All Acutely Ill or Injured Patients Receiving Care by Ambulance PersonnelNCT02093975
Videoconferencing Between Ambulances and Physician Manned Rapid Response Vehicles, Effects on On-site Patient Treatment and Patterns of Referral
A study testing iPad air with 4G/3G SIM card in people with All Acutely Ill or Injured Patients Receiving Care by Ambulance Personnel, run by University of Aarhus at 2 sites in Denmark.
Trial summary
Physician manned rapid response vehicles are a limited resource in the prehospital handling of acute patients. In this study mobile videoconferencing between ambulances and the rapid response vehicles enables patient consultation at a distance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- All Acutely Ill or Injured Patients Receiving Care by Ambulance Personnel
- What is being tested?
- iPad air with 4G/3G SIM card
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2014to Dec 2014
- 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
- All patients receiving prehospital care by ambulance personnel
- Must receive either telephone or video consultation by physician in rapid response vehicle
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Lægebilen, Hospitalsenheden Horsens
Horsens, 8700
Responce A/S
Horsens, 8700
About this study
Official title: Telemedical Solutions in Medical Emergencies, Advantages and Disadvantages for Patients, Healthcare Professionals, and Healthcare System. Study 3: Videoconferencing Between Ambulances and Physician Manned Rapid Response Vehicles, Effects on On-site Patient Treatment and Pattern of Referral
Physician manned rapid response vehicles are a limited resource in the prehospital handling of acute patients.
In this study mobile videoconferencing between ambulances and the rapid response vehicles enables patient consultation at a distance. Video consultation between patient and the prehospital physician can take place when the patient is at home or in the ambulance.
The primary aim of this study is to examine the effect of video consultation between physician manned rapid response vehicles and patients receiving treatment by ambulance personnel on the number of patients receiving final treatment on-site in the pre-hospital setting
- Being tested
- iPad air with 4G/3G SIM card
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPad air with 4G/3G SIM cardDevice
Also called LifeSizeClearSea
iPad air with 4G/3G SIM card is used as device for videoconferencing. LifeSizeClearSea solution is used for videoconferencing.
Video consultation
| Study group | Role | What they receive |
|---|---|---|
| Video consultation | Experimental | Patients in this arm receive video consultation from physician in doctor manned rapid response vehicle. Receives: Device: iPad air with 4G/3G SIM card |
| Telephone consultation | Active comparator | Patients receiving prehospital care by ambulance personnel whom receive telephone consultation/supervision by physician in rapid response vehicle. Receives: Device: iPad air with 4G/3G SIM card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients receiving final treatment on-site prehospitally
Measured: Final treatment is registered for the present consultation, expected assesment averagely within 1 hour. Expected to be presented up to 36 months after assessment
Secondary outcomes (3)
Readmission
For all patients receiving consultation from physician manned rapid response vehicles the number of patients admitted to hospital within 3 days will assessed.
Measured: Within 3 days of primary contact. Will be assessed up to 24 months after primary contact. Expected to be presented up to 36 months after assessment.
Change in site of referral
If the department to receive the patient is changed during consultation between physician in rapid response vehicle and patient
Measured: If destination for patient is changed during consultatation with physician it wille be assessed at the end of consultation, expected averagely to be within 1 hour after consultation, expected to presented up to 24 months after primary assessment
Number of treatments delivered by ambulance personnel
Measured: The number of treatments delivered by ambulance personnel during consultation with physician in rapid response vehicle. Expected to be assessed averagely within 1 hour of consultation. Expected to be presented up 36 months after primary assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Acutely Ill or Injured Patients Receiving Care by Ambulance PersonnelStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region
- Responsible party
- Principal investigator, Nikolaj Raaber, University of Aarhus
- Investigators
- Nikolaj Raaber, MD, Principal investigator, Central Denmark RegionErika Christensen, MD, medical director, Study director, Central Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093975
- Sponsor's protocol ID
- NRAA3
- Status last verified
- Dec 2015
- First submitted
- 12 Mar 2014
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedical Solutions in Medical Emergencies, Advantages and Disadvantages for Patients, Healthcare Professionals, and Healthcare System. Study 3: Videoconferencing Between Ambulances and Physician Manned Rapid Response Vehicles, Effects on On-site Patient Treatment and Pattern of Referral
- ClinicalTrials.gov ID
- NCT02093975
- Acronym / sponsor ID
- NRAA3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Central Denmark Region
- Study start
- May 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 21 Mar 2014 (estimated)
- 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.
Physician manned rapid response vehicles are a limited resource in the prehospital handling of acute patients.
In this study mobile videoconferencing between ambulances and the rapid response vehicles enables patient consultation at a distance. Video consultation between patient and the prehospital physician can take place when the patient is at home or in the ambulance.
The primary aim of this study is to examine the effect of video consultation between physician manned rapid response vehicles and patients receiving treatment by ambulance personnel on the number of patients receiving final treatment on-site in the pre-hospital setting
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video consultation | Experimental | Device: iPad air with 4G/3G SIM cardPatients in this arm receive video consultation from physician in doctor manned rapid response vehicle. |
| Telephone consultation | Active comparator | Device: iPad air with 4G/3G SIM cardPatients receiving prehospital care by ambulance personnel whom receive telephone consultation/supervision by physician in rapid response vehicle. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients receiving prehospital care by ambulance personnel
- Must receive either telephone or video consultation by physician in rapid response vehicle
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| iPad air with 4G/3G SIM cardAlso: LifeSizeClearSeaiPad air with 4G/3G SIM card is used as device for videoconferencing. LifeSizeClearSea solution is used for videoconferencing. Video consultation | Device | Telephone consultation, Video consultation |
Primary outcome
Number of patients receiving final treatment on-site prehospitally
Time frame: Final treatment is registered for the present consultation, expected assesment averagely within 1 hour. Expected to be presented up to 36 months after assessment
3 secondary outcomes
Readmission
Time frame: Within 3 days of primary contact. Will be assessed up to 24 months after primary contact. Expected to be presented up to 36 months after assessment.
Change in site of referral
Time frame: If destination for patient is changed during consultatation with physician it wille be assessed at the end of consultation, expected averagely to be within 1 hour after consultation, expected to presented up to 24 months after primary assessment
Number of treatments delivered by ambulance personnel
Time frame: The number of treatments delivered by ambulance personnel during consultation with physician in rapid response vehicle. Expected to be assessed averagely within 1 hour of consultation. Expected to be presented up 36 months after primary assessment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
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.
Nikolaj Raaber, MD principal investigator
Central Denmark Region
Erika Christensen, MD, medical director study director
Central Denmark Region
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPad air with 4G/3G SIM card in people with All Acutely Ill or Injured Patients Receiving Care by Ambulance Personnel, run by University of Aarhus at 2 sites in Denmark.
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 2 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: withdrawn, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of patients receiving final treatment on-site prehospitally (time frame: Final treatment is registered for the present consultation, expected assesment averagely within 1 hour. Expected to be presented up to 36 months after assessment). 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 8 Dec 2015.