Clinical trial NCT02322944: China PEACE II: Quality Improvement for Acute Myocardial Infarction
Official title: China Patient-centered Evaluative Assessment of Cardiac Events II: Quality Improvement for Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: acute myocardial infarction
quality improvement
reperfusion therapy
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2014-12-23
Enrollment: 8000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to develop quality improvement strategies and relevant tools focusing on reperfusion therapy in patients with STEMI, and to evaluate their effectiveness via a hospital-level cluster randomized clinical trial, based on the nationally representative collaborative network of over 100 hospitals established in China PEACE retrospective study. In a baseline survey period, through consecutively recruiting all eligible inpatients and collecting relevant medical information, the performance of all participating hospitals before the implementation of the intervention will be assessed. During the following intervention period, 6-10 hospitals that show the strong willingness and ability to collaborate will be selected as "process optimization group". Their clinical pathways and team building will be re-organized for the purpose of quality improvement, and develop individualized treatment strategies and process. Meanwhile, other participating hospitals will be divided into intervention and control groups in a 1:1 ratio, in which the intervention group will take the treatment improvement strategy into implementation, while the control group will maintain the routine practice pattern. All hospitals will consecutively recruit qualified patients in the same method adopted in baseline period. Then the reperfusion rates and other performance measures will be compared among different groups (process optimization, intervention and control).

Detailed description: This study aims to develop quality improvement strategies and relevant tools focusing on reperfusion therapy in patients with STEMI, and to evaluate their effectiveness via a hospital-level cluster randomized clinical trial, based on the nationally representative collaborative network of over 100 hospitals established in China PEACE retrospective study. The primary outcome measure is reperfusion rate among eligible patients with STEMI, and secondary ones include timeliness of primary PCI (D2B) and fibrinolytic therapy (D2N). the assessment is based on consecutively recruiting all eligible inpatients, as well as collecting relevant medical information via a case report form finished by local doctors and central medical record abstraction.

During the first study period, the baseline performance of all 100 participating hospitals before the implementation of the intervention will be assessed.

During the following period, 3-5 PCI-capable and 3-5 non-PCI capable hospitals that show the strong willingness and ability to collaborate will be selected as "process optimization group". Their clinical pathways and team building will be re-organized for the purpose of quality improvement, and develop individualized treatment strategies and process, including examining local hospitals' workflow to determine the key link affecting the rate of reperfusion therapy and its timeliness (such as pre-paid policy for fibrinolytic or PPCI, thrombolytic drug preparation, cardiac catheterization laboratory preparation, transferring from the ER to the Cath lab, interventional medical team gathering, etc.). Also, QI strategies and tools developed in the current study will be provided to these hospital, including training in standardized treatment pattern; building quality management team and determining improvement goals; periodical quality feedback report and regular quality meeting; tools like a wristband in order to remind all medical staff involved in the treatment process, workflow posters and cards, a CRF including a flowchart to inform the management steps, study website serving as the communication platform.

Meanwhile, other participating hospitals will be divided into intervention and control groups in a 1:1 ratio using minimization allocation, in which the intervention group will take the QI strategies and tools developed in the current study as mentioned above, while the control group will maintain the routine practice pattern. Then the outcome measures and other performance indicators will be compared among different groups (process optimization, intervention and control).

Eligibility criteria: Inclusion Criteria:

* Patients with STEMI who arrive at the hospital within 12 hours from the symptoms onset.

Exclusion Criteria:

* Received reperfusionthrombolytic therapy before the index hospitalization;
* AMI occurring during hospitalization;
* Chest trauma resulting in secondary acute myocardial infarction.

Primary outcomes:
measure: Reperfusion therapy rate
timeFrame: 24 hours after admission
Secondary outcomes:
measure: Timeliness of primary PCI
timeFrame: 24 hours after admission
measure: Timeliness of thrombolytic therapy
timeFrame: 24 hours after admission
measure: Timeliness of primary PCI
timeFrame: 24 hours after admission
measure: Timeliness of thrombolytic therapy
timeFrame: 24 hours after admission
Other outcomes:
measure: In-hospital mortality
timeFrame: 10 days on average (during hospitalization)
measure: Aspirin use within 24 hours
timeFrame: 24 hours after admission
measure: Heparin use within 24 hours
timeFrame: 24 hours after admission
measure: Evaluation of left ventricular function
timeFrame: 24 hours after admission
measure: β-blockers use during hospitalization
timeFrame: 10 days on average (during hospitalization)
measure: Statins use during hospitalization
timeFrame: 10 days on average (during hospitalization)
measure: ACEI/ARB use during hospitalization
timeFrame: 10 days on average (during hospitalization)
measure: Aspirin use at discharge
timeFrame: 10 days on average (during hospitalization)
measure: Clopidogrel (or ticagrelor) use at discharge
timeFrame: 10 days on average (during hospitalization)
measure: β-blockers use at discharge
timeFrame: 10 days on average (during hospitalization)
measure: ACEI/ARB use at discharge
timeFrame: 10 days on average (during hospitalization)
measure: Statins use at discharge
timeFrame: 10 days on average (during hospitalization)
Locations:
city: Jiaozuo
country: China
facility: Qinyang People's Hospital
state: Henan
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases
name: Lixin Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: