Yilong Wang1, Zixiao Li1, Ying Xian2, Xingquan Zhao3, Hao Li1, Haipeng Shen4, Chunxue Wang3, Liping Liu5, Chunjuan Wang6, Yuesong Pan7, David Wang8, Janet Prvu Bettger9, Gregg C Fonarow10, Lee H Schwamm11, Sidney C Smith12, Eric D Peterson2, Yongjun Wang13. 1. 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. 2. Duke Clinical Research Institute, Duke University Medical Center, Durham, NC. 3. China National Clinical Research Center for Neurological Diseases, Beijing, China; Vascular Neurology, Department of Neurology, Beijing TianTan Hospital, Capital Medical University, Beijing, China. 4. Department of Statistics & Operations Research, University of North Carolina at Chapel Hill, Chapel Hill, NC. 5. 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. 6. 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. 7. 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. 8. Illinois Neurological Institute Stroke Network, Sisters of the Third Order of St Francis Healthcare System, University of Illinois College of Medicine, Peoria, IL. 9. Duke Clinical Research Institute, Duke University Medical Center, Durham, NC; Duke University School of Nursing, Duke University, Durham, NC. 10. Ronald Reagan-UCLA Medical Center, Los Angeles, CA. 11. Massachusetts General Hospital, Boston, MA. 12. Center for Cardiovascular Science and Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC. 13. 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.
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. AIMS: This study implements a targeted multifaceted quality improvement intervention in AIS patients and identifies the feasibility and efficacy of this intervention. DESIGN: 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.
RCT Entities:
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. AIMS: This study implements a targeted multifaceted quality improvement intervention in AIS patients and identifies the feasibility and efficacy of this intervention. DESIGN: 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.