Community Engagement for Early Recognition and Immediate Action in Stroke

NCT ID: NCT02301299

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1322 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2019-06-30

Brief Summary

The investigators plan to develop and adapt a community-partnered intervention using community health promoters ("Stroke Promoters") to deliver messaging regarding stroke symptom awareness and the need for calling 911 after stroke onset. The study investigators will implement this intervention in south side Chicago communities and measure the impact on symptom onset to hospital arrival times and EMS utilization using an interrupted time-series analysis.

Detailed Description

The CEERIAS community-partnered research project has the following specific aims:

1. To examine personal, community, and cultural barriers to calling 911 after stroke onset and adapt a culturally-tailored intervention for delivery in multi-ethnic communities (African American, Hispanic, non-Hispanic White) surrounding a hospital on the south side of Chicago;

2. To implement a culturally-adapted stroke awareness and action program and monitor its penetration and adoption using the RE-AIM (Reach, Evaluate, Adoption, Implementation, Maintenance) framework in multi-ethnic communities on the south side of Chicago; and

3. To assess change in early hospital arrival and EMS use at a intervention hospital before and after the community intervention.

For aim 1, the investigators will explore and identify facilitators and barriers to calling 911 for stroke through focus groups conducted and involving key stakeholders including children and adults, stroke survivors, neighborhood alderman/legislators, spiritual and community leaders, school teachers, and stroke advocacy group members. The CEERIAS team will test and culturally refine our core community-partnered pilot intervention for implementation.

For aim 2, the investigators will identify and train Stroke Promoters from collaborating community organizations on the adapted intervention techniques and messages, provide materials for public dissemination, and evaluate and monitor adoption and implementation in the surrounding communities.

For aim 3, the investigators will perform an interrupted time-series analysis of EMS use and early hospital arrival among stroke patients before and after our intervention in south side Chicago communities. The research team will also compare time trends in EMS use and early hospital arrival for stroke with concurrent control PSCs on the north side of Chicago and PSCs in St. Louis.

If the intervention is successful, the effect will be an increase in EMS use for stroke which will translate into earlier treatment for stroke and reduced death and disability. The CEERIAS results will be generalizable to other urban communities in the US and should be salient to other health emergencies such as heart attack and cardiac arrest.

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Community-based Stroke Awareness Program

Neighborhoods in the south side of Chicago surrounding a primary stroke center hospital will be targeted for a community-partnered stroke awareness and action educational campaign. To assess the effectiveness of this intervention, the investigators will monitor early hospital arrival and EMS use for stroke over a 60-month period comparing performance at the primary stroke center hospital using an interrupted time-series analysis.

Community-based Stroke Awareness Program

Intervention Type: BEHAVIORAL

A culturally-adapted stroke awareness and action program will be delivered by trained Stroke Promoters in the targeted neighborhoods in the south side of Chicago. Community Stroke Promoters will be trained on 1) the benefits of early recognition and EMS utilization for stroke (i.e. stroke centers, tPA), 2) culturally-adapted solutions to current barriers (i.e. misperceptions about vulnerability, severity, mistrust, costs), and 3) cues to aid in stroke recognition and immediate action. The intervention will take place at community settings throughout a 1-year period.

Interventions

Community-based Stroke Awareness Program

A culturally-adapted stroke awareness and action program will be delivered by trained Stroke Promoters in the targeted neighborhoods in the south side of Chicago. Community Stroke Promoters will be trained on 1) the benefits of early recognition and EMS utilization for stroke (i.e. stroke centers, tPA), 2) culturally-adapted solutions to current barriers (i.e. misperceptions about vulnerability, severity, mistrust, costs), and 3) cues to aid in stroke recognition and immediate action. The intervention will take place at community settings throughout a 1-year period.

Intervention Type: BEHAVIORAL

Other Intervention Names

Community Stroke Promoter Program

Eligibility Criteria

Inclusion Criteria

• Adults 18 years of age or older
• Hispanic, African American, or Caucasian/White
• Reside within the following Chicago Zip Codes: 60617, 60619, 60620, 60621, 60628, 60629, 06032, 60639, or 60649

Exclusion Criteria

• < 18 years old
• Ethnic groups outside our targeted population
• Outside targeted catchment area

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Shyam Prabhakaran

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shyam Prabhakaran, MD MS

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Neelum T Aggarwal, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Knitasha Washington, DHA FACHE

Role: PRINCIPAL_INVESTIGATOR

Washington Howard and Associates

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

References

Prabhakaran S, Richards CT, Kwon S, Wymore E, Song S, Eisenstein A, Brown J, Kandula NR, Mason M, Beckstrom H, Washington KV, Aggarwal NT. A Community-Engaged Stroke Preparedness Intervention in Chicago. J Am Heart Assoc. 2020 Sep 15;9(18):e016344. doi: 10.1161/JAHA.120.016344. Epub 2020 Sep 6.

Reference Type: DERIVED

PMID: 32893720 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU00102919

Identifier Type: -

Identifier Source: org_study_id