Benefits of stroke treatment delivered using a mobile stroke unit trial

Jose Miguel Yamal; Suja S. Rajan; Stephanie A. Parker; Asha P. Jacob; Michael O. Gonzalez; Nicole R. Gonzales; Ritvij Bowry; Andrew D. Barreto; Tzu Ching Wu; David R. Lairson; David Persse; Barbara C. Tilley; David Chiu; Jose I. Suarez; William J. Jones; Andrei Alexandrov; James C. Grotta

doi:10.1177/1747493017711950

Benefits of stroke treatment delivered using a mobile stroke unit trial

Jose Miguel Yamal, Suja S. Rajan, Stephanie A. Parker, Asha P. Jacob, Michael O. Gonzalez, Nicole R. Gonzales, Ritvij Bowry, Andrew D. Barreto, Tzu Ching Wu, David R. Lairson, David Persse, Barbara C. Tilley, David Chiu, Jose I. Suarez, William J. Jones, Andrei Alexandrov, James C. Grotta

Research output: Contribution to journal › Article › peer-review

27 Scopus citations

Abstract

Rationale: Mobile stroke units speed treatment for acute ischemic stroke, thereby possibly improving outcomes. Aim: To compare mobile stroke unit and standard management clinical outcomes, healthcare utilization, and cost-effectiveness in tissue plasminogen activator-eligible acute ischemic stroke patients calling 911. Sample size: 693. Eighty percent power with 0.05 type I error rate to detect a difference of 0.09 in mean utility-weighted modified Rankin scale between groups. Design: Phase III, multicenter, prospective cluster-randomized (mobile stroke unit versus standard management weeks) comparative effectiveness study in tissue plasminogen activator-eligible patients. Outcomes: Primary: Ninety-day mean utility-weighted modified Rankin scale. Coprimary: cost-effectiveness based on EQ5D quality of life and one year poststroke costs. Analysis: Two-sample t-test and linear regression adjusting for covariates; incremental cost-effectiveness ratio and net benefit regression. Results: As of March 2017, 288 tissue plasminogen activator-eligible patients have been enrolled (173 in the mobile stroke unit arm and 115 in the standard management arm). Two new centers start in early 2017 with target end of recruitment September 2019. Conclusion: This is the first randomized study to test for disability, healthcare utilization, and cost-effectiveness of a mobile stroke unit. The progress of the study suggests that it is feasible. Management of tissue plasminogen activator eligible acute ischemic stroke patients by a mobile stroke unit could potentially result in less disability and healthcare utilization, and be cost effective. Mobile stroke units are very costly. This trial may determine if the fixed cost can be justified by a reduction in disability and healthcare utilization. Clinical Trial Registration: NCT02190500.

Original language	English (US)
Pages (from-to)	321-327
Number of pages	7
Journal	International Journal of Stroke
Volume	13
Issue number	3
DOIs	https://doi.org/10.1177/1747493017711950
State	Published - Apr 1 2018
Externally published	Yes

Keywords

Acute stroke
Emergency Medical Services
ambulance
phase III clinical trial
prehospital
thrombolysis

ASJC Scopus subject areas

Neurology

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10.1177/1747493017711950

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Yamal, J. M., Rajan, S. S., Parker, S. A., Jacob, A. P., Gonzalez, M. O., Gonzales, N. R., Bowry, R., Barreto, A. D., Wu, T. C., Lairson, D. R., Persse, D., Tilley, B. C., Chiu, D., Suarez, J. I., Jones, W. J., Alexandrov, A., & Grotta, J. C. (2018). Benefits of stroke treatment delivered using a mobile stroke unit trial. International Journal of Stroke, 13(3), 321-327. https://doi.org/10.1177/1747493017711950

