Objective: To describe consent-related failures in patients eligible for tissue plasminogen activator (tPA) and to assess if race-ethnic disparities exist in the informed consent process for intravenous tPA for acute ischemic stroke (AIS) at primary stroke centers (PSCs) in Chicago, Illinois.
Background: Disparities in stroke care include observed differences in stroke incidence, severity, mortality, acute management, and rehabilitation. There are no data regarding race-ethnic disparities in informed consent for tPA.
Methods: A retrospective analysis of stroke admissions using the Get With The Guidelines (GWTG) Stroke registry of 15 PSCs in the city of Chicago between January 2013 and June 2015. We analyzed the proportion of consent-related failures (delay or refusal) among tPA-eligible patients who were treated > 60 minutes from arrival or did not receive tPA, overall and stratified by race.
Results: There were 1,029 (39.1% white, mean age 65.1 years) tPA-eligible patients presenting through emergency departments at the 15 PSCs. Among these, 324 (31.5%) received tPA 60 minutes, and 569 (55.3%) did not receive tPA. Of those with delayed or no treatment (n=705), 72 (10.2%) experienced consent-related failures. There was a trend toward higher rates of consent-related failures in non-whites vs. whites (12.1% vs. 7.4%; p=0.056).
Conclusions: At Chicago’s PSCs, consent-related delay or refusal of consent occurs in at least 7% of tPA-eligible patients. Furthermore, non-whites may be more likely to experience consent-related failures than whites. Consent-related delays, as with any treatment delay in tPA eligible patients, may result in worse outcomes. Further research should focus on barriers to informed consent in stroke thrombolysis, specifically addressing potential race-ethnic disparities in the informed consent process.