Identifying the barriers and enablers for a triage, treatment, and transfer clinical intervention to manage acute stroke patients in the emergency department : A systematic review using the theoretical domains framework (TDF)

Background Clinical guidelines recommend that assessment and management of patients with stroke commences early including in emergency departments (ED). To inform the development of an implementation intervention targeted in ED, we conducted a systematic review of qualitative and quantitative studies to identify relevant barriers and enablers to six key clinical behaviours in acute stroke care: appropriate triage, thrombolysis administration, monitoring and management of temperature, blood glucose levels, and of swallowing difficulties and transfer of stroke patients in ED. Methods Studies of any design, conducted in ED, where barriers or enablers based on primary data were identified for one or more of these six clinical behaviours. Major biomedical databases (CINAHL, OVID SP EMBASE, OVID SP MEDLINE) were searched using comprehensive search strategies. The barriers and enablers were categorised using the theoretical domains framework (TDF). The behaviour change technique (BCT) that best aligned to the strategy each enabler represented was selected for each of the reported enablers using a standard taxonomy. Results Five qualitative studies and four surveys out of the 44 studies identified met the selection criteria. The majority of barriers reported corresponded with the TDF domains of “environmental, context and resources” (such as stressful working conditions or lack of resources) and “knowledge” (such as lack of guideline awareness or familiarity). The majority of enablers corresponded with the domains of “knowledge” (such as education for physicians on the calculated risk of haemorrhage following intravenous thrombolysis [tPA]) and “skills” (such as providing opportunity to treat stroke cases of varying complexity). The total number of BCTs assigned was 18. The BCTs most frequently assigned to the reported enablers were “focus on past success” and “information about health consequences.” Conclusions Barriers and enablers for the delivery of key evidence-based protocols in an emergency setting have been identified and interpreted within a relevant theoretical framework. This new knowledge has since been used to select specific BCTs to implement evidence-based care in an ED setting. It is recommended that findings from similar future reviews adopt a similar theoretical approach. In particular, the use of existing matrices to assist the selection of relevant BCTs

Thrombolysis ImPlementation in Stroke (TIPS): Evaluating the effectiveness of a strategy to increase the adoption of best evidence practice - protocol for a cluster randomised controlled trial in acute stroke care

Background: Stroke is a leading cause of death and disability internationally. One of the three effective interventions in the acute phase of stroke care is thrombolytic therapy with tissue plasminogen activator (tPA), if given within 4.5 hours of onset to appropriate cases of ischaemic stroke.Objectives: To test the effectiveness of a multi-component multidisciplinary collaborative approach compared to usual care as a strategy for increasing thrombolysis rates for all stroke patients at intervention hospitals, while maintaining accepted benchmarks for low rates of intracranial haemorrhage and high rates of functional outcomes for both groups at three months.Methods and design: A cluster randomised controlled trial of 20 hospitals across 3 Australian states with 2 groups: multi- component multidisciplinary collaborative intervention as the experimental group and usual care as the control group. The intervention is based on behavioural theory and analysis of the steps, roles and barriers relating to rapid assessment for thrombolysis eligibility; it involves a comprehensive range of strategies addressing individual-level and system-level change at each site. The primary outcome is the difference in tPA rates between the two groups post-intervention. The secondary outcome is the proportion of tPA treated patients in both groups with good functional outcomes (modified Rankin Score (mR

Describing hospital utilisation and associated factors following stroke using linked clinical registry and hospital administrative data.

