- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07377149
Improving the Quality of Coronary Artery Bypass Grafting (CABG Quality)
Quality Improvement Intervention on Utilization of Arterial Grafts for Coronary Artery Bypass Grafting
This is a healthcare quality improvement study focused on increasing the utilization of arterial grafts in isolated coronary artery bypass grafting (CABG). Evidence indicates that arterial grafts, compared with venous grafts, provide superior long-term patency, which are recommended to use by the clinical practice guidelines.
In hospitals where the use of the internal mammary artery as a graft is relatively low(<90%) among CABG patients, multiple interventions will be implemented to improve its adoption rate.
In hospitals where internal mammary artery graft utilization is already high(≥90%), various interventions will be introduced to promote the use of multiple arterial grafts (defined as the use of two or more arterial conduits).
The study targets healthcare professionals as the primary subjects of intervention, with no direct interventions applied to patients during the study period. Changes in the internal mammary artery graft utilization rate and the multiple arterial graft utilization rate before and after the intervention will serve as the primary endpoints for evaluating intervention effectiveness in the two types of hospitals, respectively.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zhe Zheng, MD, PhD
- Phone Number: +86 88396051
- Email: zhengzhe@fuwai.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Patients whose data used to monitor the quality
Inclusion Criteria:
Aged ≥ 18 years old; Indicated for CABG and undergoing CABG.
Exclusion Criteria:
History of prior CABG; Concurrent other cardiac surgeries on the day of CABG; Malignant tumor or life expectancy < 1 year;
- 50% stenosis of left subclavian artery; Pregnant women; Individuals diagnosed with mental illness or cognitive impairment (International Classification of Diseases-10 codes F01-F99); Patients considered by the investigator to have other factors unsuitable for inclusion.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Improving the utilization rate of arterial grafts for coronary artery bypass grafting
In this stepped-wedge cluster randomized trial (SW-CRT) with a self-controlled design, hospitals were categorized into two groups according to their internal mammary artery graft usage rates, thereby forming two SW-CRT.
Healthcare professionals at these hospitals will receive tailored interventions.
The effectiveness of each intervention is assessed by comparing the usage rates before and after implementation within each SW-CRT.
|
Hospitals with low usage rates aim to improve internal mammary artery graft utilization through interventions including education, theoretical training, technical training, conference exchanges, and regular feedback on quality monitoring results.
Hospitals with already high usage rates focus on increasing multi-arterial graft usage rates through similar intervention methods such as education, theoretical training, technical training, conference exchanges focus on multi-arterial graft use.
The usage rates of multi-arterial graft for each hospital will be regular feed backed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospitals with low usage rates of internal mammary artery: internal mammary artery graft utilization rate
Time Frame: Duration of hospital stay(from date of admission to date of discharge)
|
Internal mammary artery graft utilization rate: the utilization rate of at least one internal mammary artery graft in patients received isolated coronary artery bypass grafting.
|
Duration of hospital stay(from date of admission to date of discharge)
|
|
Hospitals with high usage rates of internal mammary artery: multiple arterial graft utilization rate
Time Frame: Duration of hospital stay(from date of admission to date of discharge)
|
Multiple arterial graft utilization rate: the utilization rate of two or more arterial conduits in patients received isolated coronary artery bypass grafting.
|
Duration of hospital stay(from date of admission to date of discharge)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
In-hospital all-cause mortality rate
Time Frame: Duration of hospital stay(from date of admission to date of discharge)
|
The in-hospital all-cause mortality rate of patients received isolated coronary artery bypass grafting.
|
Duration of hospital stay(from date of admission to date of discharge)
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-2849
- 2025ZD0546704 (Other Identifier: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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