Variability in the Perception of Informed Consent for IV-tPA during Telestroke Consultation

Abstract

Objective: To study the perception of informed consent among various raters for thrombolysis in acute ischemic stroke patients receiving intravenous tissue plasminogen activator (IV-tPA). Methods: Twenty randomly selected videotaped telestroke consultations of acute stroke patients administered IV-tPA were retrospectively reviewed. Adequacy of informed consent was reviewed by five raters: a neurologist and emergency physician who routinely treat stroke, a medical risk management paralegal, a bioethicist, and a lay person. Raters assessed the quality of the informed consent presentation by the treating physician and the degree of understanding demonstrated by the patient/family authorizing consent. Factors associated with adequacy of consent were analyzed. Results: Consent was rated as adequately understood by the patient-family in 78.6% cases. Agreement between all five raters with regard to the patient-family understanding of consent was poor and also between the subgroups of non-physician and physician (all k < 0.20). Similarly, the quality of the physician consent process was poor for agreement between all five raters (k = 0.07) or between the subgroup of the three non-physician raters (k = −0.06) and fair between the two physician raters (k = 0.24). The legal reviewer and the bioethicist rated the physician consent process as being of lower quality than did the two physicians and the layperson. Conclusion: Despite high variability in the perception of informed consent among raters in this time-sensitive clinical situation, almost 80% of patients were rated by all reviewers as having adequate understanding of risks and benefits of tPA. This suggests the need for a standardized but brief tPA consent process that includes patient/family demonstration of understanding.

Getting the Gist Across Is Enough for Informed Consent for Acute Stroke Thrombolytics

“…17 Given the extreme time constraints of acute stroke treatment, tPA discussions with patients and families are often short, an average of 2.7 minutes by some estimates, leaving little time for a full discussion of patient values and preferences. 18 Second, these discussions most often occur in the busy resuscitation bays of an Emergency department (ED). This setting is suboptimal for the in-depth, deliberative exploration of a patients' values central to shared decision making due to the fast-paced and chaotic nature of the ED.…”

Telemedicine in pre-hospital care: a review of telemedicine applications in the pre-hospital environment

“…Due to its novel uses, medico-legal concerns have led to questions about the relevance and clarity of communication during informed consent. However, analysis of video-taped telemedicine consultations of acute stroke patients before intravenous administration of tissue plasminogen activator showed that 80% of observers rated informed consent as adequate [[ 23 ]]. Administration of tissue thromboplasminogen activator (tPA) within 3 to 4.5 h [[ 49 ]–[ 51 ]] of an acute ischemic stroke remains the gold standard in its management.…”

Acute Stroke

“…A study of the quality of informed consent during acute telestroke encounters suggests that perceptions of the nature and completeness of informed consent vary substantially according to the perspective of the rater. 4 If we accept that true informed consent is an unlikely outcome in an acute stroke emergency, then, we must consider alternative ethical frameworks for emergency decision making, namely shared decision making, presumed consent, and exception from informed consent.…”