Introduction Survivors of stroke have complex needs from ongoing disabilities and have increased risk of cardiovascular diseases. The societal costs are therefore substantial. Person-level longitudinal data on the longer-term hospital utilizations of patients with stroke in Australia, and the factors that may influence usage in this setting, are rarely reported. Objectives and Approach We used person-level linkages between the Australian Stroke Clinical Registry (AuSCR: 2009-2013) and hospital admission and Emergency Department (ED) data from four states to examine determinants of hospital utilisation following stroke. The index event was the first event recorded in AuSCR. The rate of hospital contacts/person/year was calculated from contacts 30-365 days post-discharge. Disability was determined from responses to EQ-5D-3L data collected at 90-180 days post-stroke. Comorbidities were identified using ICD-10 discharge diagnosis codes (5 year look back including the index event). Negative binomial regression was used adjusting for patient clustering by hospital and pre-stroke contacts and stratified by disability. Results Among 10,082 adults with acute stroke (55% male, median age 74 years, 81% ischaemic, 14% hemorrhagic, 5% undetermined, 44% with disability) from 39 hospitals, 57% had a hospital admission or ED contact in the first 30-365 days post-hospital discharge, with median contacts/person/year post-stroke of 1.09 (Q1, Q3: 0, 3.27) compared to a pre-contact rate of 0 (Q1, Q3: 0, 2.18). The strongest associations with subsequent hospital contacts were prior contacts (IRR:1.10, 95%CI:1.07, 1.13), not able to walk on admission (stroke severity) (IRR:1.19, 95%CI 1.07, 1.31) and having a higher comorbidity index score (IRR:1.18, 95%CI:1.14, 1.22). Within stratified cohorts younger age was associated with increased contacts in those with disability ( Conclusion/Implications In a large linked cohort of patients we have demonstrated the substantial ongoing burden that stroke imposes on hospital systems, particularly regarding survivors with other comorbidities and younger survivors with disability. Knowledge of disability and comorbidity burden may assist with targeting community and hospital interventions to reduce post-stroke hospital usage

Tranexamic acid for intracerebral haemorrhage within 2 hours of onset : protocol of a phase II randomised placebo-controlled double-blind multicentre trial

Rationale Haematoma growth is common early after intracerebral haemorrhage (ICH), and is a key determinant of outcome. Tranexamic acid, a widely available antifibrinolytic agent with an excellent safety profile, may reduce haematoma growth. Methods and design Stopping intracerebral haemorrhage with tranexamic acid for hyperacute onset presentation including mobile stroke units (STOP-MSU) is a phase II double-blind, randomised, placebo-controlled, multicentre, international investigator-led clinical trial, conducted within the estimand statistical framework. Hypothesis In patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared with placebo. Sample size estimates A sample size of 180 patients (90 in each arm) would be required to detect an absolute difference in the primary outcome of 20% (placebo 39% vs treatment 19%) under a two-tailed significance level of 0.05. An adaptive sample size re-estimation based on the outcomes of 144 patients will allow a possible increase to a prespecified maximum of 326 patients. Intervention Participants will receive 1 g intravenous tranexamic acid over 10 min, followed by 1 g intravenous tranexamic acid over 8 hours; or matching placebo. Primary efficacy measure The primary efficacy measure is the proportion of patients with haematoma growth by 24 +/- 6 hours, defined as either >= 33% relative increase or >= 6 mL absolute increase in haematoma volume between baseline and follow-up CT scan. Discussion We describe the rationale and protocol of STOP-MSU, a phase II trial of tranexamic acid in patients with ICH within 2 hours from onset, based in participating mobile stroke units and emergency departments.Peer reviewe

Protocol of a randomized controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS)

