Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000804684
Ethics application status
Approved
Date submitted
30/05/2023
Date registered
26/07/2023
Date last updated
14/07/2024
Date data sharing statement initially provided
26/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute Telestroke Implementation to optimise Treatment rates, incorporating video-conferencing & virtual reality education
Scientific title
Incorporating Telestroke (live video) at paramedic point of care and virtual reality training to optimise treatment rates and clinical outcomes for acute stroke patients
Secondary ID [1] 308896 0
Nil known
Universal Trial Number (UTN)
U1111-1287-7429
Trial acronym
At-It+ (Acute Telestroke Implementation to optimise Treatment rates, incorporating video-conferencing & virtual reality education)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 328889 0
Condition category
Condition code
Stroke 325882 325882 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This hybrid implementation-effectiveness study applies a paramedic workflow intervention and virtual reality training intervention seeking to upskill paramedics in stroke assessment and transport decision-making and assess the effectiveness of a neurologist-supported video call in pre-hospital workflow.

PARAMEDIC WORKFLOW INTERVENTION VIA NEUROLOGIST VIDEO CALL
Stroke patients will be identified and assessed by paramedics per existing pathways based on the time since last seen well, stroke assessment score (based on Hunter-8) and previous function (by modified Rankin Score). If assessment scores are within pre-determined cut-off ranges, this will trigger a video-call for video assessment support by the stroke neurologist on-call. The video call will seek to a) confirm if the patient is a candidate for transport by-pass directly to the comprehensive stroke centre and b) the likelihood that patient will be a candidate for endovascular clot retrieval. It is anticipated that the video call will take approximately 5-minutes per patient, depending on case complexity and any aspects requiring clarification / discussion. Data will be collected regarding every patient in the 90-minute drive-time radius from the comprehensive stroke centre in which local ambulance services identified stroke-like symptoms and performed the Hunter-8. Compliance with the video-call protocol will be documented based on hospital records of all stroke transport cases, via existing process in hospital stroke records. Under conditions where video-conferencing is not available (e.g. equipment malfunction, insufficient WiFi signal, neurologist unavailable), paramedics will complete assessment and transport according to the existing business-as-usual protocols.

EDUCATION / TRAINING INTERVENTION VIA VIRTUAL REALITY TRAINING
Novel, tailored, interactive virtual reality-based training will be implemented to support paramedic up-skilling in stroke assessment and transport decision-making. Paramedics will complete a single virtual reality training session delivered on-site at training facilities, in station and/or via workshops (1 x ~30-minute session + debriefing). Virtual reality training sessions will be completed individually or in small groups (e.g. up to 8 paramedics and one facilitator). Training will be delivered by senior paramedic staff and supported by research team members. During each session, paramedics will use the virtual reality headset and controller to navigate through the training module. In the training module, paramedics complete a virtual stroke case from a first-person perspective, with workflow proceeding from the initial 000 call, patient assessment, transport and handover. During training, paramedics make active decisions and receive feedback on their responses in the virtual reality headset. Paramedics will then apply the workflow algorithm for all stroke patients encountered following completion of training, supported by process documentation (e.g. laminated transport algorithm forms). Training data will be assessed via data audits, surveys and interviews.

All paramedic staff involved in acute stroke assessment and management and/or paramedic training at local ambulance sites will be invited by the research team to complete semi-structured qualitative interviews to assess existing enablers and barriers and document outcomes of implementation.

Data will be collected continuously, with staggered implementation of the intervention across the training population (VR training & video-enabled neurologist workflow) over the intervention period. Training roll-out will occur within real-world local ambulance processes and informed by staff availability to complete VR training sessions (e.g. on-demand workshops, in-station training, training centre deployment).
Intervention code [1] 326269 0
Treatment: Devices
Intervention code [2] 326346 0
Treatment: Other
Comparator / control treatment
No control group. Pre / post-analysis will be performed based on stroke management workflow decisions at the individual paramedic level comparing the pre-intervention periods to the timeframe after each individual paramedic completes training and enters the active trial phase. The pre-intervention period will be defined as the timeframe from 12 months prior, and up until, the first virtual reality training session (i.e. 30 June 2022 to 01 July 2023) and sourced from existing hospital and paramedic records documenting stroke cases in the comprehensive stroke centre catchment.
Control group
Historical

Outcomes
Primary outcome [1] 333872 0
Levels of diagnostic accuracy (assessed using the positive likelihood ratio) of eligible and non-eligible patients transported to the comprehensive stroke centre for endovascular clot retrieval following the introduction of training with the 12-months period prior to its introduction, as a composite measure based on paramedic and hospital records.
Timepoint [1] 333872 0
Cumulative data will be assessed 12 months post-implementation of the training program (compared to the 12-month period prior)
Primary outcome [2] 333873 0
Virtual reality training package acceptability in the paramedic population, based on a study-specific questionnaire and semi-structured interviews with a member of the research team.
Timepoint [2] 333873 0
Data will be assessed 12 months post-implementation of the training program.
Secondary outcome [1] 418591 0
Any change in the number of patients classified as very likely candidates for endovascular clot retrieval at the time of the call receiving endovascular clot retrieval (excluding patients with intracranial haemorrhage on initial CT imaging), based on paramedic and hospital records.
Timepoint [1] 418591 0
Cumulative data will be assessed 12 months post-implementation of the training program (compared to the 12-month period prior)
Secondary outcome [2] 418592 0
Proportion of patients brought by ambulance to hospitals within the catchment area with a primary diagnosis of stroke on discharge from hospital assessed by paramedics using the Hunter-8 workflow pathway, based on paramedic and hospital records.
Timepoint [2] 418592 0
Cumulative data will be assessed 12 months post-implementation of the training program (compared to the 12-month period prior)
Secondary outcome [3] 418593 0
Any change in the number of confirmed participants engaged in training across the sites compared to the prior rate of engagement with existing face-to-face training, based on tracking of virtual reality training sessions and an audit of training records.
Timepoint [3] 418593 0
Cumulative data will be assessed 12 months post-implementation of the training program (compared to the 12-month period prior)
Secondary outcome [4] 418594 0
Feasibility, acceptability, appropriateness and sustainability of the Hunter-8 tool, determined as a composite measure by a combination of responses to a feedback survey designed specifically for this study and semi-structured interviews with a member of the research team.
Timepoint [4] 418594 0
Cumulative data will be assessed 12 months post-implementation of the training program (compared to the 12-month period prior)

