Emergency Medical ServicesNCT03323229
SatCare: Remote Support for Ambulance Clinicians in Medical Emergencies
A study testing Enhanced communications & ultrasound in people with Emergency Medical Services and Emergency Service, Hospital, run by University of Aberdeen at 3 sites in United Kingdom.
Trial summary
SatCare is a randomised controlled trial involving rapid standardised ultrasound assessment of patients with shock, major trauma, abdominal pain, chest pain or breathlessness in emergency ambulances. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Emergency Medical Services, Emergency Service, Hospital
- What is being tested?
- Enhanced communications & ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Dec 2017to 31 Jan 2019
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with:
- significant trauma: any case where the mechanism of injury, anatomical defect or physiological upset triggers the paramedic to pre-alert a 'trauma call' to the receiving Emergency Department
- chest pain: pain felt below the clavicles and above the costal margin, whether anterior or posterior
- shortness of breath: any patient complaining of 'shortness of breath' or with paramedic examination positive for 'respiratory distress' whether by increased respiratory rate, effort or both
- abdominal pain: any pain felt below the costal margin and above the bony pelvis
- cardiovascular shock of unknown origin: either a systolic blood pressure below 100 mmHg or any symptoms or signs of syncope on elevation of the head, cool peripheries or extended capillary refill time
- Attended by a study ambulance
- Recruitment occurs within the hours supported by the Emergency Department: Monday to Friday, 09:00 to 17:00
Who cannot join
- Non-emergency ambulance transfers
- General practitioner requested emergency ambulances
- Patients under arrest or held in prison
- No potential value in performing ultrasound (e.g., none of the diagnoses listed above)
- Lack of consent for scan (if in intervention arm)
- Lack of capacity to consent to scan / no patient representative to provide consent
Show all 10Show fewer
- Evidence of any condition leading to lack of capacity to give informed consent prior to the commencement of the study, as documented on the patient's electronic patient record
- Non-English speakers
- Outside the emergency department supported hours (Monday to Friday, 09:00 to 17:00)
- Paramedic decision to exclude patient, for reasons such as urgency of transport (i.e., where thorough on-scene evaluation would not normally be offered) or other lack of suitability
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Centre for Rural Health
Inverness, Scotland, IV2 3JH
NHS Highland: Raigmore Hospital
Inverness, Scotland
Scottish Ambulance Service
Inverness, Scotland
About this study
SatCare is a randomised controlled trial involving rapid standardised ultrasound assessment of patients with shock, major trauma, abdominal pain, chest pain or breathlessness in emergency ambulances. The scans will take less than 5 minutes and be transmitted to a hospital-based expert for review, providing support and instructions for optimal prehospital care.
Five Highland Scottish Ambulance Service ambulances covering areas more than 30 minutes from Raigmore Hospital, Inverness, UK, will be equipped with an ultrasound machine (M-Turbo, FujiFilm Sonosite) and satellite transmission system plus webcam, and will be deployed in real emergency situations. When dispatched to a potentially eligible patient, the attending paramedic will contact Raigmore Hospital's emergency department to check the availability of an emergency medicine specialist and obtain study group allocation (ultrasound with enhanced telecommunications plus usual care versus usual care alone). Following verbal consent from the patient, trained paramedics will perform the condition-specific scan protocol in the ambulance at the incident site, and transmit the recordings and patient video via satellite to the emergency department for specialist analysis. The consultant will give advice on patient management via standard ambulance communications systems while it is en route to the hospital.
The remotely supported prehospital ultrasound implementation will be examined in terms of its delivery and functioning. An economic evaluation will compare its use with care as usual for eligible patients transported by ambulance, modelling the costs and benefits of this service expansion and determining optimum use. It is hoped that the results, anticipated to be available in 2019, will provide an evidence base for the use of prehospital ultrasound for emergency care.
