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

Overview

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.

Full Title of Study: “Clinical Pathways for the Management of Acute Coronary Syndromes – Phase 3″

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2014

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The George Institute for Global Health, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yangfeng Wu, senior director – The George Institute for Global Health, China
  • Overall Official(s)
    • Yangfeng Wu, PhD, Principal Investigator, George Institute for global health, China

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