Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

SatCare: Remote Support for Ambulance Clinicians in Medical Emergencies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Scottish Ambulance Service
NHS Highland
Information provided by (Responsible Party):
Dr L Eadie, University of Aberdeen

Brief 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. 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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. Time from ambulance arrival at scene to definitive treatment or discharge [ Time Frame: up to 3 months post recruitment ]
    Measured in hours and minutes

  3. Mortality rate [ Time Frame: up to 3 months post recruitment ]
  4. 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

  5. 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.

  6. 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.

  7. Patient and staff satisfaction with the intervention [ Time Frame: 15 months ]
    Collected using custom created questionnaires

  8. Patient and staff satisfaction with the intervention [ Time Frame: 15 months ]
    Collected using custom created interview schedules

  9. 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.

  10. Communications system data upload rate [ Time Frame: 15 months ]
    Data upload speeds will be recorded (kb/s).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Leila Eadie, PhD +44(0)1463255888 l.eadie@abdn.ac.uk

Locations
Layout table for location information
United Kingdom
Centre for Rural Health Recruiting
Inverness, Scotland, United Kingdom, IV2 3JH
Contact: Leila Eadie    +44(0)1463255888    l.eadie@abdn.ac.uk   
NHS Highland: Raigmore Hospital Recruiting
Inverness, Scotland, United Kingdom
Contact: Emergency Department         
Scottish Ambulance Service Recruiting
Inverness, Scotland, United Kingdom
Contact: North Division         
Sponsors and Collaborators
University of Aberdeen
Scottish Ambulance Service
NHS Highland
Investigators
Layout table for investigator information
Principal Investigator: Leila Eadie University of Aberdeen
Principal Investigator: Philip Wilson University of Aberdeen
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Dr L Eadie, Research Fellow, University of Aberdeen
ClinicalTrials.gov Identifier: NCT03323229    
Other Study ID Numbers: 2-060-17
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dr L Eadie, University of Aberdeen:
Ultrasonography
Ambulances
Satellite Communications
Telemedicine
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Disease Attributes
Pathologic Processes