Clinical trial NCT01398228: Clinical Pathways for the Management of Acute Coronary Syndromes - Phase 3,CPACS-3
Official title: Clinical Pathways for the Management of Acute Coronary Syndromes - Phase 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndromes
Keywords: Quality of care
Acute Coronary Syndromes (ACS)
Lead sponsor: The George Institute for Global Health, China
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 29934
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* admitted to participating hospitals
* diagnosed as Acute Coronary Syndromes(ACS) at the time of death or discharge
* aged 18 years or older

Exclusion Criteria:

* death happened within 10 mins after arriving hospital
* ACS happened during hospitalization due to other health problem
* patients already registered in the database

Primary outcomes:
measure: incidence rate of in-hospital major adverse cardiovascular events (MACE)
timeFrame: from hospitaliztion to 1 week after discharge
Secondary outcomes:
measure: in-hospital all cause deaths
timeFrame: from hospitaliztion to 1 week after discharge
measure: a patient level composite score calculated by KPIs of ACS care
timeFrame: During Hospitalization, an expected average of 10 days
measure: each of the 16 KPIs (patient level)
timeFrame: During hospitalization, an expected average of 10 days
measure: a composite of MACE and re-hospitalization due to cardiovascular disease within 6 months after discharge
timeFrame: in 6 months after discharge
Other outcomes:
Locations:
city: Bijie
country: China
facility: Weining hospital
state: Anhui
city: Bozhou
country: China
facility: Lixin people's hospital
state: Anhui
city: Bozhou
country: China
facility: Woyang people's hospital
state: Anhui
city: Chaohu
country: China
facility: Wuwei people's hospital
state: Anhui
city: Fuyang
country: China
facility: Yingshang people's hospital
state: Anhui
city: Fuyang
country: China
facility: Linquan people's hospital
state: Anhui
city: Huaibei
country: China
facility: Suixi people's hospital
state: Anhui
city: Liuan
country: China
facility: Shucheng people's hospital
state: Anhui
city: Liuan
country: China
facility: Huoshang hospital
state: Anhui
city: Dingxi
country: China
facility: Zhuanglang people's hospital
state: Gansu
city: Lanzhou
country: China
facility: Gaolan people's hospital
state: Gansu
city: Pingliang
country: China
facility: Jingning people's hospital
state: Gansu
city: Pingliang
country: China
facility: Zhuangliang people's hospital
state: Gansu
city: Jiangmen
country: China
facility: Taishan people's hospital
state: Guangdong
city: Meizhou
country: China
facility: Wuhua people's hospital
state: Guangdong
city: Qingyuan
country: China
facility: Lianzhou people's hospital
state: Guangdong
city: Zhanjiang
country: China
facility: Wuchuan people's hospital
state: Guangdong
city: Buwei
country: China
facility: Pu'an people's hospital
state: Guizhou
city: Tongren
country: China
facility: Dejiang
state: Guizhou
city: Zunyi
country: China
facility: Yuqing people's hospital
state: Guizhou
city: Baoding
country: China
facility: Gaoyang hospital
state: Hebei
city: Baoding
country: China
facility: Tang county hospital
state: Hebei
city: Baoding
country: China
facility: Yi county hospital
state: Hebei
city: Chengde
country: China
facility: Weichang manchu mongolia atounomous county hospital
state: Hebei
city: Handan
country: China
facility: Quzhou hospital
state: Hebei
city: Jizhou
country: China
facility: Jizhou hospital
state: Hebei
city: Qinhuangdao
country: China
facility: Qinglong hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Zanhuang hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Shenze hospital
state: Hebei
city: Xingtai
country: China
facility: Pingxiang people's hospital
state: Hebei
