Clinical Pathways for the Management of Acute Coronary Syndromes - Phase 3,CPACS-3

Acute Coronary Syndromes Clinical Trial

— CPACS-3  

Official title:

Clinical Pathways for the Management of Acute Coronary Syndromes - Phase 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398228
• Other study ID #: CPACS-3
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: August 8, 2016
• Start date: September 2011
• Est. completion date: June 2015

Study information

• Verified date: August 2016
• Source: The George Institute for Global Health, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29934
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Syndrome

Intervention

Behavioral:
• quality improvement initiatives
A six component quality improvement intervention will be implemented. These components include: establishment of a quality improvement team, hospital performance audit and feedback, implementation of a clinical pathway, training of physicians and nurses, online technical support and patient education.

Locations

Country	Name	City	State
China	Huaxian people's hospital	Anyang	Henan
China	Tongyu people's hospital	Baicheng	Jilin
China	Linjiang hospital	Baishan	Jilin
China	Gaoyang hospital	Baoding	Hebei
China	Tang county hospital	Baoding	Hebei
China	Yi county hospital	Baoding	Hebei
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	Pu'an people's hospital	Buwei	Guizhou
China	Changzhi steel and iron group head hospital	Changzhi	Shanxi
China	Qingyuan people's hospital	Changzhi	Shanxi
China	Wuwei people's hospital	Chaohu	Anhui
China	Beipiao 1st people's hospital	Chaoyang	Liaoning
China	Lingyuan people's hospital	Chaoyang	Liaoning
China	Weichang manchu mongolia atounomous county hospital	Chengde	Hebei
China	Ba lin zuo qi people's hospital	Chifeng	Inner Mongolia
China	Wafangdian people's hospital	Dalian	Liaoning
China	Zhuanghe central hospital	Dalian	Liaoning
China	Kuandian Manchu Autonomous County Central Hospital	Dandong	Liaoning
China	Hunyuan people's hospital	Datong	Shanxi
China	Dazhu people's hospital	Dazhou	Sichuan
China	Zhuanglang people's hospital	Dingxi	Gansu
China	Jianshi people's hospital	Enshi	Hubei
China	Qingyuan Manchu Autonomous County people's hospital	Fushun	Liaoning
China	Linquan people's hospital	Fuyang	Anhui
China	Yingshang people's hospital	Fuyang	Anhui
China	Cangxi people's hospital	Guangyuan	Sichuan
China	Quzhou hospital	Handan	Hebei
China	Mian county hospital	Hanzhong	Shaanxi
China	Xixiang hospital	Hanzhong	Shaanxi
China	Chengwu people's hospital	Heze	Shandong
China	Houma people's hospital	Houma	Shanxi
China	Suixi people's hospital	Huaibei	Anhui
China	A rong qi people's hospital	Hulin	Inner Mongolia
China	Taishan people's hospital	Jiangmen	Guangdong
China	Wuzhi people's hospital	Jiaozuo	Henan
China	Pingyin people's hospital	Jinan	Shandong
China	Gaoping people's hospital	Jincheng	Shanxi
China	Lingshi people's hospital	Jinzhong	Shanxi
China	Beizhen people's hospital	Jinzhou	Liaoning
China	Songzi people's hospital	Jinzhou	Hubei
China	Jizhou hospital	Jizhou	Hebei
China	Gaolan people's hospital	Lanzhou	Gansu
China	Mianning people's hospital	Liangshan	Sichuan
China	DongHai people's hospital	Lianyungang	Jiangsu
China	Dong'e people's hospital	Liaocheng	Shandong
China	Dong feng people's hospital	Liaoyuan	Jilin
China	Guxian people's hospital	Linfen	Shanxi
China	Pu xian people's hospital	Linfen	Shanxi
China	Xiangfen people's hospital	Linfen	Shanxi
China	Yicheng people's hospital	Linfen	Shanxi
China	Yinan people's hospital	Linyi	Shandong
China	Huoshang hospital	Liuan	Anhui
China	Shucheng people's hospital	Liuan	Anhui
China	Ruyang people's hospital	Luoyang	Henan
China	Xuyong people's hospital	Luzhou	Sichuan
China	Wuhua people's hospital	Meizhou	Guangdong
China	Xixia people's hospital	Nanyang	Henan
China	Jingning people's hospital	Pingliang	Gansu
China	Zhuangliang people's hospital	Pingliang	Gansu
China	Lianzhou people's hospital	Qingyuan	Guangdong
China	Qinglong hospital	Qinhuangdao	Hebei
China	Shenze hospital	Shijiazhuang	Hebei
China	Zanhuang hospital	Shijiazhuang	Hebei
China	Danjiangkou's first hospital	Shiyan	Hubei
China	Qian'an hospital	Songyuan	Jilin
China	Xintai people's hospital	Tai'an	Shandong
China	Lou fan people's hospital	Taiyuan	Shanxi
China	Changtu people's hospital	Tieling	Liaoning
China	Huinan people's hospital	Tonghua	Jilin
China	Huolinguole hospital	Tongliao	Inner Mongolia
China	Zha lu te people's hospital	Tongliao	Inner Mongolia
China	Dejiang	Tongren	Guizhou
China	Linqu people's hospital	Weifang	Shandong
China	Fuping hospital	Weinan	Shaanxi
China	Hancheng people's hospital	Weinan	Shaanxi
China	Hu county hospital	Xi'an	Shaanxi
China	Tongcheng people's hospital	Xian'ning	Hubei
China	Gucheng people's hospital	Xiangfan	Hubei
China	Pingxiang people's hospital	Xingtai	Hebei
China	Chang huan hong li hospital	Xinxiang	Henan
China	Shangcheng people's hospital	Xinyang	Henan
China	Yuanping people's hospital	Xinzhou	Shanxi
China	Zichang hospital	Yan'an	Shaanxi
China	Changbai montain protection and development zone central hospital	Yanbian	Jilin
China	Hunchun people's hospital	Yanbian	Jilin
China	Dongtai people's hospital	Yancheng	Jiangsu
China	Gaoyou people's hospital	Yangzhou	Jiangsu
China	Penglai people's hospital	Yantai	Shandong
China	Yidu's first hospital	Yichang	Hubei
China	Yingcheng people's hospital	Yingcheng	Hubei
China	Yitong 1st people's hospital	Yitong	Jilin
China	Shenmu hospital	Yulin	Shaanxi
China	Huanqu people's hospital	Yuncheng	Shanxi
China	Wuchuan people's hospital	Zhanjiang	Guangdong
China	Zhongxiang people's hospital	Zhongxiang	Hubei
China	Dancheng people's hospital	Zhoukou	Henan
China	Pingyu people's hospital	Zhumadian	Henan
China	Huantai people's hospital	Zibo	Shandong
China	Yuqing people's hospital	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
The George Institute for Global Health, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence rate of in-hospital major adverse cardiovascular events (MACE)	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.	from hospitaliztion to 1 week after discharge	No
Secondary	in-hospital all cause deaths	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.	from hospitaliztion to 1 week after discharge	No
Secondary	a patient level composite score calculated by KPIs of ACS care	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.	During Hospitalization, an expected average of 10 days	No
Secondary	each of the 16 KPIs (patient level)	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.	During hospitalization, an expected average of 10 days	No
Secondary	a composite of MACE and re-hospitalization due to cardiovascular disease within 6 months after discharge		in 6 months after discharge	No