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Community Engagement for Early Recognition and Immediate Action in Stroke

Community Engagement for Early Recognition and Immediate Action in Stroke

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02301299
Acronym
CEERIAS
Enrollment
1322
Registered
2014-11-25
Start date
2014-10-31
Completion date
2019-06-30
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

stroke, barriers, community

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.

Interventions

BEHAVIORALCommunity-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.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Northwestern University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Early Arrival After Stroke Onset5 years; January 2013 to December 2017Early 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.
Emergency Medical Services (EMS) Utilization for Stroke5 years; January 2013 to December 2017Emergency 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

MeasureTime frameDescription
Change in Knowledge and Self-efficacy12 monthsSpecified 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention Hospital
Neighborhoods in the south side of Chicago surrounding the primary intervention stroke center hospital was targeted for a community-partnered stroke awareness and action educational campaign. To assess the effectiveness of this intervention, the investigators monitored early hospital arrival and EMS use for stroke over a 60-month period at the primary intervention stroke center hospitals using an interrupted time-series analysis.
1,322
Total1,322

Baseline characteristics

CharacteristicIntervention Hospital
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
772 Participants
Age, Categorical
Between 18 and 65 years
550 Participants
EMS arrival771 Participants
Race/Ethnicity, Customized
Hispanic
87 participants
Race/Ethnicity, Customized
Non-Hispanic Black
1176 participants
Race/Ethnicity, Customized
Non-Hispanic White
43 participants
Race/Ethnicity, Customized
Other
16 participants
Region of Enrollment
United States
1322 participants
Sex: Female, Male
Female
571 Participants
Sex: Female, Male
Male
751 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Early Arrival After Stroke Onset

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.

Time frame: 5 years; January 2013 to December 2017

Population: The intervention hospital is located on the south side of Chicago, within the target community intervention area. Age range of patients was 19 to 103; a majority of the patients were African-Americans, approximately half were 66 years or older and female.

ArmMeasureValue (NUMBER)
Intervention HospitalEarly Arrival After Stroke Onset0.5 change in percent early arrival/month
Comparison: The effect size was defined as the sum of expected slope change in monthly early hospital arrival rate over the standard deviation. Assuming an autocorrelation level of 0.3, both level and trend change effect size of 0.5 would be detectable at 90% power at a significance level of 0.05.p-value: <0.0001Regression, Linear
Primary

Emergency Medical Services (EMS) Utilization for Stroke

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.

Time frame: 5 years; January 2013 to December 2017

Population: Trinity hospital is located on the south side of Chicago, within the intervention areas. Age range of patients was 19 to 103; approximately a half of the patients were 66 years or older and female. A majority of the patients were non-Hispanic Blacks.

ArmMeasureValue (NUMBER)
Intervention HospitalEmergency Medical Services (EMS) Utilization for Stroke-0.8 change in percent EMS arrival/month
Comparison: The effect size was defined as the sum of expected slope change in monthly EMS use rate over the standard deviation. Assuming an autocorrelation level of 0.3, both level and trend change effect size of 0.5 would be detectable at 90% power at a significance level of 0.05. The effect size is measured in slope of change over time (negative values indicate a decrease while positive values indicate an increase in % EMS use/month).p-value: <0.0001Regression, Linear
Secondary

Change in Knowledge and Self-efficacy

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.

Time frame: 12 months

Population: We sampled residents from the target neighborhoods and comparison neighborhoods before and after the intervention using a standardized set of questions assessing knowledge, self-efficacy, and trust.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention HospitalChange in Knowledge and Self-efficacySTAT score49 score on a scaleStandard Deviation 18
Intervention HospitalChange in Knowledge and Self-efficacySelf-efficacy score4.5 score on a scaleStandard Deviation 1.6
Post-interventionChange in Knowledge and Self-efficacySTAT score51 score on a scaleStandard Deviation 17
Post-interventionChange in Knowledge and Self-efficacySelf-efficacy score2.9 score on a scaleStandard Deviation 1.5

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026