Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Secondary Prevention (MISSION-1)
Primary Purpose
Coronary Artery Bypass Grafting, Secondary Preventions
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Quality improvement strategies
Sponsored by
About this trial
This is an interventional health services research trial for Coronary Artery Bypass Grafting focused on measuring coronary artery bypass grafting, quality improvement, secondary preventions
Eligibility Criteria
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- Patients who withdrawn from hospital against doctors' recommendations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
Sites / Locations
- China National Center for Cardiovascular Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention group
Control group
Arm Description
The intervention group will take the secondary prevention quality improvement strategies into implementation.
The control goup will maintain the routine practice pattern.
Outcomes
Primary Outcome Measures
statins use at discharge
Proportion of statins prescription at discharge among eligible patients
Secondary Outcome Measures
ACEI/ARBs use at discharge
Proportion of β-blockers prescription at discharge among eligible patients
β-blockers use at discharge
Proportion of β-blockers prescription at discharge among eligible patients
aspirins use at discharge
Proportion of aspirins prescription at discharge among eligible patients
Full Information
NCT ID
NCT02430012
First Posted
April 25, 2015
Last Updated
March 19, 2019
Sponsor
China National Center for Cardiovascular Diseases
1. Study Identification
Unique Protocol Identification Number
NCT02430012
Brief Title
Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Secondary Prevention
Acronym
MISSION-1
Official Title
Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Secondary Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 18, 2016 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass Grafting, Secondary Preventions
Keywords
coronary artery bypass grafting, quality improvement, secondary preventions
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was a cluster randomized controlled trial to test the effectiveness of a smartphone-based multifaceted intervention. Sixty hospitals were randomized to the intervention group (n=30) or control group (n=30). Clinicians at intervention hospitals received multifaceted interventions (i.e., centralized training, evidenced-based checklists, and performance monitoring and feedback report) aimed at improving discharge prescription adherence, while those at control hospitals maintained routine practice.
Masking
Outcomes Assessor
Masking Description
Outcomes assessor and data extractors were blind to the results of randomization
Allocation
Randomized
Enrollment
10009 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
The intervention group will take the secondary prevention quality improvement strategies into implementation.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control goup will maintain the routine practice pattern.
Intervention Type
Behavioral
Intervention Name(s)
Quality improvement strategies
Intervention Description
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.
Primary Outcome Measure Information:
Title
statins use at discharge
Description
Proportion of statins prescription at discharge among eligible patients
Time Frame
14 days on average (during hospitalization)
Secondary Outcome Measure Information:
Title
ACEI/ARBs use at discharge
Description
Proportion of β-blockers prescription at discharge among eligible patients
Time Frame
14 days on average (during hospitalization)
Title
β-blockers use at discharge
Description
Proportion of β-blockers prescription at discharge among eligible patients
Time Frame
14 days on average (during hospitalization)
Title
aspirins use at discharge
Description
Proportion of aspirins prescription at discharge among eligible patients
Time Frame
14 days on average (during hospitalization)
Other Pre-specified Outcome Measures:
Title
education on smoking cessation at discharge
Description
Proportion of education on smoking cessation at discharge among eligible patients
Time Frame
14 days on average (during hospitalization)
Title
education on glycemic control at discharge
Description
Proportion of education on glycemic control at discharge among eligible patients
Time Frame
14 days on average (during hospitalization)
Title
education on moderate exercise at discharge
Description
Proportion of education on moderate exercise at discharge among eligible patients
Time Frame
14 days on average (during hospitalization)
Title
education on weight control at discharge
Description
Proportion of education on weight control at discharge among eligible patients
Time Frame
14 days on average (during hospitalization)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengshou Hu, MD, PhD
Organizational Affiliation
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
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zhe Zheng, MD, PhD
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
China National Center for Cardiovascular Diseases
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
12. IPD Sharing Statement
Learn more about this trial
Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Secondary Prevention
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