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Trial registered on ANZCTR


Registration number
ACTRN12611000792921
Ethics application status
Approved
Date submitted
26/07/2011
Date registered
28/07/2011
Date last updated
11/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and Safety of a Transient Ischaemic Attack (TIA) Electronic Support Tool
Scientific title
Multi-centre randomised controlled trial comparing the effect of general practitioner utilisation of a TIA electronic decision support tool in the management of TIA/minor stroke patients versus usual care on the subsequent 90 day stroke risk, degree of guideline adherence, and overall treatment costs.
Secondary ID [1] 262715 0
Nil
Universal Trial Number (UTN)
U1111-1123-1863
Trial acronym
FASTEST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transient Ischaemic Attack 270421 0
Stroke 270422 0
Condition category
Condition code
Stroke 270563 270563 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Utilisation of a TIA electronic decision support (EDS) tool during the management of patients suspected of having suffered a TIA or stroke.

The tool is a web based module that GPs access by clicking a menu button situated on the navigation bar of their practice management software that links them to the software provider (BPAC.Inc) module site. From there they select the TIA/Stroke EDS tool from a menu. Once selected a single page of tick boxes opens up for GPs to complete covering items such as relevant aspects of history of presenting illness and a brief focused physical examination. Fields for relevant past medical history (e.g. diabetes and smoking history) are automatically populated by extracting data directly from the practice management system. Completing the page of background and clinical presentation data takes approximately 2-5 minutes depending on the GP’s familiarity with the tool. Based on this information the software confirms or rejects TIA/stroke as the likely diagnosis. If TIA or stroke is confirmed a triage recommendation is generated based on a validated risk score (ABCD2) supplemented by several other variables taken from the New Zealand TIA guidelines and clinical experience. If patients are triaged into the “low risk” category GPs are offered the option of either referring them to a specialist TIA clinic or to manage the patients themselves in the community. If community management is selected a step by step outline is provided with links to pre-populated relevant prescriptions, radiology referral forms, and life-style information leaflets. If patients are triaged into the “high risk” category GPs are advised to refer them to hospital for specialist assessment and diagnostic work-up to be achieved within 24 hours and GPs are not offered the community management option. However, if a GP feels that ED referral is not appropriate in any given situation (e.g. the patient refuses to attend ED) then the GP has the option to override this recommendation and refer patients to an outpatient specialist TIA clinic instead, as long as a reason for overriding the recommendation is specified. Referrals to hospital are automatically generated and contain all required information to allow the specialist to prioritise them appropriately. In the case of a hyper-acute stroke that is within the 4.5 hour thrombolysis window the tool is immediately aborted and the GP is advised to call 111 for emergent hospital transfer to a centre where stroke thrombolysis is available.

A GP sees on average 1 TIA patient per month which also represents the average anticipated frequency of EDS use. Each TIA presentations requires only a single use of the EDS.
Intervention code [1] 267057 0
Other interventions
Comparator / control treatment
Usual care without assistance from the TIA EDS tool.

Usual care involves taking a history and performing a phyisical examination. Then a diagnosis is rendered and a management plan devised that could involved hospital referral or community management. However, community management without access to the TIA tool precludes urgent access to publicly funded diagnostics such as a head CT as these investigations are limited to specialists in New Zealand. The GP can consult with any resource except for the TIA EDS. Non-EDS resources would include text books, medical web sites, or phoning a specialist for advice.
Control group
Active

Outcomes
Primary outcome [1] 269306 0
Primary Outcome 1: all subsequent strokes in patients who presented with TIA or minor stroke to GP practices enrolled into study
Timepoint [1] 269306 0
Within 90 days from presentation
Primary outcome [2] 269307 0
Primary Outcome 2: NZ TIA Guideline adherence as assessed by data linkage to medical records
Timepoint [2] 269307 0
From presentation to completion of treatment event (e.g. hospital admission)
Secondary outcome [1] 279337 0
Secondary Outcome 1: all cause mortality, myocardial infarction (MI), and intracerebral haemorrhage (ICH)
Timepoint [1] 279337 0
Within 90 days of initial presentation
Secondary outcome [2] 279338 0
Secondary Outcome 2: adverse events related to EDS use as assessed by data linkage to medical records.

