China PEACE II: Quality Improvement for Acute Myocardial Infarction

NCT ID: NCT02322944

Last Updated: 2016-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-07-31

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).

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intervention group

The intervention group will take the treatment quality improvement strategies and tools into implementation.

Group Type: EXPERIMENTAL

Quality improvement strategies and tools

Intervention Type: BEHAVIORAL

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.

Control group

The control group will maintain the routine practice pattern.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Quality improvement strategies and tools

Intervention Type: BEHAVIORAL

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.

Process optimization

Intervention Type: BEHAVIORAL

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)

Interventions

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.

Intervention Type: 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)

Intervention Type: BEHAVIORAL

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lixin Jiang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, National Center for Cardiovascular Diseases

Locations

Qinyang People's Hospital

Jiaozuo, Henan, China

Countries

China

Other Identifiers

MOST-2013BAI09B01

Identifier Type: -

Identifier Source: org_study_id