Introduction: The New York State Department of Health (NYS DOH) began designation of Stroke Centers in 2004. Investigators sought to ascertain current informed consent procedures in the 0-3 hour and 3-4.5 hour treatment windows.
Hypothesis: There is an association between IV tPA informed consent practices and hospital demographics among NYS DOH Stroke Centers across treatment windows.
Methods: Hospitals were sent a 13-question on-line survey to determine whether written, verbal or no consent was required within the 0-3 hour and 3-4.5 hour treatment windows. Surveys were conducted in August and September of 2014. Hospital size, academic vs. non-academic and authorizers of consent were obtained. Chi-square tests were used to assess possible association between demographic measures and whether or not consent was required in either treatment window.
Results: One hundred and eleven of the 117 Stroke Centers responded (95%). Within the 3-hour treatment window, 28% required written consent compared to 54% that required verbal approval. In the 3-4.5 hour treatment window, 97 (87%) used IV tPA with 59% requiring written consent, compared to 33% requiring verbal discussion only. Combining both treatment windows, 98% accepted a health care proxy or surrogate to give consent in lieu of the patient. Among hospitals with fewer than 500 beds, 86% (70/81) did require some form of written or verbal consent within the 3-hour treatment window, compared to only 70% (21/30) of hospitals with 500+ beds (p < 0.05). Beyond the 3-hour treatment window, there was no significant association between bed size and consent requirement. Fifty five percent of hospitals were academic vs. 45% non-academic. Academic status was not related to form of consent during either time window.
Conclusions: The majority of hospitals did not require written consent within the 3-hour treatment window, but did require written consent for the 3-4.5 hour treatment window (2-fold increase in latter window). Smaller hospitals were significantly more likely than larger hospitals to require any form of consent in the 0-3 hour window. Further research should be conducted to determine whether this variability in consent for IV tPA affects clinical outcomes, which may in turn impact health policy and practice.