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

August 8, 2016 updated by: Yangfeng Wu, The George Institute for Global Health, China

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29934

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bijie, Anhui, China, 553100
        • Weining hospital
      • Bozhou, Anhui, China, 236700
        • Lixin people's hospital
      • Bozhou, Anhui, China, 236700
        • Woyang people's hospital
      • Chaohu, Anhui, China, 238300
        • Wuwei People's Hospital
      • Fuyang, Anhui, China, 236200
        • Yingshang people's hospital
      • Fuyang, Anhui, China, 236400
        • Linquan people's hospital
      • Huaibei, Anhui, China, 235100
        • Suixi people's hospital
      • Liuan, Anhui, China, 231300
        • Shucheng People's Hospital
      • Liuan, Anhui, China, 237200
        • Huoshang hospital
    • Gansu
      • Dingxi, Gansu, China, 730500
        • Zhuanglang people's hospital
      • Lanzhou, Gansu, China, 730200
        • Gaolan people's hospital
      • Pingliang, Gansu, China, 743400
        • Jingning people's hospital
      • Pingliang, Gansu, China, 744600
        • Zhuangliang people's hospital
    • Guangdong
      • Jiangmen, Guangdong, China, 529200
        • Taishan people's Hospital
      • Meizhou, Guangdong, China, 514400
        • Wuhua people's hospital
      • Qingyuan, Guangdong, China, 513300
        • Lianzhou People's Hospital
      • Zhanjiang, Guangdong, China, 524500
        • Wuchuan People's Hospital
    • Guizhou
      • Buwei, Guizhou, China, 561500
        • Pu'an people's hospital
      • Tongren, Guizhou, China, 565200
        • Dejiang
      • Zunyi, Guizhou, China, 564400
        • Yuqing people's hospital
    • Hebei
      • Baoding, Hebei, China, 071500
        • Gaoyang hospital
      • Baoding, Hebei, China, 072300
        • Tang county hospital
      • Baoding, Hebei, China, 074200
        • Yi county hospital
      • Chengde, Hebei, China, 068400
        • Weichang manchu mongolia atounomous county hospital
      • Handan, Hebei, China, 057200
        • Quzhou hospital
      • Jizhou, Hebei, China, 053200
        • Jizhou hospital
      • Qinhuangdao, Hebei, China, 066500
        • Qinglong hospital
      • Shijiazhuang, Hebei, China, 051200
        • Zanhuang hospital
      • Shijiazhuang, Hebei, China, 052500
        • Shenze hospital
      • Xingtai, Hebei, China, 054500
        • Pingxiang People's Hospital
    • Henan
      • Anyang, Henan, China, 456400
        • Huaxian People's Hospital
      • Jiaozuo, Henan, China, 454950
        • Wuzhi people's hospital
      • Luoyang, Henan, China, 471200
        • Ruyang People's Hospital
      • Nanyang, Henan, China, 474500
        • Xixia people's hospital
      • Xinxiang, Henan, China, 453000
        • Chang huan hong li hospital
      • Xinyang, Henan, China, 465300
        • Shangcheng people's hospital
      • Zhoukou, Henan, China, 477100
        • Dancheng People's Hospital
      • Zhumadian, Henan, China, 463400
        • Pingyu People's Hospital
    • Hubei
      • Enshi, Hubei, China, 445300
        • Jianshi people's hospital
      • Jinzhou, Hubei, China, 434200
        • Songzi People's Hospital
      • Shiyan, Hubei, China, 442700
        • Danjiangkou's first hospital
      • Xian'ning, Hubei, China, 437400
        • Tongcheng people's hospital
      • Xiangfan, Hubei, China, 441700
        • Gucheng People's Hospital
      • Yichang, Hubei, China, 443300
        • Yidu's first hospital
      • Yingcheng, Hubei, China, 432400
        • Yingcheng People's Hospital
      • Zhongxiang, Hubei, China, 431900
        • Zhongxiang People's Hospital
    • Inner Mongolia
      • Chifeng, Inner Mongolia, China, 025400
        • Ba lin zuo qi people's hospital
      • Hulin, Inner Mongolia, China, 162700
        • A rong qi people's hospital
      • Tongliao, Inner Mongolia, China, 029100
        • Zha lu te people's hospital
      • Tongliao, Inner Mongolia, China, 029200
        • Huolinguole hospital
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222300
        • DongHai people's hospital
      • Yancheng, Jiangsu, China, 224200
        • Dongtai People'S Hospital
      • Yangzhou, Jiangsu, China, 225600
        • Gaoyou people's hospital
    • Jilin
      • Baicheng, Jilin, China, 137000
        • Tongyu people's hospital
      • Baishan, Jilin, China, 134600
        • Linjiang hospital
      • Liaoyuan, Jilin, China, 136300
        • Dong feng people's hospital
      • Songyuan, Jilin, China, 131400
        • Qian'an hospital
      • Tonghua, Jilin, China, 135100
        • Huinan people's hospital
      • Yanbian, Jilin, China, 133000
        • Changbai montain protection and development zone central hospital
      • Yanbian, Jilin, China, 133300
        • Hunchun people's hospital
      • Yitong, Jilin, China, 130700
        • Yitong 1st people's hospital
    • Liaoning
      • Chaoyang, Liaoning, China, 122000
        • Beipiao 1st people's hospital
      • Chaoyang, Liaoning, China, 122500
        • Lingyuan people's hospital
