住院期间护理质量改善举措对患者出院后六个月急性冠状动脉综合征二级预防的影响：一项大型阶梯楔形和整群随机对照试验。
Impact of In-Hospital Quality of Care Improvement Initiative on Secondary Prevention of Acute Coronary Syndrome in Six Months After Patient Discharge: A Large Stepped Wedge- and Cluster-Randomized Controlled Trial.
作者信息
Xie Gaoqiang, Patel Anushka, Du Xin, Sun Yihong, Li Xian, Wu Tao, Hao Zhixin, Gao Runlin, Wu Yangfeng
机构信息
Clinical Research Institute, Institute of Advanced Clinical Medicine (G.X., Y.W.), Peking University, Beijing, China.
Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education (G.X., Y.W.), Peking University, Beijing, China.
出版信息
Circ Cardiovasc Qual Outcomes. 2025 May;18(5):e011441. doi: 10.1161/CIRCOUTCOMES.124.011441. Epub 2025 Apr 4.
BACKGROUND
Patients discharged after acute coronary syndrome experience a high risk of major adverse cardiovascular events (MACE) within the first 6 months. We examined whether a quality of care improvement initiative implemented in hospitals affects clinical preventive management and outcomes after discharge.
METHODS
We used data from the third phase of the CPACS-3 study (Clinical Pathways for Acute Coronary Syndromes in China), a large stepped wedge- and cluster-randomized trial conducted from 2011 to 2015, to evaluate the effectiveness of an in-hospital quality of care improvement program on the composite score of preventive medication use and the risk of MACE in 6 months after discharge among acute coronary syndrome survivors. The intervention included establishing a quality of care improvement team, training clinical staff, implementing acute coronary syndrome clinical pathways, performance assessment and feedback, online technical support, and patient education. A total of 101 hospitals were randomized into 4 wedges, and the intervention was initiated randomly by wedge and step. Participants recruited before (control) and after (intervention) the intervention initiation were compared with generalized estimating equations, adjusting for clustering and time trend.
RESULTS
A total of 23 258 patients (11 224 in the intervention group and 12 034 in the control group), with a mean age of 63.6±11.6 years and 39% women, had available follow-up data on MACE and 14 826 patients (6813 in the intervention group and 8013 in the control group) had available data on preventive medication use at 6 months were analyzed. Compared with the control period, the mean preventive medication use score during the intervention period was higher at 6 months (65.8 versus 60.4 for intervention and control periods, adjusted mean difference, 3.7 [95% CI, 0.3-7.0]), but the 6-month incidence of MACE showed no difference (5.8% versus 6.6%, adjusted odds ratio, 1.04 [95% CI, 0.83-1.29]).
CONCLUSIONS
The in-hospital multifaceted quality of care improvement intervention in resource-constrained Chinese hospitals increased preventive medication use among acute coronary syndrome survivors in the 6 months after discharge, but this did not translate into a reduction in MACE.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01398228.
背景
急性冠状动脉综合征患者出院后的头6个月内发生主要不良心血管事件（MACE）的风险很高。我们研究了医院实施的护理质量改进举措是否会影响出院后的临床预防管理和结局。
方法
我们使用了CPACS - 3研究（中国急性冠状动脉综合征临床路径）第三阶段的数据，该研究是一项于2011年至2015年进行的大型阶梯楔形整群随机试验，以评估医院护理质量改进计划对急性冠状动脉综合征幸存者出院后6个月预防用药综合评分和MACE风险的有效性。干预措施包括成立护理质量改进团队、培训临床工作人员、实施急性冠状动脉综合征临床路径、绩效评估与反馈、在线技术支持以及患者教育。总共101家医院被随机分为4个楔形组，干预措施按楔形组和步骤随机启动。使用广义估计方程对干预开始前（对照组）和干预开始后（干预组）招募的参与者进行比较，并对聚类和时间趋势进行调整。
结果
共有23258例患者（干预组11224例，对照组12034例）纳入分析，这些患者的平均年龄为63.6±11.6岁，女性占39%，有关于MACE的可用随访数据，并且有14826例患者（干预组6813例，对照组8013例）有出院后6个月预防用药的可用数据。与对照期相比，干预期6个月时预防用药的平均得分更高（干预期和对照期分别为65.8和60.4，调整后的平均差异为3.7 [95% CI，0.3 - 7.0]），但6个月时MACE的发生率无差异（5.8%对6.6%，调整后的比值比为1.04 [95% CI，0.83 - 1.29]）。
结论
在中国资源有限的医院中实施的院内多方面护理质量改进干预措施增加了急性冠状动脉综合征幸存者出院后6个月的预防用药，但这并未转化为MACE的减少。
注册信息
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