Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Secondary Prevention (MISSION-1)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Bypass Grafting; Secondary Preventions
• Intervention / Treatment: Behavioral: Quality improvement strategies

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10009
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • China National Center for Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients underwent CABG during the enrollment period in participating sites

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; The intervention group will take the secondary prevention quality improvement strategies into implementation.	Behavioral: Quality improvement strategies; Training with guidelines of secondary preventions; determining improvement goals; tools (workflow posters and cards, checklists to inform the use of secondary prevention medications); periodical quality feedback report.
No Intervention: Control group; The control goup will maintain the routine practice pattern.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
statins use at discharge	Proportion of statins prescription at discharge among eligible patients	14 days on average (during hospitalization)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACEI/ARBs use at discharge	Proportion of β-blockers prescription at discharge among eligible patients	14 days on average (during hospitalization)
β-blockers use at discharge	Proportion of β-blockers prescription at discharge among eligible patients	14 days on average (during hospitalization)
aspirins use at discharge	Proportion of aspirins prescription at discharge among eligible patients	14 days on average (during hospitalization)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
education on smoking cessation at discharge	Proportion of education on smoking cessation at discharge among eligible patients	14 days on average (during hospitalization)
education on glycemic control at discharge	Proportion of education on glycemic control at discharge among eligible patients	14 days on average (during hospitalization)
education on moderate exercise at discharge	Proportion of education on moderate exercise at discharge among eligible patients	14 days on average (during hospitalization)
education on weight control at discharge	Proportion of education on weight control at discharge among eligible patients	14 days on average (during hospitalization)

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Study Director: Shengshou Hu, MD, PhD, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China; Principal Investigator: Zhe Zheng, MD, PhD, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): September 18, 2016
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: April 25, 2015
• First Submitted That Met QC Criteria: April 25, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: coronary artery bypass grafting; quality improvement; secondary preventions
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: MOST-2013BAI09B01-2