Acutely IllNCT02228317
Emergency Medical Technician Treat-and-leave Patients Receiving Telemedicine Consultation With Emergency Medical Dispatch Physician - a Controlled Before and After Pilot-study
A study testing Telemedicine consultation in people with Acutely Ill and Acutely Injured, run by University of Aarhus at 1 site in Denmark.
Trial summary
A large part of acutely ill patient's access to the health care system starts by calling the emergency number 1-1-2 and thereby getting in touch with the emergency medical dispatch center (EMDC). In most cases an ambulance is dispatched and the patient is brought to the hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acutely Ill, Acutely Injured
- What is being tested?
- Telemedicine consultation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 774 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Nov 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
- Patients receiving an emergency ambulance after calling the EMDC Patients who are going to be admitted to a Hospital in the Central Denmark Region.
- Patients who are going to be transported as category 2 patients (non-critical illness, not requiring transport with activated lightning and sirens.
Who cannot join
- Critically ill patients (Patients who are going to be transported as category 1 patients (critical-illness, requiring immediate transport with activated sirens and warning lights )
- Patients who are not supposed to be admitted to a hospital in the Central Denmark Region
Trial locations and contacts
1 site in 1 country.
About this study
A large part of acutely ill patient's access to the health care system starts by calling the emergency number 1-1-2 and thereby getting in touch with the emergency medical dispatch center (EMDC). In most cases an ambulance is dispatched and the patient is brought to the hospital. These patients are not referred by a physician (eg. a GP) and represent an unselected subpopulation of the acutely ill patients. At present, all non-critically ill patients not evaluated by a pre-hospital physician are normally be transported to hospital as category 2 (without activated emergency lightning and sirens).A part of this patient population, however, is not critically ill and a proportion of these may not need hospital admittance . Emergency medical technicians (EM) are not allowed to treat - and- leave patients without a physician's involvement. If the EMT had 24/7 online access to medical control i.e. in form of a physician present in the EMDC , the number of patients transported to hospital for assessment may be reduced as well as response times for patients actually needing ambulance transportation. This could potentially reduce the workload on the whole healthcare system involved in the management of these patients - thereby potentially reducing costs.
The objective of this study is to evaluate if a systematic telemedical assessment by an EMDC-physician of all patients who receive an ambulance but are not critically ill and would have a category 2 transport to hospital can reduce the number of the patients that are transported to hospital and save costs and time.
- Conditions
- Acutely Ill, Acutely Injured
- Being tested
- Telemedicine consultation
- Keywords
- Emergency Medical Dispatch, Telemedicine, Emergency Medical Services, Pre-hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine consultationDevice
Also called For video consultation iPAD AIR 4G/3G 16 GB will be used., LifeSize ClearSea solution will be used for videoconferencing., 4G/3G mobile network., For telephone consultation Nokia C2-01 GSM telephone will be used.
Telemedicine consultation done by telephone or video
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine consultation | Experimental | EMTs will systematically establish teleconsultation by either telephone or video with the EMDC-physician in all cases of non-critical illness Receives: Device: Telemedicine consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expenses related to EMDC physician vs. savings obtained by avoided admissions
Cost of 24 hour EMDC physician vs. savings obtained by avoided admissions. Calculations of average transport related costs will be provided by the Prehospital Emergency Medical Services Aarhus and average cost of hospitalization for a patient hospitalized 24 hours or less at the emergency dept. will be provided by the Regional Hospital Horsens. The percentage of treat-and-leave patients in the intervention period will be compared to a historical control group represented by the average percentage of treat-and-leave patients for the previous 12 months (August 2013 to August 2014). The savings obtained by avoided admissions will be calculated by multiplying the difference in the proportion of treat and leave patients with the number of patients the previous 12 months who are receiving an ambulance after dialing 112. The EMDC physician related costs will be calculated from the present table of salary for specialist physicians in Denmark.
Measured: Will be assessed at the time of consultation, expected to be presented within 36 months after assessment
Secondary outcomes (6)
Percentage of avoided hospital admissions
Is the difference in percentage of treat-and-leave patients in the intervention period and historical control period
Measured: Treated-and-left or not will be assessed at the time of consultation, expected to be presented within 36 months of assessment
Response time for ambulances
Defined as the average response time for ambulances dispatched by EMDC. The average response time is calculated as the time where the emergency medical dispatcher gets an assignment (registered manually by the dispatcher) to the arrival of the ambulance at scene (registered manually by the EMS technician). This definition of response time is predefined politically and is the gold standard for this measurement across dispatch centers in Denmark.
Measured: Is assessed at the time the EMT registers arrival on site, expected to be presented within 36 months of assessment
Hospital admission within 3 days
Percentage of patients where initial hospital admission is avoided, but are admitted to hospital within 72 hours after primary contact.
