Clinical Pathways for the Management of Acute Coronary Syndromes - Phase 3,CPACS-3
- Conditions
- Acute Coronary Syndromes
- Interventions
- Behavioral: quality improvement initiatives
- Registration Number
- NCT01398228
- Lead Sponsor
- The George Institute for Global Health, China
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29934
- admitted to participating hospitals
- diagnosed as Acute Coronary Syndromes(ACS) at the time of death or discharge
- aged 18 years or older
- death happened within 10 mins after arriving hospital
- ACS happened during hospitalization due to other health problem
- patients already registered in the database
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 quality improvement initiatives Group 1 will receive quality improvement initiatives first, after 6 months of baseline initiation. Group 2 quality improvement initiatives Group 2 will receive quality improvement initiatives second, after 6 months of the intervention initiation for Group 1. Group 3 quality improvement initiatives Group 3 will receive quality improvement initiatives third, after 6 months of the intervention initiation for Group 2. Group 4 quality improvement initiatives Group 4 will receive quality improvement initiatives forth, after 6 months of the intervention initiation for Group 3.
- Primary Outcome Measures
Name Time Method incidence rate of in-hospital major adverse cardiovascular events (MACE) 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.
- Secondary Outcome Measures
Name Time Method a composite of MACE and re-hospitalization due to cardiovascular disease within 6 months after discharge in 6 months after discharge in-hospital all cause deaths from hospitaliztion to 1 week after discharge 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.
a patient level composite score calculated by KPIs of ACS care During Hospitalization, an expected average of 10 days A patient-level composite score is formed by dividing the total number of 15 pre-defined binary KPIs a patient receives by the total sum of KPIs a patient is eligible to receive. 15 KPI include: receive the first ECG within 10 minutes after arrival, receive aspirin within 24 hours of arrival, receive clopidogrel within 24 hours of arrival, receive statin within 24 hours of arrival, prescribe aspirin at discharge, prescribed clopidogrel at discharge, prescribed beta-blocker at discharge, prescribed statin at discharge, LVSD prescribed ACEI or ARB at discharge, STEMI that arrive hospital within 12 hours of symptom onset receive fibrinolysis, STEMI that received fibrinolytic therapy received this within 30 minutes of arrival, final diagnosis consistent with ECG and biomarker findings, receive both aspirin and clopidogrel within 24 hours, patient receive both aspirin and clopidogrel with loading dose within 24 hours, patient receive statin with loading dose within 24 hours.
each of the 16 KPIs (patient level) During hospitalization, an expected average of 10 days receive the first ECG within 10 minutes after arrival, receive aspirin within 24 hours of arrival, receive clopidogrel within 24 hours of arrival, receive statin within 24 hours of arrival, prescribe aspirin at discharge, prescribed clopidogrel at discharge, prescribed beta-blocker at discharge, prescribed statin at discharge, LVSD prescribed ACEI or ARB at discharge, STEMI that arrive hospital within 12 hours of symptom onset receive fibrinolysis, STEMI that received fibrinolytic therapy received this within 30 minutes of arrival, final diagnosis consistent with ECG and biomarker findings, receive both aspirin and clopidogrel within 24 hours, patient receive both aspirin and clopidogrel with loading dose within 24 hours, patient receive statin with loading dose within 24 hours and length of stay.
Related Research Topics
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Trial Locations
- Locations (102)
Weichang manchu mongolia atounomous county hospital
🇨🇳Chengde, Hebei, China
Zhuanghe central hospital
🇨🇳Dalian, Liaoning, China
Pu xian people's hospital
🇨🇳Linfen, Shanxi, China
Zha lu te people's hospital
🇨🇳Tongliao, Inner Mongolia, China
Linquan people's hospital
🇨🇳Fuyang, Anhui, China
Zhuangliang people's hospital
🇨🇳Pingliang, Gansu, China
Pingyu people's hospital
🇨🇳Zhumadian, Henan, China
Danjiangkou's first hospital
🇨🇳Shiyan, Hubei, China
Qian'an hospital
🇨🇳Songyuan, Jilin, China
Qingyuan Manchu Autonomous County people's hospital
🇨🇳Fushun, Liaoning, China
Beizhen people's hospital
🇨🇳Jinzhou, Liaoning, China
Hancheng people's hospital
