ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000750189

Ethics application status

Approved

Date submitted

10/04/2019

Date registered

20/05/2019

Date last updated

17/10/2022

Date data sharing statement initially provided

20/05/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Trial of Advanced CT Imaging and Combined Education Support for stroke patient access to reperfusion therapies

Scientific title

Trial of Advanced CT Imaging and Combined Education Support for stroke patient access to endovascular therapy (EVT) using a hub and spoke model of care

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1230-4161

Trial acronym

TACTICS (Trial of Advanced CT Imaging and Combined education Support)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Condition category

Condition code

Stroke

Ischaemic

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

BASELINE, INTERVENTION AND POST-INTERVENTION PERIODS

Stroke care data including acute case data, process times, advanced imaging profile, stroke reperfusion treatment, inter-hospital transfer of care and haemorrhage transformation will be obtained for a 9 month period (3 months baseline, 3 months intervention, 3 months post-intervention) for each cluster.

BASELINE PERIOD

Installation of AutoMIStar software; situational analysis of ‘status quo’; and commencement of TACTICS data collection mechanisms. Cluster stroke reperfusion therapy co-ordinators in each cluster, site champions and acute stroke access teams at each hospital will be identified.

Situational analysis of ‘status quo’
The 3-month baseline phase will involve individual site meetings along with review of multimodal CT image analysis software and stroke reperfusion protocols and processes at each site. This, together with voluntary staff surveys and key informant interviews regarding individual, social context and health system factors relating to acute stroke care, will form the basis of a site readiness assessment for each site, in order to establish a ‘status quo’ prior to implementing the study intervention. Interviews will be conducted both individually and as a group and will be tape-recorded.

Theoretical framework
Concepts from the Theoretical Domains Framework (TDF) and the Capability, Opportunity, Motivation and Behaviour (COM-B) approach will underpin the design, implementation and evaluation of the TACTICS ‘package intervention’ towards optimised workflow and patient selection for stroke reperfusion therapy.

Development of the ‘package intervention’
The TACTICS ‘package intervention’ will be developed in collaboration with experts from ambulance, emergency, radiology, stroke and behavioural science. The educational package will include didactic and interactive educational elements delivered by members of the research team and key stakeholders through a face to face cluster workshop, collaborative cluster teleconferences, ad hoc site meetings , a training manual or similar resource developed by the research team at The University of Newcastle, and case scenarios (via virtual reality technology or other method).

The package will include: (i) the rationale behind advanced imaging (CTA & CTP); (ii) utilisation of the AutoMIStar software, which is essentially automated but the user can alter the output at a variety of steps if they choose;. (iii) interpretation of advanced imaging output (CTA & CTP); (iv) criteria relating to patient selection, based on core/penumbra maps and angiography to identify patients with high likelihood of good and poor response to IVT; and (v) assessment of each site’s current multimodal CT acquisition protocols by an experienced CT radiographer from the research team.
The AutoMIStar software is a medical image processing software that allows the advanced visualization and analysis of perfusion and diffusion images. The software provides the user with a set of metrics allowing the investigator to adopt an evidence-based approach selection of patients to treatment. Evidence from research randomised clinical trials of reperfusion therapy has indicated the need for penumbra imaging profiling of patients in the selection for therapy.
The package will also include: (i) a template set of consensus clinical pathways and protocols towards optimal stroke reperfusion workflow; (ii) review of current cluster workflow using process mapping methodology; (iii) identifying gaps between current and ideal workflow; (iv) brainstorming around barriers and potential solutions; (v), prioritising change effort based on feasibility and importance; (vi) developing an action plan, and vii) monitoring progress by reviewing site and cluster specific processes and mechanisms including progress towards action plan goals. Sites will be encouraged to capture, review and use their own data and current protocols and pathways to look at process measures such as door-in-door-out (DIDO) and door-to groin (DTG) treatment times, which will be supported by educational and problem-solving elements and a template set of evidence based tools and resources to boost capability, motivation and opportunity of acute stroke access teams to make improvements within their cluster towards an optimal stroke reperfusion workflow.

INTERVENTION PERIOD

Rollout and tailoring of the ‘package intervention’
The ‘package intervention’ will be delivered based on the rollout schedule by key stakeholders, opinion leaders and member of the research team with expertise in acute stroke care, advanced imaging interpretation, workflow optimisation, adult education (andragogy) and behaviour change at individual, social context and health system levels. To ensure relevance of the ‘package intervention’ for each Cluster, the package will be tailored to the specific context and needs of each Cluster. The site assessment at baseline and the outcomes of the initial Cluster workshop will assist with this. Engagement with key stakeholders, including hospital quality improvement/governance, will be emphasised throughout the trial.

