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Trial registered on ANZCTR


Registration number
ACTRN12619001678189
Ethics application status
Approved
Date submitted
12/11/2019
Date registered
29/11/2019
Date last updated
29/11/2019
Date data sharing statement initially provided
29/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The utility of telestroke compared with paramedic scores to accurately identify stroke reperfusion candidates in the pre-hospital setting
Scientific title
The utility of telestroke compared with paramedic scores to accurately identify stroke reperfusion candidates in the pre-hospital setting
Secondary ID [1] 299684 0
None
Universal Trial Number (UTN)
U1111-1243-3363
Trial acronym
none
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Stroke 315154 0
Condition category
Condition code
Stroke 313475 313475 0 0
Ischaemic
Stroke 313672 313672 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions consists of remote neurologist support for paramedics inside an ambulance to help diagnose whether a patient has truly suspected a stroke and whether they are eligible for reperfusion therapy. The support is rendered using iPads installed inside the ambulance connecting to the remote neurologist via videconferencing software. The workflow is outlined for the paramedics inside the ambulance using laminated cards. The videoconferencing approach allows the neurologist to make a verbal and visual assessment of the patient. This trial only assesses the diagnostic accurate of this approach, does not effect patient management, and does not involve any medications. Each individual patient will be assessed inside the ambulance only once during the ambulance transfer and each assessment will take between 5 and 15 minutes. The 'intervention' is an assessment itself that is standardised although we expect some degree of inter-assessor variation which is not dissimilar to any acute stroke assessment in light of the fact that patients vary between one another requiring some adaptation of the assessment approach.

The control arm will be using standard pre-hospital paramedic assessment scores (FAST and PASTA) to confirm stroke diagnosis and likelihood of being a reperfusion therapy candidate. The scores consist of a few items around the patient's presentation (eg face weakness, speech difficulties, arm weakness) that are added up to determine diagnosis.

Intervention code [1] 316044 0
Diagnosis / Prognosis
Comparator / control treatment
Patients managed without access to telestroke consultation using routinely used pre-hospital paramadic screening tools.
(1) FAST score (Face-arm-speech-time) + absence of abnormal glucose/seizure
(2) PASTA score - as above plus Los Angeles Motor scale, disability, and age.
Both of these are published in the New Zealand ambulance mannual.
Control group
Active

Outcomes
Primary outcome [1] 321940 0
Accuracy of predicting eventual in-hospital reperfusion decision

% of patients accurately predicted by scoring system versus neurologist assessment as being an eventual reperfsion candidate as determined by the attending neurologist in the emergency department.
Timepoint [1] 321940 0
within 24 hours of hospital arrival
Secondary outcome [1] 376757 0
Sensitivity and specificity of approach in predicting stroke ‘eligible’ for thrombolysis (i.e stroke confirmed and arrive in ED within treatment window).

Intervention arm: After each assessment the neurologists will record their diagnosis and whether the patient is a reperfusion candidate in a database. This will be completed prior to the patient undergoing additional testing in the emergency department. The eventual discharge diagnosis and treatment decision by the hospital team will be used as the comparator.

Control arm: Paramedics will record their FAST and PASTA scores in their routine clinical documentation prior to hospital arrival and these will also be compared to eventual diagnosis and treatment decisions as per above.
Timepoint [1] 376757 0
24 hours after hospital arrival
Secondary outcome [2] 376758 0
Door-to-needle/groin time (this is assessed in relation to the recorded time that the thrombolytic dose as given/clot retrieval started depending on which therapy is chosen).

Door time is recorded by the ED triage nurse upon hospital arrival and documented in the patient notes. Needle and groin times are recorded by the stroke team and documented in the patient notes. This data is collected in the central register and data from this register will be linked to the study database to match recorded time frames to each study patient.
Timepoint [2] 376758 0
24 hours after hospital arrival
Secondary outcome [3] 376759 0
Service cost,

This will be determined by calculating the videconferencing equipment and service fees (provided to us by the ambulance provider), the neurologist cost (time recorded in the study database), and cost of paramedic training (provided by the study PI and tutorial cost/prep time for the speaker and lecture time for the paramedics recorded for each educational event).

Timepoint [3] 376759 0
7 days after admission
Secondary outcome [4] 377166 0
Sensitivity and specificity of approach in predicting large vessel occlusion (LVO)

This will be determined by the documented prediction from the neurologist ie 'stroke for clot retrieval' (intervention arm) or the paramedic screening tool i.e. PASTA positive (control arm) and compared to presence of LVO on neuroimaging as determined by the reporting neuroradiologist who is blinded to study group. LVO is defined as ICA, MCA, ACA, basilar occlusion.
Timepoint [4] 377166 0
24 hours after hospital arrival

Eligibility
Key inclusion criteria
Patient identified by paramedic as possible stroke (triggering a pre-hospital stroke alert) and transported within one of the trial ambulances to Wellington Hospital.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient presents outside of trial operating hours (8am to 10pm M-S)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At individual patient level there was no concealment (cluster randomised controlled tiral)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of ambulances occurred by sequentially pulling ambulance numbers out of a concealed bag. The first six were allocated to group A the second six to group B.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Cluster randomisation at level of ambulance
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Sample Size
The sample size will be 55 per group. This will allow identification of a difference of 20% in terms of our primary outcome, diagnostic accuracy of predicting stroke reperfusion ‘eligible’ strokes, with 90% power and 5% error.
Analysis
Dichotomous variables will be analysed using logistic regression reporting odds ratios and continuous variables with be analysed using linear regression. Analysis will be completed in Stata.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22101 0
New Zealand
State/province [1] 22101 0
Wellington

Funding & Sponsors
Funding source category [1] 304161 0
Charities/Societies/Foundations
Name [1] 304161 0
Wellington Free Ambulance
Address [1] 304161 0
19 Davis Street Thorndon
Wellington 6011
Country [1] 304161 0
New Zealand
Primary sponsor type
Hospital
Name
Capital & Coast District Health Board
Address
Department of Neurology
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 304389 0
Hospital
Name [1] 304389 0
Capital & Coast DHB
Address [1] 304389 0
69 Riddiford Street
Newtown,
Wellington 6021
Country [1] 304389 0
New Zealand
Other collaborator category [1] 281029 0
Charities/Societies/Foundations
Name [1] 281029 0
Wellington Free Ambulance
Address [1] 281029 0
19 Davis Street Thorndon
Wellington 6011
Country [1] 281029 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304638 0
CCDHB Ethics Committee
Ethics committee address [1] 304638 0
Clinical Trials Unit
69 Riddiford Street
Newtown,
Wellington 6021
Ethics committee country [1] 304638 0
New Zealand
Date submitted for ethics approval [1] 304638 0
23/01/2019
Approval date [1] 304638 0
13/02/2019
Ethics approval number [1] 304638 0
CCDHB050219

Summary
Brief summary
Stroke reperfusion therapy is time critical. Improving pre-hospital diagnostic accuracy including likelihood of large vessel occlusion (LVO) can aid in making efficient and appropriate diversion decisions and has the potential to improve onset-to-treatment time.
This study aims to investigate whether pre-hospital telestroke improves diagnostic accuracy and accurate identification of potential reperfusion candidates compared with other currently used paramedic scoring systems. This is a pragmatic community based cluster randomised controlled trial in the greater Wellington area comparing specialist telestroke assessments inside the ambulance with routine use of the FAST (‘Face, Arm, Speech, and Time’) plus the PASTA score to correctly identify stroke reperfusion candidates including LVO patients. The PASTA score is a New Zealand adaptation of the Los Angeles Motor Scale (LAMS) where LAMS >2, Glasgow Coma Scale >5, age >15, and absence of glucose derangement and seizure are used as positive predictors of likely LVO. The target sample size is 55 patients in each study arm to identify 20% difference in diagnostic accuracy using telestroke over PASTA with 90% power and 5% error. This study includes an economic analysis of resource use in relation to patient benefit.
Trial website
none
Trial related presentations / publications
none
Public notes
none

Contacts
Principal investigator
Name 97678 0
A/Prof Annemarei Ranta
Address 97678 0
Department of Medicine
University of Otago, Wellington
PO Box 7343
23 Mein Street
Newtown
Wellington 6242
Country 97678 0
New Zealand
Phone 97678 0
+64 48061031
Fax 97678 0
Email 97678 0
anna.ranta@otago.ac.nz
Contact person for public queries
Name 97679 0
A/Prof Annemarei Ranta
Address 97679 0
Department of Medicine
University of Otago, Wellington
PO Box 7343
23 Mein Street
Newtown
Wellington 6242
Country 97679 0
New Zealand
Phone 97679 0
+64 48061031
Fax 97679 0
Email 97679 0
anna.ranta@otago.ac.nz
Contact person for scientific queries
Name 97680 0
A/Prof Annemarei Ranta
Address 97680 0
Department of Medicine
University of Otago, Wellington
PO Box 7343
23 Mein Street
Newtown
Wellington 6242
Country 97680 0
New Zealand
Phone 97680 0
+64 48061031
Fax 97680 0
Email 97680 0
anna.ranta@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data dictionary and anonymised patient data (demographics and outcomes) can be provided upon request if ethics approval granted.
When will data be available (start and end dates)?
Three months following publication of results and up to five years following publication.
Available to whom?
Researchers who provide a methodologically sound proposal plus case-by-case basis at the discretion of Primary Investigator.
Available for what types of analyses?
To achieve aims approved in the proposal (unless additional ethics is achieved) via a meta-analysis.
How or where can data be obtained?
Email: anna.ranta@otago.ac.nz
What supporting documents are/will be available?
No other documents available
Summary results
No Results