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Trial registered on ANZCTR

Registration number

ACTRN12614000939695

Ethics application status

Approved

Date submitted

15/08/2014

Date registered

2/09/2014

Date last updated

17/12/2019

Date data sharing statement initially provided

17/12/2019

Date results provided

17/12/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

T3 Trial: Triage, Treatment and Transfer of Patients with Stroke in Emergency Departments

Scientific title

A cluster randomised controlled trial to evaluate the effectiveness of a multidisciplinary organisational intervention to improve triage, treatment and transfer of acute stroke patients in Emergency Departments (EDs), relative to usual care, on death or dependency (defined as modified Rankin Scale [mRS] >=2) 90-days post hospital admission.

Secondary ID [1]

APP1024812

Universal Trial Number (UTN)

U1111-1159-4170

Trial acronym

T3 Trial

Linked study record

Health condition

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

Stroke

Health services research

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

T3 Intervention
This organisational intervention will be implemented in Emergency Departments (EDs) and will target health care professional behaviour for acute stroke management. We will design evidence-based clinical protocols for triage, treatment and transfer following acute stroke. (Ai) routine assignment of stroke patients to triage Category 1 or 2; (Aii) time-sensitive ‘trigger’ screening for tPA eligibility; (Aiii) instigation of protocols for prompt management of fever, hyperglycaemia and swallowing; (Aiv) rapid transfer of patients from ED to the stroke unit. These protocols will be implemented using an evidence-based implementation strategy consisting of:
(Bi) workshops to identify local barriers and enablers and to identify clinical champions; (Bii) didactive and interactive education; (Biii) use of local clinical opinion leaders (site clinical champions); and (Biv) reminders in the form of email, telephone and site visits. The overall duration of the intervention period is anticipated to last for 12 to 18 months. Once we have recruited our required sample size the intervention period will cease.

For the duration of the trial, control group EDs will not receive any T3 Trial intervention elements.

As part of our intervention, site visits will be undertaken to discuss adherence to the intervention. This will be supported by email and telephone contact. Medical record audit will provide protocol adherence rates at the conclusion of the trial.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Usual care

Usual care will be the current treatment that stroke patients receive when admitted to EDs randomised to the control group. There will be no T3 trial intervention elements introduced at these sites.

Control group

Active

Outcomes

Primary outcome [1]

Death or dependency (defined as modified Rankin Scale [mRS] >= 2)

Timepoint [1]

Timepoint: 90-days post-hospital admission

Secondary outcome [1]

Secondary Outcome 1:
Barthel Index [BI]) >= 95 (dependency score)

Timepoint [1]

Timepoint: 90 days post hospital admission

Secondary outcome [2]

Secondary Outcome 2:
mean SF-36 Physical Component Score [PCS]

Timepoint [2]

Timepoint: 90 days post hospital admission

Secondary outcome [3]

Secondary Outcome 3:
mean SF-36 Mental Component Score [MCS]

Timepoint [3]

Timepoint: 90-days post-hospital admission

Eligibility

Key inclusion criteria

Cluster level (ED): Hospitals with EDs located in the Australian states of New South Wales, Queensland, Victoria and Australian Capital Territory

Patient level: English-speaking; admitted to the stroke unit via ED with a clinical diagnosis of ischaemic stroke or intracerebral haemorrhage; presented to hospital less than 48 hours from symptom onset; access to a telephone.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Presenting to hospital more than 48 hours from symptom onset; requiring palliative care only; identified non-cerebrovascular causes of acute focal neurological deficits (seizure, hypoglycaemia, toxic or metabolic encephalopathies); sub-arachnoid haemorrhage; and acute and chronic subdural haemorrhage.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Cluster level: Cluster guardians will provide written informed cluster consent, agreeing that their ED can be randomised to either the intervention or control arm of the trial. They will agree to the intervention becoming ‘business as usual’ should they be allocated to the intervention group. This is in contrast to Emergency departments randomised to the control arm who will just continue usual care.

Patient level: Clinical Research Assistants (CRAs) at each study site who will be masked to trial design will enrol eligible patients. All eligible patients will be given a Patient Information Statement (PIS) outlining the collection of data and the 90 days follow-up process. This PIS outlines the opt-out consent process, with contact details provided to the study team for further questions or to opt-out.

As this is a cluster randomised controlled trial, randomisation of EDs and allocation to either intervention or control group will be conducted simultaneously – see below.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Allocation will be based on clusters (EDs) rather than individuals. Each ED will be assigned a unique study number. EDs will be stratified by State and hospital baseline thrombolysis rates.