🇨🇳Weinan, Shaanxi, China
Shenmu hospital
🇨🇳Yulin, Shaanxi, China
Pingyin people's hospital
🇨🇳Jinan, Shandong, China
Dong'e people's hospital
🇨🇳Liaocheng, Shandong, China
Xintai people's hospital
🇨🇳Tai'an, Shandong, China
Yinan people's hospital
🇨🇳Linyi, Shandong, China
Changzhi steel and iron group head hospital
🇨🇳Changzhi, Shanxi, China
Houma people's hospital
🇨🇳Houma, Shanxi, China
Guxian people's hospital
🇨🇳Linfen, Shanxi, China
Xiangfen people's hospital
🇨🇳Linfen, Shanxi, China
Yuanping people's hospital
🇨🇳Xinzhou, Shanxi, China
Gaoping people's hospital
🇨🇳Jincheng, Shanxi, China
Changtu people's hospital
🇨🇳Tieling, Liaoning, China
Dongtai people's hospital
🇨🇳Yancheng, Jiangsu, China
Linjiang hospital
🇨🇳Baishan, Jilin, China
Tongyu people's hospital
🇨🇳Baicheng, Jilin, China
Dong feng people's hospital
🇨🇳Liaoyuan, Jilin, China
Changbai montain protection and development zone central hospital
🇨🇳Yanbian, Jilin, China
Yitong 1st people's hospital
🇨🇳Yitong, Jilin, China
Lingshi people's hospital
🇨🇳Jinzhong, Shanxi, China
Hunchun people's hospital
🇨🇳Yanbian, Jilin, China
Huinan people's hospital
🇨🇳Tonghua, Jilin, China
Beipiao 1st people's hospital
🇨🇳Chaoyang, Liaoning, China
Lingyuan people's hospital
🇨🇳Chaoyang, Liaoning, China
Cangxi people's hospital
🇨🇳Guangyuan, Sichuan, China
Wafangdian people's hospital
🇨🇳Dalian, Liaoning, China
Fengxiang hospital
🇨🇳Baoji, Shaanxi, China
Weining hospital
🇨🇳Bijie, Anhui, China
Lixin people's hospital
🇨🇳Bozhou, Anhui, China
Woyang people's hospital
🇨🇳Bozhou, Anhui, China
Wuwei people's hospital
🇨🇳Chaohu, Anhui, China
Shucheng people's hospital
🇨🇳Liuan, Anhui, China
Huoshang hospital
🇨🇳Liuan, Anhui, China
Lianzhou people's hospital
🇨🇳Qingyuan, Guangdong, China
Yingshang people's hospital
🇨🇳Fuyang, Anhui, China
Suixi people's hospital
🇨🇳Huaibei, Anhui, China
Gaolan people's hospital
🇨🇳Lanzhou, Gansu, China
Jingning people's hospital
🇨🇳Pingliang, Gansu, China
Taishan people's hospital
🇨🇳Jiangmen, Guangdong, China
Pu'an people's hospital
🇨🇳Buwei, Guizhou, China
Yuqing people's hospital
🇨🇳Zunyi, Guizhou, China
Kuandian Manchu Autonomous County Central Hospital
🇨🇳Dandong, Liaoning, China
Fuping hospital
🇨🇳Weinan, Shaanxi, China
Zhuanglang people's hospital
🇨🇳Dingxi, Gansu, China
Yicheng people's hospital
🇨🇳Linfen, Shanxi, China
Xixiang hospital
🇨🇳Hanzhong, Shaanxi, China
Lou fan people's hospital
🇨🇳Taiyuan, Shanxi, China
Mianning people's hospital
🇨🇳Liangshan, Sichuan, China
Mian county hospital
🇨🇳Hanzhong, Shaanxi, China
Wuzhi people's hospital
🇨🇳Jiaozuo, Henan, China
Wuhua people's hospital
🇨🇳Meizhou, Guangdong, China
Quzhou hospital
🇨🇳Handan, Hebei, China
Shangcheng people's hospital
🇨🇳Xinyang, Henan, China
Jianshi people's hospital
🇨🇳Enshi, Hubei, China
Wuchuan people's hospital
🇨🇳Zhanjiang, Guangdong, China
Dejiang
🇨🇳Tongren, Guizhou, China
Hu county hospital
🇨🇳Xi'an, Shaanxi, China
Xuyong people's hospital
🇨🇳Luzhou, Sichuan, China
Huanqu people's hospital
🇨🇳Yuncheng, Shanxi, China
Dazhu people's hospital
🇨🇳Dazhou, Sichuan, China
Zichang hospital
🇨🇳Yan'an, Shaanxi, China
Gaoyang hospital
🇨🇳Baoding, Hebei, China
Tang county hospital
🇨🇳Baoding, Hebei, China
Jizhou hospital
🇨🇳Jizhou, Hebei, China
Ruyang people's hospital
🇨🇳Luoyang, Henan, China
Yi county hospital
🇨🇳Baoding, Hebei, China
Xixia people's hospital
🇨🇳Nanyang, Henan, China
Dancheng people's hospital
🇨🇳Zhoukou, Henan, China
Chengwu people's hospital
🇨🇳Heze, Shandong, China
Qinglong hospital
🇨🇳Qinhuangdao, Hebei, China
Zanhuang hospital
🇨🇳Shijiazhuang, Hebei, China
Shenze hospital
🇨🇳Shijiazhuang, Hebei, China
Pingxiang people's hospital
🇨🇳Xingtai, Hebei, China
Huaxian people's hospital
🇨🇳Anyang, Henan, China
Linqu people's hospital
🇨🇳Weifang, Shandong, China
Penglai people's hospital
🇨🇳Yantai, Shandong, China
Huantai people's hospital
🇨🇳Zibo, Shandong, China
Chang huan hong li hospital
🇨🇳Xinxiang, Henan, China
Songzi people's hospital
🇨🇳Jinzhou, Hubei, China
Tongcheng people's hospital
🇨🇳Xian'ning, Hubei, China
Gucheng people's hospital
🇨🇳Xiangfan, Hubei, China
Yingcheng people's hospital
🇨🇳Yingcheng, Hubei, China
Zhongxiang people's hospital
🇨🇳Zhongxiang, Hubei, China
Ba lin zuo qi people's hospital
🇨🇳Chifeng, Inner Mongolia, China
Yidu's first hospital
🇨🇳Yichang, Hubei, China
Qingyuan people's hospital
🇨🇳Changzhi, Shanxi, China
Hunyuan people's hospital
🇨🇳Datong, Shanxi, China
A rong qi people's hospital
🇨🇳Hulin, Inner Mongolia, China
DongHai people's hospital
🇨🇳Lianyungang, Jiangsu, China
Gaoyou people's hospital
🇨🇳Yangzhou, Jiangsu, China
Huolinguole hospital
🇨🇳Tongliao, Inner Mongolia, China