title: Rationale and design of a cluster-randomized multifaceted intervention trial to improve stroke care quality in China: The GOLDEN BRIDGE-Acute Ischemic Stroke.
abstract: BACKGROUND
  Prior studies have demonstrated a significant gap between guideline-based recommendations and clinical practice in the management of acute ischemic stroke (AIS) in China.
  
  
  OBJECTIVE
  This study implements a targeted multifaceted quality improvement intervention in AIS patients and identifies the feasibility and efficacy of this intervention.
  
  
  METHODS
  This 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.
  
  
  CONCLUSIONS
  If 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.
authors.affiliation: 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.
authors.forename: Yilong
authors.initials: Y
authors.lastname: Wang
authors.affiliation: 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.
authors.forename: Zixiao
authors.initials: Z
authors.lastname: Li
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
authors.forename: Ying
authors.initials: Y
authors.lastname: Xian
authors.affiliation: China National Clinical Research Center for Neurological Diseases, Beijing, China; Vascular Neurology, Department of Neurology, Beijing TianTan Hospital, Capital Medical University, Beijing, China.
authors.forename: Xingquan
authors.initials: X
authors.lastname: Zhao
authors.affiliation: 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.
authors.forename: Hao
authors.initials: H
authors.lastname: Li
authors.affiliation: Department of Statistics & Operations Research, University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Haipeng
authors.initials: H
authors.lastname: Shen
authors.affiliation: China National Clinical Research Center for Neurological Diseases, Beijing, China; Vascular Neurology, Department of Neurology, Beijing TianTan Hospital, Capital Medical University, Beijing, China.
authors.forename: Chunxue
authors.initials: C
authors.lastname: Wang
authors.affiliation: China National Clinical Research Center for Neurological Diseases, Beijing, China; Neuro-intensive Care Unit, Department of Neurology, Beijing TianTan Hospital, Capital Medical University, Beijing, China.
authors.forename: Liping
authors.initials: L
authors.lastname: Liu
authors.affiliation: Tiantan Clinical Trial and Research Center for Stroke, Department of Neurology, Beijing TianTan Hospital, Capital Medical University, Beijing, China; Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.
authors.forename: Chunjuan
authors.initials: C
authors.lastname: Wang
authors.affiliation: Tiantan Clinical Trial and Research Center for Stroke, Department of Neurology, Beijing TianTan Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease, Beijing, China.
authors.forename: Yuesong
authors.initials: Y
authors.lastname: Pan
authors.affiliation: Illinois Neurological Institute Stroke Network, Sisters of the Third Order of St Francis Healthcare System, University of Illinois College of Medicine, Peoria, IL.
authors.forename: David
authors.initials: D
authors.lastname: Wang
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC; Duke University School of Nursing, Duke University, Durham, NC.
authors.forename: Janet
authors.initials: J
authors.lastname: Prvu Bettger
authors.affiliation: Ronald Reagan-UCLA Medical Center, Los Angeles, CA.
authors.forename: Gregg C
authors.initials: GC
authors.lastname: Fonarow
authors.affiliation: Massachusetts General Hospital, Boston, MA.
authors.forename: Lee H
authors.initials: LH
authors.lastname: Schwamm
authors.affiliation: Center for Cardiovascular Science and Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Sidney C
authors.initials: SC
authors.lastname: Smith
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.affiliation: 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; Vascular Neurology, Department of Neurology, Beijing TianTan Hospital, Capital Medical University, Beijing, China. Electronic address: yongjunwang1962@gmail.com.
authors.forename: Yongjun
authors.initials: Y
authors.lastname: Wang
mesh_terms: D002545:Brain Ischemia / Q000628:therapy*; D002681:China; D002985:Clinical Protocols; D019091:Critical Pathways; D006761:Hospitals / Q000592:standards*; D006801:Humans; D010348:Patient Care Team; D058996:Quality Improvement / Q000458:organization & administration*; D020521:Stroke / Q000628:therapy*