Adverse events relate to erroneous diagnosis of TIA leading to unwarranted therapy and related medication side effects, erroneous diagnosis of a non-TIA or falsely low triage score with resultant preventable stroke.
Timepoint [2] 279338 0
Within 90 days of initial presentation
Secondary outcome [3] 279339 0
Secondary Outcome 3: cost comparison between intervention and placebo arm as assessed by data linkage to medical records.

Cost will be assessed from a health service point of view including physician fees, diagnostic fees, and hospital/rehabilitation costs.
Timepoint [3] 279339 0
Within 90 days of initial presentation
Secondary outcome [4] 307232 0
TIA
Timepoint [4] 307232 0
Within 90 days of initial presentation

Eligibility
Key inclusion criteria
GP willingness to be a) randomised to either intervention or placebo group, b) GP willingness to register ALL patients suspected of having a TIA, c) GP practice equipped with electronic medical record system that interfaces with EDS format
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior use/familiarity with the TIA EDS tool. Location outside of the designated study areas (Hawke's Bay, Whanganui, and Southern DHB)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
GPs will be invited to participate via an invitation letter. Once consent has been signed they will be randomised at the practice level (cluster design) in order to minimise any potential learning effect created by software use.
A randomisation schedule will be drawn up by the statistical advisor to the project, as the identity of the study practices will remain unknown to him. The PI and other researchers will know the name and location of the practices but will refer to them by number (1-30). As practices agree to participate the study’s PI will notify statistical advisor and he will advise her as to the study group allocation of the practice (Intervention or Control group). The PI will make these requests in separate phone calls for each practice, not knowing the randomisation schedule in advance.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
According to order in which practices agree to participate
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 3749 0
New Zealand
State/province [1] 3749 0

Funding & Sponsors
Funding source category [1] 267534 0
Government body
Name [1] 267534 0
Health Research Council
Address [1] 267534 0
Level 3, 110 Stanley Street, Auckland 1010, New Zealand
Country [1] 267534 0
New Zealand
Primary sponsor type
Individual
Name
Dr Annemarei Ranta
Address
Department of Neurology
Private Bag 11036
MidCentral Health
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 266572 0
Individual
Name [1] 266572 0
A/Prof Susan Dovey
Address [1] 266572 0
Department of General Practice
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
9016
Country [1] 266572 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269490 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 269490 0
Ministry of Health
133 Molesworth St
PO Box 5013
Wellington
Ethics committee country [1] 269490 0
New Zealand
Date submitted for ethics approval [1] 269490 0
29/07/2011
Approval date [1] 269490 0
14/09/2011
Ethics approval number [1] 269490 0

Summary
Brief summary
The primary purpose of this study is o assess the efficacy and safety of the transient ischaemic attack (TIA)/Stroke electronic decision support (EDS) tool. The study will focus on the effects of EDS use in the GP setting on stroke prevention, national guideline adherence, potentially associated risks, and cost compared with routine care.
Trial website
Trial related presentations / publications
Presentation at International Stroke Conference, SanDiego, 13 Feb 2014, oral abstract.
Public notes

Contacts
Principal investigator
Name 32933 0
Dr Annemarei Ranta
Address 32933 0
Department of neurology Private Bag 11036 MidCentral Health Palmerston North 4442
Country 32933 0
New Zealand
Phone 32933 0
+64 6 350 8623
Fax 32933 0
Email 32933 0
anna.ranta@midcentraldhb.govt.nz
Contact person for public queries
Name 16180 0
Dr Dr Annemarei Ranta
Address 16180 0
Department of neurology
Private Bag 11036
MidCentral Health
Palmerston North 4442
Country 16180 0
New Zealand
Phone 16180 0
+64 6 350 8623
Fax 16180 0
+64 6 3508831
Email 16180 0
anna.ranta@midcentraldhb.govt.nz
Contact person for scientific queries
Name 7108 0
Dr Dr Annemarei Ranta
Address 7108 0
Department of neurology
Private Bag 11036
MidCentral Health
Palmerston North 4442
Country 7108 0
New Zealand
Phone 7108 0
+64 6 350 8623
Fax 7108 0
+64 6 3508831
Email 7108 0
anna.ranta@midcentraldhb.govt.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary