An interventional study of Stroke Ready in Stroke, Acute and Stroke, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Michigan · Not applicable, Interventional, and Health services research
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.
In this study, the participants who received the intervention are a separate group from those analyzed in the outcome measures. Stroke Ready was a multilevel intervention that included a hospital based emergency department optimization component conducted from October 2017 through May 2018 and a community based stroke preparedness intervention conducted from June 2018 through March 2020. The emergency department component focused on improving hospital level acute stroke care processes and did not involve participant enrollment, individual level data collection, or participant level outcomes. Stroke education sessions were offered to community members in quadrant based groups between 2017 and 2020, but this was simply for administrative purposes, not for analytical distinctions among the groups. Demographic information was collected based on workshop educators' perceptions of those in attendance and not taken at the individual level.
Outcome measures about acute stroke treatment rates were collected Flint wide for two different time periods: a preintervention period from July 2010 to September 2017 and a postintervention period from October 2017 to March 2020. The postintervention period was defined based on the initiation of the Stroke Ready intervention in October 2017, corresponding to the start of the emergency department optimization component.
Outcome measure data was not directly related to the intervention, as the intervention was performed among community members and outcomes obtained in people who had a stroke or TIA within time periods before and after the intervention. The workshop data was collected without identifiers at the group level based on perceptions of stroke educators. Baseline data for stroke patients was acquired from the medical record.
Consequently, the information in the Participant Flow and Adverse Events modules only reflects those who attended the community workshops in person or remotely and has no relation to the population addressed in the outcome measures.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 5,970 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria:Adult stroke patients who presented to one of three hospitals in the Flint community.
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.
Utilization of Thrombolysis Among Ischemic Stroke and Transient Ischemic Attack (TIA) Patients
Proportion of Tissue Plasminogen Activator (tPA) treatment utilization among ischemic stroke and TIA patients in pre vs. post intervention periods in all Genesee county hospitals. This is a distinct group of county-wide patients who may or may not include any individuals who received the workshop intervention.
Time frame: Data for this outcome was from county-wide medical records from July 2010 through September 2017 (pre-intervention) and from October 2017 through March 2020 (post-intervention, defined by initiation of the emergency department optimization component).
Percent of Stroke and TIA Patients Who Arrive to the Emergency Department by Ambulance
Stroke and TIA patient arrival by EMS in Pre vs. Post Intervention periods
Time frame: Data was gathered retrospectively from the medical record for Flint stroke or TIA patients from October 2017 through March 2020, following initiation of the Stroke Ready intervention.
All four quadrants received the same workshops. Participants were individuals attending workshops. Outcome measures used de-identified, city-wide stroke and TIA patient data from pre- and post-intervention periods under an IRB-approved waiver of consent; these patients were not enrolled. Peer leaders were not enrolled. The intervention also included a hospital-based emergency department optimization component beginning October 2017 that did not involve participant enrollment.
| Milestone | Stroke Ready Community Intervention Quadrant 1 | Stroke Ready Community Intervention Quadrant 2 | Stroke Ready Community Intervention Quadrant 3 | Stroke Ready Community Intervention Quadrant 4 |
|---|---|---|---|---|
| Started | 1509 | 0 | 0 | 0 |
| Completed | 1509 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Stroke Ready Community Intervention Quadrant 1 | Stroke Ready Community Intervention Quadrant 2 | Stroke Ready Community Intervention Quadrant 3 | Stroke Ready Community Intervention Quadrant 4 |
|---|---|---|---|---|
| Started | 0 | 1526 | 0 | 0 |
| Completed | 0 | 1526 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Stroke Ready Community Intervention Quadrant 1 | Stroke Ready Community Intervention Quadrant 2 | Stroke Ready Community Intervention Quadrant 3 | Stroke Ready Community Intervention Quadrant 4 |
|---|---|---|---|---|
| Started | 0 | 0 | 2329 | 0 |
| Completed | 0 | 0 | 2329 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Stroke Ready Community Intervention Quadrant 1 | Stroke Ready Community Intervention Quadrant 2 | Stroke Ready Community Intervention Quadrant 3 | Stroke Ready Community Intervention Quadrant 4 |
|---|---|---|---|---|
| Started | 0 | 0 | 0 | 606 |
| Completed | 0 | 0 | 0 | 606 |
| Not completed | 0 | 0 | 0 | 0 |
Proportion of Tissue Plasminogen Activator (tPA) treatment utilization among ischemic stroke and TIA patients in pre vs. post intervention periods in all Genesee county hospitals. This is a distinct group of county-wide patients who may or may not include any individuals who received the workshop intervention.
