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

Coronary Artery Bypass Grafting Clinical Trial

— MISSION-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430012
• Other study ID #: MOST-2013BAI09B01-2
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: September 2017

Study information

• Verified date: June 2015
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10009
• Est. completion date: September 2017
• Est. primary completion date: September 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting
• Neoplasm Metastasis
• Secondary Preventions

Intervention

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.

Locations

Country	Name	City	State
China	China National Center for Cardiovascular Diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	education on smoking cessation at discharge	Proportion of education on smoking cessation at discharge among eligible patients	14 days on average (during hospitalization)
Other	education on glycemic control at discharge	Proportion of education on glycemic control at discharge among eligible patients	14 days on average (during hospitalization)
Other	education on moderate exercise at discharge	Proportion of education on moderate exercise at discharge among eligible patients	14 days on average (during hospitalization)
Other	education on weight control at discharge	Proportion of education on weight control at discharge among eligible patients	14 days on average (during hospitalization)
Primary	statins use at discharge	Proportion of statins prescription at discharge among eligible patients	14 days on average (during hospitalization)
Secondary	ACEI/ARBs use at discharge	Proportion of ß-blockers prescription at discharge among eligible patients	14 days on average (during hospitalization)
Secondary	ß-blockers use at discharge	Proportion of ß-blockers prescription at discharge among eligible patients	14 days on average (during hospitalization)
Secondary	aspirins use at discharge	Proportion of aspirins prescription at discharge among eligible patients	14 days on average (during hospitalization)