Measured: Will be assessed at the 72 hours after consultation, expected to be presented within 36 months of assessment
Time consumption by EMDC physician
Registered as the time from receiving phone call or establishing video contact to connection is discontinued
Measured: Will be assessed within 1 minute after end of consultation, expected to be presented within 36 months after assessment
Cause of death
Audit on all patients dying within 30 days of primary contact. Patient's electronic medical record will be assessed by two independent consultant physicians with no relation to EMDC in order to evaluate if death of a treat-and-leave patient can be attributed to treat-and-leave
Measured: Will be assessed as soon as possible after the occurence of death, normally within 24 hours, expected to be presented within 36 months of assessment
Patient's evaluation
Patient's evaluation of prehospital care. Telephone survey of all included patients in the intervention period will be conducted within 72 hours after teleconsultation with EMDC-physician
Measured: Will be assessed within 72 hours after end of consultation, expected to be presented within 36 months after assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acutely IllStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region, Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228317
- Sponsor's protocol ID
- NRA5
- Status last verified
- Jul 2014
- First submitted
- 11 Jul 2014
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Medical Technician Treat-and-leave Patients Receiving Telemedicine Consultation With Emergency Medical Dispatch Physician - a Controlled Before and After Pilot-study
- ClinicalTrials.gov ID
- NCT02228317
- Acronym / sponsor ID
- NRA5
- Conditions
- Acutely Ill, Acutely Injured
- Keywords
- Emergency Medical Dispatch, Telemedicine, Emergency Medical Services, Pre-hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 774 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Central Denmark Region, Aarhus University Hospital
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Aug 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.
A large part of acutely ill patient's access to the health care system starts by calling the emergency number 1-1-2 and thereby getting in touch with the emergency medical dispatch center (EMDC). In most cases an ambulance is dispatched and the patient is brought to the hospital. These patients are not referred by a physician (eg. a GP) and represent an unselected subpopulation of the acutely ill patients. At present, all non-critically ill patients not evaluated by a pre-hospital physician are normally be transported to hospital as category 2 (without activated emergency lightning and sirens).A part of this patient population, however, is not critically ill and a proportion of these may not need hospital admittance . Emergency medical technicians (EM) are not allowed to treat - and- leave patients without a physician's involvement. If the EMT had 24/7 online access to medical control i.e. in form of a physician present in the EMDC , the number of patients transported to hospital for assessment may be reduced as well as response times for patients actually needing ambulance transportation. This could potentially reduce the workload on the whole healthcare system involved in the management of these patients - thereby potentially reducing costs.
The objective of this study is to evaluate if a systematic telemedical assessment by an EMDC-physician of all patients who receive an ambulance but are not critically ill and would have a category 2 transport to hospital can reduce the number of the patients that are transported to hospital and save costs and time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemedicine consultation | Experimental | Device: Telemedicine consultationEMTs will systematically establish teleconsultation by either telephone or video with the EMDC-physician in all cases of non-critical illness |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receiving an emergency ambulance after calling the EMDC Patients who are going to be admitted to a Hospital in the Central Denmark Region.
- Patients who are going to be transported as category 2 patients (non-critical illness, not requiring transport with activated lightning and sirens.
Key exclusion criteria (2 listed)
- Critically ill patients (Patients who are going to be transported as category 1 patients (critical-illness, requiring immediate transport with activated sirens and warning lights )
- Patients who are not supposed to be admitted to a hospital in the Central Denmark Region
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 |
|---|---|---|
| Telemedicine consultationAlso: For video consultation iPAD AIR 4G/3G 16 GB will be used., LifeSize ClearSea solution will be used for videoconferencing., 4G/3G mobile network., For telephone consultation Nokia C2-01 GSM telephone will be used.Telemedicine consultation done by telephone or video | Device | Telemedicine consultation |
Primary outcome
Expenses related to EMDC physician vs. savings obtained by avoided admissions
Time frame: Will be assessed at the time of consultation, expected to be presented within 36 months after assessment
Cost of 24 hour EMDC physician vs. savings obtained by avoided admissions. Calculations of average transport related costs will be provided by the Prehospital Emergency Medical Services Aarhus and average cost of hospitalization for a patient hospitalized 24 hours or less at the emergency dept. will be provided by the Regional Hospital Horsens. The percentage of treat-and-leave patients in the intervention period will be compared to a historical control group represented by the average percentage of treat-and-leave patients for the previous 12 months (August 2013 to August 2014). The savings obtained by avoided admissions will be calculated by multiplying the difference in the proportion of treat and leave patients with the number of patients the previous 12 months who are receiving an ambulance after dialing 112. The EMDC physician related costs will be calculated from the present table of salary for specialist physicians in Denmark.
6 secondary outcomes
Percentage of avoided hospital admissions
Time frame: Treated-and-left or not will be assessed at the time of consultation, expected to be presented within 36 months of assessment
Response time for ambulances
Time frame: Is assessed at the time the EMT registers arrival on site, expected to be presented within 36 months of assessment
Hospital admission within 3 days
Time frame: Will be assessed at the 72 hours after consultation, expected to be presented within 36 months of assessment
Time consumption by EMDC physician
Time frame: Will be assessed within 1 minute after end of consultation, expected to be presented within 36 months after assessment
Cause of death
Time frame: Will be assessed as soon as possible after the occurence of death, normally within 24 hours, expected to be presented within 36 months of assessment
Patient's evaluation
Time frame: Will be assessed within 72 hours after end of consultation, expected to be presented within 36 months after assessment
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 9 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine consultation in people with Acutely Ill and Acutely Injured, run by University of Aarhus at 1 site 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 2 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 9 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 1 site 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 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?
Expenses related to EMDC physician vs. savings obtained by avoided admissions (time frame: Will be assessed at the time of consultation, expected to be presented within 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 9 Dec 2015.