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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 i

Detailed Summary:
Sponsor: The George Institute for Global Health, China

Current Primary Outcome: incidence rate of in-hospital major adverse cardiovascular events (MACE) [ Time Frame: from hospitaliztion to 1 week after discharge ]

Original Primary Outcome: incidence rate of in-hospital major adverse cardiovascular events (MACE) [ Time Frame: during hospitaliztion, an expected average of 10 days ]

Current Secondary Outcome:

• 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.
• 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.
• 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.
• a composite of MACE and re-hospitalization due to cardiovascular disease within 6 months after discharge [ Time Frame: in 6 months after discharge ]

Original Secondary Outcome:

• door to ECG time [ Time Frame: During Hospitalization, an expected average of 10 days ]
• proportion of patients receiving aspirin/clopidogrel/statin within 24 hours of arrival at hospital [ Time Frame: during hospitaliztion, an expected average of 10 days ]
• Proportion of eligible patients receiving fibrinolysis [ Time Frame: during hospitaliztion, an expected average of 10 days ]
• door to needle time [ Time Frame: during hospitaliztion, an expected average of 10 days ]
• proportion of patients evaluated for left ventricular failure [ Time Frame: during hospitaliztion, an expected average of 10 days ]
• proportion of patients discharged on anti-platelet therapy/beta-blocker/statin/ACEI or ARB [ Time Frame: during hospitaliztion, an expected average of 10 days ]
• hospital length of stay [ Time Frame: during hospitaliztion, an expected average of 10 days ]
• proportion of patients with a final diagnosis consistent with ECG and biomarkers. [ Time Frame: during hospitaliztion, an expected average of 10 days ]

Dates:
Date Received: July 18, 2011
Date Started: September 2011
Date Completion:
Last Updated: August 8, 2016
Last Verified: August 2016