city: Anyang
country: China
facility: Huaxian people's hospital
state: Henan
city: Jiaozuo
country: China
facility: Wuzhi people's hospital
state: Henan
city: Luoyang
country: China
facility: Ruyang people's hospital
state: Henan
city: Nanyang
country: China
facility: Xixia people's hospital
state: Henan
city: Xinxiang
country: China
facility: Chang huan hong li hospital
state: Henan
city: Xinyang
country: China
facility: Shangcheng people's hospital
state: Henan
city: Zhoukou
country: China
facility: Dancheng people's hospital
state: Henan
city: Zhumadian
country: China
facility: Pingyu people's hospital
state: Henan
city: Enshi
country: China
facility: Jianshi people's hospital
state: Hubei
city: Jinzhou
country: China
facility: Songzi people's hospital
state: Hubei
city: Shiyan
country: China
facility: Danjiangkou's first hospital
state: Hubei
city: Xian'ning
country: China
facility: Tongcheng people's hospital
state: Hubei
city: Xiangfan
country: China
facility: Gucheng people's hospital
state: Hubei
city: Yichang
country: China
facility: Yidu's first hospital
state: Hubei
city: Yingcheng
country: China
facility: Yingcheng people's hospital
state: Hubei
city: Zhongxiang
country: China
facility: Zhongxiang people's hospital
state: Hubei
city: Chifeng
country: China
facility: Ba lin zuo qi people's hospital
state: Inner Mongolia
city: Hulin
country: China
facility: A rong qi people's hospital
state: Inner Mongolia
city: Tongliao
country: China
facility: Zha lu te people's hospital
state: Inner Mongolia
city: Tongliao
country: China
facility: Huolinguole hospital
state: Inner Mongolia
city: Lianyungang
country: China
facility: DongHai people's hospital
state: Jiangsu
city: Yancheng
country: China
facility: Dongtai people's hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Gaoyou people's hospital
state: Jiangsu
city: Baicheng
country: China
facility: Tongyu people's hospital
state: Jilin
city: Baishan
country: China
facility: Linjiang hospital
state: Jilin
city: Liaoyuan
country: China
facility: Dong feng people's hospital
state: Jilin
city: Songyuan
country: China
facility: Qian'an hospital
state: Jilin
city: Tonghua
country: China
facility: Huinan people's hospital
state: Jilin
city: Yanbian
country: China
facility: Changbai montain protection and development zone central hospital
state: Jilin
city: Yanbian
country: China
facility: Hunchun people's hospital
state: Jilin
city: Yitong
country: China
facility: Yitong 1st people's hospital
state: Jilin
city: Chaoyang
country: China
facility: Beipiao 1st people's hospital
state: Liaoning
city: Chaoyang
country: China
facility: Lingyuan people's hospital
state: Liaoning
city: Dalian
country: China
facility: Zhuanghe central hospital
state: Liaoning
city: Dalian
country: China
facility: Wafangdian people's hospital
state: Liaoning
city: Dandong
country: China
facility: Kuandian Manchu Autonomous County Central Hospital
state: Liaoning
city: Fushun
country: China
facility: Qingyuan Manchu Autonomous County people's hospital
state: Liaoning
city: Jinzhou
country: China
facility: Beizhen people's hospital
state: Liaoning
city: Tieling
country: China
facility: Changtu people's hospital
state: Liaoning
city: Baoji
country: China
facility: Fengxiang hospital
state: Shaanxi
city: Hanzhong
country: China
facility: Xixiang hospital
state: Shaanxi
city: Hanzhong
country: China
facility: Mian county hospital
state: Shaanxi
city: Weinan
country: China
facility: Fuping hospital
state: Shaanxi
city: Weinan
country: China
facility: Hancheng people's hospital
state: Shaanxi
city: Xi'an
country: China
facility: Hu county hospital
state: Shaanxi
city: Yan'an
country: China
facility: Zichang hospital
state: Shaanxi
city: Yulin
country: China
facility: Shenmu hospital
state: Shaanxi
