Trial Outcomes & Findings for Stroke Ready - Optimizing Acute Stroke Care (NCT NCT03645590)

Last Updated: 2026-05-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

5970 participants

Primary outcome timeframe

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).

Results posted on

2026-05-01

Participant Flow

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.

People for whom retrospective outcome data were acquired (stroke or TIA patients presenting to hospitals before and after initiation of Stroke Ready in October 2017) were not considered participants. Quadrants were used for administrative purposes only and outcome data were captured citywide. Pre and post periods apply only to retrospective outcome data, not enrolled workshop participants.

Unit of analysis: quadrants

Participant milestones

Participant milestones
Measure	Stroke Ready Community Intervention Quadrant 1 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. This multi-level intervention was conducted in Flint, Michigan. In the community intervention, participants attended peer-led stroke preparedness workshops (ranging from 5 to 60 minutes). These took place at community events, schools, community organization meetings, faith-based organizations, workplaces, senior centers, shelters, and beauty salons/barber shops. Intervention rollout occurred in a step-wedge process, with workshop enrollment targeted in a specific quadrant. (Peer leaders were not considered "enrolled".) Quadrant 1's workshop interventions occurred from 6/1/2018 - 11/30/2018.	Stroke Ready Community Intervention Quadrant 2 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. This multi-level intervention was conducted in Flint, Michigan. In the community intervention, participants attended peer-led stroke preparedness workshops (ranging from 5 to 60 minutes). These took place at community events, schools, community organization meetings, faith-based organizations, workplaces, senior centers, shelters, and beauty salons/barber shops. Intervention rollout occurred in a step-wedge process, with workshop enrollment targeted in a specific quadrant. (Peer leaders were not considered "enrolled".) Quadrant 2's workshop interventions occurred from 12/1/2018 - 5/31/2019.	Stroke Ready Community Intervention Quadrant 3 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. This multi-level intervention was conducted in Flint, Michigan. In the community intervention, participants attended peer-led stroke preparedness workshops (ranging from 5 to 60 minutes). These took place at community events, schools, community organization meetings, faith-based organizations, workplaces, senior centers, shelters, and beauty salons/barber shops. Intervention rollout occurred in a step-wedge process, with workshop enrollment targeted in a specific quadrant. (Peer leaders were not considered "enrolled".) Quadrant 3's workshop interventions occurred from 6/1/2019 - 11/30/2019.	Stroke Ready Community Intervention Quadrant 4 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. This multi-level intervention was conducted in Flint, Michigan. In the community intervention, participants attended peer-led stroke preparedness workshops (ranging from 5 to 60 minutes). These took place at community events, schools, community organization meetings, faith-based organizations, workplaces, senior centers, shelters, and beauty salons/barber shops. Intervention rollout occurred in a step-wedge process, with workshop enrollment targeted in a specific quadrant. (Peer leaders were not considered "enrolled".) During 2020, due to COVID, a relatively smaller number of participants "attended" workshops virtually. Quadrant 4's workshop interventions occurred in person from 12/1/2019 to 3/12/2020 and additional virtual workshops occurred from 3/13/2020 - 8/31/2020.
Quad 1 intervention 6/1/2018-11/30/2018 STARTED	1509 1	0 0	0 0	0 0
Quad 1 intervention 6/1/2018-11/30/2018 COMPLETED	1509 1	0 0	0 0	0 0
Quad 1 intervention 6/1/2018-11/30/2018 NOT COMPLETED	0 0	0 0	0 0	0 0
Quad. 2 intervention 12/1/2018-5/31/2019 STARTED	0 0	1526 1	0 0	0 0
Quad. 2 intervention 12/1/2018-5/31/2019 COMPLETED	0 0	1526 1	0 0	0 0
Quad. 2 intervention 12/1/2018-5/31/2019 NOT COMPLETED	0 0	0 0	0 0	0 0
Quad.3 intervention 6/1/2019-11/30/2019 STARTED	0 0	0 0	2329 1	0 0
Quad.3 intervention 6/1/2019-11/30/2019 COMPLETED	0 0	0 0	2329 1	0 0
Quad.3 intervention 6/1/2019-11/30/2019 NOT COMPLETED	0 0	0 0	0 0	0 0
Quad.4 intervention 12/1/2019-8/31/2020 STARTED	0 0	0 0	0 0	606 1
Quad.4 intervention 12/1/2019-8/31/2020 COMPLETED	0 0	0 0	0 0	606 1
Quad.4 intervention 12/1/2019-8/31/2020 NOT COMPLETED	0 0	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

