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Optimising Time to Thrombectomy in Regional Australia: The Stroke Capable Ambulance (SCA) Program – Part 1

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001529730
Acronym
SCA-1
Enrollment
53
Registered
2022-12-12
Start date
2022-12-25
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a prospective, non-randomised, cluster cross-over study of paramedic-led, multi-pronged, process of care re-engineering intervention. The intervention will include education, change in care pathways enabling patient bypass and hospital pre-notification of suspected LVO stroke using a defined clinical assessment scoring system (Hunter-8 or ACT-FAST) supported by tele health technology to enable expert consultation where indicated. We will compare process of care times between the original and re-engineered process of care. This is a paramedic-led multi-pronged intervention including education, change in care pathway to enable patient bypass and hospital pre-notification of suspected LVO stroke using a defined clinical assessment scoring system (Hunter-8 or ACT-FAST/MASS), supported by tele health technology to enable expert consultation where indicated. The aim of the study is to test whether implementing a paramedic-based patient bypass model supported by telehealth tools and patient assessments significantly improves the time to arterial puncture for thrombectomy treatment for participants with sufficient indications for such treatments.

Interventions

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 betwe

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.

Sponsors

South Western Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026