city: Heze
country: China
facility: Chengwu people's hospital
state: Shandong
city: Jinan
country: China
facility: Pingyin people's hospital
state: Shandong
city: Liaocheng
country: China
facility: Dong'e people's hospital
state: Shandong
city: Linyi
country: China
facility: Yinan people's hospital
state: Shandong
city: Tai'an
country: China
facility: Xintai people's hospital
state: Shandong
city: Weifang
country: China
facility: Linqu people's hospital
state: Shandong
city: Yantai
country: China
facility: Penglai people's hospital
state: Shandong
city: Zibo
country: China
facility: Huantai people's hospital
state: Shandong
city: Changzhi
country: China
facility: Changzhi steel and iron group head hospital
state: Shanxi
city: Changzhi
country: China
facility: Qingyuan people's hospital
state: Shanxi
city: Datong
country: China
facility: Hunyuan people's hospital
state: Shanxi
city: Houma
country: China
facility: Houma people's hospital
state: Shanxi
city: Jincheng
country: China
facility: Gaoping people's hospital
state: Shanxi
city: Jinzhong
country: China
facility: Lingshi people's hospital
state: Shanxi
city: Linfen
country: China
facility: Pu xian people's hospital
state: Shanxi
city: Linfen
country: China
facility: Xiangfen people's hospital
state: Shanxi
city: Linfen
country: China
facility: Guxian people's hospital
state: Shanxi
city: Linfen
country: China
facility: Yicheng people's hospital
state: Shanxi
city: Taiyuan
country: China
facility: Lou fan people's hospital
state: Shanxi
city: Xinzhou
country: China
facility: Yuanping people's hospital
state: Shanxi
city: Yuncheng
country: China
facility: Huanqu people's hospital
state: Shanxi
city: Dazhou
country: China
facility: Dazhu people's hospital
state: Sichuan
city: Guangyuan
country: China
facility: Cangxi people's hospital
state: Sichuan
city: Liangshan
country: China
facility: Mianning people's hospital
state: Sichuan
city: Luzhou
country: China
facility: Xuyong people's hospital
state: Sichuan
Study officials:
affiliation: George Institute for global health, China
name: Yangfeng Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xie W, Patel A, Boersma E, Feng L, Li M, Gao R, Wu Y. Chronic kidney disease and the outcomes of fibrinolysis for ST-segment elevation myocardial infarction: A real-world study. PLoS One. 2021 Jan 19;16(1):e0245576. doi: 10.1371/journal.pone.0245576. eCollection 2021.
citation: Sun Y, Feng L, Li X, Gao R, Wu Y. The sex difference in 6-month MACEs and its explaining variables in acute myocardial infarction survivors: Data from CPACS-3 study. Int J Cardiol. 2020 Jul 15;311:1-6. doi: 10.1016/j.ijcard.2020.03.043. Epub 2020 Mar 20.
citation: Feng L, Li M, Xie W, Zhang A, Lei L, Li X, Gao R, Wu Y. Prehospital and in-hospital delays to care and associated factors in patients with STEMI: an observational study in 101 non-PCI hospitals in China. BMJ Open. 2019 Nov 10;9(11):e031918. doi: 10.1136/bmjopen-2019-031918.
citation: Wu Y, Li S, Patel A, Li X, Du X, Wu T, Zhao Y, Feng L, Billot L, Peterson ED, Woodward M, Kong L, Huo Y, Hu D, Chalkidou K, Gao R; CPACS-3 Investigators. Effect of a Quality of Care Improvement Initiative in Patients With Acute Coronary Syndrome in Resource-Constrained Hospitals in China: A Randomized Clinical Trial. JAMA Cardiol. 2019 May 1;4(5):418-427. doi: 10.1001/jamacardio.2019.0897.
citation: Li S, Wu Y, Du X, Li X, Patel A, Peterson ED, Turnbull F, Lo S, Billot L, Laba T, Gao R; CPACS-3 investigators. Rational and design of a stepped-wedge cluster randomized trial evaluating quality improvement initiative for reducing cardiovascular events among patients with acute coronary syndromes in resource-constrained hospitals in China. Am Heart J. 2015 Mar;169(3):349-55. doi: 10.1016/j.ahj.2014.12.005. Epub 2014 Dec 18.