NCT01398228

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29,934

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

102 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

3.3 years

First QC Date

July 18, 2011

Last Update Submit

August 8, 2016

Conditions

Keywords

Quality of careAcute Coronary Syndromes (ACS)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

Study Arms (4)

Group 1

OTHER

Group 1 will receive quality improvement initiatives first, after 6 months of baseline initiation.

Behavioral: quality improvement initiatives

Group 2

OTHER

Group 2 will receive quality improvement initiatives second, after 6 months of the intervention initiation for Group 1.

Behavioral: quality improvement initiatives

Group 3

OTHER

Group 3 will receive quality improvement initiatives third, after 6 months of the intervention initiation for Group 2.

Behavioral: quality improvement initiatives

Group 4

OTHER

Group 4 will receive quality improvement initiatives forth, after 6 months of the intervention initiation for Group 3.

Behavioral: quality improvement initiatives

Interventions

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.

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (102)

Weining hospital

Bijie, Anhui, 553100, China

Location

Lixin people's hospital

Bozhou, Anhui, 236700, China

Location

Woyang people's hospital

Bozhou, Anhui, 236700, China

Location

Wuwei people's hospital

Chaohu, Anhui, 238300, China

Location

Yingshang people's hospital

Fuyang, Anhui, 236200, China

Location

Linquan people's hospital

Fuyang, Anhui, 236400, China

Location

Suixi people's hospital

Huaibei, Anhui, 235100, China

Location

Shucheng people's hospital

Liuan, Anhui, 231300, China

Location

Huoshang hospital

Liuan, Anhui, 237200, China

Location

Zhuanglang people's hospital

Dingxi, Gansu, 730500, China

Location

Gaolan people's hospital

Lanzhou, Gansu, 730200, China

Location

Jingning people's hospital

Pingliang, Gansu, 743400, China

Location

Zhuangliang people's hospital

Pingliang, Gansu, 744600, China

Location

Taishan people's hospital

Jiangmen, Guangdong, 529200, China

Location

Wuhua people's hospital

Meizhou, Guangdong, 514400, China

Location

Lianzhou people's hospital

Qingyuan, Guangdong, 513300, China

Location

Wuchuan people's hospital

Zhanjiang, Guangdong, 524500, China

Location

Pu'an people's hospital

Buwei, Guizhou, 561500, China

Location

Dejiang

Tongren, Guizhou, 565200, China

Location

Yuqing people's hospital

Zunyi, Guizhou, 564400, China

Location

Gaoyang hospital

Baoding, Hebei, 071500, China

Location

Tang county hospital

Baoding, Hebei, 072300, China

Location

Yi county hospital

Baoding, Hebei, 074200, China

Location

Weichang manchu mongolia atounomous county hospital

Chengde, Hebei, 068400, China

Location

Quzhou hospital

Handan, Hebei, 057200, China

Location

Jizhou hospital

Jizhou, Hebei, 053200, China

Location

Qinglong hospital

Qinhuangdao, Hebei, 066500, China

Location

Zanhuang hospital

Shijiazhuang, Hebei, 051200, China

Location

Shenze hospital

Shijiazhuang, Hebei, 052500, China

Location

Pingxiang people's hospital

Xingtai, Hebei, 054500, China

Location

Huaxian people's hospital

Anyang, Henan, 456400, China

Location

Wuzhi people's hospital

Jiaozuo, Henan, 454950, China

Location

Ruyang people's hospital

Luoyang, Henan, 471200, China

Location

Xixia people's hospital

Nanyang, Henan, 474500, China

Location

Chang huan hong li hospital

Xinxiang, Henan, 453000, China

Location

Shangcheng people's hospital

Xinyang, Henan, 465300, China

Location

Dancheng people's hospital

Zhoukou, Henan, 477100, China

Location

Pingyu people's hospital

Zhumadian, Henan, 463400, China

Location

Jianshi people's hospital

Enshi, Hubei, 445300, China

Location

Songzi people's hospital

Jinzhou, Hubei, 434200, China

Location

Danjiangkou's first hospital

Shiyan, Hubei, 442700, China

Location

Tongcheng people's hospital

Xian'ning, Hubei, 437400, China

Location

Gucheng people's hospital

Xiangfan, Hubei, 441700, China

Location

Yidu's first hospital

Yichang, Hubei, 443300, China

Location

Yingcheng people's hospital

Yingcheng, Hubei, 432400, China

Location

Zhongxiang people's hospital

Zhongxiang, Hubei, 431900, China

Location

Ba lin zuo qi people's hospital

Chifeng, Inner Mongolia, 025400, China

Location

A rong qi people's hospital

Hulin, Inner Mongolia, 162700, China

Location

