Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The CEERIAS community-partnered research project has the following specific aims:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years; January 2013 to December 2017 |
| 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. | 5 years; January 2013 to December 2017 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32893720 | Derived | Prabhakaran S, Richards CT, Kwon S, Wymore E, Song S, Eisenstein A, Brown J, Kandula NR, Mason M, Beckstrom H, Washington KV, Aggarwal NT. A Community-Engaged Stroke Preparedness Intervention in Chicago. J Am Heart Assoc. 2020 Sep 15;9(18):e016344. doi: 10.1161/JAHA.120.016344. Epub 2020 Sep 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 hospital using an interrupted time-series analysis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | change in percent early arrival/month | 5 years; January 2013 to December 2017 |
|
There are no adverse events to report over the entire study period.
There are no adverse events to report over the entire study period. This was not a trial and did not include an intervention at the individual patient level.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. They will be trained on 1) benefits of early recognition and EMS utilization for stroke (ie stroke centers, tPA) 2) culturally-adapted solutions to current barriers (ie 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Wymore | Northwestern University | 3125033243 | erin.wymore@northwestern.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2016 | May 29, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 12 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| EMS arrival | Count of Participants | Participants |
|
|
|
|
| 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. | 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. | Posted | Number | change in percent EMS arrival/month | 5 years; January 2013 to December 2017 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Using SAS PROC TIMESERIES, individual admission data were aggregated into monthly time series data to calculate a monthly EMS arrival rate. In this procedure, we also generated seasonally adjusted time series data to take into account a seasonal pattern. Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG. The statistical hypothesis of the regression model was that there are a level change and a slope change after the intervention. In the regression model, we included a time variable to account for a natural trend prior to the intervention introduction (or in absence of the intervention). We assumed that the patient population was stable during the five-year period and no other factors than the intervention affected the outcome; no other potential confounding factors were not considered. A backward elimination was used to correct for autocorrelation. Maximum likelihood method was used to estimate parameters. |