Rationale: To address unmet needs, electronic messages to support person-centred goal attainment and secondary prevention may avoid hospital presentations/readmissions after stroke, but evidence is limited. Hypothesis: Compared to control participants, there will be a 10% lower proportion of intervention participants who represent to hospital (emergency/admission) within 90 days of randomisation. Methods and design: Multicentre, double-blind, randomised controlled trial with intention-to-treat analysis. The intervention group receives 12 weeks of personalised, goal-centred and administrative electronic messages, while the control group only receives administrative messages. The trial includes a process evaluation, assessment of treatment fidelity and an economic evaluation. Participants: Confirmed stroke (modified Rankin Score: 0-4), aged �18 years with internet/mobile phone access, discharged directly home from hospital. Randomisation: 1:1 computer-generated, stratified by age and baseline disability. Outcomes Assessments: Collected at 90 days and 12 months following randomisation. Outcomes: Primary: Hospital emergency presentations/admissions within 90 days of randomisation. Secondary outcomes include goal attainment, self-efficacy, mood, unmet needs, disability, quality-of-life, recurrent stroke/cardiovascular events/deaths at 90 days and 12 months, and death and cost-effectiveness at 12 months. Sample size: To test our primary hypothesis, we estimated a sample size of 890 participants (445 per group) with 80% power and two-tailed significance threshold of α=0.05. Given uncertainty for the effect size of this novel intervention, the sample size will be adaptively re-estimated when outcomes for n=668 are obtained, with maximum sample capped at 1100. Discussion: We will provide new evidence on the potential effectiveness, implementation and cost-effectiveness of a tailored eHealth intervention for survivors of stroke

A mixed-methods feasibility study of a new digital health support package for people after stroke : The Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) intervention

Background Evidence for digital health programmes to support people living with stroke is growing. We assessed the feasibility of a protocol and procedures for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial. Methods We conducted a mixed-method feasibility study. Participants with acute stroke were recruited from three hospitals (Melbourne, Australia). Eligibility: Adults with stroke discharged from hospital to home within 10 days, modified Rankin Score 0–4 and prior use of Short Message System (SMS)/email. While in hospital, recruited participants contributed to structured person-centred goal setting and completed baseline surveys including self-management skills and health-related quality of life. Participants were randomised 7–14 days after discharge via REDCap® (1:1 allocation). Following randomisation, the intervention group received a 12-week programme of personalised electronic support messages (average 66 messages sent by SMS or email) aligned with their goals. The control group received six electronic administrative messages. Feasibility outcomes included the following: number of patients screened and recruited, study retainment, completion of outcome measures and acceptability of the ReCAPS intervention and trial procedures (e.g. participant satisfaction survey, clinician interviews). Protocol fidelity outcomes included number of goals developed (and quality), electronic messages delivered, stop messages received and engagement with messages. We undertook inductive thematic analysis of interview/open-text survey data and descriptive analysis of closed survey questions. Results Between November 2018 and October 2019, 312 patients were screened; 37/105 (35%) eligible patients provided consent (mean age 61 years; 32% female); 33 were randomised (17 to intervention). Overall, 29 (88%) participants completed the12-week outcome assessments with 12 (41%) completed assessments in the allocated timeframe and 16 also completing the satisfaction survey (intervention=10). Overall, trial participants felt that the study was worthwhile and most would recommend it to others. Six clinicians participated in one of three focus group interviews; while they reported that the trial and the process of goal setting were acceptable, they raised concerns regarding the additional time required to personalise goals. Conclusion The study protocol and procedures were feasible with acceptable retention of participants. Consent and goal personalisation procedures should be centralised for the phase III trial to reduce the burden on hospital clinicians. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12618001468213 (date 31/08/2018); Universal Trial Number: U1111-1206-723

Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial

Background: Unplanned hospital presentations may occur post-stroke due to inadequate preparation for transitioning from hospital to home. The Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial was designed to test the effectiveness of receiving a 12-week, self-management intervention, comprising personalised goal setting with a clinician and aligned educational/motivational electronic messages. Primary outcome is as follows: self-reported unplanned hospital presentations (emergency department/admission) within 90-day post-randomisation. We present the statistical analysis plan for this trial. Methods/design: Participants are randomised 1:1 in variable block sizes, with stratification balancing by age and level of baseline disability. The sample size was 890 participants, calculated to detect a 10% absolute reduction in the proportion of participants reporting unplanned hospital presentations/admissions, with 80% power and 5% significance level (two sided). Recruitment will end in December 2023 when funding is expended, and the sample size achieved will be used. Logistic regression, adjusted for the stratification variables, will be used to determine the effectiveness of the intervention on the primary outcome. Secondary outcomes will be evaluated using appropriate regression models. The primary outcome analysis will be based on intention to treat. A p-value ≤ 0.05 will indicate statistical significance. An independent Data Safety and Monitoring Committee has routinely reviewed the progress and safety of the trial. Conclusions: This statistical analysis plan ensures transparency in reporting the trial outcomes. ReCAPS trial will provide novel evidence on the effectiveness of a digital health support package post-stroke. Trial registration: ClinicalTrials.gov ACTRN12618001468213. Registered on August 31, 2018. SAP version 1.13 (October 12 2023) Protocol version 1.12 (October 12, 2022) SAP revisions Ni

