跳至主要内容
临床试验/NCT02430012
NCT02430012已完成不适用

Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Secondary Prevention

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 10,009 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10,009
试验地点
1
主要终点
statins use at discharge

研究概览

简要总结

The investigators have identified underuse of secondary prevention medications at discharge of patients underwent coronary artery bypass grafting (CABG) in China. The aim of this study is to develop series of quality improvement strategies focusing on secondary prevention medications for patients underwent CABG, and to evaluate their effectiveness and safety via a hospital-level cluster randomized clinical trial. The investigators established a network of 60 hospitals which have participated into Chinese Cardiovascular Surgery Registry and submitted 50 or more CABG surgeries already. The participating sites will be divided into intervention and control groups in a 1:1 ratio. The intervention group will undertake intervention of quality improvement strategies, while the control group will maintain the routine practice pattern. All hospitals will consecutively enroll and submit data of CABG during the enrollment period, estimated for 6 months. The prescribing rates of angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), beta-blockers, statins and aspirins will be compared between 2 groups.

详细描述

The investigators have identified underuse of secondary prevention medications at discharge of patients underwent coronary artery bypass grafting (CABG) in China. The aim of this study is to develop series of quality improvement strategies focusing on secondary prevention medications for patients underwent CABG, and to evaluate their effectiveness and safety via a hospital-level cluster randomized clinical trial. The investigators established a network of 60 hospitals which have participated into Chinese Cardiovascular Surgery Registry and submitted 50 or more CABG surgeries already. The participating sites will be divided into intervention and control groups in a 1:1 ratio. The intervention group will undertake intervention of quality improvement strategies, while the control group will maintain the routine practice pattern. All hospitals will consecutively enroll and submit data of CABG during the enrollment period of estimated 6 months. The prescription rates of ACEI, ARB, beta-blockers, statins and aspirins will be compared between 2 groups.

Before the enrollment period, the investigators have developed series of quality improvement strategies focusing on secondary prevention medications for patients underwent CABG, including training with guidelines of secondary preventions, determining improvement goals with participating sites, intervention tools (workflow posters and cards, checklists to inform the use of secondary prevention medications) and periodical quality feedback reports.

In the enrollment period, participating hospitals will be divided into intervention and control groups in a 1:1 ratio using minimization allocation.

The investigators will collect data on the prescription rates from central medical record abstraction, case report forms submitted by participating sites and checklists submitted by intervention groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes assessor and data extractors were blind to the results of randomization

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients underwent CABG during the enrollment period in participating sites

排除标准

  • •Patients who die during hospitalization
  • •Patients who withdrawn from hospital against doctors' recommendations
  • •Patients who transfer out to other medical care institutions without discharge prescription

研究组 & 干预措施

Intervention group

Active Comparator

The intervention group will take the secondary prevention quality improvement strategies into implementation.

干预措施: Quality improvement strategies (Behavioral)

Control group

No Intervention

The control goup will maintain the routine practice pattern.

结局指标

主要结局

statins use at discharge

时间窗: 14 days on average (during hospitalization)

Proportion of statins prescription at discharge among eligible patients

次要结局

  • ACEI/ARBs use at discharge(14 days on average (during hospitalization))
  • β-blockers use at discharge(14 days on average (during hospitalization))
  • aspirins use at discharge(14 days on average (during hospitalization))

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验