Cluster‐Randomized Trial of Thrombolysis Implementation Support in Metropolitan and Regional Australian Stroke Centers: Lessons for Individual and Systems Behavior Change
Year: 2020
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background Intravenous thrombolytic therapy ( IVT ) with tissue plasminogen activator for acute ischemic stroke is underutilized in many parts of the world. Randomized trials to test the effectiveness of thrombolysis implementation strategies are limited. Methods and Results This study aimed to test the effectiveness of a multicomponent, multidisciplinary tissue plasminogen activator implementation package in increasing the proportion of thrombolyzed cases while maintaining accepted benchmarks for low rates of intracranial hemorrhage and high rates of functional outcomes at 3 months. A cluster randomized controlled trial of 20 hospitals in the early stages of thrombolysis implementation across 3 Australian states was undertaken. Monitoring of IVT rates during the baseline period allowed hospitals (the unit of randomization) to be grouped into 3 baseline IVT strata—very low rates (0% to ≤4.0%); low rates (>4.0% to ≤10.0%); and moderate rates (>10.0%). Hospitals were randomized to an implementation package (experimental group) or usual care (control group) using a 1:1 ratio. The 16‐month intervention was based on behavioral theory and analysis of the steps, roles, and barriers to rapid assessment for thrombolysis eligibility and involved comprehensive strategies addressing individual and system‐level change. The primary outcome was the difference in tissue plasminogen activator proportions between the 2 groups postintervention. The absolute difference in postintervention IVT rates between intervention and control hospitals adjusted for baseline IVT rate and stratum was not significant (primary outcome rate difference=1.1% (95% CI −1.5% to 3.7%; P =0.38). Rates of intracranial hemorrhage remained below international benchmarks. Conclusions The implementation package resulted in no significant change in tissue plasminogen activator implementation, suggesting that ongoing support is needed to sustain initial modifications in behavior. Clinical Trial Registration URL : www.anzctr.org.au Unique identifiers: ACTRN 12613000939796 and U1111‐1145‐6762
Authors: Christopher R. Levi, John A. Attia, Cate D'Este, Annika E. Ryan, Frans Henskens, Erin Kerr, Mark W. Parsons, Robert W. Sanson‐Fisher, Christopher F. Bladin, Richard I. Lindley, Sandy Middleton, Christine L. Paul, Craig Anderson, Tim Ang, Andrew Bivard, Greg Cadigan, Sherisse Celestino, Tim Coles, Alistair Corbett, Lisa Dark, Susan Day, Jennifer Dennett, Geoffrey Donnan, Malcolm Evans, Kavisha Fernando, Richard Geraghty, Richard Gerraty, Alice Grady, Rohan Grimley, Jason Gu, Graeme J. Hankey, Kim Hoffman, James Hughes, Jerome Ip, Bronwyn Jenkins, Mark Jones, Martin Jude, Lara Kaauwai, Malcolm Kanard, Matthew Kinchington, Martin Krause, Sarah Kuhle, Stanley Levy, Mark Longworth, Beverley Macdonald, Elizabeth Mackey, Krishna Mandaleson, Ferdi Miteff, Katherine Mohr, Stephen Moore, Kristy Morris, Elizabeth O'Brien, Christopher Oldmeadow, Bruce Paddock, Kim Parrey, Rachel Peake, Michelle Russell, Margaret Stevenson, Sanjeev Taneja, Natalie Teasdale, Zoe Terpening, Anne Van Berkel, John D. G. Watson, Yolande Weiner, Tissa Wijeratne, Alison Wilson, Nigel Wolfe
Institutions: Hunter Medical Research Institute, Hunter New England Local Health District, University of Newcastle Australia, Australian National University, Monash University, The University of Sydney, The George Institute for Global Health, Nursing Research Institute, Australian Catholic University, Eastern Health
Language: English
Subfield: Clinical Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,750
OpenAlex ID: W3000787136