Clinical trial NCT02430012: Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Secondary Prevention
Official title: Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Secondary Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Grafting
Secondary Preventions
Keywords: coronary artery bypass grafting
quality improvement
secondary preventions
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2015-04-29
Enrollment: 10009
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: statins use at discharge
timeFrame: 14 days on average (during hospitalization)
Secondary outcomes:
measure: ACEI/ARBs use at discharge
timeFrame: 14 days on average (during hospitalization)
measure: β-blockers use at discharge
timeFrame: 14 days on average (during hospitalization)
measure: aspirins use at discharge
timeFrame: 14 days on average (during hospitalization)
Other outcomes:
measure: education on smoking cessation at discharge
timeFrame: 14 days on average (during hospitalization)
measure: education on glycemic control at discharge
timeFrame: 14 days on average (during hospitalization)
measure: education on moderate exercise at discharge
timeFrame: 14 days on average (during hospitalization)
measure: education on weight control at discharge
timeFrame: 14 days on average (during hospitalization)
Locations:
city: Beijing
country: China
facility: China National Center for Cardiovascular Diseases
state: Beijing
Study officials:
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
name: Shengshou Hu, MD, PhD
role: STUDY_DIRECTOR
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
name: Zhe Zheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: