China PEACE II: Quality Improvement for Acute Myocardial Infarction
- Conditions
- Acute Myocardial Infarction
- Interventions
- Behavioral: Quality improvement strategies and toolsBehavioral: Process optimization
- Registration Number
- NCT02322944
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8000
- Patients with STEMI who arrive at the hospital within 12 hours from the symptoms onset.
- Received reperfusionthrombolytic therapy before the index hospitalization;
- AMI occurring during hospitalization;
- Chest trauma resulting in secondary acute myocardial infarction.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Quality improvement strategies and tools The intervention group will take the treatment quality improvement strategies and tools into implementation. Process optimization group Quality improvement strategies and tools The process optimization group's clinical pathways and team building will be re-organized for the purpose of quality improvement, and develop individualized treatment strategies and process. Process optimization group Process optimization The process optimization group's clinical pathways and team building will be re-organized for the purpose of quality improvement, and develop individualized treatment strategies and process.
- Primary Outcome Measures
Name Time Method Reperfusion therapy rate 24 hours after admission Reperfusion therapy rate is defined as utilization rate of thrombolytic therapy or primary PCI treatment among patients indicated with the reperfusion therapy.
- Secondary Outcome Measures
Name Time Method Timeliness of thrombolytic therapy 24 hours after admission Door to needle (D2N) time
Timeliness of primary PCI 24 hours after admission Door to balloon (D2B) time
Trial Locations
- Locations (1)
Qinyang People's Hospital
🇨🇳Jiaozuo, Henan, China