Stroke Ready - Optimizing Acute Stroke Care

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ClinicalTrials.gov Identifier: NCT03645590

Recruitment Status : Completed

First Posted : August 24, 2018

Last Update Posted : February 13, 2023

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

National Institute on Minority Health and Health Disparities (NIMHD)

Information provided by (Responsible Party):

Lesli E. Skolarus, MD, University of Michigan

Study Description

Brief Summary:

The study aims to increase acute stroke treatment rates in Flint, Michigan through a two-pronged approach of hospital and community level interventions. It also aims to inform future stroke preparedness interventions by exploring the relative importance of hospital optimization and community interventions.

Condition or disease	Intervention/treatment	Phase
Stroke, Acute Stroke	Behavioral: Stroke Ready	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	5970 participants
Allocation:	N/A
Intervention Model:	Sequential Assignment
Intervention Model Description:	Stroke Ready is a stepped wedge design to be delivered to each of the four Flint community quadrants over the course of 2 years.
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	Stroke Ready - Optimizing Acute Stroke Care
Actual Study Start Date :	June 20, 2018
Actual Primary Completion Date :	March 31, 2021
Actual Study Completion Date :	March 31, 2021

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Stroke Ready Community intervention We divided the Flint community into four quadrants. We will focus our workshops and posters on one quadrant, but not exclusively, moving quadrants every 6 months over the course of two years.	Behavioral: Stroke Ready Stroke Ready community intervention consists of peer facilitated educational workshops, stroke music video, and mass media campaign including print materials (e.g. posters, brochure), health promotion mailers, radio/Television public health service announcements, and the Stroke Ready website and Facebook page.

Outcome Measures

Primary Outcome Measures :

Acute stroke treatment rate (tPA) [ Time Frame: Time frame: 11 years of data will be reviewed ]
Acute stroke treatment rate - community wide. Retrospective data captured through medical record review

Secondary Outcome Measures :

Number of emergency department arrivals by ambulance [ Time Frame: Time frame: 11 years of data will be reviewed ]
Optimize community for acute stroke (community level)--retrospective data captured through medical record review

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:Adult stroke patients who presented to one of three hospitals in the Flint community.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645590

Locations

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United States, Michigan
Flint Communiy
Flint, Michigan, United States, 48502

Sponsors and Collaborators

University of Michigan

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

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Principal Investigator:	Lesli Skolarus, MD	University of Michigan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Robles MC, Springer MV, Corches CL, Burke JF, Lin CC, Oliver A, Skolarus LE. Stroke Ready Very Brief Intervention Improves Immediate Postintervention Stroke Preparedness. Circ Cardiovasc Qual Outcomes. 2020 Dec;13(12):e006643. doi: 10.1161/CIRCOUTCOMES.120.006643. Epub 2020 Nov 26. No abstract available.

Skolarus LE, Sales AE, Zimmerman MA, Corches CL, Landis-Lewis Z, Robles MC, McBride AC, Rehman N, Oliver A, Islam N, Springer MV, O'Brien A, Bailey S, Morgenstern LB, Meurer WJ, Burke JF. Stroke Ready: a multi-level program that combines implementation science and community-based participatory research approaches to increase acute stroke treatment: protocol for a stepped wedge trial. Implement Sci. 2019 Mar 7;14(1):24. doi: 10.1186/s13012-019-0869-3.

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Responsible Party:	Lesli E. Skolarus, MD, Associate Professor of Neurology, University of Michigan
ClinicalTrials.gov Identifier:	NCT03645590
Other Study ID Numbers:	U01MD010579 ( U.S. NIH Grant/Contract ) U01MD010579 ( U.S. NIH Grant/Contract )
First Posted:	August 24, 2018 Key Record Dates
Last Update Posted:	February 13, 2023
Last Verified:	June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases

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