NCT03645590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,970

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

March 23, 2017

Results QC Date

May 10, 2024

Last Update Submit

April 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (1)

  • 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.

Study Arms (1)

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.

Behavioral: Stroke Ready

Interventions

Stroke ReadyBEHAVIORAL

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.

Stroke Ready Community intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Flint Community

Flint, Michigan, 48502, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Principal Investigator
Organization
University of Michigan

Study Officials

  • Lesli Skolarus, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

March 23, 2017

First Posted

August 24, 2018

Study Start

June 20, 2018

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

May 1, 2026

Results First Posted

May 1, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations