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

Christopher I. Price, Lisa Shaw, Peter Dodd, Catherine Exley, Darren Flynn, Richard Francis, Saiful Islam, Mehdi Javanbakht, Rachel Lakey, Joanne Lally, Graham McClelland, Peter McMeekin, Helen Rodgers, Helen Snooks, Louise Sutcliffe, Pippa Tyrell, Luke Vale, Alan Watkins, Gary A. Ford

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Abstract

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.

Original languageEnglish
Pages (from-to)121
Number of pages1
JournalTrials
Volume20
Issue number1
DOIs
Publication statusPublished - 12 Feb 2019

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Allied Health Personnel
Randomized Controlled Trials
Stroke
Therapeutics
Ambulances
Random Allocation
Wales
National Health Programs
England
Health Care Costs
Registries
Hospital Emergency Service
Economics
Clinical Trials
Guidelines

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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 ; Ford, Gary A. / Paramedic Acute Stroke Treatment Assessment (PASTA) : study protocol for a randomised controlled trial. In: Trials. 2019 ; Vol. 20, No. 1. pp. 121.
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abstract = "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.",
author = "Price, {Christopher I.} and Lisa Shaw and Peter Dodd and Catherine Exley and Darren Flynn and Richard Francis and Saiful Islam and Mehdi Javanbakht and Rachel Lakey and Joanne Lally and Graham McClelland and Peter McMeekin and Helen Rodgers and Helen Snooks and Louise Sutcliffe and Pippa Tyrell and Luke Vale and Alan Watkins and Ford, {Gary A.}",
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Price, CI, Shaw, L, Dodd, P, Exley, C, Flynn, D, Francis, R, Islam, S, Javanbakht, M, Lakey, R, Lally, J, McClelland, G, McMeekin, P, Rodgers, H, Snooks, H, Sutcliffe, L, Tyrell, P, Vale, L, Watkins, A & Ford, GA 2019, 'Paramedic Acute Stroke Treatment Assessment (PASTA): study protocol for a randomised controlled trial', Trials, vol. 20, no. 1, pp. 121. https://doi.org/10.1186/s13063-018-3144-z

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; Ford, Gary A.

In: Trials, Vol. 20, No. 1, 12.02.2019, p. 121.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Paramedic Acute Stroke Treatment Assessment (PASTA)

T2 - study protocol for a randomised controlled trial

AU - Price, Christopher I.

AU - Shaw, Lisa

AU - Dodd, Peter

AU - Exley, Catherine

AU - Flynn, Darren

AU - Francis, Richard

AU - Islam, Saiful

AU - Javanbakht, Mehdi

AU - Lakey, Rachel

AU - Lally, Joanne

AU - McClelland, Graham

AU - McMeekin, Peter

AU - Rodgers, Helen

AU - Snooks, Helen

AU - Sutcliffe, Louise

AU - Tyrell, Pippa

AU - Vale, Luke

AU - Watkins, Alan

AU - Ford, Gary A.

PY - 2019/2/12

Y1 - 2019/2/12

N2 - 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.

AB - 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.

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DO - 10.1186/s13063-018-3144-z

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