Target audience of the ‘package intervention’
The target audience of the ‘package intervention’ will be the site champions and ASAT at each hospital, the Cluster coordinator in each Cluster and key staff involved in the processes of care from hospital arrival through to treatment / transfer to hub for EVT. Each Cluster will also be provided with recommendations of available acute stroke educational resources, which can be accessed and utilised by each hospital for educating new and rotating staff in acute stroke care.

Cluster workshop
One 2-day cluster workshop will be conducted face to face at the beginning of the intervention phase in each cluster.

The cluster workshop will involve didactic and interactive components delivered by key stakeholders, opinion leaders and members of the research team. Intervention elements will include process and pathway analysis; roles and responsibilities around communication and engagement within and between teams regarding cases, and process of care, the role of site champions and ASAT in motivating and driving change efforts within the cluster; and criteria for patient selection and contacting the hub physician on call. Activities will include review of current acute stroke reperfusion workflow within the cluster, review of ideal workflow, gap analysis, identification of barriers and prioritising solutions and strategies based on process outlining importance and feasibility. Educational elements will include advanced imaging; criteria for patient selection and contacting the hub physician on call; data capture, review and use of the TACTICS eCRF; strategies to optimise workflow and overview of TACTICS resource kit. The outcome of the workshop will be the development of an action plan with agreed action goals tailored to the cluster environment, based on strategies identified as important and achievable.

Cluster teleconferences
Three 1-hour cluster meetings conducted as teleconferences, videoconferences or a combination of these modalities will be held during the intervention phase of the study.
The cluster teleconferences will be held following the initial cluster workshop, to review change efforts against action plan, progress change, tailoring to local environment, motivation by opinion leaders, engagement with governance/quality improvement, continue pathway and protocol analysis towards optimal stroke reperfusion workflow, monitor progress via audit and review of process measures including door-to-groin (DTG) time and door-in-door-out (DIDO) time and advanced imaging output to optimise patient selection and hub and spoke transfer of care arrangements.

Virtual reality (VR) education tool
The target audience of the interactive VR acute stroke training module will be key staff involved in the assessment and/or treatment of acute stroke at primary stroke centres. The VR module is anticipated to take 20 minutes to complete. The VR headset will be provided to sites at the workshop at the commencement of the active intervention phase. One VR headset will then be deployed to each hospital throughout the intervention phase. Site coordinators will be offered at least one training session to use the tool and will be encouraged to make training available to any interested healthcare staff at their sites. Staff are able to complete training at their convenience and repeat the training, if interested. Staff receives a summary of their overall training performance in the headset immediately upon completion of training. Staff is encouraged to complete pre- and post-VR training staff surveys before and after their first VR usage. Key elements will include inter and intra hospital communication and workflows and evidence-based strategies relating to reducing treatment times and improving patient selection. The data output from the virtual reality training module will be de-identified and collected at a site level, and will include pre and post surveys matched via a unique survey identifier, outcomes of decision making and engagement with the tool.

Adjustments to research activities
Where required, trial activities will transition to a flexible delivery model to accommodate social distancing requirements and travel restrictions as a result of the pandemic. Research activities may be tailored to adapt to restrictions, including the change from a face-to-face cluster workshop to an online webinar and the provision of traditionally paper-based surveys and study resources via online modalities including online survey tools and websites. The core features of the study, including data collection, collaborative quality improvement activities within and between sites and the provision of site support from the TACTICS research team, will remain the same regardles of whether activities are delivered face-to-face or online.

Intervention code [1]

Treatment: Other

Comparator / control treatment

No treatment (staff intervention) during the control period. There will be no interaction with sites during the control period other than data collection. This is a stepped-wedge design. Each site acts as its own control over time.

Control group

Active

Outcomes

Primary outcome [1]

Proportion of all stroke patients accessing Endovascular Therapy (EVT) per Cluster (measured at hub hospital using Cluster denominator data).
This outcome will be assessed using de-identified case data entered into the TACTICS electronic case report form by hospital staff at each participating hospital (numerator). Denominator data will be ICD-10 coding of all stroke separations using Cluster denominator data

Timepoint [1]

Three months post-intervention period.

Secondary outcome [1]

Proportion accessing IVT at spoke hospitals (using denominator data for all spokes/Cluster).
This outcome will be assessed using de-identified case data entered into the TACTICS electronic case report form by hospital staff at each participating spoke hospital (numerator). Denominator data will be ICD-10 coding of all stroke separations for all spokes in a Cluster.

Timepoint [1]

Three months post-intervention period.

Secondary outcome [2]

Proportion with good functional outcome (modified Rankin scale (mRS) 0-2) of all those treated with IVT at spoke hospitals.

Timepoint [2]