Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001529730
Ethics application status
Approved
Date submitted
9/11/2022
Date registered
12/12/2022
Date last updated
10/12/2023
Date data sharing statement initially provided
12/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising Time to Thrombectomy in Regional Australia: The Stroke Capable Ambulance (SCA) Program – Part 1
Scientific title
The Stroke Capable Ambulance (SCA) program part 1, a prospective, non-randomised cluster cross-over design of acute stroke patient hospital bypass to assess time to treatment.
Secondary ID [1] 308206 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SCA-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 327957 0
Condition category
Condition code
Stroke 325022 325022 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, non-randomised cluster cross-over study design. The study will be a paramedic-led multi-pronged process of care re-engineering intervention including paramedic education, change in care pathway enabling hospital bypass and hospital pre-notification of suspected stroke patients using a defined clinical assessment scoring system (Hunter-8 or ACT-FAST) supported by telehealth technology to enable expert consultation where indicated. We will compare process of care times between the original and re-engineered process of care.

The education component of the project will be delivered through study developed in-person lectures, on-line content with assessments and ambulance station visits one month before the study initiation and the on-line content will be available for the duration of the intervention phase. This mixed model of education will be supported by paramedic educators who will assist in dissemination of the study education material in addition to the study personnel. The main intervention will consist of one hour of content for each paramedic as well as a one-hour station visit to confirm the content. Given the large number of paramedics included in the study, it is expected that multiple repeated education sessions will be required, after the study intervention has been initiated to maintain study procedure familiarity with the paramedic cohort. Adherence will be monitored through in-person exit surveys, on-line content exams and summary data from the on-line learning management system.

The tele health support for the study will be provided through a study specific phone based app which will enable paramedic access to neurologist consultation on patients that the paramedics suspect are a likely stroke patient due to a large vessel occlusion. This process of care is intended to support enhanced case communication to expedite standard of care stroke treatments. Paramedics will be trained on use of the study app during the education sessions. The study app supports in-field, at point of patient care data capture, video conferencing with a study neurologist, ambulance location tracking for pre-notification, patient handover support, as well as app supported decision assistance.

Lastly, the process of care intervention for this study will primarily be a hospital by-pass model for patients with a stroke due to a large vessel occlusion are transported directly to a thrombectomy capable hospital. Paramedics will assess stroke patients with the aid of a neurologist tele-health consult to assist with the sensitivity and specificity of the pre-hospital identification of strokes due to a large vessel occlusion. The study specific hospital-bypass protocol will be implemented as a location specific standard of care protocol change.
Intervention code [1] 324665 0
Diagnosis / Prognosis
Comparator / control treatment
As part of the cross-over study design, the study control group will be all acute ischemic stroke patients with a large vessel occlusion treated between 1 July 2022 and 12 December 2022, who went on to have thrombectomy in NSW and Victoria study defined catchment areas, aiming for a sample size of up to 80 pre-intervention records. The control group will be collected from the same study catchment till the pre-intervention sample size has been collected as part of the study.
Control group
Historical

Outcomes
Primary outcome [1] 332840 0
Time from ambulance arrival to arterial puncture for thrombectomy eligible patients in the study catchments will be recorded in the study app by the study investigators.
Timepoint [1] 332840 0
censored at 24 hours from symptom onset or last known well.
Secondary outcome [1] 414840 0
Accuracy of pre-hospital stroke assessment by paramedics compared with ED neurological assessment as a reference standard.
Timepoint [1] 414840 0
At ED arrival
Secondary outcome [2] 414841 0
Modified Rankin scale score at day 90
Timepoint [2] 414841 0
At 90 days post stroke onset
Secondary outcome [3] 414842 0
Time from symptom onset to treatment with thrombolysis in thrombolysis only eligible patients (i.e., not eligible for thrombectomy), will be recorded in the study app by the study investigators.
Timepoint [3] 414842 0
Within 24 hours of symptom onset.
Secondary outcome [4] 414843 0
90-day mortality
Timepoint [4] 414843 0
At 90 days post symptom onset
Secondary outcome [5] 414844 0
Rates of adverse and serious adverse events during transport e.g., Drop in level of consciousness, as assessed through data input by paramedics on study app and Hospital ED patient care records.
Timepoint [5] 414844 0
within 24hrs of symptom onset
Secondary outcome [6] 415582 0
Rates of adverse and serious adverse events in hospital: e.g., hemorrhagic transformation as per follow-up CT's and clinical examination, as assessed through acute hospital patient care records.
Timepoint [6] 415582 0
within 24hrs of symptom onset
Secondary outcome [7] 416305 0
Hospital door to thrombolysis time as assessed through acute hospital patient care records.
Timepoint [7] 416305 0
Within 24hrs of ED arrival
Secondary outcome [8] 416306 0
Hospital door-to-thrombectomy time as assessed through acute hospital patient care records.
Timepoint [8] 416306 0
within 24hrs of ED arrival
Secondary outcome [9] 416308 0
Primary hospital to Treatment hospital transfer time as assessed through acute hospital patient care records.
Timepoint [9] 416308 0
within 24hrs of arrival at treatment hospital ED