A list of participating EDs and stratification details will be provided in a de-identified format to an independent statistician not otherwise involved in the trial. Generation of the allocation sequence using random number generating software and assigning of EDs to either intervention or control group will be undertaken by this independent statistician.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

We plan to recruit 1160 patients from 26 clusters following implementation of the intervention and anticipate 9% loss to follow-up. With a 5% significance level and 80% power, assuming that 50% of patients in the usual care group will have mRS >=2, 60% will have Barthel Index >= 95, standard deviations for MCS and PCS of 11 and a design effect of 1.4 (the assumptions are based on our previous QASC Study), this will allow detection of a difference between intervention and control groups at 90 days post admission of:

10% for mRS >=2 (Primary outcome)

10% for Barthel Index [BI]) >= 95 (Secondary outcome 1);
0.2 standard deviations (~2.5 units) higher mean SF-36 Physical Component Score [PCS] (Secondary outcome 2); and
0.2 standard deviations (~2.5 units) higher mean SF-36 Mental Component Score [MCS] (Secondary outcome 3)

Analysis of outcomes will involve regression (logistic or linear as appropriate) with adjustment for clustering of patients within hospitals. We will undertake unadjusted analyses as well as analyses which adjust for baseline covariates. Primary analysis will be a complete case analysis with sensitivity analyses using multiple imputations to account for missing data.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/01/2015

Actual

14/07/2015

Date of last participant enrolment

Anticipated

31/10/2016

Actual

30/09/2016

Date of last data collection

Anticipated

Actual

15/02/2017

Sample size

Target

1160

Accrual to date

Final

1294

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,VIC

Recruitment hospital [1]

The Canberra Hospital - Garran

Recruitment hospital [2]

Bankstown-Lidcombe Hospital - Bankstown

Recruitment hospital [3]

Bathurst Base Hospital - Bathurst

Recruitment hospital [4]

John Hunter Hospital Royal Newcastle Centre - New Lambton

Recruitment hospital [5]

Liverpool Hospital - Liverpool

Recruitment hospital [6]

Nepean Hospital - Kingswood

Recruitment hospital [7]

Prince of Wales Hospital - Randwick

Recruitment hospital [8]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [9]

St George Hospital - Kogarah

Recruitment hospital [10]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [11]

Westmead Hospital - Westmead

Recruitment hospital [12]

Gold Coast Hospital - Southport

Recruitment hospital [13]

Nambour General Hospital - Nambour

Recruitment hospital [14]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [15]

The Townsville Hospital - Douglas

Recruitment hospital [16]

The Wesley Hospital - Auchenflower

Recruitment hospital [17]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [18]

Bendigo Health Care Group - Bendigo Hospital - Bendigo

Recruitment hospital [19]

Box Hill Hospital - Box Hill

Recruitment hospital [20]

Latrobe Regional Hospital - Traralgon

Recruitment hospital [21]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [22]

Southwest Health Care - Warrnambool - Warrnambool

Recruitment hospital [23]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [24]

Geelong Private Hospital - Geelong

Recruitment hospital [25]

Northeast Health Wangaratta - Wangaratta

Recruitment hospital [26]

The Alfred - Prahran

Recruitment postcode(s) [1]

2010 - Darlinghurst

Recruitment postcode(s) [2]

2031 - Randwick

Recruitment postcode(s) [3]

2050 - Camperdown

Recruitment postcode(s) [4]

2145 - Westmead

Recruitment postcode(s) [5]

2170 - Liverpool

Recruitment postcode(s) [6]

2200 - Bankstown

Recruitment postcode(s) [7]

2217 - Kogarah

Recruitment postcode(s) [8]

2305 - New Lambton

Recruitment postcode(s) [9]

2605 - Garran

Recruitment postcode(s) [10]

2750 - Penrith

Recruitment postcode(s) [11]

2795 - Bathurst

Recruitment postcode(s) [12]

3004 - Melbourne

Recruitment postcode(s) [13]

3050 - Royal Melbourne Hospital

Recruitment postcode(s) [14]

3065 - Fitzroy

Recruitment postcode(s) [15]

3128 - Box Hill

Recruitment postcode(s) [16]

3181 - Prahran

Recruitment postcode(s) [17]

3220 - Geelong

Recruitment postcode(s) [18]

3280 - Warrnambool

Recruitment postcode(s) [19]

3550 - Bendigo

Recruitment postcode(s) [20]

3677 - Wangaratta

Recruitment postcode(s) [21]

3844 - Traralgon

Recruitment postcode(s) [22]

4006 - Herston

Recruitment postcode(s) [23]

4066 - Auchenflower

Recruitment postcode(s) [24]

4215 - Southport

Recruitment postcode(s) [25]

4560 - Nambour

Recruitment postcode(s) [26]

4810 - Townsville

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (4PP1024812)

Address [1]

National Health and Medical Research Council, GPO Box 1421, Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Prof Sandy Middleton

Address

Nursing Research Institute - SVHA (Syd) & ACU
Executive Suite, Level 5, deLacy Building
St Vincent's Hospital, Victoria Street, Darlinghurst NSW 2010

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Australian Catholic University

Address [1]

PO Box 968, North Sydney, NSW, 2059

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/04/2012

Ethics approval number [1]

HREC/12/RPAH/32

Ethics committee name [2]

Australian Catholic University Human Ethics Research Committee

Ethics committee address [2]

Locked Bag 4115, Fitzroy, VIC, 3065

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

29/03/2012

Ethics approval number [2]

2012 16N

Ethics committee name [3]

Wangaratta Human Research Ethics Committee

Ethics committee address [3]

PO Box 386 Wangaratta VIC 3676

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

12/10/2012

Ethics approval number [3]

111

Ethics committee name [4]

South West Healthcare Multidisciplinary Ethics Committee

Ethics committee address [4]

Ryot Street, Warrnambool, Vic, 3280

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

09/10/2012

Ethics approval number [4]

5/2012

Ethics committee name [5]

Uniting Care Health, Human Research Ethics Committee

Ethics committee address [5]

Upper Floor Moorland’s House, The Wesley Hospital, 451 Coronation Drive, Auchenflower, Qld, 4066

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

Approval date [5]

11/12/2012

Ethics approval number [5]

1231

Ethics committee name [6]

ACT Government Health Directorate Human Research Ethics Committee

Ethics committee address [6]

Building 10, Level 6, Canberra Hospital, PO Box 11, Woden, ACT, 2606

Ethics committee country [6]

Australia

Date submitted for ethics approval [6]

Approval date [6]

04/02/2013

Ethics approval number [6]

ETH.1.13.009

Summary

Brief summary

In 2011, members of our research team published the results of the Quality in Acute Stroke Care (QASC) Trial.  This cluster randomised controlled trial evaluated the effectiveness of team-building workshops and education to introduce three clinical protocols to manage fever, sugar and swallowing (the FeSS protocols) in the acute stroke unit.  We found that patients cared for in stroke units who received our intervention were 16% more likely to be alive and independent 90 days following their stroke.  They also had fewer episodes of fever, lower mean temperatures, lower mean blood glucose levels, and better screening for swallowing difficulties.  This landmark trial demonstrated that teamwork and good nursing care can improve patient outcomes.  
Building on this previous work (1) we will evaluate using a cluster randomised controlled trial, an organisational intervention in EDs.  Our evidence-based T3 Trial intervention will comprise: A) evidence-based clinical protocols for triage, treatment and transfer in acute stroke comprised of: (Ai) routine assignment of stroke patients to triage Category 1 or 2; (Aii) time-sensitive ‘trigger’ screening for tPA eligibility; (Aiii) instigation of protocols for prompt management of fever, hyperglycaemia and swallowing; (Aiv) rapid transfer of patients from ED to the stroke unit.  To support implementation of the protocols we will use: B) an evidence based implementation strategy consisting of: (Bi) workshops to identify local barriers and enablers and to identify clinical champions; (Bii) didactive and interactive education; (Biii) use of local clinical opinion leaders (site clinical champions); and (Biv) reminders in the form of email, telephone and site visits.
This trial will be conducted in the EDs of hospitals with pre-existing dedicated stroke units in NSW, Victoria, Queensland and the ACT. EDs will be randomised to receive either the T3 Trial intervention or no additional support.  At 90-days post-admission, we will measure death or dependency (mRS) (primary outcome); health status; and quality of life (secondary outcomes).  A separate process analysis will examine contextual factors that may influence successful intervention uptake.  Our novel and timely intervention will bridge the theory-practice gap aiming to deliver improvements in 90-day health outcomes for a group of patients currently underserved by evidence-based practice

Reference
1.	Middleton S, McElduff P, Ward J, Grimshaw J, Dale S, D’Este C, Drury P, Griffiths R, Cheung NW, Quinn C, Evans M, Cadilhac D, Levi C. Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia and swallowing dysfunction in acute stroke improves 90-day outcomes: QASC, a cluster randomised controlled trial. The Lancet 2011; 378 (9804): 1699-1706.