Triage, treatment and transfer : Evidence-based clinical practice recommendations and models of nursing care for the first 72 hours of admission to hospital for acute stroke

[Extract] Stroke is a medical emergency and care provided in the first hours is critical in shaping patients’ long-term recovery and prognosis.1 There is robust evidence demonstrating significant reductions in death and disability with early interventions in acute stroke care, including antiplatelet therapy2 stroke unit (SU) care3 and thrombolysis.4 International clinical guidelines for stroke provide key recommendations to guide clinical practice5–8; however, uptake of evidence-based care is variable and often less than optimal.9–14 For example, among patients with ischemic stroke, rates for treatment with intravenous recombinant tissue-type plasminogen activator (r-tPA) are relatively low in the USA (5%)9 and Australia (7%),10 compared with Canada (12%)11 and some European centers (14%).1

A case of bilateral lower cranial nerve palsies after base of skull trauma With complex management issues case report and review of the literature

Introduction: Fractures of the skull base can cause lower cranial nerve palsies because of involvement of the nerves as they traverse the skull. A variety of syndromes have been described, often involving multiple nerves. These are most commonly unilateral, and only a handful of cases of bilateral cranial nerve involvement have been reported

Acute stroke patients not meeting their nutrition requirements: investigating nutrition within the enriched environment

Background & aims: Malnutrition is common after stroke. We investigated the impact of environmental enrichment strategies on dietary intake and rates of malnutrition in an acute stroke unit. Methods: We performed a before-after study. In standard care, meals were delivered to participants’ rooms whilst in the enriched environment, communal meals with assistance were offered and nutritional intake reminders were placed at the patient bedside. Nutrition supplementation was provided to both groups if indicated. Breakfast and lunch meals were directly observed while remaining intake was calculated using food charts. Nutrition requirements were calculated for energy (ratio method), protein (1 g/kg) and proportion of requirements met. Malnutrition was assessed using the Subjective Global Assessment and body weight. ANCOVA adjusting for stroke severity was used to determine between group differences. Stepwise multivariable logistic regression was performed to assess predictors of nutritional outcomes, adjusting for intervention group, demographic, clinical and baseline nutritional factors. Results: Neither standard care (n = 30, age 76.0yrs ± SD12.8) nor enriched environment (n = 30, age 76.7yrs ± SD12.1, p = 0.84) met daily requirements for energy (70.7% ± SD16.8 vs. 70.7% ± SD17.3, p = 0.94) or protein intake (73.2% ± SD18.6 vs. 69.8% ± SD17.3, p = 0.70). Mean body weight dropped: standard care 0.92 kg ± SD2.47 vs. enriched 0.64 kg ± SD3.12 (p = 0.53) and malnutrition increased: standard care 3.3%–26.6% vs. enriched 6.6%–13.3% (p = 0.07). Predictors of malnutrition on discharge in logistic regression models were: length of stay (p < 0.01) and protein (p < 0.01) or energy intake (p = 0.02). Conclusions: Acute stroke patients were not meeting nutritional requirements and losing body weight. The enriched environment showed no effect on nutritional intake. Malnutrition was associated with lower energy and protein intakes and increased length of stay