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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by The George Institute for Global Health, China
Sponsor:
Information provided by (Responsible Party):
Yangfeng Wu, The George Institute for Global Health, China
ClinicalTrials.gov Identifier:
NCT01398228
First received: July 18, 2011
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Acute Coronary Syndromes
Behavioral: quality improvement initiatives

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Clinical Pathways for the Management of Acute Coronary Syndromes - Phase 3

Resource links provided by NLM:


Further study details as provided by The George Institute for Global Health, China:

Primary Outcome Measures:
  • incidence rate of in-hospital major adverse cardiovascular events (MACE) [ Time Frame: during hospitaliztion ] [ Designated as safety issue: No ]
    In-hospital major adverse cardiovascular events (MACE) comprising all-cause mortality, myocardial infarction or recurrent myocardial infarction and non-fatal stroke.


Secondary Outcome Measures:
  • composite score calculated by KPIs of ACS care [ Time Frame: During Hospitalization, an expected average of 10 days ] [ Designated as safety issue: No ]
    13 KPIs include: Proportion of patients with their first ECG recorded within 10 minutes after hospital arrival, Proportion of patients who received aspirin or clopidogrel or statin within 24 hours of arrival at hospital,Proportion of patients who are prescribed aspirin or clopidogrel or beta-blocker or statin at hospital discharge,Proportion of patients with left ventricular systolic dysfunction who are prescribed angiotensin- converting-enzyme inhibitors or angiotensin-receptor blockers at discharge, Proportion of STEMI patients with ST-segment elevation or LBBB on the ECG and arrive hospital within 12 hours of symptom onset receiving fibrinolysis within 12 hours of symptom onset, Proportion of STEMI patients receiving fibrinolytic therapy who receive this within 30 minutes of arrival at hospital arrival, Proportion of patients with a final diagnosis consistent with ECG and biomarker findings, Mean number of days of hospitalization.

  • a composite of MACE and re-hospitalization due to cardiovascular disease within 6 months after discharge [ Time Frame: in 6 months after discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 20000
Study Start Date: September 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398228

Contacts
Contact: Shenshen Li, MSc 86-010-82800577 ext 108 shenshenl@georgeinstitute.org.cn

  Show 104 Study Locations
Sponsors and Collaborators
The George Institute for Global Health, China
Investigators
Principal Investigator: Yangfeng Wu, PhD George Institute for global health, China
  More Information

No publications provided

Responsible Party: Yangfeng Wu, senior director, The George Institute for Global Health, China
ClinicalTrials.gov Identifier: NCT01398228     History of Changes
Other Study ID Numbers: CPACS-3
Study First Received: July 18, 2011
Last Updated: July 15, 2014
Health Authority: China: National Health and Family Planning Committee

Keywords provided by The George Institute for Global Health, China:
Quality of care
Acute Coronary Syndromes (ACS)

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014