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Background: Theoretical frameworks and models based on behaviour change theories are increasingly used in the development of implementation interventions. Development of an implementation intervention is often based on the available evidence base and practical issues, i.e. feasibility and acceptability. The aim of this study was to describe the development of an implementation intervention for the T3 Trial (Triage, Treatment and Transfer of patients with stroke in emergency departments (EDs)) using theory to recommend behaviour change techniques (BCTs) and drawing on the research evidence base and practical issues of feasibility and acceptability.Methods: A stepped method for developing complex interventions based on theory, evidence and practical issues was adapted using the following steps: (1) Who needs to do what, differently? (2) Using a theoretical framework, which barriers and enablers need to be addressed? (3) Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? A researcher panel was convened to review the list of BCTs recommended for use and to identify the most feasible and acceptable techniques to adopt.Results: Seventy-six barriers were reported by hospital staff who attended the workshops (step 1: thirteen TDF domains likely to influence the implementation of the T3 Trial clinical intervention were identified by the researchers; step 2: the researcher panellists then selected one third of the BCTs recommended for use as appropriate for the clinical context of the ED and, using the enabler workshop data, devised enabling strategies for each of the selected BCTs; and step 3: the final implementation intervention consisted of 27 BCTs).Conclusions: The TDF was successfully applied in all steps of developing an implementation intervention for the T3 Trial clinical intervention. The use of researcher panel opinion was an essential part of the BCT selection process to incorporate both research evidence and expert judgment. It is recommended that this stepped approach (theory, evidence and practical issues of feasibility and acceptability) is used to develop highly reportable implementation interventions. The classifying of BCTs using recognised implementation intervention components will facilitate generalisability and sharing across different conditions and clinical settings. [ABSTRACT FROM AUTHOR]

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 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. Discussion: This theoretically informed intervention is aimed at addressing important gaps in care to maximise 90-day health outcomes for patients with stroke. [ABSTRACT FROM AUTHOR]

Background: The implementation of evidence-based protocols for stroke management in the emergency department (ED) for the appropriate triage, administration of tissue plasminogen activator to eligible patients, management of fever, hyperglycaemia and swallowing, and prompt transfer to a stroke unit were evaluated in an Australian cluster-randomised trial (T3 trial) conducted at 26 emergency departments. There was no reduction in 90-day death or dependency nor improved processes of ED care. We conducted an a priori planned process influential factors that impacted upon protocol uptake.Methods: Qualitative face-to-face interviews were conducted with purposively selected ED and stroke clinicians from two high- and two low-performing intervention sites about their views on factors that influenced protocol uptake. All Trial State Co-ordinators (n = 3) who supported the implementation at the 13 intervention sites were also interviewed. Data were analysed thematically using normalisation process theory as a sensitising framework to understand key findings, and compared and contrasted between interviewee groups.Results: Twenty-five ED and stroke clinicians, and three Trial State Co-ordinators were interviewed. Three major themes represented key influences on evidence uptake: (i) Readiness to change: reflected strategies to mobilise and engage clinical teams to foster cognitive participation and collective action; (ii) Fidelity to the protocols: reflected that beliefs about the evidence underpinning the protocols impeded the development of a shared understanding about the applicability of the protocols in the ED context (coherence); and (iii) Boundaries of care: reflected that appraisal (reflexive monitoring) by ED and stroke teams about their respective boundaries of clinical practice impeded uptake of the protocols.Conclusions: Despite initial high 'buy-in' from clinicians, a theoretically informed and comprehensive implementation strategy was unable to overcome system and clinician level barriers. Initiatives to drive change and integrate protocols rested largely with senior nurses who had to overcome contextual factors that fell outside their control, including low medical engagement, beliefs about the supporting evidence and perceptions of professional boundaries. To maximise uptake of evidence and adherence to intervention fidelity in complex clinical settings such as ED cost-effective strategies are needed to overcome these barriers.Trial Registration: Australian New Zealand Clinical Trials Registry ( ACTRN12614000939695 ). [ABSTRACT FROM AUTHOR]

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 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.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. [ABSTRACT FROM AUTHOR]