Triage, treatment and transfer of patients with stroke in emergency department trial (the T3 Trial): A cluster randomised trial protocol

T3 Trialist Collaborators

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Abstract

Background: Internationally recognised evidence-based guidelines recommend appropriate triage of patients with stroke in emergency departments (EDs), administration of tissue plasminogen activator (tPA), and proactive management of fever, hyperglycaemia and swallowing before prompt transfer to a stroke unit to maximise outcomes. We aim to evaluate the effectiveness in EDs of a theory-informed, nurse-initiated, intervention to improve multidisciplinary triage, treatment and transfer (T3) of patients with acute stroke to improve 90-day death and dependency. Organisational and contextual factors associated with intervention uptake also will be evaluated. Methods: This prospective, multicentre, parallel group, cluster randomised trial with blinded outcome assessment will be conducted in EDs of hospitals with stroke units in three Australian states and one territory. EDs will be randomised 1:1 within strata defined by state and tPA volume to receive either the T3 intervention or no additional support (control EDs). Our T3 intervention comprises an evidence-based care bundle targeting: (1) triage: routine assignment of patients with suspected stroke to Australian Triage Scale category 1 or 2; (2) treatment: screening for tPA eligibility and administration of tPA where applicable; instigation of protocols for management of fever, hyperglycaemia and swallowing; and (3) transfer: prompt admission to the stroke unit. We will use implementation science behaviour change methods informed by the Theoretical Domains Framework [1, 2] consisting of (i) workshops to determine barriers and local solutions; (ii) mixed interactive and didactic education; (iii) local clinical opinion leaders; and (iv) reminders in the form of email, telephone and site visits. Our primary outcome measure is 90days post-admission death or dependency (modified Rankin Scale >2). Secondary outcomes are health status (SF-36), functional dependency (Barthel Index), quality of life (EQ-5D); and quality of care outcomes, namely, monitoring and management practices for thrombolysis, fever, hyperglycaemia, swallowing and prompt transfer. Outcomes will be assessed at the patient level. A separate process evaluation will examine contextual factors to successful intervention uptake. At the time of publication, EDs have been randomised and the intervention is being implemented. Discussion: This theoretically informed intervention is aimed at addressing important gaps in care to maximise 90-day health outcomes for patients with stroke. Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12614000939695. Registered 2 September 2014.

Original languageEnglish
Article number139
JournalImplementation Science
Volume11
Issue number1
DOIs
Publication statusPublished - 18 Oct 2016
Externally publishedYes

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Patient Transfer
Triage
Clinical Protocols
Hospital Emergency Service
Stroke
Tissue Plasminogen Activator
Deglutition
Hyperglycemia
Fever
Therapeutics
Patient Care Bundles
Outcome Assessment (Health Care)
Education
Quality of Health Care
Practice Management
New Zealand
Telephone
Health Status
Registries
Publications

