Stroke, Stroke, Acute
Conditions
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.
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.
Interventions
BEHAVIORALStroke 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.
Sponsors
University of Michigan
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Adult stroke patients who presented to one of three hospitals in the Flint community.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Utilization of Thrombolysis Among Ischemic Stroke and Transient Ischemic Attack (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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Stroke and TIA Patients Who Arrive to the Emergency Department by Ambulance | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLesli Skolarus, MD
University of Michigan
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Participants perceived by workshop educators to be 18-40 | 916 Participants |
| Age, Customized Participants perceived by workshop educators to be 41-64 | 3312 Participants |
| Age, Customized Participants perceived by workshop educators to be 65 and over | 1478 Participants |
| Race/Ethnicity, Customized Attendees at workshops where group was perceived by educators to be approximately evenly Black/White | 2620 Participants |
| Race/Ethnicity, Customized Attendees at workshops where group was perceived by educators to be mostly Black | 2066 Participants |
| Race/Ethnicity, Customized Attendees at workshops where group was perceived by educators to be mostly White | 1020 Participants |
| Region of Enrollment United States | 5970 Participants |
| Sex/Gender, Customized Attendees at workshops where group was perceived by educators to be approximately evenly male/female | 4056 Participants |
| Sex/Gender, Customized Attendees at workshops where group was perceived by educators to be mostly female | 1522 Participants |
| Sex/Gender, Customized Attendees at workshops where group was perceived by educators to be mostly male | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5,970 |
| other Total, other adverse events | 0 / 5,970 |
| serious Total, serious adverse events | 0 / 5,970 |
Outcome results
None listed