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

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000939695
Acronym
T3 Trial
Enrollment
1294
Registered
2014-09-02
Start date
2015-07-14
Completion date
2016-09-30
Last updated
2020-01-13

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

Conditions

None listed

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.

Interventions

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 a

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.

Sponsors

Prof Sandy Middleton
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

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

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 12, 2026