264 workshop participants received virtual intervention, from whom no demographic data other than US location was collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stroke Ready Community Intervention Workshop Attendees n=5970 Participants Participants attended peer-led stroke preparedness workshops (ranging from 5 to 60 minutes). These took place at community events, schools, community organizations meetings, faith-based organizations, workplaces, senior centers, shelters, and beauty salons/barber shops. As noted in Detailed Description, stroke education sessions were offered to community members. Demographic information provided below was collected based on workshop educators' perceptions of those in attendance and not taken at the individual level. The information in this section only reflects those who attended the workshops. This is a separate population from the Flint Stroke patients. Community-wide education was delivered because: 1) it is impossible to predict who will have a stroke and thus need stroke education and 2) bystanders call 911 if they witness a stroke. Outcome measure data was not directly related to the intervention. These patients had no direct interaction with the study and no demographic data was collected from them.
Age, Customized Participants perceived by workshop educators to be 18-40	916 Participants n=5706 Participants • 264 workshop participants received virtual intervention, from whom no demographic data other than US location was collected.
Age, Customized Participants perceived by workshop educators to be 41-64	3312 Participants n=5706 Participants • 264 workshop participants received virtual intervention, from whom no demographic data other than US location was collected.
Age, Customized Participants perceived by workshop educators to be 65 and over	1478 Participants n=5706 Participants • 264 workshop participants received virtual intervention, from whom no demographic data other than US location was collected.
Sex/Gender, Customized Attendees at workshops where group was perceived by educators to be mostly female	1522 Participants n=5706 Participants • 264 workshop participants received virtual intervention, from whom no demographic data other than US location was collected.
Sex/Gender, Customized Attendees at workshops where group was perceived by educators to be mostly male	128 Participants n=5706 Participants • 264 workshop participants received virtual intervention, from whom no demographic data other than US location was collected.
Sex/Gender, Customized Attendees at workshops where group was perceived by educators to be approximately evenly male/female	4056 Participants n=5706 Participants • 264 workshop participants received virtual intervention, from whom no demographic data other than US location was collected.
Race/Ethnicity, Customized Attendees at workshops where group was perceived by educators to be mostly Black	2066 Participants n=5706 Participants • 264 participants were not in person attendees, but received training online - and race data was not collected from them.
Race/Ethnicity, Customized Attendees at workshops where group was perceived by educators to be mostly White	1020 Participants n=5706 Participants • 264 participants were not in person attendees, but received training online - and race data was not collected from them.
Race/Ethnicity, Customized Attendees at workshops where group was perceived by educators to be approximately evenly Black/White	2620 Participants n=5706 Participants • 264 participants were not in person attendees, but received training online - and race data was not collected from them.
Region of Enrollment United States	5970 Participants n=5970 Participants

PRIMARY outcome

Timeframe: 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).

Population: Pre population is Flint stroke patients between July 2010 and September 2017. Post population is Flint stroke and TIA patients between October 2017 and March 2020, defined based on the initiation of the Stroke Ready intervention beginning with the emergency department optimization component in October 2017 (see Detailed Description).

