AVERT2(a very early rehabilitation trial, a very effective reproductive trigger): retrospective observational analysis of the number of babies born to trial staff

Objective: To report the number of participants needed to recruit per baby born to trial staff during AVERT, a large international trial on acute stroke, and to describe trial management consequences. Design: Retrospective observational analysis. Setting: 56 acute stroke hospitals in eight countries. Participants: 1074 trial physiotherapists, nurses, and other clinicians. Outcome measures: Number of babies born during trial recruitment per trial participant recruited. Results: With 198 site recruitment years and 2104 patients recruited during AVERT, 120 babies were born to trial staff. Births led to an estimated 10% loss in time to achieve recruitment. Parental leave was linked to six trial site closures. The number of participants needed to recruit per baby born was 17.5 (95% confidence interval 14.7 to 21.0); additional trial costs associated with each birth were estimated at 5736 Australian dollars on average. Conclusion: The staff absences registered in AVERT owing to parental leave led to delayed trial recruitment and increased costs, and should be considered by trial investigators when planning research and estimating budgets. However, the celebration of new life became a highlight of the annual AVERT collaborators’ meetings and helped maintain a cohesive collaborative group

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 (mRS <2) and the proportion with intracranial haemorrhage (mRS ≥2), compared to international benchmarks. DISCUSSION TIPS will trial a comprehensive, multi-component and multidisciplinary collaborative approach to improving thrombolysis rates at multiple sites. The trial has the potential to identify methods for optimal care which can be implemented for stroke patients during the acute phase. Study findings will include barriers and solutions to effective thrombolysis implementation and trial outcomes will be published whether significant or not. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry: ACTRN12613000939796

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 (mRS <2) and the proportion with intracranial haemorrhage (mRS ≥2), compared to international benchmarks. DISCUSSION: TIPS will trial a comprehensive, multi-component and multidisciplinary collaborative approach to improving thrombolysis rates at multiple sites. The trial has the potential to identify methods for optimal care which can be implemented for stroke patients during the acute phase. Study findings will include barriers and solutions to effective thrombolysis implementation and trial outcomes will be published whether significant or not. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN1261300093979

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

Aphasia therapy in the acute hospital setting: Is it justified?

Introduction: Robey (1998) reported that people who receive intense aphasia therapy in the acute phase have more than twofold the improvement of those treated in the chronic phase. Despite such evidence, conjecture regarding the optimum timing, intensity and duration of rehabilitation persists (Kwakkel et al., 2004). Method: A prospective randomised, open labelled, single blinded study was conducted to determine the impact of daily aphasia therapy in the acute setting on communication outcomes at discharge and at 6 months post stroke. Participants (N = 59) were randomised to either daily or weekly therapy while in hospital (χ = 22 days). Results: A principal component analysis identified three clusters of outcome measures that displayed a significant between group difference at acute discharge and at 6 months. When stroke severity, initial aphasia severity and gender were controlled, patients who received daily therapy, showed significantly better outcomes than those who received weekly therapy. Results of a longitudinal random-effects regression analysis to determine prognostic factors influencing communication status at 6 months post stroke will be discussed. Conclusions: This study showed that despite large inter-subject variability, people with moderate-severe aphasia who received daily therapy in the acute hospital setting made significantly positive gains in effective communication skills at hospital discharge and that these gains were maintained at 6 months. This study showed that aphasia therapy in the acute hospital setting is beneficial and appropriate for people with moderate-severe aphasia. Discussion will focus on addressing who benefits from therapy and how much therapy is appropriate in the very early recovery phase. Godecke, E., Hird, K., & Lalor, E. (2008). Aphasia therapy in the acute hospital setting: Is it justified? Internal Medicine Journal, 38(Suppl 4), A88

Implementing clinical guidelines for acute stroke management: Do nurses have a lead role?

Objective: Health professionals should be aware of, and implement, best practice clinical guidelines for stroke care. Using the latest National Stroke Foundation Clinical Guidelines for Acute Stroke Management this study aimed to determine which member of the multidisciplinary team would most likely be responsible for taking the lead role for implementing each recommendation. Methods: Three nurses and one allied health professional independently classified each of the 148 recommendations according to whom they thought most likely to take the lead role in implementing each recommendation. A teleconference was held to discuss any differences of opinion and gain consensus. Results: The multidisciplinary team was identified as responsible for taking the lead role most often (n=54, 36%), followed by medical practitioners (n=52, 35%) and nurses (n=13, 8%). Nurses were identified as being involved either as the lead initiator or as part of the multidisciplinary team in implementing 79 (53%) of recommendations. A significantly higher percentage of recommendations where implementation was determined to be led by medical practitioners were attributed a Grade A or B strength of evidence (ie higher strength) (49%) when compared with those recommendations determined to be led by nurses (6%) (p=0.04). There was no significant difference between the number of Level I or II based recommendations determined to be led by medical practitioners compared to those led by nurses (59%; 11% respectively; p=0.26). Conclusions: Neuroscience nurses have a key role in the multidisciplinary stroke team and should contribute to the implementation of many of the evidence based guideline recommendations for acute stroke

Very early poststroke aphasia therapy: A pilot randomized controlled efficacy trial

Background and purpose: Early stroke rehabilitation has shown benefits over spontaneous recovery. Insufficient evidence exists to determine the benefits of early aphasia intervention. We hypothesized that daily aphasia therapy would show better communication outcomes than usual care (UC) in early poststroke recovery. Method: This prospective, randomized, single-blinded, controlled trial was conducted in three acute-care hospitals in Perth, Australia, each with over 200 stroke admissions annually. Patients with acute stroke causing moderate to severe aphasia were recruited at a median of three-days (range: 0–10 days) to receive daily aphasia therapy or usual care therapy. Individually tailored, impairment-based intervention was provided for the acute hospital stay or intervention phase (median: 19 days; range: 5–76). Primary outcome measures were the aphasia quotient and functional communication profile at acute hospital discharge or four-weeks poststroke, whichever came first. A random-number generator and sealed envelopes were used to randomize participants. Assessments were completed by a blinded assessor. Results: Fifty-nine participants were recruited, with six withdrawals (10%) and seven deaths (12%) at six-months. Ninety percent had ischemic strokes, with 56·5% experiencing a total anterior circulation stroke. The group mean (±SD) age was 69·1 (±13·9) years. Six participants (18·75%) in the daily aphasia therapy group did not complete the minimum (150 min) therapy required for this study. The daily aphasia therapy intervention phase mean therapy session time was 45 min (range: 30–80) and the total mean amount of therapy for the daily aphasia therapy participants was 331 min (range: 30–1415). Four (15%) participants in the usual care group received therapy. The collective total therapy provided to these participants was 295 min over seven sessions. Usual care participants received an average of 10·5 min of therapy per week during the intervention phase. At the primary end point, a generalized estimating equations model demonstrated that after controlling for initial aphasia severity, participants receiving daily aphasia therapy scored 15·1 more points (P=0·010) on the aphasia quotient and 11·3 more points (P=0·004) on the functional communication profile than those receiving usual care therapy. Conclusions: Daily aphasia therapy in very early stroke recovery improved communication outcomes in people with moderate to severe aphasia