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Effect of an Enhanced Paramedic Acute Stroke Treatment Assessment on Thrombolysis Delivery During Emergency Stroke Care: A Cluster Randomized Clinical Trial.

ABSTRACT: Importance:Rapid thrombolysis treatment for acute ischemic stroke reduces disability among patients who are carefully selected, but service delivery is challenging. Objective:To determine whether an enhanced Paramedic Acute Stroke Treatment Assessment (PASTA) intervention increased hospital thrombolysis rates. Design, Setting, and Participants:This multicenter, cluster randomized clinical trial took place between December 2015 and July 2018 in 3 ambulance services and 15 hospitals. Clusters were paramedics based within ambulance stations prerandomized to PASTA or standard care. Patients attended by study paramedics were enrolled after admission if a hospital specialist confirmed a stroke and paramedic assessment started within 4 hours of onset. Allocation to PASTA or standard care reflected the attending paramedic's randomization status. Interventions:The PASTA intervention included additional prehospital information collection, a structured hospital handover, practical assistance up to 15 minutes after handover, a predeparture care checklist, and clinician feedback. Standard care reflected national guidelines. Main Outcomes and Measures:Primary outcome was the proportion of patients receiving thrombolysis. Secondary outcomes included time intervals and day 90 health (with poor status defined as a modified Rankin Score >2, to represent dependency or death). Results:A total of 11?478 patients were screened following ambulance transportation; 1391 were eligible and approached, but 177 did not consent. Of 1214 patients enrolled (mean [SD] age, 74.7 [13.2] years; 590 women [48.6%]), 500 were assessed by 242 paramedics trained in the PASTA intervention and 714 were assessed by 355 paramedics continuing with standard care. The paramedics trained in the PASTA intervention took a mean of 13.4 (95% CI, 9.4-17.4) minutes longer (P?

SUBMITTER: Price CI

PROVIDER: S-EPMC7154959 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Effect of an Enhanced Paramedic Acute Stroke Treatment Assessment on Thrombolysis Delivery During Emergency Stroke Care: A Cluster Randomized Clinical Trial.

Price Christopher I CI Shaw Lisa L Islam Saiful S Javanbakht Mehdi M Watkins Alan A McMeekin Peter P Snooks Helen H Flynn Darren D Francis Richard R Lakey Rachel R Sutcliffe Lou L McClelland Graham G Lally Joanne J Exley Catherine C Rodgers Helen H Russell Ian I Vale Luke L Ford Gary A GA

JAMA neurology 20200701 7

<h4>Importance</h4>Rapid thrombolysis treatment for acute ischemic stroke reduces disability among patients who are carefully selected, but service delivery is challenging.<h4>Objective</h4>To determine whether an enhanced Paramedic Acute Stroke Treatment Assessment (PASTA) intervention increased hospital thrombolysis rates.<h4>Design, setting, and participants</h4>This multicenter, cluster randomized clinical trial took place between December 2015 and July 2018 in 3 ambulance services and 15 ho ...[more]

PMID: 32282015

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Project description:BACKGROUND:Despite evidence from clinical trials that intravenous (IV) thrombolysis is a cost-effective treatment for selected acute ischaemic stroke patients, there remain large variations in the rate of IV thrombolysis delivery between stroke services. This study is evaluating whether an enhanced care pathway delivered by paramedics (the Paramedic Acute Stroke Treatment Assessment (PASTA)) could increase the number of patients who receive IV thrombolysis treatment. METHODS:Study design: Cluster randomised trial with economic analysis and parallel process evaluation. SETTING:National Health Service ambulance services, emergency departments and hyper-acute stroke units within three geographical regions of England and Wales. Randomisation: Ambulance stations within each region are the units of randomisation. According to station allocation, paramedics based at a station deliver the PASTA pathway (intervention) or continue with standard stroke care (control). Study intervention: The PASTA pathway includes structured pre-hospital information collection, prompted pre-notification, structured handover of information in hospital and assistance with simple tasks during the initial hospital assessment. Study-trained intervention group paramedics deliver this pathway to adults within 4 h of suspected stroke onset. Study control: Standard stroke care according to national and local guidelines for the pre-hospital and hospital assessment of suspected stroke. PARTICIPANTS:Participants enrolled in the study are adults with confirmed stroke who were assessed by a study paramedic within 4 h of symptom onset. PRIMARY OUTCOME:Proportion of participants receiving IV thrombolysis. SAMPLE SIZE:1297 participants provide 90% power to detect a 10% difference in the proportion of patients receiving IV thrombolysis. DISCUSSION:The results from this trial will determine whether an enhanced care pathway delivered by paramedics can increase thrombolysis delivery rates. TRIAL REGISTRATION:ISRCTN registry, ISRCTN12418919 . Registered on 5 November 2015.

