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Completed

NCT Number: NCT02430012

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality improvement strategies

Behavioral

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 outcomes

  1. statins use at discharge

    Time frame: 14 days on average (during hospitalization)

    Proportion of statins prescription at discharge among eligible patients

Secondary outcomes

  1. ACEI/ARBs use at discharge

    Time frame: 14 days on average (during hospitalization)

    Proportion of β-blockers prescription at discharge among eligible patients

  2. β-blockers use at discharge

    Time frame: 14 days on average (during hospitalization)

    Proportion of β-blockers prescription at discharge among eligible patients

  3. aspirins use at discharge

    Time frame: 14 days on average (during hospitalization)

    Proportion of aspirins prescription at discharge among eligible patients

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Acronym: MISSION-1

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 29, 2015
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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