Alexis Kaiser1, Stephanie Bartlett4, Evan Templeton3, Carl Pafford2, Lynn DCruz5, Veronica Kassab5, Shelley Varner Perez6, Asia Madayag5, Lindsay Martinez4, Amber Comer5
1Neurology, 2Emergency Medicine, Indiana University School of Medicine, 3Indiana University School of Medicine, 4IUPUI, 5Indiana University, 6IU Health
Objective:
To determine patient demographics and clinical characteristics that impact whether consent was documented for administration of thrombolytic therapy for acute ischemic stroke (AIS).
Background:
Thrombolytic therapy is the standard of care in eligible patients presenting with AIS. Physicians are challenged to: 1) identify an AIS; 2) explain thrombolytic therapy; and 3) consent the patient and/or surrogate decision-maker efficiently and effectively. There is no consensus in clinician practice towards obtaining and documenting consent for thrombolytics in AIS.
Design/Methods:
A multicenter mixed-methods cohort study included 442 patients who received thrombolytics for AIS. Demographics, including primary language, were collected from the electronic medical record (EMR). Code status, co-morbid dementia, stroke location, and initial NIHSS were also collected. Chi Square analysis was conducted to determine differences between two cohorts, patients who received thrombolysis and had documented consent and those who did not have documented consent in their EMR. Bivariate and multivariate regression were performed to determine associations with having documented consent. Thematic analysis was conducted on documented conversations to identify themes regarding consent for thrombolytics.
Results:
The minority of patients (28.5%) had documented consent for thrombolysis in their EMR. In multivariate analysis, patients who were older (p<0.001), non-white (p=0.004), primary language other than English (p=0.03), co-morbid dementia (p<0.001), or had a DNR/partial code status (p=0.02) were more likely to have documented consent. Thematic analysis identified themes for documenting consent including risks and benefits, outcomes, and paternalism.
Conclusions:
Documented consent was present in the minority of EMRs for patients treated with thrombolytics for AIS. Documented consent was more prevalent in populations with dementia, older age, primary language other than English, non-white, and code status. Qualitative analysis found effective consent was not documented in most cases. Given variation in consent documentation, it may be beneficial to develop standardized evidence-based language to guide these conversations.