Back to resultsStroke Ready - Optimizing Acute Stroke Care
Primary Purpose
Stroke, Acute, Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stroke Ready
Sponsored by
About this trial
This is an interventional health services research trial for Stroke, Acute
Eligibility Criteria
Inclusion criteria:Adult stroke patients who presented to one of three hospitals in the Flint community.
Sites / Locations
- Flint Communiy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stroke Ready Community intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
Acute stroke treatment rate (tPA)
Acute stroke treatment rate - community wide. Retrospective data captured through medical record review
Secondary Outcome Measures
Number of emergency department arrivals by ambulance
Optimize community for acute stroke (community level)--retrospective data captured through medical record review
Full Information
NCT ID
NCT03645590
First Posted
March 23, 2017
Last Updated
June 15, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT03645590
Brief Title
Stroke Ready - Optimizing Acute Stroke Care
Official Title
Stroke Ready - Optimizing Acute Stroke Care
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Stroke
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
N/A
Enrollment
5970 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stroke Ready Community intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stroke Ready
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acute stroke treatment rate (tPA)
Description
Acute stroke treatment rate - community wide. Retrospective data captured through medical record review
Time Frame
Time frame: 11 years of data will be reviewed
Secondary Outcome Measure Information:
Title
Number of emergency department arrivals by ambulance
Description
Optimize community for acute stroke (community level)--retrospective data captured through medical record review
Time Frame
Time frame: 11 years of data will be reviewed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:Adult stroke patients who presented to one of three hospitals in the Flint community.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesli Skolarus, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Flint Communiy
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33238728
Citation
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.
Results Reference
derived
PubMed Identifier
30845958
Citation
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.
Results Reference
derived
Learn more about this trial
Stroke Ready - Optimizing Acute Stroke Care
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