Abstract
BackgroundInternationally 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.MethodsThis 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 90 days 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.DiscussionThis theoretically informed intervention is aimed at addressing important gaps in care to maximise 90-day health outcomes for patients with stroke.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12614000939695. Registered 2 September 2014. Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-016-0503-6) contains supplementary material, which is available to authorized users.
Highlights
Recognised evidence-based guidelines recommend appropriate triage of patients with stroke in emergency departments (EDs), administration of tissue plasminogen activator, and proactive management of fever, hyperglycaemia and swallowing before prompt transfer to a stroke unit to maximise outcomes
Middleton et al Implementation Science (2016) 11:139 (Continued from previous page). This theoretically informed intervention is aimed at addressing important gaps in care to maximise 90-day health outcomes for patients with stroke
Hypothesis Patient outcomes and quality of care Compared to patients who receive care in EDs randomised to the control group, patients who receive care in EDs randomised to receive the T3 intervention will have: Patient primary outcome 1) 10 % decrease in the proportion of patients dead or dependent 90 days post hospital admission (dependency defined as modified Rankin Score ≥2) Patient secondary outcome 2) 10 % increase in the proportion of patients with improved functional dependency 90 days post hospital admission (Barthel Index (BI) ≥95)
Summary
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. Key elements of stroke care applicable to EDs are appropriate triage; treatment by administration of tissue plasminogen activator (tPA) to eligible patients and management of fever, hyperglycaemia and swallowing; followed by prompt transfer to an acute stroke unit. Allocation of an Australasian Triage Scale (ATS) category 1 (to be seen immediately) or category 2 (to be seen within 10 min) is recommended for patients presenting to EDs with signs or symptoms of acute stroke [6] These targets are not always met; an analysis of Victorian ambulance data demonstrated that 30 % of patients with stroke were not allocated an ATS category of 1 or 2 [7]. Inappropriate triage allocation resulting in delays in assessment and diagnosis may have a flow-on adverse effect on provision of thrombolysis to patients who may benefit and create delays in implementation of other elements of evidence-based stroke care
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