Paramedic Acute Stroke Treatment Assessment (PASTA): study protocol for a randomised controlled trial

Price, Christopher I., Shaw, Lisa, Dodd, Peter, Exley, Catherine, Flynn, Darren, Francis, Richard, Islam, Saiful, Javanbakht, Mehdi, Lakey, Rachel, Lally, Joanne, McClelland, Graham, McMeekin, Peter, Rodgers, Helen, Snooks, Helen, Sutcliffe, Louise, Tyrell, Pippa, Vale, Luke, Watkins, Alan and Ford, Gary A. (2019) Paramedic Acute Stroke Treatment Assessment (PASTA): study protocol for a randomised controlled trial. Trials, 20 (1). p. 121. ISSN 1745-6215

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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.

Item Type: Article
Additional Information: Funding information: This project is part of a programme grant funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (title: Promoting Effective and Rapid Stroke care (PEARS). project number: RP-PG-1211-20012). The views and opinions expressed here are those of the authors and do not necessarily reflect those of the NIHR, NHS or Department of Health. The NIHR advised on the study design but had no role in writing this manuscript or the decision to submit for publication.
Uncontrolled Keywords: Stroke, Pre-hospital research, Paramedics, RCT, Economic evaluation, Parallel process evaluation
Subjects: A300 Clinical Medicine
B200 Pharmacology, Toxicology and Pharmacy
Department: Faculties > Health and Life Sciences > Nursing, Midwifery and Health
Depositing User: Elena Carlaw
Date Deposited: 01 Mar 2019 10:58
Last Modified: 10 Nov 2021 10:27

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