Read the detailed description
Research objectives:
- To assess the patient health impact of enhanced telecommunications and remotely-supported point-of-care ultrasound scanning (RS-POCUS) in prehospital situations
- To assess the impact of introducing this intervention on current care systems, via interviews with various stakeholders involved in the trial (e.g., patients, paramedics, emergency medicine consultants, hospital management, etc.) and health economic modelling
Research questions:
- What is the health gain, as assessed by the EQ-5D-5L (EuroQol five dimension questionnaire, 5-level version) score at three months, associated with the use of enhanced telecommunications and RS-POCUS?
- What is the estimated cost-per-QALY associated with the prehospital RS-POCUS?
- Where in the care system and in which situations does the intervention produce the greatest impact?
- How does the use of RS-POCUS affect time to definitive treatment in the studied patient groups?
Patient Randomisation:
Patients will be randomized to the intervention or control group prior to obtaining consent (Zelen randomisation), an approach considered optimal in trials where care is time-critical and patients may be highly stressed. This simplifies and shortens the in-ambulance consent process because the details of the random allocation and its associated uncertainty don't need to be explained until later.
Randomisation is performed using randomisation envelopes with codes printed on them, located in the ambulances. Codes will be reported and recorded on the emergency department contact log when a potential patient call-out occurs. If on arrival at the emergency scene the patient meets the inclusion criteria, the paramedic will obtain the patient's study group allocation by opening the envelope.
Consent:
It is crucial that delays to patient transfer are reduced to an absolute minimum in the ultrasound scanning group. The process of scanning is rapid and offers virtually no risk to the patient, but delays due to requesting consent are potentially more problematic and need to be minimised as much as possible. It is therefore proposed to have a two-stage consent process: a brief verbal consent to scanning and data transmission in the ambulance, and on arrival at the hospital, full written consent to health record analysis and to complete a follow-up questionnaire three months later.
If patients are assessed by the paramedic to lack the mental capacity and understanding to provide meaningful consent, an eligible proxy (relative, welfare attorney or guardian) accompanying the patient may provide consent on his or her behalf in line with the Adults with Incapacity Act, Scotland (2000). If a participant who is unable to consent shows any signs of unwillingness to take part or distress, they will be immediately withdrawn from the study.
Patient follow-up:
Patients will be asked to complete a standard EQ-5D-5L (health-related quality of life) questionnaire 3 months after recruitment to the trial, plus a short satisfaction/service use questionnaire. Ten patients from both the scanned and control groups will be approached at this time to ask if they would be willing to be interviewed about the use of ambulance-based ultrasound. If other specific interesting themes meriting further investigation arise from the interviews, these may be explored further with additional interviews in other participants. Patient involvement in the trial will end on completion of this 3-month follow-up.
Analyses:
The primary outcome is defined as the patient EQ-5D-5L (EuroQol five dimension questionnaire) score three months after the original ambulance episode. Analysis will be on an intention to treat basis with a per protocol analysis as a sensitivity. Pre-specified descriptive subgroup analyses will examine EQ-5D-5L results by age group, reason for scan and transport distance.
The economic analysis will include both a within-trial economic evaluation and a model-based economic evaluation. The within-trial analyses will take the form of a cost-utility analysis from the perspective of the National Health Service. The model-based analysis will also take the perspective of the NHS, but try to take into account wider societal costs such as unpaid carer time and costs, using standard national figures to estimate these contributions. A Markov model will be used to extrapolate from the short-term trial outcomes into the longer term.
- Being tested
- Enhanced communications & ultrasound
- Keywords
- Ultrasonography, Ambulances, Satellite Communications, Telemedicine
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced communications & ultrasoundDiagnostic test
Paramedics will perform standardised point-of-care ultrasound scan protocols (specific to the patient's symptom set) and record a short (<1 minute) video summarising the patient's condition and current management. These will be transmitted via satellite to consultants at the receiving hospital before the ambulance leaves the incident scene. The emergency department consultants will provide support and advice on continuing patient management via standard ambulance communications systems while it is en route to the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Usual care (control group) | No intervention | Patient receives care as usual. |
| Enhanced communications & ultrasound | Experimental | The paramedic will record a brief video summary of the patient's condition, then remotely supported point of care ultrasound scans will be performed, and both file types sent to the hospital for review and feedback from the consultant. Receives: Diagnostic Test: Enhanced communications & ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D-5L (EuroQol five dimension, five level) score three months after the initial ambulance episode
The EQ-5D-5L questionnaire includes assessments of mobility, self-care, daily activities undertaken, pain, discomfort, anxiety and depression.Completion of the EQ-5D-5L leads to the establishment of 243 distinct states, each with corresponding numerical quality of life value.
