Clinical Pathways for the Management of Acute Coronary Syndromes - Phase 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29,934
- 试验地点
- 102
- 主要终点
- incidence rate of in-hospital major adverse cardiovascular events (MACE)
研究概览
简要总结
The burden of chronic, non-communicable disease, of which cardiovascular disease comprises a significant component, has increased rapidly and substantially in China over recent years. Over the coming decades China is predicted to experience a 69% increase in acute coronary disease(ACS), amounting to nearly 8 million additional events. A recent randomized trial of more than 15,000 patients with acute coronary syndromes, the second phase of Clinical Pathway for acute coronary syndromes in China (CPACS-2) study, showed that a quality improvement initiative could improve aspects of hospital care, including the proportion of patients discharged on appropriate medication. The study also identified a number of barriers to improved care including out of pocket costs and administration systems. However, the study was not able to determine the impact on clinical outcomes or the cost-effectiveness of the intervention. The aim of the third phase of the Clinical Pathway for acute coronary syndromes in China (CPACS-3) study is to determine whether a complex intervention comprising a clinical pathway for ACS management in combination with a number of physician and patient-oriented education tools can improve the quality of care and health outcomes among ACS patient admitted to resource-limited (provincial) hospitals. The effectiveness of the intervention will be evaluated using a cluster randomized trial (stepped wedge design) of ACS patients admitted to 104 hospitals in China. The study will incorporate two additional components (1) a qualitative substudy to identify the barriers and enablers to improved care and (2) a study comparing the cost-effectiveness of the intervention compared to usual care, from the perspective of the health care provider. The study will be conducted in conjunction with the Chinese Ministry of Health and the Chinese Society of Cardiology. The findings from CPACS3 will be able to inform health policy-makers about the extent to which quality improvement initiatives can reduce the risk of death and disability among the millions of ACS patients admitted to hospitals in China each year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admitted to participating hospitals
- •diagnosed as Acute Coronary Syndromes(ACS) at the time of death or discharge
- •aged 18 years or older
排除标准
- •death happened within 10 mins after arriving hospital
- •ACS happened during hospitalization due to other health problem
- •patients already registered in the database
结局指标
主要结局
incidence rate of in-hospital major adverse cardiovascular events (MACE)
时间窗: from hospitaliztion to 1 week after discharge
In-hospital major adverse cardiovascular events (MACE) comprising all-cause mortality, myocardial infarction or recurrent myocardial infarction and non-fatal stroke.The in-hospital mortality will include patients who deid during hospitalization, patients who gave up treatment and home and die within 1 week after returning home, and patients transfer to superior hospitals but die within one day.
次要结局
- in-hospital all cause deaths(from hospitaliztion to 1 week after discharge)
- a patient level composite score calculated by KPIs of ACS care(During Hospitalization, an expected average of 10 days)
- each of the 16 KPIs (patient level)(During hospitalization, an expected average of 10 days)
- a composite of MACE and re-hospitalization due to cardiovascular disease within 6 months after discharge(in 6 months after discharge)
研究者
Yangfeng Wu
senior director
The George Institute for Global Health, China