Cite this

@article{e28207e762d24b229f1b049a88e4f5e2,
title = "Triage, treatment and transfer of patients with stroke in emergency department trial (the T3 Trial): A cluster randomised trial protocol",
abstract = "Background: Internationally recognised evidence-based guidelines recommend appropriate triage of patients with stroke in emergency departments (EDs), administration of tissue plasminogen activator (tPA), and proactive management of fever, hyperglycaemia and swallowing before prompt transfer to a stroke unit to maximise outcomes. We aim to evaluate the effectiveness in EDs of a theory-informed, nurse-initiated, intervention to improve multidisciplinary triage, treatment and transfer (T3) of patients with acute stroke to improve 90-day death and dependency. Organisational and contextual factors associated with intervention uptake also will be evaluated. Methods: This prospective, multicentre, parallel group, cluster randomised trial with blinded outcome assessment will be conducted in EDs of hospitals with stroke units in three Australian states and one territory. EDs will be randomised 1:1 within strata defined by state and tPA volume to receive either the T3 intervention or no additional support (control EDs). Our T3 intervention comprises an evidence-based care bundle targeting: (1) triage: routine assignment of patients with suspected stroke to Australian Triage Scale category 1 or 2; (2) treatment: screening for tPA eligibility and administration of tPA where applicable; instigation of protocols for management of fever, hyperglycaemia and swallowing; and (3) transfer: prompt admission to the stroke unit. We will use implementation science behaviour change methods informed by the Theoretical Domains Framework [1, 2] consisting of (i) workshops to determine barriers and local solutions; (ii) mixed interactive and didactic education; (iii) local clinical opinion leaders; and (iv) reminders in the form of email, telephone and site visits. Our primary outcome measure is 90days post-admission death or dependency (modified Rankin Scale >2). Secondary outcomes are health status (SF-36), functional dependency (Barthel Index), quality of life (EQ-5D); and quality of care outcomes, namely, monitoring and management practices for thrombolysis, fever, hyperglycaemia, swallowing and prompt transfer. Outcomes will be assessed at the patient level. A separate process evaluation will examine contextual factors to successful intervention uptake. At the time of publication, EDs have been randomised and the intervention is being implemented. Discussion: This theoretically informed intervention is aimed at addressing important gaps in care to maximise 90-day health outcomes for patients with stroke. Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12614000939695. Registered 2 September 2014.",
author = "{T3 Trialist Collaborators} and Sandy Middleton and Chris Levi and Simeon Dale and Cheung, {N. Wah} and Elizabeth McInnes and Julie Considine and Catherine D'Este and Cadilhac, {Dominique A.} and Jeremy Grimshaw and Richard Gerraty and Louise Craig and Verena Schadewaldt and Patrick McElduff and Mark Fitzgerald and Clare Quinn and Greg Cadigan and Sonia Denisenko and Mark Longworth and Jeanette Ward and Chris May and Rohan Grimley and Richard Paolini and Rosemary Phillips and Enna Salema and Janne Pitkin and Toni Sheridan",
year = "2016",
month = "10",
day = "18",
doi = "10.1186/s13012-016-0503-6",
language = "English",
volume = "11",
journal = "Implementation Science",
issn = "1748-5908",
publisher = "BioMed Central",
number = "1",

}

Triage, treatment and transfer of patients with stroke in emergency department trial (the T3 Trial) : A cluster randomised trial protocol. / T3 Trialist Collaborators.

In: Implementation Science, Vol. 11, No. 1, 139, 18.10.2016.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Triage, treatment and transfer of patients with stroke in emergency department trial (the T3 Trial)

T2 - A cluster randomised trial protocol

AU - T3 Trialist Collaborators

AU - Middleton, Sandy

AU - Levi, Chris

AU - Dale, Simeon

AU - Cheung, N. Wah

AU - McInnes, Elizabeth

AU - Considine, Julie

AU - D'Este, Catherine

AU - Cadilhac, Dominique A.