Measured: 3 months post recruitment
Secondary outcomes (10)
Cost per QALY (Quality Adjusted Life Year)
Estimates of cost per QALY are generated using costs and EQ-5D-5L score. The QALY is a measure of disease burden, encompassing both the quality and quantity of life lived. Quality of life is rated between 0 ('worst possible health') and 1 ('best possible health'). The QALY is calculated from the amount of time spent in a particular health state weighted by the utility (quality) score given to that health state.
The QALY gained by a specific treatment is compared with an existing standard or no intervention. The relative costs of the two interventions are then compared and the cost of the new treatment in excess of the standard is calculated. This figure is then divided by the QALY of the new intervention to give the cost per QALY (£ per QALY). Lower costs per QALY are preferred by healthcare systems, as they are thought to provide better value for money.
Measured: 3 months post recruitment
Time from ambulance arrival at scene to definitive treatment or discharge
Measured in hours and minutes
Measured: up to 3 months post recruitment
Mortality rate
Measured: up to 3 months post recruitment
Process evaluation (to investigate intervention use, acceptance and optimisation)
Includes interviews with stakeholders and anonymised descriptions of cases in which management was altered as a result of the intervention
Measured: 15 months
Costs to the NHS
Covering staff and equipment costs, treatment costs, etc. Costs will be measured in UK Pounds Sterling and compiled into a Total Costs figure to compare costs with/without the intervention.
Measured: 15 months
Relative efficiency calculations (cost-consequences analysis)
A cost-consequences analysis is an economic evaluation where disaggregated costs and a range of outcomes are presented to allow readers to form their own opinion on relevance and relative importance. A descriptive table presents the primary and secondary outcome results together with the estimates of the mean costs associated with each intervention.
Measured: 15 months
Patient and staff satisfaction with the intervention
Collected using custom created questionnaires
Measured: 15 months
Patient and staff satisfaction with the intervention
Collected using custom created interview schedules
Measured: 15 months
Communications system connection speed
The communications system connection speed - the time to locate the satellite, connect to it, and connect to the end server - will be recorded (minutes and seconds). Any failure to connect will be noted.
Measured: 15 months
Communications system data upload rate
Data upload speeds will be recorded (kb/s).
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start1 Dec 2017
- Primary completion1 Apr 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency Medical ServicesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- Scottish Ambulance Service, NHS Highland
- Responsible party
- Sponsor
- Investigators
- Leila Eadie, Principal investigator, University of AberdeenPhilip Wilson, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323229
- Sponsor's protocol ID
- 2-060-17
- Status last verified
- Feb 2021
- First submitted
- 9 Oct 2017
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eadie L, Mulhern J, Regan L, Mort A, Shannon H, Macaden A, Wilson P. Remotely supported prehospital ultrasound: A feasibility study of real-time image transmission and expert guidance to aid diagnosis in remote and rural communities. J Telemed Telecare. 2018 Oct;24(9):616-622. doi: 10.1177/1357633X17731444. Epub 2017 Sep 18.
PubMed 28920524
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SatCare: Remote Support for Ambulance Clinicians in Medical Emergencies
- ClinicalTrials.gov ID
- NCT03323229
- Acronym / sponsor ID
- 2-060-17
- Keywords
- Ultrasonography, Ambulances, Satellite Communications, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- Scottish Ambulance Service, NHS Highland
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 26 Oct 2017 (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.
SatCare is a randomised controlled trial involving rapid standardised ultrasound assessment of patients with shock, major trauma, abdominal pain, chest pain or breathlessness in emergency ambulances. The scans will take less than 5 minutes and be transmitted to a hospital-based expert for review, providing support and instructions for optimal prehospital care.
