Abstract TP287: Informed Consent for IV tPA in New York State Designated Stroke Centers: A Current Snapshot
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.
Author Disclosures: M.I. Weintraub: None. A.D. Colello: None. S.A. Johnson: Employment; Modest; Currently employed at the AHA ASA. F. McClellan: Employment; Modest; Previously employed at the AHA ASA.. S.P. Cole: None. C. Benesch: None. S.H. Rudolph: None. S.R. Levine: None.
- © 2016 by American Heart Association, Inc.