Eligibility
Key inclusion criteria
All paramedic staff working within the study catchment area (with 90-minute drive time servicing the comprehensive stroke centre) will be eligible to participate in virtual reality training and semi-structured interviews. After completing training, all paramedics will conduct subsequent stroke patient assessments and transport decision-making applying the workflow intervention protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential paramedic participants will be ineligible to participate if they are unable to complete the trial education component or unable to use the video-conferencing technology. These instances will be documented to inform implementation feasibility, but the individual case will not be included in the overall analysis. Patient cases will be excluded where they are outside of the study catchment area, where the paramedic does not suspect the patient has a stroke and if the patient presents significant medical or logistical challenges that greatly delay standard stroke treatment.

Study design
Purpose of the study
Educational / counselling / training
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be collected continuously, with staggered implementation of the intervention across the training population (VR training & video-enabled neurologist workflow) over to the intervention period. Training roll-out will occur within real-world local ambulance processes and informed by staff availability to complete VR training sessions (e.g. on-demand workshops, in-station training, training centre deployment).

PARAMEDIC WORKFLOW INTERVENTION
Data will be collected from every consecutive patient identified in the field by local ambulance services in a 90-minute drive-time radius from comprehensive stroke centre, which have Hunter-8 / mRS scores over the thresholds defined in the transport algorithm and are within time windows for reperfusion therapy. Items collected will be the same as current data captured in audits of the telestroke network (e.g. patient details, stroke assessment scores, mRS scores, transport location / time). Minimal additional data relating to the telephone / videoconference call will also be captured (e.g. time of call, call duration, neurologist assessment regarding likely treatment eligibility, whether neurologist input altered the transport decision). The resource implications will be compared to historical data from the preceding 12-month period within the study area.

EDUCATION / TRAINING INTERVENTION
Data will be captured via data audits, surveys and interviews (e.g. virtual reality usage, location, user demographics, training time, user feedback). Assessment tools have been informed by Proctor’s taxonomy of implementation outcomes to assess user (trainee & trainer) perception of the VR training approach in terms of: acceptability, appropriateness, adoption, feasibility, fidelity, implementation cost, penetration and sustainability.

Semi-structured interview transcripts will be checked for errors in conjunction with the digital audio recordings. The constant comparative method of qualitative data analysis will be used to analyse the interview transcripts. Transcripts of the individual interviews will be assigned a series of codes independently by two members of the research team. Differences will be resolved through discussion between the coders, and with other members of the research team if required. The codes will be grouped into similar themes and concepts under the Theoretical Domains Framework.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
20/03/2024
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
200
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23905 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 39389 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 313107 0
Government body
Name [1] 313107 0
Hunter New England LHD
Country [1] 313107 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital (Hunter New England LHD)
Address
Lookout Road, New Lambton Heights, NSW, 2305
Country
Australia
Secondary sponsor category [1] 315828 0
None
Name [1] 315828 0
Address [1] 315828 0
Country [1] 315828 0
Other collaborator category [1] 282691 0
Government body
Name [1] 282691 0
NSW Ambulance
Address [1] 282691 0
Balmain Road, Rozelle, NSW, 2039
Country [1] 282691 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312356 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 312356 0
Ethics committee country [1] 312356 0
Australia
Date submitted for ethics approval [1] 312356 0
30/01/2023
Approval date [1] 312356 0
08/03/2023
Ethics approval number [1] 312356 0
HNELHD HREC: 2019/PID14621; 2019/ETH13062; 19/10/16/4.06

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

Contacts
Principal investigator
Name 124362 0
Prof Neil Spratt
Address 124362 0
John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305
Country 124362 0
Australia
Phone 124362 0
+61 2 4921 6171
Fax 124362 0
Email 124362 0
[email protected]
Contact person for public queries
Name 124363 0
Steven Maltby
Address 124363 0
University of Newcastle, University Drive, Callaghan, NSW, 2308
Country 124363 0
Australia
Phone 124363 0
+61 2 4042 0173
Fax 124363 0
Email 124363 0
[email protected]
Contact person for scientific queries
Name 124364 0
Neil Spratt
Address 124364 0
John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305
Country 124364 0
Australia
Phone 124364 0
+61 2 4921 6171
Fax 124364 0
Email 124364 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
Data pertaining to individuals 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.