Changes in Informed Consent Policy and Treatment Delays in Stroke Thrombolysis.

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.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1016/j.jstrokecerebrovasdis.2020.105551

Publication Info

Xu, Hanzhang, Deidre Anne De Silva, Fung Peng Woon, Marcus Eng Hock Ong, David B Matchar, Janet Prvu Bettger, Daniel T Laskowitz, Ying Xian, et al. (2020). Changes in Informed Consent Policy and Treatment Delays in Stroke Thrombolysis. Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association, 30(3). p. 105551. 10.1016/j.jstrokecerebrovasdis.2020.105551 Retrieved from https://hdl.handle.net/10161/22765.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Xu

Hanzhang Xu

Associate Professor in the School of Nursing

Areas of Expertise:

Global Health; Social Determinants of Health; Cardiovascular Disease; Alzheimer's Disease and Related Dementias; and Population Aging

Matchar

David Bruce Matchar

Professor of Medicine

My research relates to clinical practice improvement - from the development of clinical policies to their implementation in real world clinical settings. Most recently my major content focus has been cerebrovascular disease. Other major clinical areas in which I work include the range of disabling neurological conditions, cardiovascular disease, and cancer prevention.
Notable features of my work are: (1) reliance on analytic strategies such as meta-analysis, simulation, decision analysis and cost-effectiveness analysis; (2) a balancing of methodological rigor the needs of medical professionals; and (3) dependence on interdisciplinary groups of experts.
This approach is best illustrated by the Stroke Prevention Patient Outcome Research Team (PORT), for which I served as principal investigator. Funded by the AHCPR, the PORT involved 35 investigators at 13 institutions. The Stroke PORT has been highly productive and has led to a stroke prevention project funded as a public/private partnership by the AHCPR and DuPont Pharma, the Managing Anticoagulation Services Trial (MAST). MAST is a practice improvement trial in 6 managed care organizations, focussing on optimizing anticoagulation for individuals with atrial fibrillation.
I serve as consultant in the general area of analytic strategies for clinical policy development, as well as for specific projects related to stroke (e.g., acute stroke treatment, management of atrial fibrillation, and use of carotid endarterectomy.) I have worked with AHCPR (now AHRQ), ACP, AHA, AAN, Robert Wood Johnson Foundation, NSA, WHO, and several pharmaceutical companies.
Key Words: clinical policy, disease management, stroke, decision analysis, clinical guidelines

Bettger

Janet Prvu Bettger

Adjunct Associate in the Department of Orthopaedic Surgery

Dr. Bettger’s research is dedicated to establishing real world evidence aimed to improve health care quality and policies that reduce the burden of disease and disability. As a health services researcher and implementation scientist, her research extends from observational studies to randomized and pragmatic trials. She was the Founding Director of Duke Roybal Center for Translational Research in the Behavioral and Social Sciences of Aging and the Founding Director of Undergraduate Initiatives for the Duke-Margolis Center for Health Policy. She has examined implementation of several integrated care models to improve the transition home from the hospital (VERITAS with virtual exercise therapy after knee replacement, COMPASS for stroke, RECOVER for stroke in rural China, and coordinated care for trauma patients in Tanzania). She also studies implementation of community-based models of care that can prevent functional decline. These include the CTSA-funded IMPAC RCT of integrating physical therapists into primary care as first line providers to address musculoskeletal pain, the VA-funded Gerofit program of structured and progressive in-person and virtual group exercise for older Veterans, MRC-funded SINEMA RCT of a village-based model supporting stroke recovery in China, and a NIDCD study comparing three primary care protocols for older adult hearing healthcare.

In addition to the evidence translation studies in China (RECOVER and SINEMA) and Tanzania, she has partnered with experts in Singapore on stroke systems research, and worked on large cluster randomized trials to improve evidence-based care in Brazil, Peru, Argentina (BRIDGE-Stroke) and China (CNSR and Golden Bridge). To address health locally, she was the faculty sponsor to launch Exercise is Medicine at Duke and Help Desk, a student volunteer community resource navigator model addressing social determinants of health.

Dr. Bettger received her BA from the University of Western Ontario, Canada and her MS from the University of Wisconsin–LaCrosse where she studied community reintegration for stroke and brain-injured patients transitioning from hospital to home. Her doctoral training in Rehabilitation Sciences, completed at Boston University, concluded with an investigation of patterns of functional recovery and factors affecting outcomes in patients transitioning home following acute rehabilitation. While working on her doctorate, she also worked in state government as the director of the Paul Coverdell National Acute Stroke Registry. Dr. Bettger completed post-doctoral training at the University of Pennsylvania with a NIH NRSA research fellowship in neurorehabilitation, a research fellowship at the NewCourtland Center for Transitions and Health, and a Switzer Fellowship funded by the National Institute on Disability and Rehabilitation Research to study the role of the environment on functional outcomes. She completed additional research training at Duke as a mentored scholar in comparative effectiveness research funded by AHRQ. As of July 2022, she is an Adjunct Associate Professor for Duke's Department of Orthopaedics and has transitioned out of her role as Co-Director of the Duke Clinical and Translational Institute (CTSA) Pilots Accelerator Core working with NCCU. She is affiliate faculty with Duke's Science and Society, Duke-Margolis Center for Health Policy, the Duke Clinical Research Institute (DCRI) and Duke Global Health Institute (DGHI), is a Senior Fellow of the Duke Center for the Study of Aging and Human Development, and is a Fellow of the American Heart Association. 

Laskowitz

Daniel Todd Laskowitz

Professor of Neurology

Our laboratory uses molecular biology, cell culture, and animal modeling techniques to examine the CNS response to acute injury. In particular, our laboratory examines the role of microglial activation and the endogenous CNS inflammatory response in exacerbating secondary injury following acute brain insult. Much of the in vitro work in this laboratory is dedicated to elucidating cellular responses to injury with the ultimate goal of exploring new therapeutic interventions in the clinical setting of stroke, intracranial hemorrhage, and closed head injury.

In conjunction with the Multidisciplinary Neuroprotection Laboratories, we also focus on clinically relevant small animal models of acute CNS injury. For example, we have recently characterized murine models of closed head injury, subarachnoid hemorrhage, intracranial hemorrhage and perinatal hypoxia-ischemia, in addition to the standard rodent models of focal stroke and transient forebrain ischemia. Recently we have adapted several of these models from the rat to the mouse to take advantage of murine transgenic technology. The objective of these studies are two-fold: to gain better insight into the cellular responses and pathophysiology of acute brain injury, and to test novel therapeutic strategies for clinical translation. In both cell culture systems and animal models, our primary focus is on examining the role of oxidative stress and inflammatory mechanism in mediating brain injury following acute brain insult, and examining the neuroprotective effects of endogenous apolipoprotein E in the injured mammalian central nervous system.

Our laboratory is committed to translational research, and has several active clinical research protocols, which are designed to bring the research performed in the Multidisciplinary Research Laboratories to the clinical arena. These protocols are centered around patients following stroke and acute brain injury, and are primarily based out of the Emergency Room and Neurocritical Care Unit. For example, we are currently examining the role of inflammatory mediators for use as a point-of-care diagnostic marker following stroke, intracranial hemorrhage, and closed head injury. We have recently translated a novel apoE mimetic from the preclinical setting to a multi center Phase 2 trial evaluating efficacy in intracranial hemorrhage. We are also examining the functional role of different polymorphisms of of inflammatory cytokines in the setting of acute brain injury and neurological dysfunction following cardiopulmonary bypass.


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