Eligibility
Key inclusion criteria
1. Adults >=18 years of age.
2. Paramedic assessed as a potential stroke meeting the Hunter-8 (scoring above 8 points)
or FAST criteria (scoring positive) for a large vessel occlusion (LVO).
3. Presenting within 24 hours of symptom onset or last known well.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Paramedic does not suspect the patient has a stroke.
2. The patient presents significant medical or logistical challenges which greatly delay
standard treatment.
3. Patient outside of study catchment (region).
4. Acute medical or neurological instability making bypass of the local hospital infeasible
5. Pregnancy
6. Patients enrolled in another trial or investigational product
7. Any other medical contraindication at discretion of investigator

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The cross over time will be once the pre-intervention sample has recruited and the study logistics are in place the deliver the intervention. Paramedic-led multi-pronged intervention including education, change in care pathway enabling patient bypass and hospital pre-notification of suspected stroke using a defined clinical assessment scoring system (Hunter-8 or ACT-FAST/MASS) supported by telehealth technology to enable expert consultation where indicated.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The full sample analysis will be conducted on the data that comprises all the participants in the selected catchment areas who required ambulance assessment and had a final neurological diagnosis of stroke established through specialist clinical/radiological assessment at the final treating hospital. The statistical analysis plan document providing detailed description of the pre-planned analyses will be formulated prior to the study data lock.
The primary hypothesis that implementing a paramedic-based patient bypass model supported by telehealth tools and patient assessments significantly improves the time to thrombectomy treatment for participants with sufficient indications for such treatments, will be tested using either parametric (Weibull) or semi-parametric (Cox proportional hazard) or median regression depending on the nature of the underlying time distribution. Patient age and stroke onset to ambulance call time will be included as adjustment covariates, and individual catchments will be included as random effects in the chosen regression model. Quantile regression estimates on key quantiles (25th, median, and 75th percentile) will be provided with respective 95% confidence intervals to fully characterize the treatment effect.
The accuracy of stroke diagnosis by paramedics using ED neurological assessment as a reference standard will be compared within area of receiver operator curves framework, comparing areas under the curve in pre and post crossover phases. Standard diagnostic testing parameters such as sensitivity and specificity, positive and negative predictive value and diagnostic odds ratio will be reported. Modified Rankin scale score at day 90 and mortality by day 90 will be compared between pre and post crossover phases using either binary (for mortality and dichotomous mRS outcomes) or ordinal (for mRS across the ordinal scale) regression models with age and baseline stroke severity as adjustment covariates, and individual catchments will be included as random effects in the chosen regression model. Time from symptom onset to treatment with thrombolysis in thrombolysis only eligible patients (ie, not eligible for thrombectomy) will be investigated as per the approach adopted for the analysis of primary outcome. Rates of adverse and serious adverse events during the pre-hospital and during hospital admission period, will be compared using Poisson regression modelling with age and baseline stroke severity as adjustment covariates, and individual treating hospitals will be included as random effects in the chosen regression model. Time from symptom onset to thrombolysis in thrombectomy eligible patients, will be investigated as per the approach adopted for the analysis of primary outcome.
Process measures will be analysed using appropriate regression models within mixed effect regression modelling framework using either catchment or treating hospital as appropriate. The historical control group are taken prior to the introduction of the study intervention and are limited in number of participants to the study protocol sample size calculation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/12/2022
Actual
25/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
53
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 23381 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 23382 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 38778 0
2170 - Liverpool
Recruitment postcode(s) [2] 38779 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 312463 0
Other Collaborative groups
Name [1] 312463 0
Australian Stroke Alliance
Country [1] 312463 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Administration Building
Eastern Campus, Liverpool Hospital
Locked Bag 7279
LIVERPOOL BC NSW 1871
Country
Australia
Secondary sponsor category [1] 314045 0
None
Name [1] 314045 0
Address [1] 314045 0
Country [1] 314045 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311808 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 311808 0
Ethics committee country [1] 311808 0
Australia
Date submitted for ethics approval [1] 311808 0
29/04/2022
Approval date [1] 311808 0
02/06/2022
Ethics approval number [1] 311808 0
2022/ETH00715

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122434 0
Prof Mark Parsons
Address 122434 0
Liverpool Hospital
Corner of Elizabeth and Goulburn Streets,
Liverpool, NSW
2170
Country 122434 0
Australia
Phone 122434 0
+61 2 8738 6511
Fax 122434 0
Email 122434 0
[email protected]
Contact person for public queries
Name 122435 0
Mark Parsons
Address 122435 0
Liverpool Hospital
Corner of Elizabeth and Goulburn Streets,
Liverpool, NSW
2170
Country 122435 0
Australia
Phone 122435 0
+61 2 8738 6511
Fax 122435 0
Email 122435 0
[email protected]
Contact person for scientific queries
Name 122436 0
Mark Parsons
Address 122436 0
Liverpool Hospital
Corner of Elizabeth and Goulburn Streets,
Liverpool, NSW
2170
Country 122436 0
Australia
Phone 122436 0
+61 2 8738 6511
Fax 122436 0
Email 122436 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Medical data pertaining to an individual will not be made public. Only aggregate summary data will be published.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.