Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Community Engagement for Early Recognition and Immediate Action in Stroke (CEERIAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02301299
Recruitment Status : Completed
First Posted : November 25, 2014
Results First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Shyam Prabhakaran, Northwestern University

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.

Condition or disease Intervention/treatment
Ischemic Stroke Behavioral: Community-based Stroke Awareness Program

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.


Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 1322 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 60 Months
Official Title: Community Engagement for Early Recognition and Immediate Action in Stroke
Actual Study Start Date : October 2014
Actual Primary Completion Date : May 2018
Actual Study Completion Date : June 30, 2019

Group/Cohort Intervention/treatment
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.
Behavioral: 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.
Other Name: Community Stroke Promoter Program




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301299


Locations
Layout table for location information
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Patient-Centered Outcomes Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Shyam Prabhakaran, MD MS Northwestern University
Principal Investigator: Neelum T Aggarwal, MD Rush University Medical Center
Principal Investigator: Knitasha Washington, DHA FACHE Washington Howard and Associates
  Study Documents (Full-Text)

Documents provided by Shyam Prabhakaran, Northwestern University:

Layout table for additonal information
Responsible Party: Shyam Prabhakaran, Professor of Neurology, Northwestern University
ClinicalTrials.gov Identifier: NCT02301299     History of Changes
Other Study ID Numbers: STU00102919
First Posted: November 25, 2014    Key Record Dates
Results First Posted: September 9, 2019
Last Update Posted: September 9, 2019
Last Verified: July 2019
Keywords provided by Shyam Prabhakaran, Northwestern University:
stroke
barriers
community
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases