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

Not Applicable

Completed

• Conditions: Acute Coronary Syndromes

• 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

Study Timeline

• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Study Start: 2011-09
• Primary Completion: 2014-12
• Study Completion: 2015-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29934

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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.
a composite of MACE and re-hospitalization due to cardiovascular disease within 6 months after discharge	in 6 months after discharge

Trial Locations

Locations (102)

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

Yingshang people's hospital; 🇨🇳 Fuyang, Anhui, China

Linquan people's hospital; 🇨🇳 Fuyang, Anhui, China

Suixi people's hospital; 🇨🇳 Huaibei, Anhui, China

Shucheng people's hospital; 🇨🇳 Liuan, Anhui, China

Huoshang hospital; 🇨🇳 Liuan, Anhui, China

Zhuanglang people's hospital; 🇨🇳 Dingxi, Gansu, China

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