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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... Full description

Journal Title: The American heart journal 2014, Vol.169 (3), p.349-355
Main Author: Li, Shenshen, MPH
Other Authors: Wu, Yangfeng, MD, PhD , Du, Xin, MD, PhD , Li, Xian, MD, MSc , Patel, Anushka, MD, PhD , Peterson, Eric D., MD, MPH , Turnbull, Fiona, MD, PhD , Lo, Serigne, PhD , Billot, Laurent, MSc , Laba, Tracey, PhD , Gao, Runlin, MD, MSc
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: United States: Elsevier Inc
ID: ISSN: 0002-8703
Link: https://www.ncbi.nlm.nih.gov/pubmed/25728724
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title: 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
format: Article
creator:
  • Li, Shenshen, MPH
  • Wu, Yangfeng, MD, PhD
  • Du, Xin, MD, PhD
  • Li, Xian, MD, MSc
  • Patel, Anushka, MD, PhD
  • Peterson, Eric D., MD, MPH
  • Turnbull, Fiona, MD, PhD
  • Lo, Serigne, PhD
  • Billot, Laurent, MSc
  • Laba, Tracey, PhD
  • Gao, Runlin, MD, MSc
subjects:
  • Abridged Index Medicus
  • Acute Coronary Syndrome - complications
  • Acute Coronary Syndrome - therapy
  • Acute coronary syndromes
  • Angina pectoris
  • Cardiac patients
  • Cardiovascular
  • Cardiovascular Diseases - epidemiology
  • Cardiovascular Diseases - prevention & control
  • China
  • Clinical outcomes
  • Clinical trials
  • Coronary heart disease
  • Critical Pathways
  • Drug therapy
  • Evaluation
  • Heart attacks
  • Hospitalization
  • Hospitals
  • Humans
  • Myocardial Infarction - epidemiology
  • Outcome Assessment (Health Care)
  • Quality control
  • Quality Improvement - organization & administration
  • Randomized Controlled Trials as Topic
  • Recurrence
  • Research Design
  • Secondary Prevention
  • Stroke - epidemiology
ispartof: The American heart journal, 2014, Vol.169 (3), p.349-355
description: 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.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0002-8703
fulltext: fulltext
issn:
  • 0002-8703
  • 1097-6744
url: Link


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titleRational 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
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creatorLi, Shenshen, MPH ; Wu, Yangfeng, MD, PhD ; Du, Xin, MD, PhD ; Li, Xian, MD, MSc ; Patel, Anushka, MD, PhD ; Peterson, Eric D., MD, MPH ; Turnbull, Fiona, MD, PhD ; Lo, Serigne, PhD ; Billot, Laurent, MSc ; Laba, Tracey, PhD ; Gao, Runlin, MD, MSc
creatorcontribLi, Shenshen, MPH ; Wu, Yangfeng, MD, PhD ; Du, Xin, MD, PhD ; Li, Xian, MD, MSc ; Patel, Anushka, MD, PhD ; Peterson, Eric D., MD, MPH ; Turnbull, Fiona, MD, PhD ; Lo, Serigne, PhD ; Billot, Laurent, MSc ; Laba, Tracey, PhD ; Gao, Runlin, MD, MSc ; CPACS-3 investigators
descriptionBackground 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.
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subjectAbridged Index Medicus ; Acute Coronary Syndrome - complications ; Acute Coronary Syndrome - therapy ; Acute coronary syndromes ; Angina pectoris ; Cardiac patients ; Cardiovascular ; Cardiovascular Diseases - epidemiology ; Cardiovascular Diseases - prevention & control ; China ; Clinical outcomes ; Clinical trials ; Coronary heart disease ; Critical Pathways ; Drug therapy ; Evaluation ; Heart attacks ; Hospitalization ; Hospitals ; Humans ; Myocardial Infarction - epidemiology ; Outcome Assessment (Health Care) ; Quality control ; Quality Improvement - organization & administration ; Randomized Controlled Trials as Topic ; Recurrence ; Research Design ; Secondary Prevention ; Stroke - epidemiology
ispartofThe American heart journal, 2014, Vol.169 (3), p.349-355
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descriptionBackground 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.
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titleRational 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
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atitleRational 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
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abstractBackground 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.
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pmid25728724
doi10.1016/j.ahj.2014.12.005