Development of SCRIPtS: Standardized Consent Redesign and Implementation Protocol for tPA in Stroke

Northwestern University At Chicago, Evanston IL

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Abstract

Project Summary In the United States annually, nearly 800,000 patients experience a stroke, which remains a leading cause of disability and the fifth leading cause of death. Tissue-type plasminogen activator (tPA), delivered intravenously, is the only proven, evidence-based medication for acute ischemic stroke (AIS). The benefits of tPA on AIS patient outcomes is extremely time-dependent within a narrow 4.5-hour window. Every 10-minute delay in receiving tPA can result in more brain damage and greater disability. National guidelines recommend that hospitals complete the clinical and imaging evaluation of an eligible AIS patient and administer tPA within 60 minutes of a patient's arrival in the emergency department (ED), also known as door-to-needle (DTN) time. Our preliminary data from hospital-based registries and physician surveys suggest that (1) obtaining informed consent causes delays or results in refusal of AIS therapies in approximately 8-21% of eligible patients; (2) despite endorsing the need for informed consent, most acute stroke care clinicians do not receive any formal training in how to obtain informed consent for AIS therapies; and (3) stark differences in clinician preferences exist: emergency medicine physicians and those at non-academic medical centers require informed consent for tPA more often than neurologists and clinicians at academic medical centers. Since the majority of stroke patients are treated by emergency medicine physicians and at non-academic medical centers, improving the informed consent process for tPA is imperative to reducing the time to treatment and reducing refusal of tPA for AIS patients. The proposed two-year F32 Fellowship research study would accomplish the following aims: (1) develop a standardized user-centered informed consent guide that balances patient/caregiver expectation and physician preferences, (2) analyze the acute stroke code work flow to identify the opportunities for systems and processes of care redesigns to effectively integrate a new informed consent process, and (3) assess the feasibility of a Standardized Consent Redesign and Implementation Protocol for tPA in Stroke (SCRIPtS). The project will build upon completed pilot studies that have identified the facilitators and barriers to informed consent for tPA from the perspective of both patients and clinicians. In total, the proposed research study will develop, optimize integration, and then test SCRIPtS for feasibility in an iterative manner that will standardize, streamline, and refine the informed consent process for tPA. The SCRIPtS intervention and data from the proposed research study will be used to apply for independent (R) awards to test the effectiveness of SCRIPtS in a multi-hospital cluster randomized trial.