Trial Outcomes & Findings for Community Engagement for Early Recognition and Immediate Action in Stroke (NCT NCT02301299)

Last Updated: 2019-09-09

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1322 participants

Primary outcome timeframe

5 years; January 2013 to December 2017

Results posted on

2019-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	1322
Overall Study COMPLETED	1322
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Community Engagement for Early Recognition and Immediate Action in Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Hospital n=1322 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	550 Participants n=5 Participants
Age, Categorical >=65 years	772 Participants n=5 Participants
Sex: Female, Male Female	571 Participants n=5 Participants
Sex: Female, Male Male	751 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	87 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	1176 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	43 participants n=5 Participants
Race/Ethnicity, Customized Other	16 participants n=5 Participants
Region of Enrollment United States	1322 participants n=5 Participants
EMS arrival	771 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Hospital n=1322 Participants Analysis goal: to examine the impact of the CEERIAS intervention (December 2015-March 2016) on early arrival (≤3 hours) among ischemic stroke patients.	Post-intervention Post-intervention survey group
Early Arrival After Stroke Onset	0.5 change in percent early arrival/month	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention Hospital n=1322 Participants Analysis goal: to examine the impact of the CEERIAS intervention (December 2015-March 2016) on early arrival (≤3 hours) among ischemic stroke patients.	Post-intervention Post-intervention survey group
Emergency Medical Services (EMS) Utilization for Stroke	-0.8 change in percent EMS arrival/month	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention Hospital n=364 Participants Analysis goal: to examine the impact of the CEERIAS intervention (December 2015-March 2016) on early arrival (≤3 hours) among ischemic stroke patients.	Post-intervention n=363 Participants Post-intervention survey group
Change in Knowledge and Self-efficacy STAT score	49 score on a scale Standard Deviation 18	51 score on a scale Standard Deviation 17
Change in Knowledge and Self-efficacy Self-efficacy score	4.5 score on a scale Standard Deviation 1.6	2.9 score on a scale Standard Deviation 1.5

Adverse Events

Community-based Stroke Awareness Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Erin Wymore

Northwestern University

Phone: 3125033243

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place