Project description:Tenecteplase is a fibrinolytic drug with higher fibrin specificity and longer half-life than the standard stroke thrombolytic, alteplase, permitting the convenience of single bolus administration. Tenecteplase, at 0.5 mg/kg, has regulatory approval to treat ST-segment-elevation myocardial infarction, for which it has equivalent 30-day mortality and fewer systemic hemorrhages. Investigated as a thrombolytic for ischemic stroke over the past 15 years, tenecteplase is currently being studied in several phase 3 trials. Based on a systematic literature search, we provide a qualitative synthesis of published stroke clinical trials of tenecteplase that (1) performed randomized comparisons with alteplase, (2) compared different doses of tenecteplase, or (3) provided unique quantitative meta-analyses. Four phase 2 and one phase 3 study performed randomized comparisons with alteplase. These and other phase 2 studies compared different tenecteplase doses and effects on early outcomes of recanalization, reperfusion, and substantial neurological improvement, as well as symptomatic intracranial hemorrhage and 3-month disability on the modified Rankin Scale. Although no single trial prospectively demonstrated superiority or noninferiority of tenecteplase on clinical outcome, meta-analyses of these trials (1585 patients randomized) point to tenecteplase superiority in recanalization of large vessel occlusions and noninferiority in disability-free 3-month outcome, without increases in symptomatic intracranial hemorrhage or mortality. Doses of 0.25 and 0.4 mg/kg have been tested, but no advantage of the higher dose has been suggested by the results. Current clinical practice guidelines for stroke include intravenous tenecteplase at either dose as a second-tier option, with the 0.25 mg/kg dose recommended for large vessel occlusions, based on a phase 2 trial that demonstrated superior recanalization and improved 3-month outcome relative to alteplase. Ongoing randomized phase 3 trials may better define the comparative risks and benefits of tenecteplase and alteplase for stroke thrombolysis and answer questions of tenecteplase efficacy in the >4.5-hour time window, in wake-up stroke, and in combination with endovascular thrombectomy.

Project description:Thrombolysis using intravenous (IV) tissue plasminogen activator (tPA) is one of few evidence-based acute stroke treatments, yet achieving high rates of IV tPA delivery has been problematic. The 4.5-h treatment window, the complexity of determining eligibility criteria and the availability of expertise and required resources may impact on treatment rates, with barriers encountered at the levels of the individual clinician, the social context and the health system itself. The review aimed to describe health system factors associated with higher rates of IV tPA administration for ischemic stroke and to identify whether system-focussed interventions increased tPA rates for ischemic stroke.Published original English-language research from four electronic databases spanning 1997-2014 was examined. Observational studies of the association between health system factors and tPA rates were described separately from studies of system-focussed intervention strategies aiming to increase tPA rates. Where study outcomes were sufficiently similar, a pooled meta-analysis of outcomes was conducted.Forty-one articles met the inclusion criteria: 7 were methodologically rigorous interventions that met the Cochrane Collaboration Evidence for Practice and Organization of Care (EPOC) study design guidelines and 34 described observed associations between health system factors and rates of IV tPA. System-related factors generally associated with higher IV tPA rates were as follows: urban location, centralised or hub and spoke models, treatment by a neurologist/stroke nurse, in a neurology department/stroke unit or teaching hospital, being admitted by ambulance or mobile team and stroke-specific protocols. Results of the intervention studies suggest that telemedicine approaches did not consistently increase IV tPA rates. Quality improvement strategies appear able to provide modest increases in stroke thrombolysis (pooled odds ratio = 2.1, p = 0.05).In order to improve IV tPA rates in acute stroke care, specific health system factors need to be targeted. Multi-component quality improvement approaches can improve IV tPA rates for stroke, although more thoughtfully designed and well-reported trials are required to safely increase rates of IV tPA to eligible stroke patients.

Project description:Background and purposeTime is brain: benefits of intravenous thrombolysis (IVT) in ischemic stroke last for 4.5 hours but rapidly decrease as time progresses following symptom onset. The goal of the Acute Brain Care (ABC) intervention study was to reduce the door-to-needle time (DNT) to ≤30 minutes by optimizing in-hospital stroke treatment.MethodsWe performed a single-centre before (pre-intervention period: 2000-2005) versus after (post-intervention period: 2006-2012) comparison in a cohort of consecutive patients treated with IVT. The intervention consisted of the implementation of a multidisciplinary stroke protocol combining simple strategies to reduce the DNT. Primary endpoint was the DNT, presented as proportion ≤30 minutes and median time. Secondary clinical endpoints were symptomatic intracranial hemorrhage (SICH), and favourable outcome defined as a modified Rankin scale (mRs) score of 0-2 at 3 months. Endpoints were additionally adjusted for baseline imbalances between the groups.ResultsIn the pre-intervention period, none (0.0%) of the 100 patients (mean age 63.8 years, median National Institutes of Health Stroke Scale [NIHSS] score 14) treated with IVT had a DNT ≤30 minutes compared to 234 (62.7%) of the 373 patients (mean age 66.7 years, median NIHSS score 10) in the post-intervention period (p<0.001). The median DNT decreased from 75 (IQR 60-105) to 28 minutes (IQR 20-37, p<0.001). SICH rate remained stable (3.0% versus 4.4%, OR 1.50, 95% CI 0.43─5.25; adjusted OR 5.47, 95% CI 0.69-42.12). The proportion of patients with a favourable outcome increased (38.9% versus 52.3%, OR 1.72, 95% CI 1.09-2.73) but lost statistical significance after adjustment (adjusted OR 1.46, 95% CI 0.82-2.61).ConclusionsImportant and sustained reduction of the DNT to 30 minutes or less can be safely achieved by optimizing in-hospital stroke treatment. With its simple strategies, the ABC-protocol is a pragmatic framework for increasing the therapeutic yield in time-dependent stroke treatment.

Dataset Information

Effect of an Enhanced Paramedic Acute Stroke Treatment Assessment on Thrombolysis Delivery During Emergency Stroke Care: A Cluster Randomized Clinical Trial.

Publications

Effect of an Enhanced Paramedic Acute Stroke Treatment Assessment on Thrombolysis Delivery During Emergency Stroke Care: A Cluster Randomized Clinical Trial.

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