Rationale and design of a cluster-randomized multifaceted intervention trial to improve XXXX care quality in China: The GOLDEN BRIDGE-Acute Ischemic Stroke.

@entity1 @entity64 @entity204
BACKGROUND: Prior studies have demonstrated a significant gap between guideline-based recommendations and clinical practice in the management of @entity64 ( @entity64 ) in China. AIMS: This study implements a targeted multifaceted quality improvement intervention in @entity64 @entity1 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 @entity64 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 @entity1 in the trial will be 4,800. Primary outcome is the measure of the adherence to @entity64 evidence-based performance measures including the composite measure (defined as the total number of interventions performed among eligible @entity1 divided by the total number of possible interventions among eligible @entity1 ) and the all-or-none measure (defined as the proportion of eligible @entity1 who receive all of the performance measure interventions for which they are eligible). Secondary @entity1 outcomes include @entity204 ; a new vascular event; disability; and all-cause @entity204 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 @entity64 management in China.
