China PEACE II: Quality Improvement for Acute Myocardial Infarction (PEACE-QI-AMI)

China Patient-centered Evaluative Assessment of Cardiac Events II: Quality Improvement for Acute Myocardial Infarction

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).

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Behavioral: Quality improvement strategies and tools; Behavioral: Process optimization

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).

• Study Type: Interventional
• Enrollment (Actual): 8000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Jiaozuo, Henan, China
      • Qinyang People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention group will take the treatment quality improvement strategies and tools into implementation.	Behavioral: Quality improvement strategies and tools; Training in standardized treatment pattern; building quality management team and determining improvement goals; tools (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); periodical quality feedback report and regular quality meeting; study website serving as the communication platform.
No Intervention: Control group; The control group will maintain the routine practice pattern.
Experimental: Process optimization group; 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.	Behavioral: Quality improvement strategies and tools; Training in standardized treatment pattern; building quality management team and determining improvement goals; tools (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); periodical quality feedback report and regular quality meeting; study website serving as the communication platform.; Behavioral: Process optimization; Examining local hospitals' workflow to determine the key link affecting the rate of reperfusion therapy and its timeliness (such as thrombolytic drug preparation, cardiac catheterization laboratory preparation, transferring from the ER to the cath lab, interventional medical team gathering, etc.) and systems (such as pre-paid policy for thrombolysis or PPCI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reperfusion therapy rate	Reperfusion therapy rate is defined as utilization rate of thrombolytic therapy or primary PCI treatment among patients indicated with the reperfusion therapy.	24 hours after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeliness of thrombolytic therapy	The proportion of door to needle time (D2N) within 30 minutes among all patients receiving fibrinolytic therapy.	24 hours after admission
Timeliness of primary PCI	The proportion of door to balloon (D2B) within 90 minutes among all patients receiving PPCI.	24 hours after admission
Timeliness of primary PCI	Door to balloon (D2B) time	24 hours after admission
Timeliness of thrombolytic therapy	Door to needle (D2N) time	24 hours after admission

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
β-blockers use during hospitalization	Proportion of β-blockers use during hospitalization among eligible patients.	10 days on average (during hospitalization)
Statins use during hospitalization	Proportion of statins use during hospitalization among eligible patients.	10 days on average (during hospitalization)
Aspirin use at discharge	Proportion of aspirin use at discharge among eligible patients.	10 days on average (during hospitalization)
Clopidogrel (or ticagrelor) use at discharge	Proportion of Clopidogrel (or ticagrelor) use at discharge among eligible patients.	10 days on average (during hospitalization)
β-blockers use at discharge	Proportion of β-blockers use at discharge among eligible patients.	10 days on average (during hospitalization)
Statins use at discharge	Proportion of statins use at discharge among eligible patients.	10 days on average (during hospitalization)
In-hospital mortality	Proportion of in-hospital mortality or withdraw treatment due to a terminal status at discharge.	10 days on average (during hospitalization)
Aspirin use within 24 hours	Proportion of aspirin use within 24 hours of admission among eligible patients	24 hours after admission
Heparin use within 24 hours	Proportion of heparin use within 24 hours of admission among eligible patients	24 hours after admission
Evaluation of left ventricular function	Proportion of left ventricular function evaluation within 24 hours of admission among all patients.	24 hours after admission
ACEI/ARB use during hospitalization	Proportion of ACEI/ARB use during hospitalization among eligible patients.	10 days on average (during hospitalization)
ACEI/ARB use at discharge	Proportion of ACEI/ARB use at discharge among eligible patients.	10 days on average (during hospitalization)

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Lixin Jiang, MD, PhD, Fuwai Hospital, National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 15, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (Estimate): December 23, 2014

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: acute myocardial infarction; quality improvement; reperfusion therapy
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: MOST-2013BAI09B01