Five Highland Scottish Ambulance Service ambulances covering areas more than 30 minutes from Raigmore Hospital, Inverness, UK, will be equipped with an ultrasound machine (M-Turbo, FujiFilm Sonosite) and satellite transmission system plus webcam, and will be deployed in real emergency situations. When dispatched to a potentially eligible patient, the attending paramedic will contact Raigmore Hospital's emergency department to check the availability of an emergency medicine specialist and obtain study group allocation (ultrasound with enhanced telecommunications plus usual care versus usual care alone). Following verbal consent from the patient, trained paramedics will perform the condition-specific scan protocol in the ambulance at the incident site, and transmit the recordings and patient video via satellite to the emergency department for specialist analysis. The consultant will give advice on patient management via standard ambulance communications systems while it is en route to the hospital.
The remotely supported prehospital ultrasound implementation will be examined in terms of its delivery and functioning. An economic evaluation will compare its use with care as usual for eligible patients transported by ambulance, modelling the costs and benefits of this service expansion and determining optimum use. It is hoped that the results, anticipated to be available in 2019, will provide an evidence base for the use of prehospital ultrasound for emergency care.
Detailed description
Research objectives:
- To assess the patient health impact of enhanced telecommunications and remotely-supported point-of-care ultrasound scanning (RS-POCUS) in prehospital situations
- To assess the impact of introducing this intervention on current care systems, via interviews with various stakeholders involved in the trial (e.g., patients, paramedics, emergency medicine consultants, hospital management, etc.) and health economic modelling
Research questions:
- What is the health gain, as assessed by the EQ-5D-5L (EuroQol five dimension questionnaire, 5-level version) score at three months, associated with the use of enhanced telecommunications and RS-POCUS?
- What is the estimated cost-per-QALY associated with the prehospital RS-POCUS?
- Where in the care system and in which situations does the intervention produce the greatest impact?
- How does the use of RS-POCUS affect time to definitive treatment in the studied patient groups?
Patient Randomisation:
Patients will be randomized to the intervention or control group prior to obtaining consent (Zelen randomisation), an approach considered optimal in trials where care is time-critical and patients may be highly stressed. This simplifies and shortens the in-ambulance consent process because the details of the random allocation and its associated uncertainty don't need to be explained until later.
Randomisation is performed using randomisation envelopes with codes printed on them, located in the ambulances. Codes will be reported and recorded on the emergency department contact log when a potential patient call-out occurs. If on arrival at the emergency scene the patient meets the inclusion criteria, the paramedic will obtain the patient's study group allocation by opening the envelope.
Consent:
It is crucial that delays to patient transfer are reduced to an absolute minimum in the ultrasound scanning group. The process of scanning is rapid and offers virtually no risk to the patient, but delays due to requesting consent are potentially more problematic and need to be minimised as much as possible. It is therefore proposed to have a two-stage consent process: a brief verbal consent to scanning and data transmission in the ambulance, and on arrival at the hospital, full written consent to health record analysis and to complete a follow-up questionnaire three months later.
If patients are assessed by the paramedic to lack the mental capacity and understanding to provide meaningful consent, an eligible proxy (relative, welfare attorney or guardian) accompanying the patient may provide consent on his or her behalf in line with the Adults with Incapacity Act, Scotland (2000). If a participant who is unable to consent shows any signs of unwillingness to take part or distress, they will be immediately withdrawn from the study.
Patient follow-up:
Patients will be asked to complete a standard EQ-5D-5L (health-related quality of life) questionnaire 3 months after recruitment to the trial, plus a short satisfaction/service use questionnaire. Ten patients from both the scanned and control groups will be approached at this time to ask if they would be willing to be interviewed about the use of ambulance-based ultrasound. If other specific interesting themes meriting further investigation arise from the interviews, these may be explored further with additional interviews in other participants. Patient involvement in the trial will end on completion of this 3-month follow-up.
