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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Northwestern University
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Shyam Prabhakaran, Northwestern University
ClinicalTrials.gov Identifier:
NCT02301299
First received: November 21, 2014
Last updated: September 27, 2016
Last verified: September 2016
  Purpose
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 2 large 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 Intervention
Ischemic Stroke
Behavioral: Community-based Stroke Awareness Program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Community Engagement for Early Recognition and Immediate Action in Stroke

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Early arrival after stroke onset [ Time Frame: 12 months ]
    Early hospital arrival will be defined as the proportion of stroke patients arriving within 3 hours from symptom onset to the 2 targeted primary stroke center hospitals

  • Emergency medical services (EMS) utilization for stroke [ Time Frame: 12 months ]
    Emergency medical services (EMS) utilization (%) will be defined as the proportion of stroke patients arriving to the emergency department by EMS


Secondary Outcome Measures:
  • Knowledge, self-efficacy, and perceptions [ Time Frame: 12 months ]
    Change in stroke knowledge, self-efficacy, and perceptions in sample of residents living in the targeted neighborhoods


Estimated Enrollment: 1000
Study Start Date: October 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Community-based Stroke Awareness Program
Neighborhoods in the south side of Chicago surrounding 2 primary stroke center hospitals 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 at the 2 primary stroke center hospitals 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

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 2 hospitals 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 2 multi-ethnic communities on the south side of Chicago; and
  3. To assess change in early hospital arrival and EMS use at 2 intervention hospitals 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 2 south side Chicago communities. The research team will also compare time trends in EMS use and early hospital arrival for stroke with control PSCs on the north and west sides 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02301299

Contacts
Contact: Shyam Prabhakaran, MD MS 312-503-2994 sprabhak@nm.org
Contact: Erin Wymore, BA MS 312-503-3243 erin.wymore@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Erin Wymore, BA MS    312-503-3243    erin.wymore@northwestern.edu   
Contact: Shyam Prabhakaran, MD MS    312-503-2994    sprabhak@nm.org   
Sponsors and Collaborators
Northwestern University
Patient-Centered Outcomes Research Institute
Investigators
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
  More Information

Responsible Party: Shyam Prabhakaran, Professor of Neurology, Northwestern University
ClinicalTrials.gov Identifier: NCT02301299     History of Changes
Other Study ID Numbers: STU00102919
Study First Received: November 21, 2014
Last Updated: September 27, 2016

Keywords provided by Northwestern University:
stroke
barriers
community

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2017