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

March 19, 2019 updated by: China National Center for Cardiovascular Diseases
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10009

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
statins use at discharge
Time Frame: 14 days on average (during hospitalization)
Proportion of statins prescription at discharge among eligible patients
14 days on average (during hospitalization)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ACEI/ARBs use at discharge
Time Frame: 14 days on average (during hospitalization)
Proportion of β-blockers prescription at discharge among eligible patients
14 days on average (during hospitalization)
β-blockers use at discharge
Time Frame: 14 days on average (during hospitalization)
Proportion of β-blockers prescription at discharge among eligible patients
14 days on average (during hospitalization)
aspirins use at discharge
Time Frame: 14 days on average (during hospitalization)
Proportion of aspirins prescription at discharge among eligible patients
14 days on average (during hospitalization)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
education on smoking cessation at discharge
Time Frame: 14 days on average (during hospitalization)
Proportion of education on smoking cessation at discharge among eligible patients
14 days on average (during hospitalization)
education on glycemic control at discharge
Time Frame: 14 days on average (during hospitalization)
Proportion of education on glycemic control at discharge among eligible patients
14 days on average (during hospitalization)
education on moderate exercise at discharge
Time Frame: 14 days on average (during hospitalization)
Proportion of education on moderate exercise at discharge among eligible patients
14 days on average (during hospitalization)
education on weight control at discharge
Time Frame: 14 days on average (during hospitalization)
Proportion of education on weight control at discharge among eligible patients
14 days on average (during hospitalization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOST-2013BAI09B01-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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