Trial Design
Rational 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

https://doi.org/10.1016/j.ahj.2014.12.005Get rights and content

Background

Acute coronary syndromes (ACSs) are a major cause of morbidity and mortality, yet effective ACS treatments are frequently underused in clinical practice. Randomized trials including the CPACS-2 study suggest that quality improvement initiatives can increase the use of effective treatments, but whether such programs can impact hard clinical outcomes has never been demonstrated in a well-powered randomized controlled trial.

Design

The CPACS-3 study is a stepped-wedge cluster-randomized trial conducted in 104 remote level 2 hospitals without PCI facilities in China. All hospitalized ACS patients will be recruited consecutively over a 30-month period to an anticipated total study population of more than 25,000 patients. After a 6-month baseline period, hospitals will be randomized to 1 of 4 groups, and a 6-component quality improvement intervention will be implemented sequentially in each group every 6 months. These components include the following: establishment of a quality improvement team, implementation of a clinical pathway, training of physicians and nurses, hospital performance audit and feedback, online technical support, and patient education. All patients will be followed up for 6 months postdischarge. The primary outcome will be the incidence of in-hospital major adverse cardiovascular events comprising all-cause mortality, myocardial infarction or reinfarction, and nonfatal stroke.

Conclusions

The CPACS-3 study will be the first large randomized trial with sufficient power to assess the effects of a multifaceted quality of care improvement initiative on hard clinical outcomes, in patients with ACS.

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

References (33)

  • A.G. Turpie

    Burden of disease: medical and economic impact of acute coronary syndromes

    Am J Manag Care

    (2006)
  • F.G. Kushner et al.

    2009 Focused updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction (updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (updating the 2005 Guideline and 2007 Focused Update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines

    Circulation

    (2009)
  • J.L. Anderson et al.

    2011 ACCF/AHA focused update incorporated into the ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines

    Circulation

    (2011)
  • O. Berwanger et al.

    Effect of a multifaceted intervention on use of evidence-based therapies in patients with acute coronary syndromes in Brazil: the BRIDGE-ACS randomized trial

    JAMA

    (2012)
  • Z.M. Chen et al.

    Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial

    Lancet

    (2005)
  • E.D. Peterson et al.

    Association between hospital process performance and outcomes among patients with acute coronary syndromes

    JAMA

    (2006)
  • 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 Cardiology
      Citation 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 Journal
      Citation 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 Journal
      Citation 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 Lancet
      Citation 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.

    View all citing articles on Scopus

    David A. Morrow, MD, MPH, served as guest editor for this article.

    NCT01398228

    View full text