      • Dalian, Liaoning, China, 116200
        • Zhuanghe central hospital
      • Dalian, Liaoning, China, 116300
        • Wafangdian people's hospital
      • Dandong, Liaoning, China, 118200
        • Kuandian Manchu Autonomous County Central Hospital
      • Fushun, Liaoning, China, 113300
        • Qingyuan Manchu Autonomous County people's hospital
      • Jinzhou, Liaoning, China, 122000
        • Beizhen people's hospital
      • Tieling, Liaoning, China, 112500
        • Changtu people's hospital
    • Shaanxi
      • Baoji, Shaanxi, China, 721400
        • Fengxiang hospital
      • Hanzhong, Shaanxi, China, 723500
        • Xixiang hospital
      • Hanzhong, Shaanxi, China, 724200
        • Mian county hospital
      • Weinan, Shaanxi, China, 711700
        • Fuping hospital
      • Weinan, Shaanxi, China, 714200
        • Hancheng people's hospital
      • Xi'an, Shaanxi, China, 710300
        • Hu county hospital
      • Yan'an, Shaanxi, China, 717300
        • Zichang hospital
      • Yulin, Shaanxi, China, 719300
        • Shenmu Hospital
    • Shandong
      • Heze, Shandong, China, 274200
        • Chengwu people's hospital
      • Jinan, Shandong, China, 250400
        • Pingyin people's hospital
      • Liaocheng, Shandong, China, 252200
        • Dong'e people's hospital
      • Linyi, Shandong, China, 276300
        • Yinan people's hospital
      • Tai'an, Shandong, China, 271200
        • Xintai People's Hospital
      • Weifang, Shandong, China, 262600
        • Linqu people's hospital
      • Yantai, Shandong, China, 265600
        • Penglai People's Hospital
      • Zibo, Shandong, China, 256400
        • Huantai people's hospital
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Changzhi steel and iron group head hospital
      • Changzhi, Shanxi, China, 046500
        • Qingyuan People's Hospital
      • Datong, Shanxi, China, 037400
        • Hunyuan people's hospital
      • Houma, Shanxi, China, 043000
        • Houma People's Hospital
      • Jincheng, Shanxi, China, 048400
        • Gaoping People's Hospital
      • Jinzhong, Shanxi, China, 031300
        • Lingshi people's hospital
      • Linfen, Shanxi, China, 041200
        • Pu xian people's hospital
      • Linfen, Shanxi, China, 041500
        • Xiangfen people's hospital
      • Linfen, Shanxi, China, 042400
        • Guxian people's hospital
      • Linfen, Shanxi, China, 043500
        • Yicheng people's hospital
      • Taiyuan, Shanxi, China, 030300
        • Lou fan people's hospital
      • Xinzhou, Shanxi, China, 034100
        • Yuanping people's hospital
      • Yuncheng, Shanxi, China, 043700
        • Huanqu people's hospital
    • Sichuan
      • Dazhou, Sichuan, China, 635100
        • Dazhu people's hospital
      • Guangyuan, Sichuan, China, 628400
        • Cangxi people's hospital
      • Liangshan, Sichuan, China, 615600
        • Mianning people's hospital
      • Luzhou, Sichuan, China, 464400
        • Xuyong people's hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1
Group 1 will receive quality improvement initiatives first, after 6 months of baseline initiation.
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.
Other: Group 2
Group 2 will receive quality improvement initiatives second, after 6 months of the intervention initiation for Group 1.
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.
Other: Group 3
Group 3 will receive quality improvement initiatives third, after 6 months of the intervention initiation for Group 2.
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.
Other: Group 4
Group 4 will receive quality improvement initiatives forth, after 6 months of the intervention initiation for Group 3.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence rate of in-hospital major adverse cardiovascular events (MACE)
Time Frame: 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.
from hospitaliztion to 1 week after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-hospital all cause deaths
Time Frame: 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.
from hospitaliztion to 1 week after discharge
a patient level composite score calculated by KPIs of ACS care
Time Frame: 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.
During Hospitalization, an expected average of 10 days
each of the 16 KPIs (patient level)
Time Frame: 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.
During hospitalization, an expected average of 10 days
a composite of MACE and re-hospitalization due to cardiovascular disease within 6 months after discharge
Time Frame: in 6 months after discharge
in 6 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The George Institute for Global Health, China

Investigators

  • Principal Investigator: Yangfeng Wu, PhD, George Institute for global health, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 18, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimate)

July 20, 2011

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPACS-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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