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| ID | Type | Description | Link |
|---|---|---|---|
| U01MD010579 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stroke Ready | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion criteria:Adult stroke patients who presented to one of three hospitals in the Flint community.
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| Name | Affiliation | Role |
|---|---|---|
| Lesli Skolarus, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flint Community | Flint | Michigan | 48502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33238728 | Derived | 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. | |
| 30845958 | Derived | 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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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Quad 1 intervention 6/1/2018-11/30/2018 |
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| Quad. 2 intervention 12/1/2018-5/31/2019 |
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| Quad.3 intervention 6/1/2019-11/30/2019 |
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| Quad.4 intervention 12/1/2019-8/31/2020 |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stroke Ready Community Intervention Workshop Attendees | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Observational demographic categories were added to the implementation checklists completed by peer educators during the events and workshops to capture participant characteristic information. Demographic categories included: race (primarily black, primarily white, or both black and white); sex (primarily female, primarily male, or both female and male); and age (18-40, 41-64, 65 and over) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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). | Posted | Number | Percent of stroke and TIA patients | 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). |
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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.
Reporting serious adverse events (SAEs) are based on the guidelines of the International Conference on Harmonization (ICH). Workshop participants were not asked for AE data. Any AE information that participants in the workshops chose to share is reported below. AEs were collected during the time of the workshop and up to 60 minutes after the workshops.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. This multi-level intervention was conducted in Flint, Michigan, an urban, low-income, predominantly Black community. In the community intervention, participants were welcomed to attend 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. Intervention rollout occurred in a step-wedge process, with enrollment targeted in a specific quadrant. Adverse events for the workshops were only measured during the Stroke Ready Intervention. Pre and post the intervention the study had no interaction with participants so adverse events were not monitored. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | University of Michigan | 734-615-2766 | lerusche@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2021 | May 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| COMPLETED | Completed means participants attended the workshops. |
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| NOT COMPLETED |
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| COMPLETED | Completed means participants attended the workshops. |
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| NOT COMPLETED |
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| COMPLETED | Completed means participants were present at the workshops. |
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| NOT COMPLETED |
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264 workshop participants received virtual intervention, from whom no demographic data other than US location was collected. |
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | Observational demographic categories were added to the implementation checklists completed by peer educators during the events and workshops to capture participant characteristic information. Demographic categories included: race (primarily black, primarily white, or both black and white); sex (primarily female, primarily male, or both female and male); and age (18-40, 41-64,65 and over) | 264 workshop participants received virtual intervention, from whom no demographic data other than US location was collected. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Observational demographic categories were added to the implementation checklists completed by peer educators during the events and workshops to capture participant characteristic information. Demographic categories included: race (primarily black, primarily white, or both black and white); sex (primarily female, primarily male, or both female and male); and age (18-40, 41-64, 65 and over). | 264 participants were not in person attendees, but received training online - and race data was not collected from them. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG000 |
| Flint Stroke and TIA Patients Before Initiation of Stroke Ready Intervention |
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. |
| OG001 | Flint Stroke and TIA Patients After Initiation of Stroke Ready Intervention | Post-intervention population is Flint stroke patients between October 2017 and March 2020. |
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| Secondary | 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 | 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). | Posted | Number | Percent of stroke and TIA patients | 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. |
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| Post-Hoc | Age of Patients With Stroke or TIA From Retrospective Data Pull for the Genesee County Hospitals | 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. | Note: the population analyzed here is not participants in workshops (the intervention), but county-wide patients whose data was collected retrospectively. | Posted | Mean | Standard Deviation | years | 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). |
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| Post-Hoc | Sex of Flint Stroke and TIA Patients | The data source to identify sex was the electronic medical record and administrative data from all Genesee County hospitals. | Posted | Number | patients (not participants in workshops) | 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. |
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| Post-Hoc | Customized Race/Ethnicity of Flint Patients Who Presented With Stroke or TIA Pre- and Post- Intervention | Retrospective data analysis of Genesee county stroke and TIA patients' race | Posted | Number | patients (not participants in workshops) | From July 2010 through September 2017, and from October 2017 through March 2020. |
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| 0 |
| 5,970 |
| 0 |
| 5,970 |
| 0 |
| 5,970 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |