital Emergency Care: Randomised Controlled Trial
A study testing Mandatory phone call consultation and Mandatory audiovisual consultation in people with Telemedicine and Emergency Medical Service, run by Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O. at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Telemedicine, Emergency Medical Service
- What is being tested?
- Mandatory phone call consultation and Mandatory audiovisual consultation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteCzechia
- Study dates
- 17 Oct 2019to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Zdravotnická záchranná služba Karlovarského kraje, p.o.
Karlovy Vary, Carlsbad Region, 360 06
About this study
Official title: Audiovisual Consultations by Paramedics With an Emergency Medical Service Physician in Low Urgency Events: Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Telemedicine, Emergency Medical Service
- Being tested
- Mandatory phone call consultation, Mandatory audiovisual consultation
- Keywords
- Pre-hospital care, Audiovisual consultation, Non-transport, Low urgency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandatory phone call consultationDevice
Also called mandatory phone consultation (via Czech mobile network provider O2 Czech, GSM), mandatory telephone consultation (via Czech mobile network provider O2 Czech, GSM)
Use of audio consultation (EMS crew smartphones, doctor smarphone) Smartphone (Xiaomi Redmi Note) and bluetooth handsfree headset (Jabra Talk)
Mandatory audiovisual consultationDevice
Also called Mandatory video conference 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.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | CONTROL group: low urgency cases with routine operation of paramedic crew with optional consultation with a doctor over the phone. |
| PHONE | Experimental | In the PHONE group, there will be a mandatory consultation of a doctor over the phone in all low urgency cases. Receives: Device: Mandatory phone call consultation |
| VIDEO | Experimental | In the VIDEO group, there will be a mandatory consultation of a doctor over the audiovisual consultation in low urgency cases Receives: Device: Mandatory audiovisual consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study
Secondary outcomes (1)
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.
Measured: until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start17 Oct 2019
- Primary completion30 Nov 2019
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roman Sýkora, MD, Ph.D., Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
- Investigators
- Jiri Smetana, MD, Study director, Zdravotnická záchranná služba Karlovarskeho kraje, PO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312321
- Sponsor's protocol ID
- Telemedicina_10/11/2019
- Acronym
- Telemedicine
- Status last verified
- Mar 2020
- First submitted
- 29 Jan 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiovisual Consultations by Paramedics With an Emergency Medical Service Physician in Low Urgency Events: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04312321
- Acronym / sponsor ID
- Telemedicine / Telemedicina_10/11/2019
- Conditions
- Telemedicine, Emergency Medical Service
- Keywords
- Pre-hospital care, Audiovisual consultation, Non-transport, Low urgency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.University, hospital or other
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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) .
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –CONTROL group: low urgency cases with routine operation of paramedic crew with optional consultation with a doctor over the phone. |
| PHONE | Experimental | Device: Mandatory phone call consultationIn the PHONE group, there will be a mandatory consultation of a doctor over the phone in all low urgency cases. |
| VIDEO | Experimental | Device: Mandatory audiovisual consultationIn the VIDEO group, there will be a mandatory consultation of a doctor over the audiovisual consultation in low urgency cases |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandatory phone call consultationAlso: mandatory phone consultation (via Czech mobile network provider O2 Czech, GSM), mandatory telephone consultation (via Czech mobile network provider O2 Czech, GSM)Use of audio consultation (EMS crew smartphones, doctor smarphone) Smartphone (Xiaomi Redmi Note) and bluetooth handsfree headset (Jabra Talk) | Device | PHONE |
| Mandatory audiovisual consultationAlso: Mandatory video conference consultationSmartphone (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. | Device | VIDEO |
Primary outcome
Non-transport of low urgency EMS case to hospital
Time frame: until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study
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.
1 secondary outcome
The rate of repeated trips within 48 hours after the patient had been treated at home.
Time frame: until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiri Smetana, MD study director
Zdravotnická záchranná služba Karlovarskeho kraje, PO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandatory phone call consultation and Mandatory audiovisual consultation in people with Telemedicine and Emergency Medical Service, run by Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-transport of low urgency EMS case to hospital (time frame: until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.