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Published in: Trials 1/2019

Open Access 01-12-2019 | Stroke | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2019

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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.
Appendix
Available only for authorised users
Literature
1.
Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, et al. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014;383:245–54.CrossRef
2.
National Audit Office. Reducing brain damage: faster access to better stroke care. London: National Audit Office; 2005.
3.
4.
5.
Lorenzano S, Ahmed N, Tatlisumak T, Gomis M, Davalos A, Mikulik R, Sevcik P, Ollikainen J, Wahlgren N, Toni D, et al. Within-day and weekly variations of thrombolysis in acute ischemic stroke: results from Safe Implementation of Treatments in Stroke-International Stroke Thrombolysis Register. Stroke. 2014;45:176–84.CrossRef
6.
National Institute for Health and Care Excellence (NICE). Alteplase for treating acute ischaemic stroke (review of technology appraisal guidance 122). NICE technology appraisal guidance, vol. 264. London: NICE; 2012.
7.
Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, et al. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44:870–947.CrossRef
8.
Intercollegiate Stroke Working Party. National Clinical Guideline for Stroke. 5th ed. London: Royal College of Physicians; 2016.
9.
Harbison J, Hossain O, Jenkinson D, Davis J, Louw SJ, Ford GA. Diagnostic accuracy of stroke referrals from primary care, emergency room physicians, and ambulance staff using the Face Arm Speech Test. Stroke. 2003;34:71–6.CrossRef
10.
Patel MD, Rose KM, O'Brien EC, Rosamond WD. Prehospital notification by emergency medical services reduces delays in stroke evaluation: findings from the North Carolina Stroke Care Collaborative. Stroke. 2011;42:2263–8.CrossRef
11.
Mosley I, Nicol M, Donnan G, Patrick I, Kerr F, Dewey H. The impact of ambulance practice on acute stroke care. Stroke. 2007;38:2765–70.CrossRef
12.
Alberti G. Emergency care ten years on: reforming emergency care. London: Department of Health; 2007.
13.
Berglund A, Svensson L, Sjostrand C, von Arbin M, von Euler M, Wahlgren N, Collaborators H, Engerstrom L, Hojeberg B, Kall TB, et al. Higher prehospital priority level of stroke improves thrombolysis frequency and time to stroke unit: the Hyper Acute STroke Alarm (HASTA) study. Stroke. 2012;43:2666–70.CrossRef
14.
Puolakka T, Kuisma M, Lankimaki S, Puolakka J, Hallikainen J, Rantanen K, Lindsberg PJ. Cutting the prehospital on-scene time of stroke thrombolysis in Helsinki: a prospective interventional study. Stroke. 2016;47:3038–40.CrossRef
15.
Ebinger M, Winter B, Wendt M, Weber JE, Waldschmidt C, Rozanski M, Kunz A, Koch P, Kellner PA, Gierhake D, et al. Effect of the use of ambulance-based thrombolysis on time to thrombolysis in acute ischemic stroke: a randomized clinical trial. JAMA. 2014;311:1622–31.CrossRef
16.
Liman TG, Winter B, Waldschmidt C, Zerbe N, Hufnagl P, Audebert HJ, Endres M. Telestroke ambulances in prehospital stroke management: concept and pilot feasibility study. Stroke. 2012;43:2086–90.CrossRef
17.
Bergrath S, Reich A, Rossaint R, Rortgen D, Gerber J, Fischermann H, Beckers SK, Brokmann JC, Schulz JB, Leber C, et al. Feasibility of prehospital teleconsultation in acute stroke--a pilot study in clinical routine. PLOS One. 2012;7:e36796.CrossRef
18.
McMeekin P, Gray J, Ford GA, Rodgers H, Price CI. Modelling the efficiency of local versus central provision of intravenous thrombolysis after acute ischemic stroke. Stroke. 2013;44:3114–9.CrossRef
