Hanzhang Xu1, Deidre Anne De Silva2, Fung Peng Woon3, Marcus Eng Hock Ong4, David B Matchar5, Janet Prvu Bettger6, Daniel T Laskowitz7, Ying Xian8. 1. Department of Family Medicine and Community Health, Duke University School of Medicine, 2200 West Main Street, Office 624, 27705 Durham, NC, USA; Duke University School of Nursing, Durham, NC, USA. Electronic address: hanzhang.xu@duke.com. 2. Department of Neurology, National Neuroscience Institute, Singapore General Hospital, Singapore. Electronic address: deidre.desilva@singhealth.com.sg. 3. Department of Neurology, National Neuroscience Institute, Singapore General Hospital, Singapore. Electronic address: woon.fung.peng@singhealth.com.sg. 4. Department of Emergency Medicine, Singapore General Hospital, Singapore; Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore. Electronic address: marcus.ong.e.h@singhealth.com.sg. 5. Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore; Department of Medicine (General Internal Medicine), Duke University School of Medicine, Durham, NC, USA. Electronic address: david.matchar@duke-nus.edu.sg. 6. Duke-Margolis Center for Health Policy, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University, Durham, NC, USA. Electronic address: janet.bettger@duke.edu. 7. Duke Clinical Research Institute, Duke University, Durham, NC, USA; Department of Neurology, Duke University School of Medicine, Durham, NC, USA. Electronic address: daniel.laskowitz@duke.edu. 8. Duke Clinical Research Institute, Duke University, Durham, NC, USA; Department of Neurology, Duke University School of Medicine, Durham, NC, USA. Electronic address: ying.xian@duke.edu.
Abstract
OBJECTIVES: The efficacy of thrombolytic therapy with tissue plasminogen activator (tPA) is highly time dependent. Although clinical guidelines do not recommend written informed consent as it may cause treatment delays, local policy can supersede and require it. From 2014 to 2017, three out of five public hospitals in Singapore changed from written to verbal consent at different time points. We aimed to examine the association of hospital policy changes regarding informed consent on door-to-needle (DTN) times. MATERIALS AND METHODS: Using data from the Singapore Stroke Registry and surveys of local practice, we analyzed data of 915 acute ischemic stroke patients treated with tPA within 3 hours in all public hospitals between July 2014 to Dec 2017. Patient-level DTN times before and after policy changes were examined while adjusting for clinical characteristics, within-hospital clustering, and trends over time. RESULTS: Patient characteristics and stroke severity were similar before and after the policy changes. Overall, the median DTN times decreased from 68 to 53 minutes after the policy changes. After risk adjustment, changing from written to verbal informed consent was associated with a 5.6 minutes reduction (95% CI 1.1-10.0) in DTN times. After the policy changed, the percentage of patients with DTN ≤60 minutes and ≤45 minutes increased from 35.6% to 66.1% (adjusted OR 1.75; 95% CI 1.12-2.74) and 9.3% to 36.0% (adjusted OR 2.42; 95% CI 1.37-4.25), respectively. CONCLUSION: Changing from written to verbal consent is associated with significant improvement in the timeliness of tPA administration in acute ischemic stroke.
OBJECTIVES: The efficacy of thrombolytic therapy with tissue plasminogen activator (tPA) is highly time dependent. Although clinical guidelines do not recommend written informed consent as it may cause treatment delays, local policy can supersede and require it. From 2014 to 2017, three out of five public hospitals in Singapore changed from written to verbal consent at different time points. We aimed to examine the association of hospital policy changes regarding informed consent on door-to-needle (DTN) times. MATERIALS AND METHODS: Using data from the Singapore Stroke Registry and surveys of local practice, we analyzed data of 915 acute ischemic strokepatients treated with tPA within 3 hours in all public hospitals between July 2014 to Dec 2017. Patient-level DTN times before and after policy changes were examined while adjusting for clinical characteristics, within-hospital clustering, and trends over time. RESULTS:Patient characteristics and stroke severity were similar before and after the policy changes. Overall, the median DTN times decreased from 68 to 53 minutes after the policy changes. After risk adjustment, changing from written to verbal informed consent was associated with a 5.6 minutes reduction (95% CI 1.1-10.0) in DTN times. After the policy changed, the percentage of patients with DTN ≤60 minutes and ≤45 minutes increased from 35.6% to 66.1% (adjusted OR 1.75; 95% CI 1.12-2.74) and 9.3% to 36.0% (adjusted OR 2.42; 95% CI 1.37-4.25), respectively. CONCLUSION: Changing from written to verbal consent is associated with significant improvement in the timeliness of tPA administration in acute ischemic stroke.