Outcome measures

Outcome measures
Measure	Flint Stroke and TIA Patients Before Initiation of Stroke Ready Intervention n=2305 Participants Pre- intervention population is Flint stroke patients between July 2010 and September 2017 before the first workshop began. Data was gathered retrospectively from the medical record.	Flint Stroke and TIA Patients After Initiation of Stroke Ready Intervention n=1022 Participants Post-intervention population is Flint stroke patients between October 2017 and March 2020.
Utilization of Thrombolysis Among Ischemic Stroke and Transient Ischemic Attack (TIA) Patients	4 Percent of stroke and TIA patients	14 Percent of stroke and TIA patients

SECONDARY outcome

Timeframe: 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.

Stroke and TIA patient arrival by EMS in Pre vs. Post Intervention periods

Outcome measures

Outcome measures
Measure	Flint Stroke and TIA Patients Before Initiation of Stroke Ready Intervention n=2305 Participants Pre- intervention population is Flint stroke patients between July 2010 and September 2017 before the first workshop began. Data was gathered retrospectively from the medical record.	Flint Stroke and TIA Patients After Initiation of Stroke Ready Intervention n=1022 Participants Post-intervention population is Flint stroke patients between October 2017 and March 2020.
Percent of Stroke and TIA Patients Who Arrive to the Emergency Department by Ambulance	49 Percent of stroke and TIA patients	58 Percent of stroke and TIA patients

POST_HOC outcome

Population: Note: the population analyzed here is not participants in workshops (the intervention), but county-wide patients whose data was collected retrospectively.

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.

Outcome measures

Outcome measures
Measure	Flint Stroke and TIA Patients Before Initiation of Stroke Ready Intervention n=2305 Participants Pre- intervention population is Flint stroke patients between July 2010 and September 2017 before the first workshop began. Data was gathered retrospectively from the medical record.	Flint Stroke and TIA Patients After Initiation of Stroke Ready Intervention n=1022 Participants Post-intervention population is Flint stroke patients between October 2017 and March 2020.
Age of Patients With Stroke or TIA From Retrospective Data Pull for the Genesee County Hospitals	68.0 years Standard Deviation 14.2	67.4 years Standard Deviation 14.02

POST_HOC outcome

Timeframe: Retrospective data collected, Data for this outcome measure was gathered from county-wide medical records from July 2010 through September 2017, and from October 2017 through March 2020.

The data source to identify sex was the electronic medical record and administrative data from all Genesee County hospitals.

Outcome measures

Outcome measures
Measure	Flint Stroke and TIA Patients Before Initiation of Stroke Ready Intervention n=2305 Participants Pre- intervention population is Flint stroke patients between July 2010 and September 2017 before the first workshop began. Data was gathered retrospectively from the medical record.	Flint Stroke and TIA Patients After Initiation of Stroke Ready Intervention n=1022 Participants Post-intervention population is Flint stroke patients between October 2017 and March 2020.
Sex of Flint Stroke and TIA Patients Female	1289 patients (not participants in workshops)	559 patients (not participants in workshops)
Sex of Flint Stroke and TIA Patients Male	1016 patients (not participants in workshops)	463 patients (not participants in workshops)

POST_HOC outcome

Timeframe: From July 2010 through September 2017, and from October 2017 through March 2020.

Retrospective data analysis of Genesee county stroke and TIA patients' race

Outcome measures

Outcome measures
Measure	Flint Stroke and TIA Patients Before Initiation of Stroke Ready Intervention n=2305 Participants Pre- intervention population is Flint stroke patients between July 2010 and September 2017 before the first workshop began. Data was gathered retrospectively from the medical record.	Flint Stroke and TIA Patients After Initiation of Stroke Ready Intervention n=1022 Participants Post-intervention population is Flint stroke patients between October 2017 and March 2020.
Customized Race/Ethnicity of Flint Patients Who Presented With Stroke or TIA Pre- and Post- Intervention Black	1233 patients (not participants in workshops)	514 patients (not participants in workshops)
Customized Race/Ethnicity of Flint Patients Who Presented With Stroke or TIA Pre- and Post- Intervention Other race and ethnicity	1072 patients (not participants in workshops)	508 patients (not participants in workshops)

Adverse Events

Stroke Ready Community Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

University of Michigan

Phone: 734-615-2766

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place