George Institute for Global Health at Peking University Health Science Center, Beijing, China.
Peking University Clinical Research Institute, Beijing, China.
JAMA Cardiol. 2019 May 1;4(5):418-427. doi: 10.1001/jamacardio.2019.0897.
Prior observational studies suggest that quality of care improvement (QCI) initiatives can improve the clinical outcomes of acute coronary syndrome (ACS). To our knowledge, this has never been demonstrated in a well-powered randomized clinical trial.
To determine whether a clinical pathway-based, multifaceted QCI intervention could improve clinical outcomes among patients with ACS in resource-constrained hospitals in China.
DESIGN, SETTING, PARTICIPANTS: This large, stepped-wedge cluster randomized clinical trial was conducted in nonpercutaneous coronary intervention hospitals across China and included all patients older than 18 years and with a final diagnosis of ACS who were recruited consecutively between October 2011 and December 2014. We excluded patients who died before or within 10 minutes of hospital arrival. We recruited 5768 and 0 eligible patients for the control and intervention groups, respectively, in step 1, 4326 and 1365 in step 2, 3278 and 3059 in step 3, 1419 and 4468 in step 4, and 0 and 5645 in step 5.
The intervention included establishing a QCI team, training clinical staff, implementing ACS clinical pathways, sequential site performance assessment and feedback, online technical support, and patient education. The usual care was the control that was compared.
The primary outcome was the incidence of in-hospital major adverse cardiovascular events (MACE), comprising all-cause mortality, reinfarction/myocardial infarction, and nonfatal stroke. Secondary outcomes included 16 key performance indicators (KPIs) and the composite score developed from these KPIs.
Of 29 346 patients (17 639 men [61%]; mean [SD] age for control, 64.1 [11.6] years; mean [SD] age for intervention, 63.9 [11.7] years) who were recruited from 101 hospitals, 14 809 (50.5%) were in the control period and 14 537 (49.5%) were in the intervention period. There was no significant difference in the incidence of in-hospital MACE between the intervention and control periods after adjusting for cluster and time effects (3.9% vs 4.4%; odds ratio, 0.93; 95% CI, 0.75-1.15; P = .52). The intervention showed a significant improvement in the composite KPI score (mean [SD], 0.69 [0.22] vs 0.61 [0.23]; P < .01) and in 7 individual KPIs, including the early use of antiplatelet therapy and the use of appropriate secondary prevention medicines at discharge. No unexpected adverse events were reported.
Among resource-constrained Chinese hospitals, introducing a multifaceted QCI intervention had no significant effect on in-hospital MACE, although it improved a few of the care process indicators of evidence-based ACS management.
ClinicalTrials.gov identifier: NCT01398228.
先前的观察性研究表明，质量改进（QCI）计划可以改善急性冠状动脉综合征（ACS）的临床结果。据我们所知，这在一项强有力的随机临床试验中从未得到过证明。
确定基于临床路径的多方面 QCI 干预是否可以改善中国资源有限的医院中 ACS 患者的临床结果。
设计、设置、参与者：这项大型、分阶段楔形集群随机临床试验在中国的非经皮冠状动脉介入治疗医院进行，纳入了所有年龄大于 18 岁、最终诊断为 ACS 且连续招募的患者2011 年 10 月至 2014 年 12 月。我们排除了在到达医院之前或 10 分钟内死亡的患者。在第 1 步中，我们分别招募了 5768 和 0 名合格患者作为对照组和干预组，在第 2 步中分别招募了 4326 和 1365 名患者，在第 3 步中分别招募了 3278 和 3059 名患者，在第 4 步中分别招募了 1419 和 4468 名患者，在第 5 步中分别招募了 0 和 5645 名患者。
干预措施包括成立 QCI 团队、培训临床工作人员、实施 ACS 临床路径、连续现场绩效评估和反馈、在线技术支持和患者教育。对照组为常规护理。
主要结果是院内主要不良心血管事件（MACE）的发生率，包括全因死亡率、再梗死/心肌梗死和非致命性卒中。次要结果包括 16 个关键绩效指标（KPI）和由这些 KPI 组成的综合评分。
在 101 家医院招募的 29346 名患者（17639 名男性[61%]；对照组的平均[标准差]年龄为 64.1[11.6]岁，干预组的平均[标准差]年龄为 63.9[11.7]岁）中，有 14809 名（50.5%）患者处于对照组，14537 名（49.5%）患者处于干预组。在调整聚类和时间效应后，干预组与对照组院内 MACE 的发生率无显著差异（3.9%比 4.4%；优势比，0.93；95%置信区间，0.75-1.15；P = .52）。干预组在复合 KPI 评分（平均[标准差]，0.69[0.22]比 0.61[0.23]；P < .01）和 7 个单独的 KPI 方面均有显著改善，包括早期使用抗血小板治疗和出院时使用适当的二级预防药物。未报告任何意外不良事件。
在中国资源有限的医院中，引入多方面的 QCI 干预措施对院内 MACE 没有显著影响，但改善了一些基于证据的 ACS 管理的护理过程指标。
ClinicalTrials.gov 标识符：NCT01398228。
