Coronary Artery Bypass GraftingMISSION-1NCT02430012
Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Secondary Prevention
A study testing Quality improvement strategies in people with Coronary Artery Bypass Grafting and Secondary Preventions, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Bypass Grafting, Secondary Preventions
- What is being tested?
- Quality improvement strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,009 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients underwent CABG during the enrollment period in participating sites
Who cannot join
- 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- Patients who withdrawn from hospital against doctors' recommendations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
Trial locations and contacts
1 site in 1 country.
China1 site
China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
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, 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.
Read the 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.
- Being tested
- Quality improvement strategies
- Keywords
- coronary artery bypass grafting, quality improvement, secondary preventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality improvement strategiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | The intervention group will take the secondary prevention quality improvement strategies into implementation. Receives: Behavioral: Quality improvement strategies |
| Control group | No intervention | The control goup will maintain the routine practice pattern. |
What is being measured
The primary outcome is the main question the study is designed to answer.
statins use at discharge
Proportion of statins prescription at discharge among eligible patients
Measured: 14 days on average (during hospitalization)
Secondary outcomes (3)
ACEI/ARBs use at discharge
Proportion of β-blockers prescription at discharge among eligible patients
Measured: 14 days on average (during hospitalization)
β-blockers use at discharge
Proportion of β-blockers prescription at discharge among eligible patients
Measured: 14 days on average (during hospitalization)
aspirins use at discharge
Proportion of aspirins prescription at discharge among eligible patients
Measured: 14 days on average (during hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJun 2015
- Primary completion18 Sep 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10,009 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shengshou Hu, MD, PhD, Study director, 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 ChinaZhe Zheng, MD, PhD, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430012
- Sponsor's protocol ID
- MOST-2013BAI09B01-2
- Acronym
- MISSION-1
- Status last verified
- Jun 2015
- First submitted
- 25 Apr 2015
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Secondary Prevention
- ClinicalTrials.gov ID
- NCT02430012
- Acronym / sponsor ID
- MISSION-1 / MOST-2013BAI09B01-2
- Keywords
- coronary artery bypass grafting, quality improvement, secondary preventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,009 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- Jun 2015
- Primary completion
- 18 Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Quality improvement strategiesThe intervention group will take the secondary prevention quality improvement strategies into implementation. |
| Control group | No intervention | –The control goup will maintain the routine practice pattern. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients underwent CABG during the enrollment period in participating sites
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality improvement strategiesTraining 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. | Behavioural | Intervention group |
Primary outcome
statins use at discharge
Time frame: 14 days on average (during hospitalization)
Proportion of statins prescription at discharge among eligible patients
3 secondary outcomes
ACEI/ARBs use at discharge
Time frame: 14 days on average (during hospitalization)
β-blockers use at discharge
Time frame: 14 days on average (during hospitalization)
aspirins use at discharge
Time frame: 14 days on average (during hospitalization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
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Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengshou Hu, MD, PhD study director
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
Zhe Zheng, MD, PhD principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality improvement strategies in people with Coronary Artery Bypass Grafting and Secondary Preventions, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
statins use at discharge (time frame: 14 days on average (during hospitalization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.