Michael I Weintraub1, Anna D Colello2, Samantha A Johnson3, Fabienne McClellan4, Steven P Cole5, Curtis Benesch6, Steven H Rudolph7, Steven R Levine8. 1. Department of Neurology, New York Medical College, Valhalla, New York. Electronic address: miwneuro@gmail.com. 2. Stroke and Cardiac Services, New York State Department of Health, Albany, New York. 3. Quality and Systems Improvement, American Heart Association/American Stroke Association, Robbinsville, New Jersey. 4. Performance Improvement and Patient Safety, University North Carolina Hospitals, Chapel Hill, North Carolina. 5. Research Design Associates, Yorktown Heights, New York. 6. Department of Neurology, University Rochester School of Medicine, Rochester, New York. 7. Department of Neurology, Maimonides Medical Center, Brooklyn, New York. 8. Department of Neurology, SUNY Downstate Medical Center and Kings County Medical Center, Brooklyn, New York.
Abstract
OBJECTIVE: Our objective was to assess informed consent procedures for intravenous tissue plasminogen activator in acute stroke among New York State (NYS) Department of Health (DOH) designated stroke centers. METHODS: A 13-question survey stratified by 0- to 3-hour and 3.0- to 4.5-hour treatment windows was used to determine the type of consent or if no consent was required. RESULTS: Of the 117 hospitals, 111 responded (95%). All 111 hospitals provided treatment within the 3-hour window, whereas 97 (87%) provided treatment beyond the 3-hour window (P < .001). For hospitals that did provide treatment, there was a difference between the percentages of hospitals requiring consent (verbal or written) within 3 hours (82%) and beyond 3 hours (92%) (P = .04). Of the hospitals requiring consent, there was a difference in the type of consent: 31 of 91 (34%) required written consent within the 3-hour window, whereas 57 of 89 (64%) required written consent beyond the 3-hour window (P < .001). Within both treatment windows, 98% accepted a health-care proxy or surrogate in lieu of the patient. Of the hospitals with less than 500 beds, 11 of 81 (14%) did not require consent within the 3-hour treatment window, compared to hospitals with 500 or more beds where 9 of 30 (30%) did not require consent within the 3-hour treatment window (P < .05). Beyond the 3-hour treatment window, hospitals with more than 500 beds required written consent-2-fold increase "compared to less than 3 hour window" (P < .05). Fifty-five percent of the hospitals were academic, whereas 45% were nonacademic. Academic status was not related to the type of consent in either window. CONCLUSIONS: Significant variability exists in the types of informed consent based on hospital bed size and treatment windows across NYS DOH designated stroke centers.
OBJECTIVE: Our objective was to assess informed consent procedures for intravenous tissue plasminogen activator in acute stroke among New York State (NYS) Department of Health (DOH) designated stroke centers. METHODS: A 13-question survey stratified by 0- to 3-hour and 3.0- to 4.5-hour treatment windows was used to determine the type of consent or if no consent was required. RESULTS: Of the 117 hospitals, 111 responded (95%). All 111 hospitals provided treatment within the 3-hour window, whereas 97 (87%) provided treatment beyond the 3-hour window (P < .001). For hospitals that did provide treatment, there was a difference between the percentages of hospitals requiring consent (verbal or written) within 3 hours (82%) and beyond 3 hours (92%) (P = .04). Of the hospitals requiring consent, there was a difference in the type of consent: 31 of 91 (34%) required written consent within the 3-hour window, whereas 57 of 89 (64%) required written consent beyond the 3-hour window (P < .001). Within both treatment windows, 98% accepted a health-care proxy or surrogate in lieu of the patient. Of the hospitals with less than 500 beds, 11 of 81 (14%) did not require consent within the 3-hour treatment window, compared to hospitals with 500 or more beds where 9 of 30 (30%) did not require consent within the 3-hour treatment window (P < .05). Beyond the 3-hour treatment window, hospitals with more than 500 beds required written consent-2-fold increase "compared to less than 3 hour window" (P < .05). Fifty-five percent of the hospitals were academic, whereas 45% were nonacademic. Academic status was not related to the type of consent in either window. CONCLUSIONS: Significant variability exists in the types of informed consent based on hospital bed size and treatment windows across NYS DOH designated stroke centers.