Trial DesignRational and design of a stepped-wedge cluster randomized trial evaluating quality improvement initiative for reducing cardiovascular events among patients with acute coronary syndromes in resource-constrained hospitals in China
Section snippets
Background
Coronary heart disease is the leading cause of death worldwide1 and now also in China.2 Between 2010 and 2019, China is predicted to experience a 69% increase in the incidence of acute coronary disease amounting to nearly 8 million additional episodes of myocardial infarction or unstable angina pectoris, compared with the decade 2000 to 2009.3 More than two-thirds of the burden of death and disability from these acute coronary syndromes (ACSs) will occur in adults younger than 65 years.3 This
Study aims
The primary aim of CPACS-3 study is to test whether the routine use of a multifaceted QCI initiative will lead to a measurable reduction in the number of in-hospital MACE in patients with ACS presenting to resource-constrained hospitals in China.
The secondary aims include the following:
- 1.
To determine whether the routine use of the initiative will improve quality of care
- 2.
To determine the major system-level facilitators and barriers to implementation and uptake of the initiative in these
Financial support and conflicts of interest
Source of funding used to support the research and creation of the article is from Sanofi, China, through an unrestricted research grant. The George Institute for Global Health at PUHSC sponsored the study and owns the data. However, the authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the manuscript, and its final contents.
Discussion
Previous randomized trials have showed that multifaceted quality improvement interventions can achieve significant improvement in the use of evidence-based therapies among patients with ACS.17, 18 However, to our knowledge, CPACS-3 will be the first trial powered to evaluate effects on hard clinical endpoints.8 In addition, this is also the first such study conducted in the resource-constrained clinical settings in a low- or middle-income country. The results of this study are anticipated to
Acknowledgements
The Steering Committee of CPACS-3 includes the following: Runlin Gao⁎ (Cardiovascular Institute and Fuwai Hospital), Yangfeng Wu⁎ (The George Institute for Global Health at PUHSC), Anushka Patel (The George Institute for Global Health), Eric Peterson (Duke Clinical Research Institute), Fiona Turnbull (The George Institute for Global Health), Kalipso Chalkidou (National Institute for Health and Clinical Excellence), Yahui Jiao (NHFPC of China), Lingzhi Kong (NHFPC of
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Cited by (25)
The sex difference in 6-month MACEs and its explaining variables in acute myocardial infarction survivors: Data from CPACS-3 study
2020, International Journal of CardiologyCitation Excerpt :The CAPSC-3 study was conducted from 2011 to 2014, and it was registered on www.clinicaltrails.gov (NCT01398228). The design of this study has been published elsewhere [8,9]. In brief, the study was a registry-based stepped wedge cluster-randomized trial to evaluate the effect of quality of care improvement interventions in improving in-hospital MACEs among ACS patients in 101 non-PCI Chinese hospitals.
I-CARE randomized clinical trial integrating depression and acute coronary syndrome care in low-resource hospitals in China: Design and rationale
2018, American Heart JournalCitation Excerpt :The interventions include the following 6 components: establishing a quality of ACS care improvement leadership group in each hospital; implementing tailored guideline-based clinical pathways; training the local cardiologists by “train-the trainers” model and online education program; using a centrally managed Web-based system to collect data and feedback on the key performance indicators on quality of ACS care assessment every 6 months; and providing online expert consultation and distributing a patient education brochure on ACS secondary prevention. Details had been published previously.30 Other than implementation of the standard ACS care, no attempt will be made to influence the management of patients randomized to UC.
Acute coronary syndrome quality improvement in Kerala (ACS QUIK): Rationale and design for a cluster-randomized stepped-wedge trial
2017, American Heart JournalCitation Excerpt :Both previously reported trials demonstrated improvements in process measures, but neither has been powered for nor has demonstrated improvements in outcomes. One large, ongoing trial in China (target N = 25,000), the CPACS-3, is powered to detect a difference in clinical outcomes.9 Similar large-scale cluster-randomized trials have not been carried out in India, a research gap at odds with the burden of disease.
Achieving best outcomes for patients with cardiovascular disease in China by enhancing the quality of medical care and establishing a learning ealth-care system
2015, The LancetCitation Excerpt :The CPACS group identified barriers to implementation of the clinical pathway,64 including absence of leadership support, variation in the capacity for care, and health-care funding constraints, and provided instructions for relevant efforts in the future. Several other studies are in progress and will provide further insights into quality improvement strategies for cardiovascular care.65,66 In addition to the need to better apply existing knowledge, China urgently needs to expand the evidence for what treatment strategy works best for which subgroup of patients.
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David A. Morrow, MD, MPH, served as guest editor for this article.
NCT01398228