Background: Fever is associated with worse outcome after intracerebral hemorrhage (ICH). Autonomic dysfunction, commonly seen after brain injury, results in reduced heart rate variability (HRV). We sought to investigate whether HRV was associated with the development of fever in patients with ICH.

Most clinicians always or often require informed consent for stroke thrombolysis. Future research should focus on standardizing content and delivery of tPA information to reduce delays.

Objective: Based on patient, caregiver, and layperson input, we aimed to identify themes, preferences, content, framing, and sequencing of the informed consent process for tPA in acute ischemic stroke (AIS) patients. Background: Informed consent potentially delays or results in refusal of tPA in up to 10% of eligible AIS patients. There remain critical gaps in the appropriate content, delivery mode, and optimal timing of the informed consent process for tPA. Methods: Using a mixed-methods qualitative approach through separate focus groups of stroke patients and caregivers, and laypeople with limited experience with stroke and from diverse race and ethnic backgrounds, we identified preferences in describing risks and benefits of tPA during AIS patient evaluation. All focus groups followed a structured guide designed to elicit participant feedback regarding (1) decision-making preferences, (2) existing and hypothetical decision aid content, and (3) timing of information delivery for an informed consent process for tPA. Results: Stroke patients (n=15) and their caregivers (n=7) preferred a shared decision-making model that included minimal information and emphasized rapid decision making. Laypeople (n=31) also preferred a shared decision-making model for providing informed consent, but had higher information needs than stroke patients and caregivers. The majority of all focus group participants expressed a preference for a verbal description of risk and benefits. A minority of laypeople desired detailed visual aids to facilitate information exchanged during the informed consent process. The majority of focus group participants preferred stacked bar graphs or pie charts over pictograms to convey information regarding outcomes following tPA. Conclusions: Qualitative analyses of informed consent for tPA suggest that laypeople have higher information needs than stroke patients and caregiver. Given that the majority of patients who receive tPA do not have a history of prior stroke, shared decision-making aids should consider laypeople preferences while remaining brief given the time-sensitivity of tPA therapy. Optimizing the shared decision-making process for tPA could reduce consent-related delays and refusals of tPA.

Introduction: The informed consent process delays or results in a refusal of therapy in up to 10% of eligible patients. Our prior work identified preferences, content, framing, sequencing of the informed consent process for tPA based on patient, physician, caregiver, and layperson input. These data were used by design teams in an iterative process with both patients and clinicians through an AHRQ-funded project to develop patient-facing decision aids ( S tandardized C onsent R edesign and I mplementation P rotocol for t PA in S troke: SCRIPtS). Hypothesis: We hypothesized that the SCRIPtS intervention would improve patient knowledge, and reduce decisional conflict and regret without impacting door to needle (DTN) time. Methods: Patients or their proxies who provided informed consent for tPA at a single academic medical center were approached from July 1, 2017 to June 30, 2019. All neurology residents who obtain informed consent for tPA were trained on the SCRIPtS intervention on July 2, 2018. Prospective data captured included: DTN time and qualitative data in the form of: patient or proxy decisional conflict (6-items) within 48h of tPA treatment, and patient or proxy decision regret (5-items) at 14 days and 90 days post-treatment. Mann-Whitney U and t-test statistics were used to compare pre-intervention (before July 2, 2018) to post-intervention results. Internal consistency of survey responses was measured using Cronbach’s α. Results: During pre-intervention, 32 patients received tPA with a median DTN of 41.7m ( + 8.8). Twenty patients received tPA post-intervention with a median DTN of 48.0m (+/- 16.3, p=0.11). Eight (63% female, 25% black) pre- and 14 (57% female, 36% black) post-SCRIPtS stroke patients or their proxies provided qualitative data. We observed a significant improvement in patient reported understanding of the side effects of tPA post-SCRIPtS (3.25 + 0.54 vs 4.14 + 0.14; p=0.02). There was no difference in measures of decisional conflict or of decision regret between groups (Cronbach’s α = 0.75). Conclusions: The small pilot study suggests that an intervention to improve patient and family understanding of risks and benefits of tPA can be successfully implemented without prolonging DTN time.