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

The George Institute for Global Health, China

Status: Completed

Conditions: Acute Coronary Syndromes

Treatments: Behavioral: quality improvement initiatives

Study type: Interventional

Funder types: Other

Identifiers

NCT01398228

CPACS-3

Details and patient eligibility

About

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.

Enrollment: 29,934 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29,934 participants in 4 patient groups

Group 1

Other group

Description:

Group 1 will receive quality improvement initiatives first, after 6 months of baseline initiation.

Treatment:

Behavioral: quality improvement initiatives

Group 2

Other group

Description:

Group 2 will receive quality improvement initiatives second, after 6 months of the intervention initiation for Group 1.

Treatment:

Behavioral: quality improvement initiatives

Group 3

Other group

Description:

Group 3 will receive quality improvement initiatives third, after 6 months of the intervention initiation for Group 2.

Treatment:

Behavioral: quality improvement initiatives

Group 4

Other group

Description:

Group 4 will receive quality improvement initiatives forth, after 6 months of the intervention initiation for Group 3.

Treatment:

Behavioral: quality improvement initiatives