EmergenciesNCT03800316
Synchronous Video (Telemedicine) Consulation in the Prehospital Setting
A study testing Video Consultation in people with Emergencies and Prehospital, run by Mayo Clinic at 1 site in United States.
Trial summary
The study team aims to test connectivity metrics and follow patient outcomes using a new, innovative synchronous video technology in the prehospital setting in three distinct areas: 1. - 911 Calls 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emergencies, Prehospital, Telemedicine
- What is being tested?
- Video Consultation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to 31 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
- Cardiac Arrest
- Hemodynamically unstable trauma patients requiring resuscitation and airway management
- Trauma patients with altered mentation requiring airway management
- Acute stroke patients
- Medical patients that refuse transport for medical evaluation Pediatric Intensive Care Telemedicine Program
- Complex clinical situations where paramedic teams need immediate management guidance
Show all 11Show fewer
- Critically ill pediatric patients requiring evaluation/stabilization for interfacility transport
- Pediatric patients requiring intervention for respiratory failure
- Pediatric patients with ongoing seizures and/or neurological abnormalities
- Hemodynamically unstable patients
- Complex clinical situations requiring medical control guidance
Who cannot join
- All other patients not list above
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The study team aims to test connectivity metrics and follow patient outcomes using a new, innovative synchronous video technology in the prehospital setting in three distinct areas:
- - 911 Calls
- - Pediatric Critical Care Transport
Currently, paramedics and pediatric transport teams seek advice from physicians using a telephone. This project replaces the phone with video consultation where the physicians can directly interact with patients, paramedics and transport teams when care advice is needed.
- Conditions
- Emergencies, Prehospital, Telemedicine, Telehealth
- Being tested
- Video Consultation
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video ConsultationDevice
Video consultation with emergency medicine physicians for patients that are critically ill prior to arrival in the ED
| Study group | Role | What they receive |
|---|---|---|
| Synchronous Video Consultation | Experimental | Testing the feasibility of a synchronous video consultation in the field prior to emergency department arrival. Receives: Device: Video Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Video Consultations Completed
Total number of video consultations completed
Measured: 1 year
Secondary outcomes (3)
Mortality
Total number of subject deaths
Measured: 1 year
Hospital Length of Stay
Total number of hours subjects were admitted to the hospital
Measured: 1 year
Emergency Room Length of Stay
Total number of hours subjects were admitted to the emergency room
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start14 Jan 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher S. Russi, Mayo Clinic
- Investigators
- Christopher S Russi, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800316
- Sponsor's protocol ID
- 18-005054
- Status last verified
- May 2020
- First submitted
- 10 Dec 2018
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synchronous Video (Telemedicine) Consulation in the Prehospital Setting
- ClinicalTrials.gov ID
- NCT03800316
- Acronym / sponsor ID
- 18-005054
- Conditions
- Emergencies, Prehospital, Telemedicine, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 11 Jan 2019 (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.
The study team aims to test connectivity metrics and follow patient outcomes using a new, innovative synchronous video technology in the prehospital setting in three distinct areas:
- - 911 Calls
- - Pediatric Critical Care Transport
Currently, paramedics and pediatric transport teams seek advice from physicians using a telephone. This project replaces the phone with video consultation where the physicians can directly interact with patients, paramedics and transport teams when care advice is needed.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synchronous Video Consultation | Experimental | Device: Video ConsultationTesting the feasibility of a synchronous video consultation in the field prior to emergency department arrival. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Cardiac Arrest
- Hemodynamically unstable trauma patients requiring resuscitation and airway management
- Trauma patients with altered mentation requiring airway management
- Acute stroke patients
- Medical patients that refuse transport for medical evaluation Pediatric Intensive Care Telemedicine Program
Key exclusion criteria (1 listed)
- All other patients not list above
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 |
|---|---|---|
| Video ConsultationVideo consultation with emergency medicine physicians for patients that are critically ill prior to arrival in the ED | Device | Synchronous Video Consultation |
Primary outcome
Video Consultations Completed
Time frame: 1 year
Total number of video consultations completed
3 secondary outcomes
Mortality
Time frame: 1 year
Hospital Length of Stay
Time frame: 1 year
Emergency Room Length of Stay
Time frame: 1 year
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 4 May 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Christopher S Russi principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Consultation in people with Emergencies and Prehospital, run by Mayo Clinic at 1 site in United States.
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 11 inclusion and 1 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 4 May 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 United States. 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?
Video Consultations Completed (time frame: 1 year). 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 4 May 2020.