Stroke, AcuteNCT03645590
Stroke Ready - Optimizing Acute Stroke Care
A study testing Stroke Ready in people with Stroke, Acute and Stroke, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute, Stroke
- What is being tested?
- Stroke Ready
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,970 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2018to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion criteria:Adult stroke patients who presented to one of three hospitals in the Flint community.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Stroke, Acute, Stroke
- Being tested
- Stroke Ready
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke ReadyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Ready Community intervention | Experimental | 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. Receives: Behavioral: Stroke Ready |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Secondary outcomes (1)
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start20 Jun 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Stroke Ready is a pre-post design. Outcome measures are pre-intervention and post-intervention assessments of thrombolytic utilization among stroke and TIA patients (not workshop participants) across the entire city of Flint, Michigan.
- Masking
- None (open label)
- Enrolment
- 5,970 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Lesli Skolarus, University of Michigan
- Investigators
- Lesli Skolarus, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645590
- Sponsor's protocol ID
- U01MD010579
- Other IDs
- U01MD010579
- Status last verified
- Feb 2026
- First submitted
- 23 Mar 2017
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33238728Skolarus 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.
PubMed 30845958
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Ready - Optimizing Acute Stroke Care
- ClinicalTrials.gov ID
- NCT03645590
- Acronym / sponsor ID
- U01MD010579
- Conditions
- Stroke, Acute, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,970 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stroke Ready is a pre-post design. Outcome measures are pre-intervention and post-intervention assessments of thrombolytic utilization among stroke and TIA patients (not workshop participants) across the entire city of Flint, Michigan.
| Arm | Type | Receives |
|---|---|---|
| Stroke Ready Community intervention | Experimental | Behavioral: Stroke ReadyWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stroke ReadyStroke 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. | Behavioural | Stroke Ready Community intervention |
Primary outcome
Utilization of Thrombolysis Among Ischemic Stroke and Transient Ischemic Attack (TIA) Patients
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).
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.
1 secondary outcome
Percent of Stroke and TIA Patients Who Arrive to the Emergency Department by Ambulance
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33238728Robles 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.
- Derived from this study: PubMed 30845958Skolarus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesli Skolarus, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stroke Ready in people with Stroke, Acute and Stroke, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilization of Thrombolysis Among Ischemic Stroke and Transient Ischemic Attack (TIA) Patients (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03645590, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.