| Percent of stroke and TIA patients | Flint Stroke and TIA Patients Before Initiation of Stroke Ready Intervention | Flint Stroke and TIA Patients After Initiation of Stroke Ready Intervention |
|---|---|---|
| Utilization of Thrombolysis Among Ischemic Stroke and Transient Ischemic Attack (TIA) Patients | 4 | 14 |
Stroke and TIA patient arrival by EMS in Pre vs. Post Intervention periods
| Percent of stroke and TIA patients | Flint Stroke and TIA Patients Before Initiation of Stroke Ready Intervention | Flint Stroke and TIA Patients After Initiation of Stroke Ready Intervention |
|---|---|---|
| Percent of Stroke and TIA Patients Who Arrive to the Emergency Department by Ambulance | 49 | 58 |
Retrospective data pulls were done with IRB permission to compare types of care before and after any stroke ready intervention in the city had begun. This is the mean age of those patients. Note this population is distinct from "participants" in the workshops.
| years | Stroke and TIA Patients in Flint Pre-intervention 7/2010-9/2017 | Stroke and TIA Patients in Flint Post-intervention 10/2017-3/2020 |
|---|---|---|
| Age of Patients With Stroke or TIA From Retrospective Data Pull for the Genesee County Hospitals | 68.0 ± 14.2 | 67.4 ± 14.02 |
The data source to identify sex was the electronic medical record and administrative data from all Genesee County hospitals.
| patients (not participants in workshops) | Stroke and TIA Patients in Flint Pre-intervention 7/2010-9/2017 | Stroke and TIA Patients in Flint Post-intervention 10/2017-3/2020 |
|---|---|---|
| Female | 1289 | 559 |
| Male | 1016 | 463 |
Retrospective data analysis of Genesee county stroke and TIA patients' race
| patients (not participants in workshops) | Stroke and TIA Patients in Flint Pre-intervention 7/2010-9/2017 | Stroke and TIA Patients in Flint Post-intervention 10/2017-3/2020 |
|---|---|---|
| Black | 1233 | 514 |
| Other race and ethnicity | 1072 | 508 |
Collected over For this study, the Flint community was divided into four administrative quadrants. The workshops, mailers, and social media focused on one quadrant at a time, progressing quadrants every 6 months over the course of two years. Adverse events were not monitoring Stroke or TIA patients as they were neither intervention workshop participants nor considered enrolled.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stroke Ready Community Intervention | 0/5,970 (0%) | 0/5,970 (0%) | 0/5,970 (0%) |
Workshop attendee demographic information was based on peer educators' perceptions of attendees, not taken at the individual or recorded at the quadrant level. 264 workshop participants received virtual intervention, from whom no demographic data other than US location was collected. Workshop participants are a separate population from the stroke and TIA patients. Outcome measure data was not directly related to the intervention. As quadrants have no age, sex or race, they couldn't be analyzed.
| Age, Customized(Participants) | Stroke Ready Community Intervention Workshop Attendees |
|---|---|
| Participants perceived by workshop educators to be 18-40 | 916 |
| Participants perceived by workshop educators to be 41-64 | 3312 |
| Participants perceived by workshop educators to be 65 and over | 1478 |
| Sex/Gender, Customized(Participants) | Stroke Ready Community Intervention Workshop Attendees |
|---|---|
| Attendees at workshops where group was perceived by educators to be mostly female | 1522 |
| Attendees at workshops where group was perceived by educators to be mostly male | 128 |
| Attendees at workshops where group was perceived by educators to be approximately evenly male/female | 4056 |
| Race/Ethnicity, Customized(Participants) | Stroke Ready Community Intervention Workshop Attendees |
|---|---|
| Attendees at workshops where group was perceived by educators to be mostly Black | 2066 |
| Attendees at workshops where group was perceived by educators to be mostly White | 1020 |
| Attendees at workshops where group was perceived by educators to be approximately evenly Black/White | 2620 |
| Region of Enrollment(Participants) | Stroke Ready Community Intervention Workshop Attendees |
|---|---|
| United States | 5970 |
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