AU - Grimshaw, Jeremy

AU - Gerraty, Richard

AU - Craig, Louise

AU - Schadewaldt, Verena

AU - McElduff, Patrick

AU - Fitzgerald, Mark

AU - Quinn, Clare

AU - Cadigan, Greg

AU - Denisenko, Sonia

AU - Longworth, Mark

AU - Ward, Jeanette

AU - May, Chris

AU - Grimley, Rohan

AU - Paolini, Richard

AU - Phillips, Rosemary

AU - Salema, Enna

AU - Pitkin, Janne

AU - Sheridan, Toni

PY - 2016/10/18

Y1 - 2016/10/18

N2 - Background: Internationally recognised evidence-based guidelines recommend appropriate triage of patients with stroke in emergency departments (EDs), administration of tissue plasminogen activator (tPA), and proactive management of fever, hyperglycaemia and swallowing before prompt transfer to a stroke unit to maximise outcomes. We aim to evaluate the effectiveness in EDs of a theory-informed, nurse-initiated, intervention to improve multidisciplinary triage, treatment and transfer (T3) of patients with acute stroke to improve 90-day death and dependency. Organisational and contextual factors associated with intervention uptake also will be evaluated. Methods: This prospective, multicentre, parallel group, cluster randomised trial with blinded outcome assessment will be conducted in EDs of hospitals with stroke units in three Australian states and one territory. EDs will be randomised 1:1 within strata defined by state and tPA volume to receive either the T3 intervention or no additional support (control EDs). Our T3 intervention comprises an evidence-based care bundle targeting: (1) triage: routine assignment of patients with suspected stroke to Australian Triage Scale category 1 or 2; (2) treatment: screening for tPA eligibility and administration of tPA where applicable; instigation of protocols for management of fever, hyperglycaemia and swallowing; and (3) transfer: prompt admission to the stroke unit. We will use implementation science behaviour change methods informed by the Theoretical Domains Framework [1, 2] consisting of (i) workshops to determine barriers and local solutions; (ii) mixed interactive and didactic education; (iii) local clinical opinion leaders; and (iv) reminders in the form of email, telephone and site visits. Our primary outcome measure is 90days post-admission death or dependency (modified Rankin Scale >2). Secondary outcomes are health status (SF-36), functional dependency (Barthel Index), quality of life (EQ-5D); and quality of care outcomes, namely, monitoring and management practices for thrombolysis, fever, hyperglycaemia, swallowing and prompt transfer. Outcomes will be assessed at the patient level. A separate process evaluation will examine contextual factors to successful intervention uptake. At the time of publication, EDs have been randomised and the intervention is being implemented. Discussion: This theoretically informed intervention is aimed at addressing important gaps in care to maximise 90-day health outcomes for patients with stroke. Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12614000939695. Registered 2 September 2014.

AB - Background: Internationally recognised evidence-based guidelines recommend appropriate triage of patients with stroke in emergency departments (EDs), administration of tissue plasminogen activator (tPA), and proactive management of fever, hyperglycaemia and swallowing before prompt transfer to a stroke unit to maximise outcomes. We aim to evaluate the effectiveness in EDs of a theory-informed, nurse-initiated, intervention to improve multidisciplinary triage, treatment and transfer (T3) of patients with acute stroke to improve 90-day death and dependency. Organisational and contextual factors associated with intervention uptake also will be evaluated. Methods: This prospective, multicentre, parallel group, cluster randomised trial with blinded outcome assessment will be conducted in EDs of hospitals with stroke units in three Australian states and one territory. EDs will be randomised 1:1 within strata defined by state and tPA volume to receive either the T3 intervention or no additional support (control EDs). Our T3 intervention comprises an evidence-based care bundle targeting: (1) triage: routine assignment of patients with suspected stroke to Australian Triage Scale category 1 or 2; (2) treatment: screening for tPA eligibility and administration of tPA where applicable; instigation of protocols for management of fever, hyperglycaemia and swallowing; and (3) transfer: prompt admission to the stroke unit. We will use implementation science behaviour change methods informed by the Theoretical Domains Framework [1, 2] consisting of (i) workshops to determine barriers and local solutions; (ii) mixed interactive and didactic education; (iii) local clinical opinion leaders; and (iv) reminders in the form of email, telephone and site visits. Our primary outcome measure is 90days post-admission death or dependency (modified Rankin Scale >2). Secondary outcomes are health status (SF-36), functional dependency (Barthel Index), quality of life (EQ-5D); and quality of care outcomes, namely, monitoring and management practices for thrombolysis, fever, hyperglycaemia, swallowing and prompt transfer. Outcomes will be assessed at the patient level. A separate process evaluation will examine contextual factors to successful intervention uptake. At the time of publication, EDs have been randomised and the intervention is being implemented. Discussion: This theoretically informed intervention is aimed at addressing important gaps in care to maximise 90-day health outcomes for patients with stroke. Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12614000939695. Registered 2 September 2014.

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U2 - 10.1186/s13012-016-0503-6

DO - 10.1186/s13012-016-0503-6

M3 - Article

VL - 11

JO - Implementation Science

JF - Implementation Science

SN - 1748-5908

IS - 1

M1 - 139

ER -