Analyses:
The primary outcome is defined as the patient EQ-5D-5L (EuroQol five dimension questionnaire) score three months after the original ambulance episode. Analysis will be on an intention to treat basis with a per protocol analysis as a sensitivity. Pre-specified descriptive subgroup analyses will examine EQ-5D-5L results by age group, reason for scan and transport distance.
The economic analysis will include both a within-trial economic evaluation and a model-based economic evaluation. The within-trial analyses will take the form of a cost-utility analysis from the perspective of the National Health Service. The model-based analysis will also take the perspective of the NHS, but try to take into account wider societal costs such as unpaid carer time and costs, using standard national figures to estimate these contributions. A Markov model will be used to extrapolate from the short-term trial outcomes into the longer term.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care (control group) | No intervention | –Patient receives care as usual. |
| Enhanced communications & ultrasound | Experimental | Diagnostic Test: Enhanced communications & ultrasoundThe paramedic will record a brief video summary of the patient's condition, then remotely supported point of care ultrasound scans will be performed, and both file types sent to the hospital for review and feedback from the consultant. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with:
- Attended by a study ambulance
- Recruitment occurs within the hours supported by the Emergency Department: Monday to Friday, 09:00 to 17:00
Key exclusion criteria (10 listed)
- Non-emergency ambulance transfers
- General practitioner requested emergency ambulances
- Patients under arrest or held in prison
- No potential value in performing ultrasound (e.g., none of the diagnoses listed above)
- Lack of consent for scan (if in intervention arm)
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 |
|---|---|---|
| Enhanced communications & ultrasoundParamedics will perform standardised point-of-care ultrasound scan protocols (specific to the patient's symptom set) and record a short (<1 minute) video summarising the patient's condition and current management. These will be transmitted via satellite to consultants at the receiving hospital before the ambulance leaves the incident scene. The emergency department consultants will provide support and advice on continuing patient management via standard ambulance communications systems while it is en route to the hospital. | Diagnostic test | Enhanced communications & ultrasound |
Primary outcome
EQ-5D-5L (EuroQol five dimension, five level) score three months after the initial ambulance episode
Time frame: 3 months post recruitment
The EQ-5D-5L questionnaire includes assessments of mobility, self-care, daily activities undertaken, pain, discomfort, anxiety and depression.Completion of the EQ-5D-5L leads to the establishment of 243 distinct states, each with corresponding numerical quality of life value.
10 secondary outcomes
Cost per QALY (Quality Adjusted Life Year)
Time frame: 3 months post recruitment
Time from ambulance arrival at scene to definitive treatment or discharge
Time frame: up to 3 months post recruitment
Mortality rate
Time frame: up to 3 months post recruitment
Process evaluation (to investigate intervention use, acceptance and optimisation)
Time frame: 15 months
Costs to the NHS
Time frame: 15 months
Relative efficiency calculations (cost-consequences analysis)
Time frame: 15 months
Patient and staff satisfaction with the intervention
Time frame: 15 months
Patient and staff satisfaction with the intervention
Time frame: 15 months
Communications system connection speed
Time frame: 15 months
Communications system data upload rate
Time frame: 15 months
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 21 Feb 2021.
- Background: PubMed 28920524Eadie L, Mulhern J, Regan L, Mort A, Shannon H, Macaden A, Wilson P. Remotely supported prehospital ultrasound: A feasibility study of real-time image transmission and expert guidance to aid diagnosis in remote and rural communities. J Telemed Telecare. 2018 Oct;24(9):616-622. doi: 10.1177/1357633X17731444. Epub 2017 Sep 18.
- European Space Agency project websiteLink provided by the sponsor.
- University of Aberdeen project websiteLink 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.
Leila Eadie principal investigator
University of Aberdeen
Philip Wilson principal investigator
University of Aberdeen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced communications & ultrasound in people with Emergency Medical Services and Emergency Service, Hospital, run by University of Aberdeen at 3 sites in United Kingdom.
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 8 inclusion and 10 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
EQ-5D-5L (EuroQol five dimension, five level) score three months after the initial ambulance episode (time frame: 3 months post recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323229, which also lists 1 linked publication.
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 21 Feb 2021.