Trial website

Trial related presentations / publications

Published abstracts

Dale S, Martinez C, McInnes E and Middleton S. How ethical is the process of ethics and governance review for multi-site trials? Results from the T3 Trial. International Journal of Stroke. 2014; 9(S1) 13
S Middleton, CR Levi, C D’Este, J Grimshaw, DA Cadilhac, J Considine, W Cheung, L McInnes. S Dale, RP Gerraty, M Fitzgerald. T3 Trial protocol: A CRCT evaluating an organisational intervention to improve triage, treatment and transfer of stroke patients in EDs. International Journal of Stroke. 2013;8(S1) 4–10
Middleton S, Levi C, D’Este C, Grimshaw J, Cadilhac D, Considine J, Cheung W, McInnes L, Dale S, Gerraty R, Fitzgerald M, Cadigan G, Denisenko S, Longworth M, McElduff P, Quinn C. T3 stroke trial protocol: Triage, treatment and transfer of patients with stroke emergency departments. International Journal of Stroke. 2013;8(S2), 1–34

Conference Presentations

Dale S, Levi C, D’Este C, Grimshaw J, Cadilhac D, Considine J, Cheung W,McInnes E, Gerraty R, Fitzgerald M, Middleton S, on behalf of the T3 Trialists. Translating evidence in stroke care: The T3 Trial Protocol. 2nd Annual NHMRC Symposium on Research Translation 2013. Sydney 2-3 October 2013

Middleton S. Levi C, D’Este C, Cadilhac D, Considine J, Cheung W, McInnes E, Dale S, Quinn C on behalf of the T3 Trialists. Translating evidence in stroke care: The Triage, Treatment and Transfer Trial Study Protocol. 21st St Vincents & Mater Health Sydney Research Symposium. Sydney: 6 September 2013. P.21.[Fast Forward Presentation & poster]. 
** Winner Beckman Coulter Prize for Outstanding Poster Presentation**

Middleton S, Levi C, D'Este C, Grimshaw J, Cadilhac D, Considine J, Cheung W, McInnes E, Dale S & Gerraty R.  T3 Stroke Trial Protocol: Triage, Treatment and Transfer of patients with stroke Emergency Departments.  Smart Stroke Conference 2013. Brisbane; 22-23 August 2013. 

Middleton S, Levi C, D'Este C, Grimshaw J, Cadilhac D, Considine J, Cheung W, McInnes E, Dale S & Gerraty R.  T3 Trial Protocol: A CRCT evaluating an organisational intervention to improve Triage, Treatment and Transfer of stroke patients in ED's. Stroke Society of Australasia Annual Scientific Meeting 2013. Darwin, 31 July – 1 August 2013. [Poster]

Middleton S, Levi C,D’Este C, Grimshaw J, Cadilhac D, Considine J, Cheung W, McInnes E, Dale S, Gerraty R, & Fitzgerald M, on behalf of the T3 Trialists. T3 Stroke Trial: Protocol for a Cluster Randomised Controlled Trial to evaluate an organisational intervention to improve Triage, Treatment and Transfer of stroke patients in Emergency Departments. European Stroke Conference 2013. London, 28-31 May 2013. [Poster]

Public notes

Our trial has a pre-intervention observational phase to inform trial recruitment methods and obtain baseline data to inform randomisation and sample size estimation. Recruitment has not yet commenced for the randomised (post-intervention) phase of the trial.

Contacts

Principal investigator

Name

Prof Sandy Middleton

Address

Nursing Research Institute St Vincent’s Health Australia (Sydney) & Australian Catholic University, Executive Suite, Level 5, DeLacy Building, St Vincents Hospital, Victoria Road, Darlinghurst, NSW, 2010, Australia

Country

Australia

Phone

+61 2 83823790

Fax

sandy.middleton@acu.edu.au

Contact person for public queries

Name

Sandy Middleton

Address

Country

Australia

Phone

+61 2 83823790

Fax

sandy.middleton@acu.edu.au

Contact person for scientific queries

Name

Sandy Middleton

Address

Country

Australia

Phone

+61 2 83823790

Fax

sandy.middleton@acu.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Embase	Nurse-Initiated Acute Stroke Care in Emergency Departments: The Triage, Treatment, and Transfer Implementation Cluster Randomized Controlled Trial.	2019	https://dx.doi.org/10.1161/STROKEAHA.118.020701
Embase	Process evaluation of an implementation trial to improve the triage, treatment and transfer of stroke patients in emergency departments (T3 trial): a qualitative study.	2020	https://dx.doi.org/10.1186/s13012-020-01057-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

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