Clinical trial NCT00724555: Acute Stroke Program of Interventions Addressing Racial and Ethnic Disparities
Official title: Acute Stroke Program of Interventions Addressing Racial and Ethnic Disparities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke
tissue plasminogen activator
tPA
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Medstar Health Research Institute
name: Howard University
name: George Washington University
name: University of Michigan
name: University of Wisconsin, Madison
name: Johns Hopkins University
name: University of Alabama at Birmingham
name: MedStar Good Samaritan Hospital
name: Union Memorial Hospital
First posted: 2008-07-29
Enrollment: 2005
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult residents of the District of Columbia

Brief summary: The purpose of this study is to increase treatment of acute stroke with tissue plasminogen activator (tPA) across the District of Columbia. This study, however, will not evaluate tPA as an intervention.

Detailed description: There are a number of well-known barriers to receiving tissue plasminogen activator (tPA) including transit time to hospital, paramedic and provider training, tPA standing orders, and provider guidelines. Among underserved populations, limited stroke knowledge, socioculturally determined attitudes, and beliefs and myths held by community members may serve as additional barriers that hinder these populations from receiving tPA and acute stroke care. Targeted multilevel interventions designed to overcome specific barriers may significantly increase the number of individuals with stroke who are appropriately treated with intravenous tPA (IV tPA) in underserved communities. Identification of the specific components of healthcare interventions that are the most effective is critical to improve delivery of acute stroke therapy.

The goal of this study is to learn more about public knowledge, attitudes, beliefs and perceptions regarding stroke and stroke treatment in order to identify sociocultural and environmental barriers to receiving tPA and acute stroke care in an underserved community. This study will also determine if implementation of a multilevel intervention program can significantly increase the number of people with ischemic stroke who are appropriately treated with IV tPA in a predominantly underserved community.

In the study, researchers will evaluate the different levels of the intervention to determine which efforts are most effective.

Eligibility criteria: Inclusion Criteria:

* diagnosis of acute ischemic stroke
* over the age of 18

Exclusion Criteria:

-

Primary outcomes:
measure: The proportion of people with ischemic stroke appropriately treated with IV tPA.
timeFrame: 4 years
Secondary outcomes:
measure: Qualitative data collected from the community will identify baseline levels of knowledge, attitudes, and perceived and encountered barriers to acute stroke treatment.
timeFrame: 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University, ASPIRE Coordinating Center
state: District of Columbia
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Washington
country: United States
facility: Providence Hospital
state: District of Columbia
city: Washington
country: United States
facility: United Medical Center (formerly known as Greater Southeast Community Hospital)
state: District of Columbia
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Washington
country: United States
facility: Howard University Hospital
state: District of Columbia
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Georgetown University
name: Chelsea Kidwell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boden-Albala B, Edwards DF, St Clair S, Wing JJ, Fernandez S, Gibbons MC, Hsia AW, Morgenstern LB, Kidwell CS. Methodology for a community-based stroke preparedness intervention: the Acute Stroke Program of Interventions Addressing Racial and Ethnic Disparities Study. Stroke. 2014 Jul;45(7):2047-52. doi: 10.1161/STROKEAHA.113.003502. Epub 2014 May 15.