19.
Choi B, Tsai D, McGillivray CG, Amedee C, Sarafin JA, Silver B. Hospital-directed feedback to Emergency Medical Services improves prehospital performance. Stroke. 2014;45:2137–40.CrossRef
20.
Iedema R, Ball C, Daly B, Young J, Green T, Middleton PM, Foster-Curry C, Jones M, Hoy S, Comerford D. Design and trial of a new ambulance-to-emergency department handover protocol: ‘IMIST-AMBO’. BMJ Qual Saf. 2012;21:627–33.CrossRef
21.
Ko HC, Turner TJ, Finnigan MA. Systematic review of safety checklists for use by medical care teams in acute hospital settings—limited evidence of effectiveness. BMC Health Serv Res. 2011;11:211.CrossRef
22.
Brott T, Adams HPJ, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989;20:864–70.CrossRef
23.
van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988;19:604–7.CrossRef
24.
NHS Commissioning Board Knowledge and Intelligence Branch. Everyone counts: planning for patients 2013/14: technical definitions. Leeds: NHS Commissioning Board; 2012.
25.
Gibson LM, Whiteley W. The differential diagnosis of suspected stroke: a systematic review. J R Coll Physicians Edinb. 2013;43:114–8.CrossRef
26.
Bruno A, Akinwuntan AE, Lin C, Close B, Davis K, Baute V, Aryal T, Brooks D, Hess DC, Switzer JA, et al. Simplified modified Rankin Scale questionnaire: reproducibility over the telephone and validation with quality of life. Stroke. 2011;42:2276–9.CrossRef
27.
Wardlaw JM, Sandercock PA, Warlow CP, Lindley RI. Trials of thrombolysis in acute ischemic stroke: does the choice of primary outcome measure really matter? Stroke. 2000;31:1133–5.CrossRef
28.
29.
Whynes DK, Sprigg N, Selby J, Berge E, Bath PM, Investigators E. Testing for differential item functioning within the EQ-5D. Med Decis Mak. 2013;33:252–60.CrossRef
30.
Rivero-Arias O, Ouellet M, Gray A, Wolstenholme J, Rothwell PM, Luengo-Fernandez R. Mapping the modified Rankin scale (mRS) measurement into the generic EuroQol (EQ-5D) health outcome. Med Decis Mak. 2010;30:341–54.CrossRef
31.
Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005;14:487–96.CrossRef
32.
33.
Manca A, Palmer S. Handling missing data in patient-level cost-effectiveness analysis alongside randomised clinical trials. Appl Health Econ Health Policy. 2005;4:65–75.CrossRef
34.
Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ. 2001;10:779–87.CrossRef
35.
Siebert U, Alagoz O, Bayoumi AM, Jahn B, Owens DK, Cohen DJ, Kuntz KM, Force I-SMGRPT. State-transition modeling: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--3. Value Health. 2012;15:812–20.CrossRef
36.
McMeekin P, Flynn D, Ford GA, Rodgers H, Gray J, Thompson RG. Development of a decision analytic model to support decision making and risk communication about thrombolytic treatment.[Erratum appears in BMC Med Inform Decis Mak. 2016;16:4; PMID: 26775145]. BMC Med Inform Decis Mak. 2015;15:90.CrossRef
37.
Felli JC, Hazen GB. Sensitivity analysis and the expected value of perfect information.[Erratum appears in Med Decis Making. 2003 Jan-Feb;23(1):97.], [Erratum appears in Med Decis Making 2001 May-Jun;21(3):254]. Med Decis Mak. 1998;18:95–109.CrossRef
38.
Charmaz K. Constructing grounded theory: a practical guide through qualitative analysis. London: SAGE Publications Ltd; 2006.
Metadata
Title
Paramedic Acute Stroke Treatment Assessment (PASTA): study protocol for a randomised controlled trial
Authors
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
Publication date
01-12-2019
Publisher
BioMed Central
Keyword
Stroke
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-3144-z

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