Objective: To assess the optimal content and contextual parameters, based on patient and physician input, of the informed consent process for tPA in acute ischemic stroke patients.
Background: Consent-related delays may contribute to worse outcomes, as any delay in tPA eligible patients is associated with worse outcomes. Informed consent, an under-studied barrier to timely tPA delivery, potentially delays or results in a refusal of therapy in up to 20% of eligible patients.
Methods: A mixed-methods qualitative study identified patient and caregiver information expectations and physician preferences in describing risks and benefits of tPA during acute stroke patient evaluations. Through interviews of stroke patients and caregivers who provided informed consent for tPA, and of neurologists and emergency medicine physicians, several themes were identified. These themes as well as strategies to standardize the informed consent process were further explored with mixed focus groups of stroke patients who received tPA, stroke patients who did not receive tPA, and caregivers.
Results: Interviewed stroke patients or their surrogates (n=15) who provided informed consent preferred a shared decision-making model of informed consent while recognizing the time urgency of tPA therapy. Interviewed physicians (n=9) expressed a desire to include patients or their surrogates in decision-making and stressed the importance of describing tPA risks, such as intracerebral hemorrhage. Stroke patients and caregivers (n=22) participating in focus groups (n=4) expressed varying information expectations. The majority of focus group participants expressed minimal information needs and preferred a verbal description of risks and benefits as compared with detailed pictographs. A minority desired a greater amount of information regarding the risk, benefits, and indication for tPA when deciding upon treatment.
Conclusions: Qualitative analyses of informed consent for tPA suggest that a standardized shared decision-making model which includes descriptions of risks could be developed to meet patient expectations and physician preferences. Optimizing the shared decision-making process for tPA could reduce consent-related delays and refusals of tPA.