SatCare: Remote Support for Ambulance Clinicians in Medical Emergencies
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|ClinicalTrials.gov Identifier: NCT03323229|
Recruitment Status : Unknown
Verified May 2018 by Dr L Eadie, University of Aberdeen.
Recruitment status was: Recruiting
First Posted : October 26, 2017
Last Update Posted : May 16, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Emergency Medical Services Emergency Service, Hospital||Diagnostic Test: Enhanced communications & ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||SatCare: Remote Support for Ambulance Clinicians in Medical Emergencies|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||April 1, 2019|
|Estimated Study Completion Date :||April 1, 2019|
No Intervention: Usual care (control group)
Patient receives care as usual.
Experimental: Enhanced communications & ultrasound
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.
Diagnostic Test: Enhanced communications & ultrasound
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.
- 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.
- Cost per QALY (Quality Adjusted Life Year) [ Time Frame: 3 months post recruitment ]
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.
- Time from ambulance arrival at scene to definitive treatment or discharge [ Time Frame: up to 3 months post recruitment ]Measured in hours and minutes
- Mortality rate [ Time Frame: up to 3 months post recruitment ]
- Process evaluation (to investigate intervention use, acceptance and optimisation) [ Time Frame: 15 months ]Includes interviews with stakeholders and anonymised descriptions of cases in which management was altered as a result of the intervention
- Costs to the NHS [ Time Frame: 15 months ]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.
- Relative efficiency calculations (cost-consequences analysis) [ Time Frame: 15 months ]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.
- Patient and staff satisfaction with the intervention [ Time Frame: 15 months ]Collected using custom created questionnaires
- Patient and staff satisfaction with the intervention [ Time Frame: 15 months ]Collected using custom created interview schedules
- Communications system connection speed [ Time Frame: 15 months ]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.
- Communications system data upload rate [ Time Frame: 15 months ]Data upload speeds will be recorded (kb/s).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323229
|Contact: Leila Eadie, PhD||+44(0)firstname.lastname@example.org|
|Centre for Rural Health||Recruiting|
|Inverness, Scotland, United Kingdom, IV2 3JH|
|Contact: Leila Eadie +44(0)1463255888 email@example.com|
|NHS Highland: Raigmore Hospital||Recruiting|
|Inverness, Scotland, United Kingdom|
|Contact: Emergency Department|
|Scottish Ambulance Service||Recruiting|
|Inverness, Scotland, United Kingdom|
|Contact: North Division|
|Principal Investigator:||Leila Eadie||University of Aberdeen|
|Principal Investigator:||Philip Wilson||University of Aberdeen|