Development of a Patient-Centered Enhanced Protocol for Informed Consent in Acute Stroke

Stroke is a leading cause of death and disability in the United States and disproportionately affects minorities. Though acute time-sensitive treatments for stroke exist, racial and ethnic disparities have been observed in all aspects of stroke including acute treatment. For example, African-Americans (AA) are more likely to die and be disabled after stroke and half as likely to receive tPA compared to non-Hispanic whites. In the United States, 40,000 patients per year require acute stroke interventions. This number will double or triple as more stroke patients are treated with newly proven endovascular reperfusion therapy (ERT) and as regional stroke systems emphasize routing of eligible patients to designated comprehensive stroke centers. The benefits of acute stroke interventions on patient outcomes is extremely time-dependent and time lost leads to more disability. National guidelines recommend that hospitals complete the clinical and imaging evaluation of an acute ischemic stroke patient and administer intravenous tissue plasminogen activator (tPA) within 60 minutes of an eligible patient’s arrival, also known as door-to-needle (DTN) time, and ERT therapy within 90 minutes of arrival. Our preliminary data suggest that 1) informed consent is a barrier to timely, acute stroke treatment, by causing a delay or resulting in refusal of treatment in approximately 25-33% of tPA-eligible stroke patients and 2) minorities are more likely than whites to experience consent-related failures. The proposed study seeks to improve the informed consent process for acute stroke interventions by assessing the optimal content and contextual parameters, detailing and quantifying the latent failures, constraints, and challenges in the informed consent process, steps that will enable us to redesign a patient-centered, culturally-sensitive, informed consent protocol for acute stroke interventions and reduce disparities in acute stroke treatment. The proposed study will address social determinants of consenting for stroke interventions and ultimately provide direction to healthcare providers about optimizing the consent process. Leveraging the existing PCORI-funded project assessing disparities in awareness and activation of 9-1-1 after stroke in Chicago (CEERIAS; PI Prabhakaran PCORI-AD-1310-07237), the proposed study will recruit community, lay persons including patients and caregivers and key informants (i.e., community leaders) from previously identified Chicago neighborhoods where stroke incidence and mortality is high and target 3 race-ethnic groups (non-Hispanic whites, non-Hispanic blacks, and Hispanics). We are requesting $25,603 to complete our two aims using a mixed methods approach: Aim 1 will assess the barriers and facilitators to obtaining informed consent for acute stroke interventions by conducting focus groups among key informants, patients, and caregivers; and Aim 2 will develop a novel, enhanced protocol for informed consent for stroke interventions (EPIC-SI) with iterative input from community stakeholders including key informants, patients, and caregivers. For the City of Chicago, the development of a patient-centered informed consent protocol for acute stroke interventions will accomplish 3 goals: (1) improve patient and family satisfaction and enhance healthcare trust; (2) increase the number of eligible patients from underserved communities who consent to stroke interventions; (3) reduce delays in DTN time (goal < 45 minutes); and, thereby 4) reduce race-ethnic disparities in stroke outcomes.