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.
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.


METHODS
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 6months. 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 6months 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.
The George Institute for Global Health at Peking University Health Science Center (PUHSC), Beijing, China.
Shenshen
S
Li
The George Institute for Global Health at Peking University Health Science Center (PUHSC), Beijing, China; Peking University Clinical Research Institute, Beijing, China. Electronic address: ywu@georgeinstitute.org.cn.
Yangfeng
Y
Wu
The George Institute for Global Health at Peking University Health Science Center (PUHSC), Beijing, China; Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Xin
X
Du
The George Institute for Global Health at Peking University Health Science Center (PUHSC), Beijing, China.
Xian
X
Li
The George Institute for Global Health, University of Sydney, Sydney, Australia.
Anushka
A
Patel
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Eric D
ED
Peterson
The George Institute for Global Health, University of Sydney, Sydney, Australia.
Fiona
F
Turnbull
The George Institute for Global Health, University of Sydney, Sydney, Australia.
Serigne
S
Lo
The George Institute for Global Health, University of Sydney, Sydney, Australia.
Laurent
L
Billot
The George Institute for Global Health, University of Sydney, Sydney, Australia.
Tracey
T
Laba
The Department of Cardiology, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Runlin
R
Gao
D054058:Acute Coronary Syndrome / Q000150:complications / Q000628:therapy*; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control*; D002681:China; D019091:Critical Pathways; D006801:Humans; D009203:Myocardial Infarction / Q000453:epidemiology; D017063:Outcome Assessment, Health Care; D058996:Quality Improvement / Q000458:organization & administration*; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012107:Research Design; D055502:Secondary Prevention; D020521:Stroke / Q000453:epidemiology