Zha lu te people's hospital

Tongliao, Inner Mongolia, 029100, China

Location

Huolinguole hospital

Tongliao, Inner Mongolia, 029200, China

Location

DongHai people's hospital

Lianyungang, Jiangsu, 222300, China

Location

Dongtai people's hospital

Yancheng, Jiangsu, 224200, China

Location

Gaoyou people's hospital

Yangzhou, Jiangsu, 225600, China

Location

Tongyu people's hospital

Baicheng, Jilin, 137000, China

Location

Linjiang hospital

Baishan, Jilin, 134600, China

Location

Dong feng people's hospital

Liaoyuan, Jilin, 136300, China

Location

Qian'an hospital

Songyuan, Jilin, 131400, China

Location

Huinan people's hospital

Tonghua, Jilin, 135100, China

Location

Changbai montain protection and development zone central hospital

Yanbian, Jilin, 133000, China

Location

Hunchun people's hospital

Yanbian, Jilin, 133300, China

Location

Yitong 1st people's hospital

Yitong, Jilin, 130700, China

Location

Beipiao 1st people's hospital

Chaoyang, Liaoning, 122000, China

Location

Lingyuan people's hospital

Chaoyang, Liaoning, 122500, China

Location

Zhuanghe central hospital

Dalian, Liaoning, 116200, China

Location

Wafangdian people's hospital

Dalian, Liaoning, 116300, China

Location

Kuandian Manchu Autonomous County Central Hospital

Dandong, Liaoning, 118200, China

Location

Qingyuan Manchu Autonomous County people's hospital

Fushun, Liaoning, 113300, China

Location

Beizhen people's hospital

Jinzhou, Liaoning, 122000, China

Location

Changtu people's hospital

Tieling, Liaoning, 112500, China

Location

Fengxiang hospital

Baoji, Shaanxi, 721400, China

Location

Xixiang hospital

Hanzhong, Shaanxi, 723500, China

Location

Mian county hospital

Hanzhong, Shaanxi, 724200, China

Location

Fuping hospital

Weinan, Shaanxi, 711700, China

Location

Hancheng people's hospital

Weinan, Shaanxi, 714200, China

Location

Hu county hospital

Xi'an, Shaanxi, 710300, China

Location

Zichang hospital

Yan’an, Shaanxi, 717300, China

Location

Shenmu hospital

Yulin, Shaanxi, 719300, China

Location

Chengwu people's hospital

Heze, Shandong, 274200, China

Location

Pingyin people's hospital

Jinan, Shandong, 250400, China

Location

Dong'e people's hospital

Liaocheng, Shandong, 252200, China

Location

Yinan people's hospital

Linyi, Shandong, 276300, China

Location

Xintai people's hospital

Tai’an, Shandong, 271200, China

Location

Linqu people's hospital

Weifang, Shandong, 262600, China

Location

Penglai people's hospital

Yantai, Shandong, 265600, China

Location

Huantai people's hospital

Zibo, Shandong, 256400, China

Location

Changzhi steel and iron group head hospital

Changzhi, Shanxi, 046000, China

Location

Qingyuan people's hospital

Changzhi, Shanxi, 046500, China

Location

Hunyuan people's hospital

Datong, Shanxi, 037400, China

Location

Gaoping people's hospital

Jincheng, Shanxi, 048400, China

Location

Lingshi people's hospital

Jinzhong, Shanxi, 031300, China

Location

Pu xian people's hospital

Linfen, Shanxi, 041200, China

Location

Xiangfen people's hospital

Linfen, Shanxi, 041500, China

Location

Guxian people's hospital

Linfen, Shanxi, 042400, China

Location

Yicheng people's hospital

Linfen, Shanxi, 043500, China

Location

Lou fan people's hospital

Taiyuan, Shanxi, 030300, China

Location

Houma people's hospital

Xintian, Shanxi, 043000, China

Location

Yuanping people's hospital

Xinzhou, Shanxi, 034100, China

Location

Huanqu people's hospital

Yuncheng, Shanxi, 043700, China

Location

Dazhu people's hospital

Dazhou, Sichuan, 635100, China

Location

Cangxi people's hospital

Guangyuan, Sichuan, 628400, China

Location

Mianning people's hospital

Liangshan, Sichuan, 615600, China

Location

Xuyong people's hospital

Luzhou, Sichuan, 464400, China

Location

Related Publications (6)

  • Xie G, Patel A, Du X, Sun Y, Li X, Wu T, Hao Z, Gao R, Wu Y. Impact of In-Hospital Quality of Care Improvement Initiative on Secondary Prevention of Acute Coronary Syndrome in Six Months After Patient Discharge: A Large Stepped Wedge- and Cluster-Randomized Controlled Trial. Circ Cardiovasc Qual Outcomes. 2025 May;18(5):e011441. doi: 10.1161/CIRCOUTCOMES.124.011441. Epub 2025 Apr 4.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Yangfeng Wu, PhD

    George Institute for global health, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior director

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 20, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations