Clinical trial NCT02301299: Community Engagement for Early Recognition and Immediate Action in Stroke
Official title: Community Engagement for Early Recognition and Immediate Action in Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: stroke
barriers
community
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-11-25
Enrollment: 1322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ischemic stroke patients arriving to the emergency department of a neighborhood primary stroke center in the south side of Chicago who are \> 18 years of age.

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.

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

Primary outcomes:
measure: Early Arrival After Stroke Onset
timeFrame: 5 years; January 2013 to December 2017
measure: Emergency Medical Services (EMS) Utilization for Stroke
timeFrame: 5 years; January 2013 to December 2017
Secondary outcomes:
measure: Change in Knowledge and Self-efficacy
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Shyam Prabhakaran, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Neelum T Aggarwal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington Howard and Associates
name: Knitasha Washington, DHA FACHE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.