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Trials / Completed

CompletedNCT01398228

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
29,934 (actual)
Sponsor
The George Institute for Global Health, China · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALquality improvement initiativesA 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.

Timeline

Start date
2011-09-01
Primary completion
2014-12-01
Completion
2015-06-01
First posted
2011-07-20
Last updated
2016-08-10

Locations

102 sites across 1 country: China

Source: ClinicalTrials.gov record NCT01398228. Inclusion in this directory is not an endorsement.