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

NCT02430012 | Completed DMC

• 1 other identifier: MOST-2013BAI09B01-2
• Study Type: interventional
• Target: 10,009
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass Grafting; Secondary Preventions

Keywords

coronary artery bypass grafting; quality improvement; secondary preventions

Outcome Measures

Primary Outcomes (1)

• statins use at discharge

  Proportion of statins prescription at discharge among eligible patients

  14 days on average (during hospitalization)

Secondary Outcomes (3)

• ACEI/ARBs use at discharge

  14 days on average (during hospitalization)

• β-blockers use at discharge

  14 days on average (during hospitalization)

• aspirins use at discharge

  14 days on average (during hospitalization)

Other Outcomes (4)

• education on smoking cessation at discharge

  14 days on average (during hospitalization)

• education on glycemic control at discharge

  14 days on average (during hospitalization)

• education on moderate exercise at discharge

  14 days on average (during hospitalization)

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

The intervention group will take the secondary prevention quality improvement strategies into implementation.

Behavioral: Quality improvement strategies

Control group

NO INTERVENTION

The control goup will maintain the routine practice pattern.

Interventions

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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients underwent CABG during the enrollment period in participating sites

You may not qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Location

Study Officials

• 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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor and data extractors were blind to the results of randomization
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2015
• First Posted: April 29, 2015
• Study Start: June 1, 2015
• Primary Completion: September 18, 2016
• Study Completion: September 1, 2017
• Last Updated: March 21, 2019

Record last verified: 2015-06

Locations

CN (1)