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American heart journal · Jun 2015
Randomized Controlled Trial Multicenter StudyRationale and design of a cluster-randomized multifaceted intervention trial to improve stroke care quality in China: The GOLDEN BRIDGE-Acute Ischemic Stroke.
- Yilong Wang, Zixiao Li, Ying Xian, Xingquan Zhao, Hao Li, Haipeng Shen, Chunxue Wang, Liping Liu, Chunjuan Wang, Yuesong Pan, David Wang, Prvu BettgerJanetJDuke Clinical Research Institute, Duke University Medical Center, Durham, NC; Duke University School of Nursing, Duke University, Durham, NC., Gregg C Fonarow, Lee H Schwamm, Sidney C Smith, Eric D Peterson, Yongjun Wang, and GOLDEN BRIDGE–AIS investigators.
- Tiantan Clinical Trial and Research Center for Stroke, Department of Neurology, Beijing TianTan Hospital, Capital Medical University, Beijing, China; China National Clinical Research Center for Neurological Diseases, Beijing, China.
- Am. Heart J. 2015 Jun 1; 169 (6): 767-774.e2.
BackgroundPrior studies have demonstrated a significant gap between guideline-based recommendations and clinical practice in the management of acute ischemic stroke (AIS) in China.AimsThis study implements a targeted multifaceted quality improvement intervention in AIS patients and identifies the feasibility and efficacy of this intervention.DesignThis is a multicenter, 2-arm, open-label, cluster-randomized trial involving 40 clusters (hospitals) from China National Network of Stroke Research. Hospitals are randomized to receive a targeted multifaceted quality improvement intervention (experimental group) or routine standard of care (control group). The multifaceted intervention includes an evidence-based clinical pathway, written care protocols, a quality coordinator, and a monitoring and feedback system of performance measures. The number of enrolled patients in the trial will be 4,800. Primary outcome is the measure of the adherence to AIS evidence-based performance measures including the composite measure (defined as the total number of interventions performed among eligible patients divided by the total number of possible interventions among eligible patients) and the all-or-none measure (defined as the proportion of eligible patients who receive all of the performance measure interventions for which they are eligible). Secondary patient outcomes include inhospital death; a new vascular event; disability; and all-cause death at 3, 6, and 12 months after initial symptom onset. All analyses will be performed according to the intention-to-treatment principle and accounted for clustering using generalized estimating equations.ConclusionsIf proven effective, this targeted multifaceted intervention model will be extended nationwide as a model to bridge the evidence-based gap in the AIS management in China.Copyright © 2015 Elsevier Inc. All rights reserved.
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