Yamal, JM, Rajan, SS, Parker, SA, Jacob, AP, Gonzalez, MO, Gonzales, NR, Bowry, R, Barreto, AD, Wu, TC, Lairson, DR, Persse, D, Tilley, BC, Chiu, D, Suarez, JI, Jones, WJ, Alexandrov, A & Grotta, JC 2018, 'Benefits of stroke treatment delivered using a mobile stroke unit trial', International Journal of Stroke, vol. 13, no. 3, pp. 321-327. https://doi.org/10.1177/1747493017711950

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title = "Benefits of stroke treatment delivered using a mobile stroke unit trial",

abstract = "Rationale: Mobile stroke units speed treatment for acute ischemic stroke, thereby possibly improving outcomes. Aim: To compare mobile stroke unit and standard management clinical outcomes, healthcare utilization, and cost-effectiveness in tissue plasminogen activator-eligible acute ischemic stroke patients calling 911. Sample size: 693. Eighty percent power with 0.05 type I error rate to detect a difference of 0.09 in mean utility-weighted modified Rankin scale between groups. Design: Phase III, multicenter, prospective cluster-randomized (mobile stroke unit versus standard management weeks) comparative effectiveness study in tissue plasminogen activator-eligible patients. Outcomes: Primary: Ninety-day mean utility-weighted modified Rankin scale. Coprimary: cost-effectiveness based on EQ5D quality of life and one year poststroke costs. Analysis: Two-sample t-test and linear regression adjusting for covariates; incremental cost-effectiveness ratio and net benefit regression. Results: As of March 2017, 288 tissue plasminogen activator-eligible patients have been enrolled (173 in the mobile stroke unit arm and 115 in the standard management arm). Two new centers start in early 2017 with target end of recruitment September 2019. Conclusion: This is the first randomized study to test for disability, healthcare utilization, and cost-effectiveness of a mobile stroke unit. The progress of the study suggests that it is feasible. Management of tissue plasminogen activator eligible acute ischemic stroke patients by a mobile stroke unit could potentially result in less disability and healthcare utilization, and be cost effective. Mobile stroke units are very costly. This trial may determine if the fixed cost can be justified by a reduction in disability and healthcare utilization. Clinical Trial Registration: NCT02190500.",

keywords = "Acute stroke, Emergency Medical Services, ambulance, phase III clinical trial, prehospital, thrombolysis",

author = "Yamal, {Jose Miguel} and Rajan, {Suja S.} and Parker, {Stephanie A.} and Jacob, {Asha P.} and Gonzalez, {Michael O.} and Gonzales, {Nicole R.} and Ritvij Bowry and Barreto, {Andrew D.} and Wu, {Tzu Ching} and Lairson, {David R.} and David Persse and Tilley, {Barbara C.} and David Chiu and Suarez, {Jose I.} and Jones, {William J.} and Andrei Alexandrov and Grotta, {James C.}",

note = "Funding Information: The men and women of the Houston Texas, Aurora Colorado, and Memphis Tennessee Fire Departments. Study Monitoring Committee: David Lairson PhD (chair), Steven Levine MD, and Robin Brey MD Publisher Copyright: {\textcopyright} 2017, {\textcopyright} 2017 World Stroke Organization.",

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day = "1",

doi = "10.1177/1747493017711950",

language = "English (US)",

volume = "13",

pages = "321--327",

journal = "International Journal of Stroke",

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T1 - Benefits of stroke treatment delivered using a mobile stroke unit trial

AU - Yamal, Jose Miguel

AU - Rajan, Suja S.

AU - Parker, Stephanie A.

AU - Jacob, Asha P.

AU - Gonzalez, Michael O.

AU - Gonzales, Nicole R.

AU - Bowry, Ritvij

AU - Barreto, Andrew D.

AU - Wu, Tzu Ching

AU - Lairson, David R.

AU - Persse, David

AU - Tilley, Barbara C.

AU - Chiu, David

AU - Suarez, Jose I.

AU - Jones, William J.

AU - Alexandrov, Andrei

AU - Grotta, James C.

