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Completed

NCT Number: NCT02301299

Community Engagement for Early Recognition and Immediate Action in Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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

  • 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;
  • 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
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community-based Stroke Awareness Program

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.

Other names: Community Stroke Promoter Program

Primary outcomes

  1. Early Arrival After Stroke Onset

    Time frame: 5 years; January 2013 to December 2017

    Early hospital arrival was defined as the proportion of stroke patients arriving within three hours from symptom onset to intervention hospital. When symptom onset time was unknown or missing, last well-known time was used as symptom onset time. When both symptom onset time and last well-known time were unknown or missing, that admission was treated as late arrival.

  2. Emergency Medical Services (EMS) Utilization for Stroke

    Time frame: 5 years; January 2013 to December 2017

    Emergency medical services (EMS) utilization (%) was defined as the proportion of stroke patients arriving to the emergency department by EMS, as opposed to private transport/taxi/other from home/scene. Admissions with Chicago Fire Department (CFD) record confirmed EMS arrival were considered as EMS arrival. All others were considered as non-EMS arrival. The effect size is measures a change in slope: percent of participants per month.

Secondary outcomes

  1. Change in Knowledge and Self-efficacy

    Time frame: 12 months

    Specified outcomes were 1) knowledge and attitudes and 2) self-efficacy. The standardized test for assessing knowledge and behavioral intent will be the Stroke Action Test, a validated assessment tool to assess emergency responses to various stroke and non-stroke scenarios. STAT has excellent reliability and takes, on average, 5 minutes to complete. Scores range from 0-100% and are the average correct responses for each of 28 items in the STAT questionnaire. For self-efficacy, we will use the Likert scale ranging from 1 (strongly agree) to 4 (strongly disagree) on the following questions based on a previous study: "1. I would not be able to tell if someone is having a stroke; and 2. If I saw someone having a stroke, I would not know what to do." Scores range from 2-8 units on the scale. For STAT, higher values indicate better outcome while for self-efficacy, lower values indicate better outcome.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: CEERIAS

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Nov 25, 2014
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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