N1 - Funding Information: The men and women of the Houston Texas, Aurora Colorado, and Memphis Tennessee Fire Departments. Study Monitoring Committee: David Lairson PhD (chair), Steven Levine MD, and Robin Brey MD Publisher Copyright: © 2017, © 2017 World Stroke Organization.

PY - 2018/4/1

Y1 - 2018/4/1

N2 - Rationale: Mobile stroke units speed treatment for acute ischemic stroke, thereby possibly improving outcomes. Aim: To compare mobile stroke unit and standard management clinical outcomes, healthcare utilization, and cost-effectiveness in tissue plasminogen activator-eligible acute ischemic stroke patients calling 911. Sample size: 693. Eighty percent power with 0.05 type I error rate to detect a difference of 0.09 in mean utility-weighted modified Rankin scale between groups. Design: Phase III, multicenter, prospective cluster-randomized (mobile stroke unit versus standard management weeks) comparative effectiveness study in tissue plasminogen activator-eligible patients. Outcomes: Primary: Ninety-day mean utility-weighted modified Rankin scale. Coprimary: cost-effectiveness based on EQ5D quality of life and one year poststroke costs. Analysis: Two-sample t-test and linear regression adjusting for covariates; incremental cost-effectiveness ratio and net benefit regression. Results: As of March 2017, 288 tissue plasminogen activator-eligible patients have been enrolled (173 in the mobile stroke unit arm and 115 in the standard management arm). Two new centers start in early 2017 with target end of recruitment September 2019. Conclusion: This is the first randomized study to test for disability, healthcare utilization, and cost-effectiveness of a mobile stroke unit. The progress of the study suggests that it is feasible. Management of tissue plasminogen activator eligible acute ischemic stroke patients by a mobile stroke unit could potentially result in less disability and healthcare utilization, and be cost effective. Mobile stroke units are very costly. This trial may determine if the fixed cost can be justified by a reduction in disability and healthcare utilization. Clinical Trial Registration: NCT02190500.

AB - Rationale: Mobile stroke units speed treatment for acute ischemic stroke, thereby possibly improving outcomes. Aim: To compare mobile stroke unit and standard management clinical outcomes, healthcare utilization, and cost-effectiveness in tissue plasminogen activator-eligible acute ischemic stroke patients calling 911. Sample size: 693. Eighty percent power with 0.05 type I error rate to detect a difference of 0.09 in mean utility-weighted modified Rankin scale between groups. Design: Phase III, multicenter, prospective cluster-randomized (mobile stroke unit versus standard management weeks) comparative effectiveness study in tissue plasminogen activator-eligible patients. Outcomes: Primary: Ninety-day mean utility-weighted modified Rankin scale. Coprimary: cost-effectiveness based on EQ5D quality of life and one year poststroke costs. Analysis: Two-sample t-test and linear regression adjusting for covariates; incremental cost-effectiveness ratio and net benefit regression. Results: As of March 2017, 288 tissue plasminogen activator-eligible patients have been enrolled (173 in the mobile stroke unit arm and 115 in the standard management arm). Two new centers start in early 2017 with target end of recruitment September 2019. Conclusion: This is the first randomized study to test for disability, healthcare utilization, and cost-effectiveness of a mobile stroke unit. The progress of the study suggests that it is feasible. Management of tissue plasminogen activator eligible acute ischemic stroke patients by a mobile stroke unit could potentially result in less disability and healthcare utilization, and be cost effective. Mobile stroke units are very costly. This trial may determine if the fixed cost can be justified by a reduction in disability and healthcare utilization. Clinical Trial Registration: NCT02190500.

KW - Acute stroke

KW - Emergency Medical Services

KW - ambulance

KW - phase III clinical trial

KW - prehospital

KW - thrombolysis

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Benefits of stroke treatment delivered using a mobile stroke unit trial

Abstract

Keywords

ASJC Scopus subject areas

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